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1. Tefferi A, Cortes J, Verstovsek S, Mesa RA, Thomas D, Lasho TL, Hogan WJ, Litzow MR, Allred JB, Jones D, Byrne C, Zeldis JB, Ketterling RP, McClure RF, Giles F, Kantarjian HM: Lenalidomide therapy in myelofibrosis with myeloid metaplasia. Blood; 2006 Aug 15;108(4):1158-64
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  • [Title] Lenalidomide therapy in myelofibrosis with myeloid metaplasia.
  • We present results of 2 similarly designed but separate phase 2 studies involving single-agent lenalidomide (CC-5013, Revlimid) in a total of 68 patients with symptomatic myelofibrosis with myeloid metaplasia (MMM).
  • Protocol treatment consisted of oral lenalidomide at 10 mg/d (5 mg/d if baseline platelet count < 100 x 10(9)/L) for 3 to 4 months with a plan to continue treatment for either 3 or 24 additional months, in case of response.
  • Additional treatment effects in these patients included resolution of leukoerythroblastosis (4 patients), a decrease in medullary fibrosis and angiogenesis (2 patients), and del(5)(q13q33) cytogenetic remission accompanied by a reduction in JAK2(V617F) mutation burden (1 patient).
  • We conclude that lenalidomide engenders an intriguing treatment activity in a subset of patients with MMM that includes an unprecedented effect on peripheral blood and bone marrow abnormalities.
  • [MeSH-major] Primary Myelofibrosis / drug therapy. Thalidomide / analogs & derivatives

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  • (PMID = 16609064.001).
  • [ISSN] 0006-4971
  • [Journal-full-title] Blood
  • [ISO-abbreviation] Blood
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Hemoglobins; 0 / Proto-Oncogene Proteins; 4Z8R6ORS6L / Thalidomide; EC 2.7.10.1 / Protein-Tyrosine Kinases; EC 2.7.10.2 / JAK2 protein, human; EC 2.7.10.2 / Janus Kinase 2; F0P408N6V4 / lenalidomide
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2. Thomas DA, Giles FJ, Albitar M, Cortes JE, Verstovsek S, Faderl S, O'Brien SM, Garcia-Manero G, Keating MJ, Pierce S, Zeldis J, Kantarjian HM: Thalidomide therapy for myelofibrosis with myeloid metaplasia. Cancer; 2006 May 1;106(9):1974-84
Hazardous Substances Data Bank. THALIDOMIDE .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Thalidomide therapy for myelofibrosis with myeloid metaplasia.
  • METHODS: Forty-four patients who had myelofibrosis with myeloid metaplasia received treatment with thalidomide in a Phase II clinical trial at a dose of 200 mg daily with escalation by 200 mg weekly until the best tolerated dose (maximum, 800 mg) was reached.
  • A complete response (without reversal of bone marrow fibrosis) was achieved in 4 patients (10%), a partial response was achieved in 4 patients (10%), and hematologic improvements in anemia, thrombopenia, and/or splenomegaly were observed in 9 patients (21%).
  • [MeSH-major] Angiogenesis Inhibitors / therapeutic use. Primary Myelofibrosis / drug therapy. Thalidomide / therapeutic use

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  • (PMID = 16583431.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Angiogenesis Inhibitors; 0 / Tumor Necrosis Factor-alpha; 4Z8R6ORS6L / Thalidomide
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3. Rumi E, Passamonti F, Boveri E, De Amici M, Astori C, Braschi M, Castagnola C, Magrini U, Cazzola M, Lazzarino M: Dyspnea secondary to pulmonary hematopoiesis as presenting symptom of myelofibrosis with myeloid metaplasia. Am J Hematol; 2006 Feb;81(2):124-7
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  • [Title] Dyspnea secondary to pulmonary hematopoiesis as presenting symptom of myelofibrosis with myeloid metaplasia.
  • We report a case of a patient with myelofibrosis with myeloid metaplasia (MMM) who presented with progressive dyspnea of unexplained origin.
  • Splenomegaly, blood smear, and bone marrow findings allowed diagnosis of MMM.
  • Finally, lung biopsy revealed irregularly distributed interstitial fibrosis with islands of erythroblasts, immature granulocytic elements, and dysplastic megakaryocytes, allowing diagnosis of pulmonary extramedullary hematopoiesis (EMH).
  • [MeSH-major] Dyspnea / etiology. Hematopoiesis, Extramedullary. Lung / pathology. Primary Myelofibrosis / diagnosis

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  • [Copyright] 2006 Wiley-Liss, Inc.
  • (PMID = 16432861.001).
  • [ISSN] 0361-8609
  • [Journal-full-title] American journal of hematology
  • [ISO-abbreviation] Am. J. Hematol.
  • [Language] eng
  • [Publication-type] Case Reports; Journal Article
  • [Publication-country] United States
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4. Vener C, Fracchiolla NS, Gianelli U, Calori R, Radaelli F, Iurlo A, Caberlon S, Gerli G, Boiocchi L, Deliliers GL: Prognostic implications of the European consensus for grading of bone marrow fibrosis in chronic idiopathic myelofibrosis. Blood; 2008 Feb 15;111(4):1862-5
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Prognostic implications of the European consensus for grading of bone marrow fibrosis in chronic idiopathic myelofibrosis.
  • Various clinical prognostic scoring systems (PSSs) have been suggested as means of selecting high-risk chronic idiopathic myelofibrosis (CIMF) patients at diagnosis.
  • The WHO has recently proposed strict diagnostic criteria for CIMF, and the European consensus for bone marrow fibrosis (BMF) grading recommends 4 classes.
  • It has been suggested that BMF grading may play a prognostic role in CIMF, but it has never been compared with the other PSSs in the same patients.
  • We tested a prognostic model for overall survival (OS) based on the WHO criteria and BMF grading in 113 consecutive patients with chronic myeloproliferative disorders (98 with CIMF and 15 with postpolycythemic myelofibrosis), and compared the findings with those of PSSs.
  • [MeSH-major] Bone Marrow / pathology. Primary Myelofibrosis / pathology
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Blood Cell Count. Chronic Disease. Europe. Female. Hemoglobins / metabolism. Humans. Male. Metaplasia / pathology. Middle Aged. Polycythemia / classification. Polycythemia / pathology. Prognosis

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  • (PMID = 18029552.001).
  • [ISSN] 0006-4971
  • [Journal-full-title] Blood
  • [ISO-abbreviation] Blood
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Hemoglobins
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5. Roche-Lestienne C, Andrieux J: [Cytogenetics and molecular genetics in myelofibrosis with myeloid metaplasia and polycythemia vera]. Pathol Biol (Paris); 2007 Feb;55(1):49-55
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  • [Title] [Cytogenetics and molecular genetics in myelofibrosis with myeloid metaplasia and polycythemia vera].
  • [Transliterated title] Cytogénétique et génétique moléculaire dans la myélofibrose avec métaplasie myéloïde et dans la polyglobulie de Vaquez.
  • Myelofibrosis with myeloid metaplasia (MMM) is a rare myeloproliferative disorder (MPD) characterized by clonal proliferation of hematopoietic progenitors.
  • 40-50% of karyotypes on blood (or more rarely on bone marrow) revealed at least one abnormality: 30% at diagnosis and 90% in blastic transformation phase.
  • A minority of patients with newly diagnosed polycythemia vera (PV) presented chromosomal abnormalities in their myeloid cells.
  • The most frequent visible alteration in MMM and PV is a 20q deletion, also characterized in other MPDs and myeloid malignancies.
  • This molecular abnormality takes an increased importance in the knowledge of the physiopathology of MPDs, particularly in PV and also in prognosis of MMM patients.
  • [MeSH-major] Polycythemia Vera / genetics. Primary Myelofibrosis / genetics

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  • (PMID = 16901657.001).
  • [ISSN] 0369-8114
  • [Journal-full-title] Pathologie-biologie
  • [ISO-abbreviation] Pathol. Biol.
  • [Language] fre
  • [Publication-type] English Abstract; Journal Article; Review
  • [Publication-country] France
  • [Chemical-registry-number] EC 2.7.10.2 / JAK2 protein, human; EC 2.7.10.2 / Janus Kinase 2
  • [Number-of-references] 60
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6. Levine RL, Wadleigh M, Cools J, Ebert BL, Wernig G, Huntly BJ, Boggon TJ, Wlodarska I, Clark JJ, Moore S, Adelsperger J, Koo S, Lee JC, Gabriel S, Mercher T, D'Andrea A, Fröhling S, Döhner K, Marynen P, Vandenberghe P, Mesa RA, Tefferi A, Griffin JD, Eck MJ, Sellers WR, Meyerson M, Golub TR, Lee SJ, Gilliland DG: Activating mutation in the tyrosine kinase JAK2 in polycythemia vera, essential thrombocythemia, and myeloid metaplasia with myelofibrosis. Cancer Cell; 2005 Apr;7(4):387-97
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Activating mutation in the tyrosine kinase JAK2 in polycythemia vera, essential thrombocythemia, and myeloid metaplasia with myelofibrosis.
  • Polycythemia vera (PV), essential thrombocythemia (ET), and myeloid metaplasia with myelofibrosis (MMM) are clonal disorders arising from hematopoietic progenitors.


7. Jones LC, Tefferi A, Vuong PT, Desmond JC, Hofmann WK, Koeffler HP: Detection of aberrant gene expression in CD34+ hematopoietic stem cells from patients with agnogenic myeloid metaplasia using oligonucleotide microarrays. Stem Cells; 2005 May;23(5):631-7
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  • [Title] Detection of aberrant gene expression in CD34+ hematopoietic stem cells from patients with agnogenic myeloid metaplasia using oligonucleotide microarrays.
  • Agnogenic myeloid metaplasia (AMM) is a clonal stem cell disorder that leads to ineffective hematopoiesis, bone marrow fibrosis, and extramedullary hematopoiesis.
  • Therefore, the aim of this study was to characterize aberrant gene expression in CD34+ hematopoietic stem cells from patients with AMM.
  • We used oligonucleotide microarrays to analyze gene expression profiles in CD34+ hematopoietic stem cells from patients with AMM compared with expression in CD34+ cells from healthy individuals.
  • Using class membership prediction analysis, we identified 75 genes whose expression profiles can accurately differentiate AMM samples from the controls.
  • Using these 75 genes, we were able to discriminate patients with AMM from the controls by hierarchical clustering (Spearman's confidence correlation).
  • The predictive power of these genes was verified by applying the algorithm to an unknown test set containing expression data from eight additional CD34+ samples (four AMM, four control).
  • Our results indicate that a subset of genes may be used to differentiate patients with AMM from healthy individuals.
  • Furthermore, we identify 95 genes whose aberrant expression may be involved in AMM.
  • [MeSH-major] Antigens, CD34. Gene Expression Regulation. Hematopoietic Stem Cells / metabolism. Oligonucleotide Array Sequence Analysis. Primary Myelofibrosis / physiopathology

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  • (PMID = 15849170.001).
  • [ISSN] 1066-5099
  • [Journal-full-title] Stem cells (Dayton, Ohio)
  • [ISO-abbreviation] Stem Cells
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / T32 CA-75956
  • [Publication-type] Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antigens, CD34
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8. Sahasrabudhe N, Davenport A: Myeloid metaplasia in the gall bladder: a case report. J Clin Pathol; 2005 Sep;58(9):998-9
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Myeloid metaplasia in the gall bladder: a case report.
  • Idiopathic myelofibrosis is often associated with myeloid metaplasia (extramedullary haemopoiesis) in the spleen and liver.
  • A 59 year old man with myelofibrosis, who underwent cholecystectomy for chronic cholecystitis, showed myeloid metaplasia in his gall bladder.
  • [MeSH-major] Gallbladder Diseases / diagnosis. Primary Myelofibrosis / complications. Primary Myelofibrosis / diagnosis

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  • [Cites] Histopathology. 2002 Sep;41(3):273-5 [12207793.001]
  • [Cites] Mod Pathol. 1989 May;2(3):270-2 [2762283.001]
  • [Cites] Clin Lab Haematol. 2002 Feb;24(1):55-9 [11843900.001]
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  • (PMID = 16126889.001).
  • [ISSN] 0021-9746
  • [Journal-full-title] Journal of clinical pathology
  • [ISO-abbreviation] J. Clin. Pathol.
  • [Language] eng
  • [Publication-type] Case Reports; Journal Article
  • [Publication-country] England
  • [Other-IDs] NLM/ PMC1770818
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9. Dupriez B, Demory JL: [Myelofibrosis with myeloid metaplasia: diagnosis and treatment]. Rev Prat; 2005 Oct 15;55(15):1680-5
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] [Myelofibrosis with myeloid metaplasia: diagnosis and treatment].
  • [Transliterated title] Diagnostic et traitement de la splénomégalie myéloïde.
  • Myelofibrosis with myeloid metaplasia is the rarest myeloproliferative syndrom.
  • Diagnosis is often easy in classical form, characterised by splenomegaly, leukoerythroblastic blood reaction and tear-drop erythrocytes on blood count and myelofibrosis on bone marrow biopsy.
  • Evolution is highly variable with a median overal survival of 40 to 60 months and numerous prognostic factors especially anemia.
  • No treatment has been demonstrated to improve survival (apart from allogenic bone marrow transplant).
  • The rarity and the complexity of the disease are the most important difficulties for the definition of standardized diagnostic, prognostic and therapeutic criteria.
  • [MeSH-major] Primary Myelofibrosis / complications. Primary Myelofibrosis / diagnosis. Primary Myelofibrosis / therapy
  • [MeSH-minor] Bone Marrow Transplantation. Diagnosis, Differential. Humans. Prognosis. Survival Analysis. Transplantation, Homologous

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  • (PMID = 16334205.001).
  • [ISSN] 0035-2640
  • [Journal-full-title] La Revue du praticien
  • [ISO-abbreviation] Rev Prat
  • [Language] fre
  • [Publication-type] English Abstract; Journal Article; Review
  • [Publication-country] France
  • [Number-of-references] 13
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10. Boula A, Mantadakis E, Xilouri I, Foudoulakis A, Samonis G: Agnogenic myeloid metaplasia with pulmonary hematopoiesis. Hematology; 2005 Dec;10(6):501-3
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Agnogenic myeloid metaplasia with pulmonary hematopoiesis.
  • Agnogenic myeloid metaplasia (AMM) is characterized by bone marrow fibrosis, splenomegaly and leukoerythroblastic anemia and is frequently accompanied by extramedullary hematopoiesis (EMH).
  • Pulmonary interstitial EMH associated with myelofibrosis has rarely been described in the medical literature and is usually fatal.
  • We report the case of a 77-year-old man with agnogenic myeloid metaplasia (AMM) treated with hydroxyurea, who seven years after diagnosis presented with dyspnea and severe hypoxemia.
  • Radionuclide bone marrow scanning demonstrated increased tracer activity on the bases of both lungs, consistent with non-hepatosplenic EMH.
  • Pulmonary EMH is rare in patients with AMM, but should be considered in patients with hypoxemia and respiratory distress.
  • [MeSH-major] Hematopoiesis, Extramedullary. Primary Myelofibrosis / pathology

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  • (PMID = 16321815.001).
  • [ISSN] 1024-5332
  • [Journal-full-title] Hematology (Amsterdam, Netherlands)
  • [ISO-abbreviation] Hematology
  • [Language] eng
  • [Publication-type] Case Reports; Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] X6Q56QN5QC / Hydroxyurea
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11. Haddad F, Anouti S, Maalouly G, Jammal M, Nemnoum R, Kettaneh A: [Dyspnea secondary to pulmonary hypertension in a patient with splenic myeloid metaplasia]. Rev Med Interne; 2009 Sep;30(9):803-5
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] [Dyspnea secondary to pulmonary hypertension in a patient with splenic myeloid metaplasia].
  • [Transliterated title] Dyspnée révélant une hypertension artérielle pulmonaire chez une malade ayant une métaplasie myéloïde de la rate.
  • There are several possible pathophysiological links between the development of pulmonary hypertension and myelofibrosis with myeloid metaplasia.
  • We report a woman with myelofibrosis and myeloid metaplasia who presented with dyspnea and massive, painful splenomegaly.
  • Dyspnea in patients with myelofibrosis and myeloid metaplasia can be secondary to pulmonary hypertension and conversely the differential diagnosis of pulmonary hypertension should include a myeloproliferative syndrome.


12. Tefferi A: Pathogenesis of myelofibrosis with myeloid metaplasia. J Clin Oncol; 2005 Nov 20;23(33):8520-30
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Pathogenesis of myelofibrosis with myeloid metaplasia.
  • The primary disease process in myelofibrosis with myeloid metaplasia (MMM) is clonal myeloproliferation with varying degrees of phenotypic differentiation.
  • This is characteristically accompanied by secondary intramedullary collagen fibrosis, osteosclerosis, angiogenesis, and extramedullary hematopoiesis.
  • The nature of the specific oncogenic mutation(s) is currently being unraveled with the recent discovery of an association between a somatic point mutation of JAK2 tyrosine kinase (V617F) and bcr/abl-negative myeloproliferative disorders, including MMM.
  • The pathogenetic mechanisms that underlie the secondary bone marrow stromal changes in MMM are also incompletely understood.
  • Mouse models of this latter disease aspect have been constructed by either in vivo overexpression of thrombopoietin (TPOhigh mice) or megakaryocyte lineage restricted underexpression of the transcription factor GATA-1 (GATA-1low mice).
  • Gene knockout experiments using such animal models have suggested the essential role of hematopoietic cell-derived transforming growth factor beta1 in inducing bone marrow fibrosis and stromal cell-derived osteoprotegerin in promoting osteosclerosis.
  • However, experimental myelofibrosis in mice does not recapitulate clonal myeloproliferation that is fundamental to human MMM.
  • Other cytokines that are implicated in mediating myelofibrosis and angiogenesis in MMM include basic fibroblast, platelet-derived, and vascular endothelial growth factors.
  • It is currently assumed that such cytokines are abnormally released from clonal megakaryocytes as a result of a pathologic interaction with neutrophils (eg, emperipolesis).
  • This latter phenomenon, through neutrophil-derived elastase, could also underlie the abnormal peripheral-blood egress of myeloid progenitors in MMM.
  • [MeSH-major] Primary Myelofibrosis / physiopathology
  • [MeSH-minor] Animals. Bone Marrow / metabolism. Bone Marrow / pathology. Cytokines / metabolism. Disease Models, Animal. Gene Expression Regulation, Neoplastic / genetics. Humans. Mice. Mutation / genetics

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  • (PMID = 16293880.001).
  • [ISSN] 0732-183X
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Cytokines
  • [Number-of-references] 201
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13. Jain V, Maheshwari A, Gulati S, Kabra M, Kalra V: Juvenile rheumatoid arthritis with myelofibrosis with myeloid metaplasia. Indian J Pediatr; 2005 Sep;72(9):789-91
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  • [Title] Juvenile rheumatoid arthritis with myelofibrosis with myeloid metaplasia.
  • Myelofibrosis with myeloid metaplasia is defined as a myeloproliferative disorder characterized by leukoerythroblastosis, tear drop erythrocytes, extramedullary hematopoesis and varying degree of myelofibrosis.
  • It may be idiopathic or secondary to a large number of conditions.
  • Here is a rare case of myelofibrosis occurring in a patient with juvenile rheumatoid arthritis.
  • [MeSH-major] Arthritis, Juvenile / complications. Primary Myelofibrosis / etiology


14. Chagraoui H, Wendling F, Vainchenker W: Pathogenesis of myelofibrosis with myeloid metaplasia: Insight from mouse models. Best Pract Res Clin Haematol; 2006;19(3):399-412

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Pathogenesis of myelofibrosis with myeloid metaplasia: Insight from mouse models.
  • Myelofibrosis with myeloid metaplasia or idiopathic myelofibrosis is a myeloproliferative disease.
  • It is known to be a stem-cell disorder that leads to a secondary and reactive stromal reaction in the bone marrow microenvironment that is responsible for impaired haematopoiesis.
  • Although progress has been made in the elucidation of the pathogenesis of idiopathic myelofibrosis, lack of suitable models has limited our understanding of the pathology.
  • These insights outline the role of transforming growth factor-beta1 and osteoprotegerin in the promotion of myelofibrosis and osteosclerosis, respectively, paying special regard to the role of abnormal megakaryocyte proliferation and maturation.
  • [MeSH-major] Primary Myelofibrosis / complications. Primary Myelofibrosis / etiology
  • [MeSH-minor] Animals. Cytokines / physiology. Disease Models, Animal. Megakaryocytes / cytology. Mice. Osteosclerosis / etiology

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  • (PMID = 16781480.001).
  • [ISSN] 1521-6926
  • [Journal-full-title] Best practice & research. Clinical haematology
  • [ISO-abbreviation] Best Pract Res Clin Haematol
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't; Review
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Cytokines
  • [Number-of-references] 72
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15. Manole I, Costăchescu G, Aldea MJ, Gavriluţ M, Dumitraşcu I: [Agnogenic myeloid metaplasia in pregnancy. Case report]. Rev Med Chir Soc Med Nat Iasi; 2010 Apr-Jun;114(2):465-9
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  • [Title] [Agnogenic myeloid metaplasia in pregnancy. Case report].
  • [Transliterated title] Metaplazia mieloidă agnogenică şi sarcina. Prezentare de caz.
  • Idiopathic myelofibrosis is a rare myeloproliferative disorder characterized by excessive accumulation of connective tissue in the bone marrow in association with anemia, splenomegaly and extramedullary hematopoiesis.
  • A rare case of pregnancy in a patient with agnogenic myeloid metaplasia who carried a term pregnancy is described.
  • CONCLUSION: Idiopathic myelofibrosis was once thought to be a contraindication to pregnancy.
  • [MeSH-major] Pregnancy Complications, Hematologic. Primary Myelofibrosis

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  • (PMID = 20700988.001).
  • [ISSN] 0048-7848
  • [Journal-full-title] Revista medico-chirurgicală̆ a Societă̆ţ̜ii de Medici ş̧i Naturaliş̧ti din Iaş̧i
  • [ISO-abbreviation] Rev Med Chir Soc Med Nat Iasi
  • [Language] rum
  • [Publication-type] Case Reports; English Abstract; Journal Article
  • [Publication-country] Romania
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16. Mesa RA, Powell H, Lasho T, Dewald G, McClure R, Tefferi A: JAK2(V617F) and leukemic transformation in myelofibrosis with myeloid metaplasia. Leuk Res; 2006 Nov;30(11):1457-60
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] JAK2(V617F) and leukemic transformation in myelofibrosis with myeloid metaplasia.
  • Amongst 42 consecutive patients with leukemic transformation (LT) from myelofibrosis with myeloid metaplasia (MMM) 72% carried the JAK2(V617F) mutation.
  • The mutation was observed at expected frequencies in all subtypes of MMM and acute myeloid leukemia.
  • [MeSH-major] Janus Kinase 2 / genetics. Leukemia, Myeloid / genetics. Primary Myelofibrosis / genetics
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Amino Acid Substitution / genetics. Cytogenetic Analysis / methods. DNA / genetics. Disease Progression. Female. Humans. Male. Middle Aged. Mutation. Reverse Transcriptase Polymerase Chain Reaction / methods. Survival Rate

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  • (PMID = 16563504.001).
  • [ISSN] 0145-2126
  • [Journal-full-title] Leukemia research
  • [ISO-abbreviation] Leuk. Res.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / 1 K23 CA96780-01
  • [Publication-type] Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 9007-49-2 / DNA; EC 2.7.10.2 / JAK2 protein, human; EC 2.7.10.2 / Janus Kinase 2
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17. Hemavathy KC, Chang TH, Zhang H, Charles W, Goldberg A, Aithal S, Novetsky AD, Wang JC: Reduced expression of TGF beta1RII in agnogenic myeloid metaplasia is not due to mutation or methylation. Leuk Res; 2006 Jan;30(1):47-53

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Reduced expression of TGF beta1RII in agnogenic myeloid metaplasia is not due to mutation or methylation.
  • Agnogenic myeloid metaplasia (AMM) is characterized by bone marrow fibrosis and enhanced proliferation of megakaryocytes and CD34+ cells.
  • We have analyzed the factors that could lead to reduced expression of TGF beta1RII in CD34+ cells of AMM patients.
  • Our results demonstrate absence of mutations in the coding region and the promoter of this gene and absence of CpG methylation of its promoter in AMM patients.
  • Further studies on transcriptional regulation of TGF beta1RII involving its cis-regulatory elements, the interacting transcription factors and their association with HDAC will provide valuable information on the pathogenesis of AMM and are under current investigation.
  • [MeSH-major] DNA Methylation. Gene Expression Regulation / genetics. Mutation. Primary Myelofibrosis / metabolism. Receptors, Transforming Growth Factor beta / biosynthesis

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  • (PMID = 16054691.001).
  • [ISSN] 0145-2126
  • [Journal-full-title] Leukemia research
  • [ISO-abbreviation] Leuk. Res.
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Receptors, Transforming Growth Factor beta; 0 / Transcription Factors; EC 2.7.11.1 / Protein-Serine-Threonine Kinases; EC 2.7.11.30 / transforming growth factor-beta type II receptor; EC 3.5.1.98 / Histone Deacetylases
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18. Ettinger DS, Jotte R, Lorigan P, Gupta V, Garbo L, Conkling P, Spigel D, McNally R, Renschler M, Oliver J: Results of a phase II trial of single-agent amrubicin (AMR) in patients with extensive disease small cell lung cancer (ED-SCLC) refractory to first-line platinum-based chemotherapy: An update. J Clin Oncol; 2009 May 20;27(15_suppl):8103

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Results of a phase II trial of single-agent amrubicin (AMR) in patients with extensive disease small cell lung cancer (ED-SCLC) refractory to first-line platinum-based chemotherapy: An update.
  • Patients (pts) with SCLC, who are refractory to first-line chemotherapy or progress within 3 months (mos) of treatment completion, are less likely to respond to additional chemotherapy and have an expected median survival of 3-5 mos.
  • The primary endpoint was response rate (ORR, by RECIST), with a goal to demonstrate an ORR ≥18% (point estimate).
  • RESULTS: In all, 75 pts were enrolled with a median age of 63 years (range 43-88), 52% female, 17% PS 2.
  • Response to 1<sup>st</sup>-line therapy was 5% complete remission (CR), 36% partial remission (PR) and 28% PD.
  • Median time from completion of 1<sup>st</sup>-line therapy to PD was 1.3 mos.
  • The primary endpoint was met with an ORR of 21% (16/75, 95% confidence interval [CI] 13.6% - 31.9%), including CR in 1 pt (1%) and PR in 15 pts (20%).
  • Stable disease was achieved in 40% of pts.
  • Median OS was 6.0 mos (95% CI 4.8-7.1 mos).
  • Median PFS was 3.2 mos (95% CI 2.4-4.0 mos).

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  • (PMID = 27964280.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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19. Battaglia M, Gernone A: Long-term use of sorafenib (SOR) in metastatic renal cell carcinoma (mRCC) previously treated with systemic therapy. J Clin Oncol; 2009 May 20;27(15_suppl):e16123

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : e16123 Background: The recent development of new targeted agents for the treatment of advanced RCC has definitely changed the approach and the outcome of this disease.
  • They were18 males and 4 females, with a median age 67 years, an ECOG PS 0-2, and the majority (96%) had undergone prior nephrectomy.
  • Patients were assessed for activity every three months (mos.) by CT.
  • The primary endpoints were response rate (RR) evaluated by RECIST criteria and time to progression (TTP).
  • RESULTS: To date, 20 pts are evaluable for response: of them, 13 (59%) achieved a partial response (PR) after 3 mos. of therapy whose median duration was 13 mos. (range, 7-18), while 7 (31%) remained with stable disease (SD) with a median length of 14 mos. (range, 5-17).
  • Among those who progressed (2 pts), the median time to disease progression was 7 mos.
  • At a median length of time of 15 mos., 18 pts. are continuing the therapy with SOR and in all of them the benefit achieved remained unchanged.
  • However, notwithstanding the rather small sample size of pts., the overall clinical benefit rate (PR+SD) turned out particularly high (> 90%): chiefly, the evidence of a long lasting disease control both for patients achieving partial response and for those with stable disease makes SOR a very useful treatment for patients with mRCC.

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  • (PMID = 27963393.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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20. Le Coutre PD, Giles F, Hochhaus A, Apperley JF, Ossenkoppele G, Haque A, Gallagher NJ, Baccarani M, Cortes J, Kantarjian H: Nilotinib in chronic myeloid leukemia patients in accelerated phase (CML-AP) with imatinib (IM) resistance or intolerance: Longer follow-up results of a phase II study. J Clin Oncol; 2009 May 20;27(15_suppl):7057

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Nilotinib in chronic myeloid leukemia patients in accelerated phase (CML-AP) with imatinib (IM) resistance or intolerance: Longer follow-up results of a phase II study.
  • : 7057 Background: Nilotinib is a potent and highly selective BCR-ABL inhibitor approved for the treatment of Ph+ CML patients (pts) in chronic phase or AP who are resistant or intolerant to prior therapy including IM.
  • METHODS: Primary endpoint was confirmed hematologic response (HR).
  • RESULTS: 137 CML-AP pts (80% IM-resistant; 20% IM-intolerant with resistance) with minimum follow-up of 11 months (mos) (median age, 57 years; median duration of prior IM treatment, 28 mos) were included.
  • Responses were rapid, with a median time to first HR of 1 mo.
  • HRs were durable at 24 mos with 54% of pts maintaining their response.
  • Cytogenetic responses were also durable with 70% of pts maintaining MCyR at 24 mos; 83% of pts maintained CCyR at 12 mos.
  • Estimated OS at 24 mos was 67%.
  • Grade 3/4 non-hematologic AEs were rare (< 1%) and included nausea, fatigue, and diarrhea.
  • CONCLUSIONS: These long-term follow-up results confirm that nilotinib induces rapid and durable responses in CML-AP pts who failed prior IM due to intolerance or resistance, with a favorable risk/benefit.

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  • (PMID = 27961447.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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21. Landau HJ, Hoffman J, Hassoun H, Elizabeth H, Riedel E, Nimer SD, Cohen A, Comenzo RL: Adjuvant bortezomib and dexamethasone following risk-adapted melphalan and stem cell transplant in patients with light-chain amyloidosis (AL). J Clin Oncol; 2009 May 20;27(15_suppl):8540

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : 8540 Background: Melphalan (MEL) and autologous stem cell transplant (SCT) induces both hematologic and clinical remissions in AL, and prolongs overall survival (OS) when complete hematologic remissions (CR) are achieved.
  • We have reported improved responses (including 39% CR) at 12 mos post-SCT using risk-adapted MEL followed by adjuvant dexamethasone (Dex) and thalidomide (Thal) (BJH 2007;139:224).
  • Response was assessed at 2-3 months (mos) and 12 mos following SCT.
  • Pts who did not achieve hematologic CR at 2-3 mos post-SCT received adjuvant therapy with Bort and Dex for up to 6 cycles (26 weeks).
  • The impact of heart disease on OS was determined using the log-rank test; BNP and Trop-I were correlated with OS using the Cox proportional hazards model.
  • Of 21 pts evaluable post-SCT, 5 achieved CR and 16<CR, 15 receiving adjuvant therapy.
  • At 12 mos post-SCT, 12 pts are evaluable.
  • In these 12 pts, the ORR was 92% (11/12) with 67% (8/12) achieving CR.
  • CONCLUSIONS: Adjuvant Bort and Dex effectively eradicates clonal plasma cell disease in pts with AL following SCT and results in an unprecedented CR rate at 12 mos post-SCT.

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  • (PMID = 27960925.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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22. Randall-Whitis L, Burger RA, Sill M, Monk BJ, Buening Ccrc B, Sorosky JI: Predictive value of serum CA125 levels in women with persistent or recurrent epithelial ovarian cancer (EOC) or primary peritoneal cancer (PPC) treated with bevacizumab (Bev) on a Gynecologic Oncology Group (GOG) phase II trial. J Clin Oncol; 2009 May 20;27(15_suppl):e16505

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Predictive value of serum CA125 levels in women with persistent or recurrent epithelial ovarian cancer (EOC) or primary peritoneal cancer (PPC) treated with bevacizumab (Bev) on a Gynecologic Oncology Group (GOG) phase II trial.
  • The primary objective of this study was to determine the proportion of pts treated with bevacizumab on a phase II clinical trial with stable disease by RECIST who demonstrated disease progression (pgrn) as assessed by modified GCIG CA125 criteria.
  • Primary endpoints of the clinical trial were progression-free (PF) survival at 6 months and response assessed by RECIST criteria.
  • Pts were removed from therapy/evaluation for disease prgn by RECIST, toxicity, or by subject request.
  • RESULTS: The median PFS by RECIST was 4.7 mos.
  • Of those patients who had prgn by CA125, the median residual time to prgn by RECIST was 1.4 mos.
  • In all, twenty-five (40.3%) pts survived PF for 6 mos. by RECIST and 16 (25.8%) by CA125.
  • Ten pts who survived PF for at least 6 mos. by RECIST indicated treatment failure before 6 mos. by CA125, or 40% of the 25 positive outcomes.
  • Eight pts continued to receive treatment for at least 4 mos. after prgn by CA125, with one continuing therapy for more than 3 years.
  • CONCLUSIONS: Serum CA125 levels were a useful marker of progression in some pts treated on this trial; however, some pts received clinical benefit from continued therapy in spite of indications of disease prgn by CA125.

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  • (PMID = 27960764.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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23. Franklin WA, Gandara DR, Kim ES, Herbst RS, Moon J, Redman MW, Olsen C, Hirsch FR, Mack P, Kelly K: SWOG S0342 and S0536: Expression of EGFR protein and markers of epithelial-mesenchymal transformation (EMT) in cetuximab/chemotherapy-treated non-small cell lung cancer (NSCLC). J Clin Oncol; 2009 May 20;27(15_suppl):11076

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] SWOG S0342 and S0536: Expression of EGFR protein and markers of epithelial-mesenchymal transformation (EMT) in cetuximab/chemotherapy-treated non-small cell lung cancer (NSCLC).
  • There was a trend for overall survival and EGFR level at each cutpoint in S0536 but the results did not achieve statistical significance (15 vs 11 mos, p=0.14; 15 vs 11 mos, p=0.20 and 14 mos vs not reached, p=0.10, respectively).
  • Vimentin (6 positive pts) was associated with a shorter PFS, HR=2.60 (1.10-6.14), p=0.03.

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  • (PMID = 27963196.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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24. Haas N, Manola J, Pins M, Liu G, McDermott D, Nanus D, Heath E, Wilding G, Dutcher J: ECOG 8802: Phase II trial of doxorubicin (Dox) and gemcitabine (Gem) in metastatic renal cell carcinoma (RCC) with sarcomatoid features. J Clin Oncol; 2009 May 20;27(15_suppl):5038

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • We evaluated Dox/Gem in these pts with locally advanced or metastatic disease to confirm previous activity of this regimen in a single institution trial.
  • METHODS: Pts received Dox 50mg/m<sup>2</sup> IV push and Gem 1500mg/m<sup>2</sup> IV over 30 minutes every 2 weeks (with G-CSF 5 mcg/kg/d days 2 or 3 to 10 or pegfilgrastim 6 mg day 2) until disease progression or unacceptable toxicity.
  • Pts were mostly male (81%), with cT3/T4 (68%), node negative (61%), M1 (58%) disease at diagnosis and ECOG PS 0-1.
  • 9 patients had stable disease.
  • Two pts are alive without progression (1 with a PFS of 2.5 years), 1 is alive with progression, and 35 patients have died.
  • Median PFS is 3.5 months (95% CI 2.8-5.2 mos).
  • Median OS is 8.8 mos (6.1-11.1 mos).
  • CONCLUSIONS: Dox/Gem met efficacy criteria in RCC with sarcomatoid features.

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  • (PMID = 27962934.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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25. Vishnu P, Jasti P, Ding L, Heilbrun LK, Venkatramanamoorthy R, LoRusso PM, Heath EI: Retrospective study of phase I clinical trials participation in patients at least 65 years of age at Karmanos Cancer Institute (KCI), Wayne State University, Detroit, Michigan. J Clin Oncol; 2009 May 20;27(15_suppl):e20626

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • The primary objective of this study was to describe the demographics, treatment, toxicity, and overall survival (OS) of all patients ≥ 65 years who presented to the Phase I clinical trials service at KCI between 1995-2005.
  • RESULTS: 216 patients met the study criteria.
  • 66% of patients had a history of cardiovascular disease but renal, liver, hematological diseases were found in less than 7% of patients at baseline.
  • The median OS for PC, PE, and PT was 3.9 mos, 2.2 mos, and 8.4 mos, respectively (p < 0.001 between any pair).

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  • (PMID = 27961597.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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26. Gutierrez M, Murgo AJ, Allen D, Turkbey I, Gardner ER, Trepel J, Chen H, Giaccone G, Doroshow JH, Kummar S: Phase I study of vandetanib (V) and bevacizumab (B) combination therapy evaluating the VEGF and EGF signal transduction pathways in adults with solid tumors and NHL. J Clin Oncol; 2009 May 20;27(15_suppl):3522

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • DIAGNOSIS: pancreatic-1, NSCLC-1, colorectal-3, peritoneal mesothelioma-1, melanoma-1, NHL-1, jejunal adenocarcinoma (JAC)-1.
  • Partial Response (PR) was achieved in 2 pts (pancreatic 14 mos + and JAC 6 mos); disease stabilization in 5 pts (4 mos +).
  • CONCLUSIONS: We decided not to escalate beyond DL 2 due to the gr 2-3 toxicities observed with chronic therapy.

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  • (PMID = 27961325.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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27. Sternberg CN, Szczylik C, Lee E, Salman PV, Mardiak J, Davis ID, Pandite L, Chen M, McCann L, Hawkins R: A randomized, double-blind phase III study of pazopanib in treatment-naive and cytokine-pretreated patients with advanced renal cell carcinoma (RCC). J Clin Oncol; 2009 May 20;27(15_suppl):5021

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • METHODS: Pts (N = 400 planned) with clear cell advanced RCC and measurable disease with no prior treatment or 1 prior cytokine-based treatment, were stratified and randomized (2:1) to pazopanib 800 mg QD or placebo.
  • The primary endpoint was progression-free survival (PFS).
  • The study had ≥ 90% power to detect an 80% improvement in PFS and a 50% improvement in OS, by stratified log-rank tests with α = 0.025 one-sided.
  • Pts received continuous treatment until disease progression (PD), death or unacceptable toxicity.
  • PFS was significantly prolonged with pazopanib in the overall study population (9.2 vs 4.2 mos; HR: 0.46; 95% CI: 0.34, 0.62; p < 0.0000001), in treatment naïve pts (11.1 vs 2.8 mos; HR: 0.40; 95% CI: 0.27, 0.60; p < 0.0000001), and in cytokine-pretreated pts (7.4 vs 4.2 mos; HR: 0.54; 95% CI: 0.35, 0.84; p < 0.001).
  • Median duration of exposure was 7.4 mos (pazopanib) and 3.8 mos (placebo).
  • The most common laboratory abnormality was ALT elevation (53%; 10% Gr 3; 2% Gr 4).
  • (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research.
  • Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings.

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  • (PMID = 27962920.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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28. Oettle H, Hilbig A, Seufferlein T, Schmid RM, Luger T, von Wichert G, Schmaus S, Heinrichs H, Schlingensiepen K: Interim results of the phase I/II study of trabedersen (AP 12009) in patients with pancreatic carcinoma, malignant melanoma, or colorectal carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):4619

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Interim results of the phase I/II study of trabedersen (AP 12009) in patients with pancreatic carcinoma, malignant melanoma, or colorectal carcinoma.
  • METHODS: 33 patients with advanced pancreatic carcinoma (stage IVA/IVB) (N=23), malignant melanoma (stage III/IV) (N=5) or colorectal carcinoma (stage III/IV) (N=5) were treated with trabedersen as 2nd-4th-line treatment.
  • PRIMARY STUDY OBJECTIVE: maximum tolerated dose (MTD); secondary objectives: safety and tolerability, pharmacokinetics and antitumor activity.
  • Of the 5 melanoma patients one from the 1st schedule showed stable disease and lived for 13.8 months; 3 patients from the 2nd schedule are still alive.
  • Median overall survival (mOS) for pancreatic carcinoma patients in the 1st schedule was 6.8 months.
  • Current mOS for pancreatic carcinoma patients in cohort 1 (N=5) of the 2nd schedule is 13.2 months; 2 of these patients are alive, one with stable disease 14.8 months after begin of trabedersen treatment.
  • A randomized, active-controlled phase II study compared to standard therapy in patients with pancreatic carcinoma is in preparation; another one in malignant melanoma is being planned.

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  • (PMID = 27964197.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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29. Jackman DM, Cioffredi L, Lindeman NI, Morse LK, Lucca J, Weckstein D, Huberman MS, Lynch TJ, Johnson BE, Janne PA: Phase II trial of erlotinib in chemotherapy-naive women with advanced pulmonary adenocarcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):8065

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • METHODS: Eligible pts were chemotherapy-naïve women, stage IIIB/ IV, PS 0-2, adenocarcinoma, and w/ available tissue for analysis of EGFR mutation status.
  • Pts received erlotinib 150 mg PO daily until disease progression or unacceptable toxicity.
  • Primary endpoint was response rate (RR).
  • EFFICACY: Response (n=84): 0 CR, 27 PR (RR 32%), 27 SD, 23 PD.
  • 7 pts not evaluable (5 tox, 1 non-progression death, 1 withdrawn consent).
  • Median TTP was 5.6 months (95% CI 4.1-7.4 mos), and median OS was 22.7 months (95% CI 15.8 - 26.0 mos).

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  • (PMID = 27962638.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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30. Diaz Romero C, Olvera N, Martínez H, Mtz Cedillo J, Cuellar M, Morales R, Álvarez M, Segura B, De la Garza J, Aguilar P: Paclitaxel plus carboplatin (PC) in patients with metastatic melanoma (MM): Experience in a single institution. J Clin Oncol; 2009 May 20;27(15_suppl):e20019

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Paclitaxel plus carboplatin (PC) in patients with metastatic melanoma (MM): Experience in a single institution.
  • : e20019 Background: The number of agents active in patients with metastatic melanoma is limited and cure is not an objective for treatment at this stage, so that clinical benefit in these patients is the most important.
  • The regimen was weekly paclitaxel (at a dose of 80 mg/m2) received on days 1, 8, and 15 of a 21-day cycle and carboplatin (AUC 5) on day 1.
  • Objective partial response were obtained in 4 patients (25%); 8 stable disease (50%) at least four months.
  • Progression disease was in 4 patients (25%).
  • The median time to disease progression for the entire group was 4.2 months (range, 1-11 mos), with a median overall survival of 8.1 months (range, 5.6-10.5 mos).

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  • (PMID = 27962551.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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31. Campos LT, Nemunaitis J, Stephenson J, Richards D, Barve M, Gardner L, Niecestro R, Sportelli P: Phase II study of single agent perifosine in patients with hepatocellular carcinoma (HCC). J Clin Oncol; 2009 May 20;27(15_suppl):e15505

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • In a phase III randomized study, sorafenib demonstrated a 2% partial response (PR) rate with a median time to symptomatic progression of 4.1 months (mos) and radiologic progression of 5.5 mos, however patients (pts) had not received prior systemic treatment.
  • Peri was evaluated in a phase II multi-disease trial where 558 pts were randomized to daily vs. weekly schedules of Peri (50/100 mg daily or 900/1,200 mg weekly) with 42 of the pts having HCC.
  • Normal organ / marrow function required.
  • Primary outcome analyses included median time to progression (TTP) and disease control rate (DCR; CR+PR+SD > 12 weeks).
  • One patient achieved a PR (3%) and 15 (47%) had stable disease > 12 weeks; overall DCR of 50%.
  • As of 12/08, one patient remains active at 12 mos.

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  • (PMID = 27962225.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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32. Vidaurre T, Wilkerson J, Bates SE, Simon R, Fojo AT: Value of stable disease (SD) in drug development of targeted therapies (TGT). J Clin Oncol; 2009 May 20;27(15_suppl):2509

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Value of stable disease (SD) in drug development of targeted therapies (TGT).
  • Aware the acceptance of SD as a measure of activity led to its being increasingly reported with traditional cytotoxic agents (CTX), we set about to methodically compare the occurrence of SD in phase II trials of TGT and CTX.
  • Thirty-eight properties including CR, PR, SD, PFS, and OS were recorded for each study.
  • For CTX vs. TGT, the median numbers of pts/study was 47.1 vs. 51.9; median PFS, 5.55 vs. 4.54 mos; and median OS, 12.55 vs. 12.88 mos.
  • The overall response rate (CR + PR) was higher with CTX than with TGT (29.4% vs. 13.3%) and demonstrated a strong correlation (p<0.0001) of uncertain importance with PFS and OS for all therapies.

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  • (PMID = 27961963.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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33. Faderl S, Thomas DA, Gandhi V, Huang X, Borthakur G, O'Brien S, Ravandi F, Plunkett W, Bretz JL, Kantarjian HM: Results of a phase I study of clofarabine (CLO) plus cyclophosphamide (CY) in adult patients (pts) with relapsed and/or refractory acute lymphoblastic leukemia (ALL). J Clin Oncol; 2009 May 20;27(15_suppl):7020

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Results of a phase I study of clofarabine (CLO) plus cyclophosphamide (CY) in adult patients (pts) with relapsed and/or refractory acute lymphoblastic leukemia (ALL).
  • METHODS: Pts ≥ 21 years (yrs) with primary refractory or relapsed ALL, NYHA class < 3, and a cardiac ejection fraction ≥ 45% were eligible.
  • Seven (23%) pts were primary refractory.
  • Among the remainder, preceding median remission duration was 8.6 mos (1-39 mos).
  • Evaluable for response were 28 pts: 3 CR (one pt in cohort 1) and 1 marrow CR (OR 14%).
  • One pt had Ph+ ALL, and one was primary refractory to HCVAD.

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  • (PMID = 27961382.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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34. Ardalan B, Feagans M, Mezentsev D, Jones C, Subbarayan PR, Walker G, Sapp M, Stephenson K, Ness J, Franceschi D, Livingstone A: Phase II study of bevacizumab (B), camptosar (I), high-dose 24-hour continuous intravenous infusion of floxuridine (F) and leucovorin (L) in patients with previously untreated metastatic colon cancer. (B-IFL). J Clin Oncol; 2009 May 20;27(15_suppl):e15114

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : e15114 Background: In a previous study, IFL was used in patients (pt) with untreated metastatic colon cancer and a median overall survival (MOS) of 31 months (m).
  • The primary end-point is MOS Methods: Each cycle involved 6 weeks (wks) of treatment.
  • The treatment cycle consisted of a 90 minute infusion of I (110 mg/m<sup>2</sup>), followed by a 24 hour infusion of F (120mg/kg) and L (500 mg/m<sup>2</sup>) on wks 1, 2, 4, 5.
  • Quality of life data and thymidylate synthase expression in peripheral blood mononuclear cells was monitored Results: 22 pt with a median age of 57 (38-82), 11 males and 11 females were enrolled.
  • 8 pt (36%) had bilobar liver disease and involvement of 1 other organ, 6 pt (27%) had bilobar liver disease with involvement of ≥ 2 other organs; 5 pt (23.5%) had bilobar liver disease; 2 pt (9%) had abdominal carcinomatosis; 1 pt (4.5 %) had involvement in one liver lobe.
  • Grade (Gr) 4 toxicity: pulmonary embolus 1 pt (5%) incidental CT finding.
  • 5 pt have died due to progression of disease.
  • The estimated median time to progression was 13 m with corresponding lower 95% confidence bound of 8.4 m.

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  • (PMID = 27960848.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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35. Boccardo F, Rubagotti A, Guglielmini P, Sismondi P, Farris A, Amadori D, Agostara B, Gambi A, Catalano G, Faedi M: Epirubicin (E) followed by cyclophosphamide, methotrexate, 5-fluorouracil (CMF) versus paclitaxel (T) followed by epirubicin and vinorelbine (EV) in patients (pts) with high-risk operable breast cancer. J Clin Oncol; 2009 May 20;27(15_suppl):e11521

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • After CT, tamoxifen (plus a LH-RH analog in menstruating women ) was given for 5 years to all HOR+ pts.S was the primary end-point.
  • RESULTS: At 82 mos median f-up, S and RFS did not differ significantly between groups (7-yr S: E-CMF:76%,T- EV:74%;adjust.

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  • (PMID = 27964621.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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36. Heymach J, Jonasch E, Wang X, Du DZ, Yan S, Xu L, Herynk MH, McKee KS, Tran HT, Tannir NM, Zurita AJ: A cytokine and angiogenic factor (CAF) plasma signature for selection of sorafenib (SR) therapy in patients (pts) with metastatic renal cell carcinoma (mRCC). J Clin Oncol; 2009 May 20;27(15_suppl):5114

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • The primary objective of this analysis was to establish a CAF signature based on a set of individual markers at BL with a significant and differential impact on the association between treatment arm and PFS.
  • Pts with high OPN benefitted more from single agent SR (7.74 vs. 3.93 mos for the combination; p = 0.007), but no differences were found for those with low OPN.
  • Lower than median on-treatment increases in sCA9 (D28, p = 0.01) and GRO-alpha (D56, p = 0.04) on SR only were also associated with a better outcome.

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  • (PMID = 27964391.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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37. Rice K, Peay K, Hudak J, Elsamanoudi S, Travis J, Lockhart R, Jennifer C, Black L, Hogue S, Brassell S: Factors for choosing prostate cancer treatment and resulting impact on health related quality of life. J Clin Oncol; 2009 May 20;27(15_suppl):9601

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • The instruments are the EPIC, EPIC Demographic, and the MOS Short-Form 36.

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  • (PMID = 27963832.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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38. Caffo O, Fellin G, Graffer U, Mussari S, Caldara A, Murgia V, Valduga F, Tomio L, Galligioni E: Cisplatin (C) and gemcitabine (G) chemotherapy with concurrent irradiation (XRT), for the conservative treatment of invasive transitional bladder cancer (ITBC) patients: Clinical outcome and long-term follow-up in a monoinstitutional experience. J Clin Oncol; 2009 May 20;27(15_suppl):e16081

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • In a dose finding trial, conducted in our hospital on ITBC patients using C and G with concurrent XRT, after maximum transurethral resection (TUR), the maximum tolerated dose of G was 400 mg/sqm (IJROBP 2003).
  • We are presenting the long-term clinical outcome of the 16 patients involved in the dose-finding trial, together with that of the 9 pts enrolled in the phase II study.
  • In dose finding study G was given weekly from 200 to 500 mg/sqm: since unacceptable toxicity was observed in 2 cases (one death for toxicity) at the higher dose level, the recommended G dose for phase II trial was 400 mg/sqm on day 1,8 q 21 for 2 courses together with C and XRT.
  • A cystoscopic re-evaluation was scheduled 6-8 weeks after treatment.
  • RESULTS: Except the pt died during treatment for toxicity, all the remaining 24 pts were microscopically disease free at cystoscopic re-evaluation.
  • Seven local and 2 distant relapses have been observed so far, at a median follow-up of 66 mos.
  • Presently, 16 pts (67%) is alive and disease-free, with 1 patient died for lung cancer.
  • All pts alive have retained their bladder, with a normal organ function, in absence of any relevant long-term toxicity.
  • Considering the 100% of complete response observed, this combination could be of interest to explore a possible enhancement of the disease control of C plus XRT, that is today the treatment of choice in the conservative therapy of ITBC.

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  • (PMID = 27963102.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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39. Vogelzang NJ, Hutson TE, Samlowski W, Somer B, Richey S, Alemany C, Loesch D, Richards P, Gardner L, Sportelli P: Phase II study of perifosine in metastatic renal cell carcinoma (RCC) progressing after prior therapy (Rx) with a VEGF receptor inhibitor. J Clin Oncol; 2009 May 20;27(15_suppl):5034

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase II study of perifosine in metastatic renal cell carcinoma (RCC) progressing after prior therapy (Rx) with a VEGF receptor inhibitor.
  • In a prior trial, 15 RCC patients (pts) were enrolled in a randomized dose finding study, 9 were evaluable for response and 3 (33%) had a partial response (PR).
  • Thus phase II trials were begun for pts who had been treated with one prior VEGFr inhibitor (Group A) or with a prior VEGFr inhibitor and prior mTOR inhibitor (Group B).
  • METHODS: To measure the objective response rate (RECIST) and PFS to single agent perifosine (100 mg qhs with food) after 3 mos of Rx; Prior Rx with vaccine therapy, bevacizumab and/or cytokines was permitted.
  • Normal organ/marrow function was required.
  • Median age 64 (range 46-80) and 36 were male; Median prior Rx was 2 (range 1 - 5); Clear cell = 37, non clear cell = 6, data n/a = 3.
  • CONCLUSIONS: Perifosine, similar to mTOR inhibitors, appears to have clinical benefit in mRCC as reflected by the PR rate and a 15 wk median overall PFS.

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  • (PMID = 27962937.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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40. Kobayashi K, Inoue A, Maemondo M, Sugawara S, Isobe H, Oizumi S, Saijo Y, Gemma A, Morita S, Hagiwara K, Nukiwa T: First-line gefitinib versus first-line chemotherapy by carboplatin (CBDCA) plus paclitaxel (TXL) in non-small cell lung cancer (NSCLC) patients (pts) with EGFR mutations: A phase III study (002) by North East Japan Gefitinib Study Group. J Clin Oncol; 2009 May 20;27(15_suppl):8016

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] First-line gefitinib versus first-line chemotherapy by carboplatin (CBDCA) plus paclitaxel (TXL) in non-small cell lung cancer (NSCLC) patients (pts) with EGFR mutations: A phase III study (002) by North East Japan Gefitinib Study Group.
  • Pts having sensitive EGFR mutations, measurable site(s), ECOG PS 0-1, age of 20-75 years, and no prior chemotherapy were randomized (1:1 ratio; balanced for institution, sex, and stage) to receive Arm A: gefitinb (250 mg/ day) orally, or Arms B: CBDCA AUC 6 and TXL 200mg/m2 in 21-day cycles until disease progression.
  • The primary endpoint was PFS, and the sample size was calculated to be 320 in total (alpha=5%, power=80%) to confirm the superiority of Arm A (hazard ratio = 0.69).
  • Their characteristics were well balanced between arms: median age=65 years; 64% female; 77% Stage IV; 93% adenocarcinoma, 61% non-smoker.
  • There were several differences in toxicities between Arm A and Arm B (grade 4 neutropenia: 1% vs. 29%, grade 3-4 liver dysfunction: 24% vs. 1%, grade 3 neuropathy: 0% vs. 5%, respectively, p<0.01).
  • Furthermore, there were no interstitial lung disease and no toxic deaths in both arms.
  • Analyzing both arms together, preliminary response rate and PFS of the 155 pts were 53.7% and 6.5 mos, respectively.

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  • (PMID = 27962807.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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41. Krop IE, Burris HA, Rugo H, O'Shaughnessy J, Vogel CL, Amler L, Strauss A, Wong EK, Klencke B, Pippen J: Quantitative assessment of HER2 status and correlation with efficacy for patients (pts) with metastatic breast cancer (MBC) in a phase II study of trastuzumab-DM1 (T-DM1). J Clin Oncol; 2009 May 20;27(15_suppl):1003

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • RESULTS: As of August 29, 2008, 112 pts had enrolled; 107 were efficacy-evaluable pts with median 4.4 mos follow-up.

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  • (PMID = 27960714.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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42. Dhodapkar MV, Bolejack V, Shaughnessy J, Matthews P, Pickering R, Qu P, Hoering A, Crowley J, Barlogie B, Southwest Oncology Group: Role of T-cell immunity to embryonal stem (ES) cell antigen SOX2 in the progression of myeloma. J Clin Oncol; 2009 May 20;27(15_suppl):8522

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : 8522 Background: Clinical outcome in patients (pts) with asymptomatic plasma-proliferative disorders, monoclonal gammopathy of undetermined significance (MGUS) and asymptomatic myeloma (AMM), is highly variable.
  • There is a need to identify specific tumor or host related features that predict the risk of disease progression.
  • METHODS: Patients with MGUS/AMM were enrolled in a prospective observational clinical protocol (SWOG S0120).
  • The presence of T cell immunity to SOX2 in freshly isolated blood / marrow mononuclear cells was analyzed using an overlapping peptide library at study entry.
  • Immunity to SOX2 correlated with features of lower risk including serum-M component < 1.5 g/dL (p=0.008), marrow plasmacytosis < 10% (p<0.001) and normal serum free light chain ratio (p=0.01).
  • CONCLUSIONS: These data demonstrate in the context of a prospective trial that T cell immunity to stem cell genes strongly correlates with a reduced risk of progression to clinical myeloma.
  • These data point to SOX2 as a potential target for the prevention of disease progression in MGUS/AMM.

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  • (PMID = 27960897.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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43. Cortes JE, Khoury HJ, Corm S, Nicolini F, Schenk T, Jones D, Hochhaus A, Craig AR, Humphriss E, Kantarjian H, Omacetaxine 202 Study Group: Subcutaneous omacetaxine mepesuccinate in imatinib-resistant chronic myeloid leukemia (CML) patients (Pts) with the T315I mutation: Data from an ongoing phase II/III trial. J Clin Oncol; 2009 May 20;27(15_suppl):7008

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Subcutaneous omacetaxine mepesuccinate in imatinib-resistant chronic myeloid leukemia (CML) patients (Pts) with the T315I mutation: Data from an ongoing phase II/III trial.
  • : 7008 Background: Omacetaxine (OM), a first-in-class cetaxine shows clinical activity against Ph+ CML with a mechanism independent of tyrosine kinase inhibition.
  • RESULTS: 66 pts (39 chronic [CP], 16 accelerated [AP] and 11 blast phase [BP]) have been enrolled.
  • Median disease duration is 58 mos.
  • OM is well tolerated with transient myelosuppression as the primary toxicity.
  • Grade 3/4 non-hematologic events are diarrhea (2%) and fatigue (4%).
  • CONCLUSIONS: Omacetaxine in T315I+ CML Pts results in de-selection of the T315I clone and induces hematologic and cytogenetic responses.

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  • (PMID = 27961380.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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44. Hartmann JT, Aschoff P, Dittmann H, Lichy M, Mayer F, Reischl G, von Weyhern C, Kanz L, Claussen CD, Pfannenberg C: The value of PET/CT with 18F-FLT and 18F-FDG in the management of metastatic germ cell tumors (GCT): A pilot study. J Clin Oncol; 2009 May 20;27(15_suppl):e16142

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • The results were validated by histopathology of resected residual masses after CTh in 7 pts or by clinical follow-up for at least 6 mos in 4 pts.
  • Presence of necrosis was judged as responder, as well as CR/PRm- within a minimum progression-free interval (PFI) of 6 mos.
  • RESULTS: 8 out of 11 pts had a PFI > 6 mos (range, 206-1337 days).
  • SUVavg decrease in early response FDG monitoring was 64% in responders and 60% in non-responders (p = 0.8), as well as 57% vs. 48% for FLT (p = 0.5), respectively, and 85% vs. 72% (FDG, p = 0.1) and 67% vs. 65% (FLT, p = 0.8) in the final monitoring.

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  • (PMID = 27963433.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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45. Mancuso AP, Donato De Paola E, Catalano A, Calabrò F, Messina C, Zivi A, Cerbone L, Vigna L, Caristo R, Sternberg CN: Phase II dose escalation study of sorafenib in patients with metastatic renal cell carcinoma (mRCC) who have had prior treatment with VEGFR-TKI antiangiogenic treatment. J Clin Oncol; 2009 May 20;27(15_suppl):e16027

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • Pts with no progressive disease (evaluated at 12 weeks) continued to receive Sorafenib at the standard dose, while progressive pts received an increasing dose (600 mg BID) with early disease restaging after 4 weeks.
  • RESULTS: 18 pts were entered; baseline characteristics: PS 0-1: 94%; median age 62 years (41-82); nephrectomy: 100%; surgery for metastatic disease: 28%, clear-cell 78%, papillary-cell 16%, sarcomatoid 6%.
  • Overall, 72% of pts had disease control without significant correlations between response to prior therapy and hypertension.
  • 14 pts had progression free survival (PFS) of 4.3 months (mos).
  • 4 pts are still in treatment with a median PFS > 8 mos.
  • Of 6 pts in which the dose was escalated, 3 benefitted with a PFS of > 3 mos.
  • Other hematological and non-hematological toxicities were g1 with a frequency < 15%.
  • In progressive patients, treatment with a higher dose could be a valid option.

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  • (PMID = 27962966.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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46. Cerbone L, Van Ginderdeuren R, Van den Oord J, Fieuws S, Spileers W, Van Eenoo L, Wozniak A, Sternberg CN, Schöffski P: Clinical presentation, pathological features, and natural course of metastatic uveal melanoma (MUM) as an orphan and commonly fatal disease. J Clin Oncol; 2009 May 20;27(15_suppl):e20005

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Clinical presentation, pathological features, and natural course of metastatic uveal melanoma (MUM) as an orphan and commonly fatal disease.
  • : e20005 Background: Uveal melanoma (UM) is a rare disease characterized by an unpredictable course and variable outcome ranging from cure by local treatment to the occurrence of untreatable metastasis.
  • RESULTS: The med. age at diagnosis of UM was 58 yrs (range 30-94).
  • MUM was more common in women (F:M ratio 48:28) and independent from the side of the primary tumor (left vs. right eye).
  • Synchronous metastasis was found in 9% of cases, all others had metachronous disease after a med. interval of 40 mos (range, 7-420).
  • Statistical analysis failed to identify predisposing factors for MUM with the exception of a significant negative correlation between age at diagnosis of UM and time until metastatic disease (Spearman ρ = -0.4, p<0.001).
  • The most frequent sites were liver (96%), lung (23%), subcutaneous (13%), bone (11%) and brain (3%).The med.
  • OS from diagnosis of UM was 46 mos (range, 2-182), and 4,5 mos after diagnosis of metastasis (range, 1-128).
  • CONCLUSIONS: In this orphan disease with female predominance metastasis occurs late, is mainly found but not confined to the liver, and is associated with high morbidity, as >1/3 of pts do not qualify for further therapy.
  • Advances in MUM can only be achieved by networking of sites interested in this tumor with systematic collection of data and tissue to improve our understanding of the molecular biology of the disease.

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  • (PMID = 27962598.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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47. Urba S, Schneider BJ, Hayman JA, Orringer M, Chang A, Pickens A, Pan C, Lee J, Foster J, Merajver S: Preoperative chemoradiation and postoperative adjuvant tetrathiomolybdate for patients with resectable esophageal cancer. J Clin Oncol; 2009 May 20;27(15_suppl):e15504

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • 13 pts completed the full 24 mos of treatment, 12 completed 10-23 mos, 15 completed 2-8 mos, and 8 completed only 1 month or less.
  • 27 pts have had disease recurrence, the majority (23 of the 27) of which was distant.
  • Current status of pts with median follow-up time of 55 months: 25 alive and disease-free, 1 alive with disease, and 43 have died.
  • Disease-free survival and overall survival are promising when compared to historical controls treated with a very similar chemoradiation regimen without TM in the past at the University of Michigan.

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  • (PMID = 27962224.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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48. Markowicz S, Nowecki ZI, Rutkowski P, Lipkowski AW, Jakubowska-Mucka A, Switaj T, Biernacka M, Misicka A, Walewski JA, Ruka W: Adjuvant vaccination with melanoma antigen pulsed dendritic cells (DCs) in stage III melanoma patients. J Clin Oncol; 2009 May 20;27(15_suppl):9039

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Adjuvant vaccination with melanoma antigen pulsed dendritic cells (DCs) in stage III melanoma patients.
  • : 9039 Background: This is a pilot study evaluating of high-risk melanoma patients (pts) treated with peptide-DC vaccine after lymphadenectomy (LND).
  • DC vaccination was designed to induce the immune response against melanoma antigens in melanoma pts who remain at high risk of dissemination after LND.
  • METHODS: DCs were generated from the bone marrow with the use GM-CSF, SCF, FLT3-L and TNFa or from peripheral blood adherent monocytes with GM-CSF and IL-4.
  • DCs pulsed with HLA-A2-binding TYR, MART-1 and gp100 peptides and/or HLA-A1-binding MAGE-1, MAGE-3 peptides, tumor lysate if available, or with tracer antigen keyhole limpet hemocyanin (KLH), were injected sc 9 times within 8 months (mos).
  • Boost injections were performed after 12 and 24 mos.
  • RESULTS: HLA-A2<sup>+</sup>, -A1<sup>+</sup> or -A3<sup>+</sup> melanoma pts (n=22), stage III, N1b-N3, enrolled between Sept.
  • Cutaneous delayed type hypersensitivity (DTH) to melanoma peptides was induced in 12 of 22 pts.
  • At least one of these responses to melanoma antigens was elicited in 17 of 22 pts.
  • Nine vaccinated pts are free of disease, and 1 is stable by Dec.
  • 2008 (follow up is 58-76 mos after LND).
  • CONCLUSIONS: The DC/peptide vaccine elicited immune responses to melanoma antigens.
  • Vaccinated pts had clinically substantially longer overall survival (OS) and disease free survival (DFS) than matched control.
  • OS was associated with the immune responsiveness to melanoma antigens and to KLH.

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  • (PMID = 27962116.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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49. Richardson PG, Chanan-Khan A, Lonial S, Krishnan A, Carroll M, Alsina M, Albitar M, Berman D, Kaplita S, Anderson K: Tanespimycin plus bortezomib in patients with relapsed and refractory multiple myeloma: Final results of a phase I/II study. J Clin Oncol; 2009 May 20;27(15_suppl):8503

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Tanespimycin plus bortezomib in patients with relapsed and refractory multiple myeloma: Final results of a phase I/II study.
  • METHODS: 72 patients (pts) with relapsed/refractory MM received 0.7 - 1.3 mg/m<sup>2</sup> Bz as IVB followed by 1-hr infusion of 100 -340 mg/m<sup>2</sup> Tan on days 1, 4, 8,11 q 21d, with 42 pts receiving the highest dose of both drugs as part of a phase II expansion.
  • RESULTS: Of 72 pts, 72% had IgG subtype with a median age of 60 yo.
  • Median time since MM diagnosis was 50 mos with median of 5 (1-15) prior regimens.
  • 58 pts with measurable disease were treated at 1 or 1.3 mg/m<sup>2</sup> Bz.
  • Median duration of response (DOR) for all pts with response (n=14) was 10.7 mos, including 3 Bz-refractory pts who had durable PR through mos 12, 22 and 28.
  • 3 other pts remain in response through 24 mos.

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  • (PMID = 27960855.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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50. Edelman MJ, Belani CP, Socinski MA, Ansari R, Obasaju CK, Monberg MJ, Chen R, Treat J: Incidence and outcomes associated with brain metastases (BM) in a three-arm phase III trial of gemcitabine in combination with carboplatin (GC) or paclitaxel (GP) versus paclitaxel plus carboplatin (PC) for advanced non-small cell lung cancer (NSCLC). J Clin Oncol; 2009 May 20;27(15_suppl):8076

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Incidence and outcomes associated with brain metastases (BM) in a three-arm phase III trial of gemcitabine in combination with carboplatin (GC) or paclitaxel (GP) versus paclitaxel plus carboplatin (PC) for advanced non-small cell lung cancer (NSCLC).
  • Analyses of pts with lung cancer from the 1970s and 1980s indicated that the incidence of BM at the time of diagnosis was approximately 10%.
  • Cycles were repeated every 21 d up to 6 cycles or disease progression.
  • Among pts with (N=194) and without (N=941) BM, response rates=28.9% and 29.1%, median survival = 7.7 mos (95% CI: 6.7, 9.3) and 8.6 mos (95% CI: 7.9, 9.5), and median time to progression = 4.3 mos (95% CI: 3.4, 5.6) and 4.6 mos (95% CI: 4.2, 5.1), respectively.
  • Median survival among pts with BM was 7.6 mos for GC (N=66, 95% CI: 6.3, 10.1), 8.2 mos for GP (N=64, 95% CI: 4.6, 10.5), and 7.7 mos for PC (N=64, 95% CI: 6.1, 10.2). CONCLUSIONS:.

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  • (PMID = 27962650.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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51. Kantarjian H, Giles F, Bhalla K, Pinilla J, Larson RA, Gattermann N, Ottmann OG, Gallagher NJ, Baccarani M, leCoutre P: Nilotinib in chronic myeloid leukemia patients in chronic phase (CML-CP) with imatinib (IM) resistance or intolerance: Longer follow-up results of a phase II study. J Clin Oncol; 2009 May 20;27(15_suppl):7029

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Nilotinib in chronic myeloid leukemia patients in chronic phase (CML-CP) with imatinib (IM) resistance or intolerance: Longer follow-up results of a phase II study.
  • METHODS: Primary endpoint was major cytogenetic response (MCyR).
  • RESULTS: CML-CP pts (n = 321, 70% IM-resistant, 30% IM-intolerant with resistance) with a minimum follow-up of 19 months (mos) were evaluated; 72% were treated with ≥600 mg/day IM prior to enrollment.
  • Median duration of prior IM treatment was 32 (<1-94) mos.
  • 59% achieved an MCyR (2.8 mos median time to MCyR; 56% in IM-resistant, and 65% in IM-intolerant pts), including 73% of pts with a baseline CHR and 44% achieved a CCyR (41% in IM-resistant; 51% in IM-intolerant pts).
  • Responses were durable, with 78% pts maintaining MCyR at 24 mos.
  • Estimated OS rate was 88% at 24 mos.
  • Gr 3/4 non-hematologic AEs were infrequent: rash, headache, and diarrhea occurred in 2% of pts.

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  • (PMID = 27961402.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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52. Bhatnagar B, Tiu RV, Gondek LP, O'Keefe C, Huh J, Advani AS, Sekeres MA, Maciejewski JP: Use of SNP-array-based karyotyping for cytogenetic prognostication in unclassified cases of myelodysplasia and associated overlap disorders. J Clin Oncol; 2009 May 20;27(15_suppl):7016

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : 7016 Background: Myeloproliferative disorders (MPD) and myelodysplastic syndromes (MDS) often have overlapping features resulting in unclassifiable cases (MDS-U and MDS/MPD-U).
  • METHODS: MDS-U (N = 17) and MDS/MPD-U (N = 61) patients were selected from an MDS database (N = 720, median age = 76, median follow-up = 42 mos).
  • MDS/MPD-U and MDS-U patients had similar OS and EFS (OS = 42 vs. 45 mos, p = 0.13; EFS = 42 vs. 45 mos p = 0.63).
  • Overall, patients with new SNP-A lesions had worse OS and EFS (OS = 41 mos vs NR, p = 0.07; EFS = 32 vs 112 mos, p = 0.07).
  • This technology will be helpful in refining diagnosis based on characteristic recurrent chromosomal lesions including UPD.

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  • (PMID = 27961389.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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53. Smith MR, Ellis G, Saad F, Tammela T, Bone H, Egerdie B, Ke C, Jun S, Dansey R, Goessl C: Effect of denosumab on bone mineral density (BMD) in women with breast cancer (BC) and men with prostate cancer (PC) undergoing hormone ablation therapy. J Clin Oncol; 2009 May 20;27(15_suppl):9520

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Effect of denosumab on bone mineral density (BMD) in women with breast cancer (BC) and men with prostate cancer (PC) undergoing hormone ablation therapy.
  • However, these treatments increase bone resorption, leading to bone loss and fractures.
  • RANKL is a key mediator of osteoclast-mediated bone resorption.
  • METHODS: Two trials were conducted: a 24-mo BC study and a 36-mo PC study.
  • Postmenopausal women with low BMD receiving AI therapy for nonmetastatic BC and men receiving ADT for nonmetastatic PC (with low BMD or history of osteoporotic fracture if < 70 yrs) were randomized to receive placebo or denosumab 60mg subcutaneously every 6 mos.
  • The primary endpoint was % change from baseline in lumbar spine (LS) BMD at 12 mos for the BC study and at 24 mos for the PC study.
  • Herein, we present changes in BMD at 24 mos at LS, total hip (TH), and 1/3 radius from both studies.
  • Power calculations were based on enrollment of at least 208 patients in the BC study (for primary endpoint only) and 1226 in the PC study (for primary and key secondary endpoints).
  • RESULTS: Denosumab increased BMD of the LS, TH, and 1/3 radius compared with placebo at 24 mos in both pt populations ( Table ).

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  • (PMID = 27964507.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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54. Hohenberger P, Oladeji O, Licht T, Dimitrakopoulou-Strauss A, Jakob J, Pink D, Schwarzbach M, Ströbel P, Reichardt P, Wardelmann E: Neoadjuvant imatinib and organ preservation in locally advanced gastrointestinal stromal tumors (GIST). J Clin Oncol; 2009 May 20;27(15_suppl):10550

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • METHODS: 36 patients with biopsy proven GIST (23 f, 13 m, median age 58 (27-85) yrs, 31 primary tumors, 5 local recurrences) of the esophagus/EGJ (n=5), stomach (n=17), duodenum (n=2), small bowel (n=3), or rectum (n=9) were treated with imatinib 400mg/d for 6 mos. preop.
  • Extent of surgery, local outcome, morbidity and response to therapy were analyzed; median follow-up is 22 mos.
  • RESULTS: Median treatment duration was 11 mos. (range 2-31 mos).
  • 33 pts. completed the treatment schedule, two died from unrelated disease, another one had to be operated for tumor rupture.
  • Histologically, one pCR and 11 near CR/good PRs were found.
  • Two local recurrences were detected at 31 and 44 mos. postop.

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  • (PMID = 27963946.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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55. Blinder VS, Patil S, Diamant A, Thind A, Maly R: Employment status among low-income Caucasian and Latina breast cancer survivors. J Clin Oncol; 2009 May 20;27(15_suppl):6612

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • METHODS: This is a prospective, longitudinal study of low-income, underserved breast cancer survivors who spoke English or Spanish, did not have metastatic disease, and were enrolled in the Medi-Cal Breast and Cervical Cancer Treatment Program.
  • We interviewed survivors at 6 mos., 18 mos., and 3 yrs. after diagnosis to assess changes in employment status.
  • The impact of independent variables including ethnicity, employment at diagnosis, job type, age, health status, and education was assessed using chi-square tests.
  • RESULTS: 666 survivors completed surveys at both 6 mos. and 3 yrs; 65% were Latina.
  • At diagnosis, 51% of Latinas and 59% of Caucasians were employed (p = 0.07), and among these, Latinas were less likely to be working at 6 and 18 mos. than Caucasians (27% vs. 47% at 6 mos., p = 0.002 and 45% vs. 59% at 18 mos., p = 0.026).
  • Job type at diagnosis was associated with RTW.
  • CONCLUSIONS: Employed low-income Latinas and Caucasians appear to follow different RTW trajectories after breast cancer, with fewer Latinas working at 6 and 18 mos.
  • Differences exist in job type between these populations; Caucasians have greater variation in job type and a trend toward greater likelihood of changing job type after breast cancer.

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  • (PMID = 27961765.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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56. Carducci MA, Armstrong DK, Collins C, Wang T, Schaefer S, Ermisch S, Musib LC, Nicol S, Thornton DE, Zhang Z: Phase I study of enzastaurin (ENZ) and bevacizumab (BV) in patients with advanced cancer: Safety, pharmacokinetics (PK), and response assessment. J Clin Oncol; 2009 May 20;27(15_suppl):3517

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • DLT was defined as C1: Grade (G)4 neutropenia ≥7 days, febrile neutropenia, G3 thrombocytopenia with bleeding or G4 thrombocytopenia; G3/G4 non-hematological toxicities, and toxicities associated with BV.
  • Nine of 43 pts (21%) had a response (CR, PR), 6 responses were in the ovarian subset (29%).
  • Median time to progression was 3.9 mos (range 0-19.2 mos) and 7.7 mos for ovarian pts (range 0.3-19.2 mos).
  • Overall, 43% remained on study without disease progression for >6 mos (51% of ovarian pts remained on study for >6 mos).

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  • (PMID = 27961299.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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57. Heng DY, Xie W, Regan MM, Cheng T, North S, Knox JJ, Kollmannsberger C, McDermott D, Rini BI, Choueiri TK: Prognostic factors for overall survival (OS) in patients with metastatic renal cell carcinoma (RCC) treated with vascular endothelial growth factor (VEGF)-targeted agents: Results from a large multicenter study. J Clin Oncol; 2009 May 20;27(15_suppl):5041

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • The median (m) OS was 22 months (95% CI: 20.0-24.8) with a median follow-up of 25 months.
  • Four of the five PFs previously identified by MSKCC were independent predictors of short survival, including hemoglobin below the lower limit of normal (LLN) (p < 0.0001), corrected calcium above the upper limit of normal (ULN) (p = 0.0006), Karnofsky performance status <80% (p < 0.0001) and time from initial diagnosis to initiation of therapy ULN (pULN (p = 0.012) were independent adverse PFs.
  • Patients were assigned one point for each poor PF and were segregated into three risk categories: favorable-risk (0 PFs, n = 133) median OS (mOS) 37.0 months; intermediate-risk (1 - 2 PFs, n = 292) mOS 28.5 months; and poor-risk (3-6 PFs, n = 139) mOS 9.4 months (log rank p < 0.0001).

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  • (PMID = 27962941.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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58. Hussain A, Onukwugha E, Seal B, Mullins CD: Visit and treatment patterns over time among elderly patients (pts) with M1 prostate cancer (PC): An analysis using SEER-Medicare. J Clin Oncol; 2009 May 20;27(15_suppl):5170

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • The study included pts with a post-diagnosis visit to a urologist; pts who saw a MOH prior to the urologist visit were excluded.
  • Pts were grouped as 1) no MOH visit, 2) MOH visit w/in 3 mos of a urologist visit, 3) MOH visit => 3 mos after a urologist visit.
  • 2) timely (i.e. within 6 mos of diagnosis); and 3) delayed, i.e.
  • => 6 mos following the diagnosis.
  • CONCLUSIONS: Approximately one-third of patients with M1 disease and a post-diagnosis urologist visit also see a medical oncologist.

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  • (PMID = 27964511.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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59. Frankenthaler A, Lee M, Seery V, Renzi S, Kinnaman M, Liu V, Friedman E, Atkins MB, Cutaneous Oncology Program: Impact of concomitant immunosuppression on the presentation and prognosis of patients with melanoma. J Clin Oncol; 2009 May 20;27(15_suppl):9070

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Impact of concomitant immunosuppression on the presentation and prognosis of patients with melanoma.
  • : 9070 Background: Melanoma has been reported to be susceptible to immune control.
  • Therefore, we hypothesized that concomitant immune suppression might impact the course of the disease.
  • METHODS: We examined the Beth Israel Deaconess Medical Center Cutaneous Oncology Program database for pts with immune suppression at the time of melanoma diagnosis.
  • The demographics and stage of these pts were compared to those in the database as a whole.
  • In addition, 3 controls matched for age, gender, stage and tumor location were identified for each case and disease outcome was compared between cases and controls.
  • RESULTS: 19 pts were identified with melanoma and concomitant immune suppression in a database of 1820 melanoma pts.
  • Melanoma stages at diagnosis were in situ 1, IB 7, IIA 1, IIB 1, IIIB 3, IIIC 5, and IV 1.
  • Compared to the database as a whole, cases were more likely to be female (84% vs 45%) and have a higher disease stage (42% stage IIIB/C vs 26%).
  • In addition, more cases appeared to have an amelanotic primary (21% vs. 5.4%) or an atypical mole syndrome (21% vs 10.2%).
  • For pts who relapsed, the cases had a shorter disease free interval (DFI) (2.1 vs 9.7 yrs) than the controls.
  • At a median f/up of 52 mos, 37% of the cases had relapsed and all of these pts had died.
  • At a median f/up of 76 mos, 30% of the controls had relapsed yet only 47% of these pts had died.
  • As a consequence, cases appeared more likely to have died of their disease than controls (42% vs 23%) (p=0.10).
  • CONCLUSIONS: Compared to the general melanoma population, pts with concomitant immune suppression appear more likely to be female, have an amelanotic primary or atypical mole syndrome and more advanced disease at presentation.
  • Thus, diagnosis and treatment of a primary melanoma at an early stage appears especially important in an immunosuppressed population.

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  • (PMID = 27962173.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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60. Gligorov J, Cals L, Tournigand C, Merad Z, Dutel J, Selle F, Zeghib N, Chibaudel B, Cvitkovic F: Gemcitabine-oxaliplatin combination (SEGEMOX) in anthracycline (A) and taxanes (T) pretreated metastatic breast cancer (MBC): Results from the GERCOR-SEGEMOX phase II trial. J Clin Oncol; 2009 May 20;27(15_suppl):1108

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : 1108 Objectives: To evaluate efficacy and safety of SEGEMOX regimen for previously A and T pre-treated MBC patients.
  • METHODS: Forty-five women with MBC not eligible for A and/or T chemotherapy were enrolled on SEGEMOX study.
  • Visceral metastases were dominant site of disease (44% liver; 36% lung; 44% bone).
  • After a median of 7.7 cycles (3.5 months of treatment); the overall response rate (ORR) is 38% [95%CI; 23%-51%] [1 CR (2.2%) and 16 PR (35.6%)]; 33% of stable disease [95%CI; 17%-43%], 24.4% progressive disease with a clinical benefit (CB) of 71% [95%CI; 57%-85%].
  • The median progression free survival (PFS) is 7.1 months for responders and 4.8 months for patients with stable disease.
  • The all population median overall survival (OS) is 21.4 months with 22.7 months MOS for responders.
  • The most frequent non hematologic toxicities were represented by grade 3 peripheral neuropathy (Levi Scale) in 11.4% of the patients and grade 2 alopecia in 11.4%.
  • For the subgroup of hormone receptor negative MBC (n = 12) the ORR is 33% [95%CI; 2%-64%], CB 50% [95%CI; 16%-73%], PFS of 2.8 months and MOS of 12 months.
  • CONCLUSIONS: The SEGEMOX combination has relevant activity in A and T not eligible MBC patients, with a manageable toxicity profile.

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  • (PMID = 27962168.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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61. Mesa RA, Kantarjian H, Tefferi A, Cheville A, Pardanani A, Levy R, Erickson-Viitanen S, Thomas D, Cortes J, Borthakur G, Verstovsek S: Functional assessment of performance status in patients with myelofibrosis (MF): Utility and feasibility of the 6-minute walk test (6MWT). J Clin Oncol; 2009 May 20;27(15_suppl):7083

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Functional assessment of performance status in patients with myelofibrosis (MF): Utility and feasibility of the 6-minute walk test (6MWT).
  • : 7083 Background: Patients with Myelofibrosis (MF) suffer from significant fatigue, constitutional symptoms and splenomegaly (Mesa et. al.
  • The 6MWT was administered in standardized fashion (American Thoracic Society: observed laps of a 30 - 35 meter long course, indoors, level, without encouragement), and then repeated for further validation.
  • Cancer 1999) embedded in the MFSAF) showed patients with a higher BFI (i.e., more fatigued) had more impairment in the 6MWT than those with low BFI scores.
  • Validation of the ability of the 6MWT to measure functional improvements in MF patients as a response to novel therapy trials is planned.

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  • (PMID = 27961476.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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62. Gerstner ER, Yip S, Wang DL, Louis DN, Iafrate AJ, Batchelor TT: MGMT methylation status may predict survival in elderly patients with newly diagnosed glioblastoma (GBM). J Clin Oncol; 2009 May 20;27(15_suppl):e13023

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • The logrank test was used to compare mPFS and mOS in patients who had methylated (ME) MGMT vs. unmethylated (UN) MGMT.
  • ME was associated with a significantly prolonged mPFS and mOS as noted in the table below which also summarizes the characteristics of the study population.

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  • (PMID = 27962794.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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63. Onukwugha E, Mullins CD, Obeidat N, Seal B, Hussain A: The impact of docetaxel (D) in an older population of patients with advanced prostate cancer (PC): A simulation study using TAX327 and SEER Medicare data. J Clin Oncol; 2009 May 20;27(15_suppl):e16074

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : e16074 Background: The survival benefit of D in treatment of hormone refractory PC (HRPC) has been established in the TAX327 trial, but it is unclear how this benefit would translate in a heterogeneous population.
  • This study sought to simulate the survival impact of D in a population of older pts with M1 PC on androgen deprivation therapy (ADT).
  • The simulated benefit was assessed at 12 mos and 24 mos post-diagnosis of M1 PC in SM pts.
  • Median survival was 15.7 mos (12.6 - 19) in the M arm and 18.9 mos [17 - 21.8] in the D3P arm (p = 0.03).
  • Median survival benefit of D was 3.2 mos based on Kaplan-Meier estimates and 2.4 mos using parametric curves in the TAX327 69+ group.
  • Following covariate-adjustment in the SM sample, at 12 mos post-diagnosis, the median survival in mos was 61.7 (CI 36.3 - 87) in the ADT group and 62 (CI 37.6 - 87.1) in the simulated ADT+D group (i.e., 0.3 mos simulated benefit of D).
  • A 0.8 mos simulated benefit was found if D was initiated 24 mos post diagnosis (in pts more likely to have HRPC).

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  • (PMID = 27963046.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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64. Richey SL, Culp SH, Wood CG, Corn PG, Jonasch E, Tannir NM: Outcome of patients (pts) with metastatic renal cell carcinoma (mRCC) treated with systemic therapy without cytoreductive nephrectomy (CN). J Clin Oncol; 2009 May 20;27(15_suppl):e16035

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • The median overall survival (OS) time of pts treated with interferon alfa (IFN-α) without CN was 7.8 months (mos) [Flanigan et al.
  • We calculated OS time from date of diagnosis until date of death or last follow up.
  • We excluded pts who had embolization, radiofrequency ablation or cryotherapy of the primary tumor.
  • Median follow-up time is 9.7 mos (range: 1.2-49.2).
  • Median OS time for all pts is 10.7 mos (95% CI: 7.6-15.4).
  • 55 pts (62.5%) had clear-cell and 33 (37.5%) had non-clear cell histology, with median OS times of 15.1 mos (95% CI: 9.6-17.7) and 7.4 mos (95% CI: 4.4-13.0), respectively.
  • ECOG performance status (PS) at time of diagnosis was correlated with OS (HR 1.54; 95% CI: 1.16-2.05; p<0.01).
  • Pts with PS 0, 1, 2, and 3 had median OS times of 22.8 mos (95% CI: 5.7,*), 16.5 mos (95% CI: 8.1-24.7), 7.6 mos (95% CI: 5.7-11.9), and 7.1 mos (95% CI: 3.3-9.6), respectively.
  • Pts with clinical evidence of lymph node (LN) involvement had worse outcome,with median OS time of 7.6 mos (95% CI: 5.6-9.8) versus 17.2 mos (95% CI: 9.8-35.5) for pts without clinical evidence of LN involvement.
  • CONCLUSIONS: In this analysis, median OS time for pts with mRCC treated in the modern era with TT without CN is superior to historical experience with IFN- α.Compromised PS, LN involvement, and non-clear cell histology were associated with worse outcome.

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  • (PMID = 27962960.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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65. Pennell NA, Videtic GM, Murthy S, Mason D, Rice TW, Mazzone P, Samsa J, Rich T, Shapiro M, Mekhail T: A phase I/II trial of perioperative paclitaxel (P), carboplatin (C), and erlotinib (E) with concurrent accelerated hyperfractionated radiation (HFRT) followed by maintenance E for stage III non-small cell lung cancer (NSCLC). J Clin Oncol; 2009 May 20;27(15_suppl):7557

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase I/II trial of perioperative paclitaxel (P), carboplatin (C), and erlotinib (E) with concurrent accelerated hyperfractionated radiation (HFRT) followed by maintenance E for stage III non-small cell lung cancer (NSCLC).
  • Non-progressors underwent resection followed by the same CRT regimen and 2 years of mE (150mg).
  • The primary endpoint of the phase I portion was the maximum tolerated dose (MTD) of E given with CRT; and for the phase II was safety and tolerability.
  • At a median follow-up of 36.5 mos the median PFS is 41.8 mos (95% CI 9.3-not yet reached).
  • Pts downstaged to pN0-1 vs those with persistent pN2-3 had a median PFS of 41.8 vs 18.1 mos (p=0.11).

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  • (PMID = 27963345.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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66. Villaflor VM, Kanteti R, Watson SM, Karrison T, Vokes EE, Salgia R: Response and survival in African American (AA) patients (pts) with non-small cell lung cancer (NSCLC) treated with erlotinib (E). J Clin Oncol; 2009 May 20;27(15_suppl):e19006

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Response and survival in African American (AA) patients (pts) with non-small cell lung cancer (NSCLC) treated with erlotinib (E).
  • EGFR activating mutations correlate with adenocarcinoma histology, non-smoking history, female gender, and Asian ethnicity.
  • It has also been determined that EGFR and met can crosstalk, and serve as potential mechanism of resistance in NSCLC.
  • We will correlate these data with EGFR mutation and c-Met expression/mutations/amplifications for markers of NSCLC.
  • Overall response rate of 13.6% (6-PR, 16-SD, 18-progessive disease, and 4 patients lost to follow up).
  • The PFS was 4.0 months; 95% CI: (2.5-6.6 mos) and overall survival 8.6 mos; 95% CI: (7.2-30.9 mos).
  • EGFR mutations and c-Met analysis will be provided by ASCO meeting in May 2009.

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  • (PMID = 27962520.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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67. Gitlitz BJ, Davies AM, Belani CP, Argiris A, Ramalingam SS, Hoffman PC, Koczwas M, Groshen SG, Gandara DR: A phase II study of the halichondrin B analog, E7389, in patients (pts) with advanced non-small cell lung cancer (NSCLC) previously treated with a taxane. A California Consortium/University of Pittsburgh/University of Chicago NCI/CTEP sponsored trial. J Clin Oncol; 2009 May 20;27(15_suppl):8056

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase II study of the halichondrin B analog, E7389, in patients (pts) with advanced non-small cell lung cancer (NSCLC) previously treated with a taxane. A California Consortium/University of Pittsburgh/University of Chicago NCI/CTEP sponsored trial.
  • METHODS: Eligible pts included: histologically confirmed advanced NSCLC, previous treatment with platinum-based therapy and a taxane, no more than 2 prior regimens, measurable disease, Zubrod performance status ≤ 2.
  • TREATMENT: E7389 1.4 mg/m<sup>2</sup> intravenously over 1-2 minutes on day 1 and 8 of a 21 day schedule until disease progression or unacceptable toxicity.
  • Stable disease rate was 60% and 24% in TS and TR pts. respectively.
  • Median progression free survival (PFS) is 6.3 mos TS pts.
  • 95%CI (2.5-8.6 mos) and 1.2 mos TR pts.
  • 95%CI (1.1-4.1 mos).
  • Major toxicity included: 19 pts (46%) with grade 3 or 4 hematologic toxicity including only 1 episode of febrile neutropenia and 8 pts (20%) with grade 3 or 4 non-hematologic toxicity attributable to drug including: fatigue (1), dehydration (2), nausea (2), constipation (2).
  • CONCLUSIONS: E7389 was well tolerated with encouraging objective response, PFS and disease control rate in the TS cohort.

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  • (PMID = 27962869.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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68. Goodman LJ, Weston JK, Mukherjee A, Sperinde J, Paquet A, Williams S, Parry G, Bates M, Koestler W, Lipton A: Quantitative measurement of HER3 total protein (H3T) and association with clinical outcome in HER2-positive metastatic breast cancer patients treated with trastuzumab. J Clin Oncol; 2009 May 20;27(15_suppl):1021

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • A previously reported H2T cutoff was used to sub-divide the patients into HER2-normal (N = 26, median TTP = 4.1 mos) and HER2-overexpressing (N = 55, median TTP = 11.1 mos, HR = 0.43, p = 0.0002) groups.
  • In the HER2-overexpressing group, high H3T expression, as defined by a positional scanning cutoff analysis, predicted shorter median time to progression (N = 25, median TTP = 6.1 mos) compared with low H3T expression (N = 30, median TTP = 13.1 mos, HR = 2.7, p = 0.0002).

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  • (PMID = 27961045.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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69. Sinibaldi VJ, Carducci MA, Moore-Cooper S, George B, Denmeade S, Drake CG, Walczak J, Pili R, Zahurak ML, Eisenberger MA: A randomized double blind phase I-II study to determine the tolerability/efficacy of two different doses of lenalidomide (L), CC- 5013, in biochemically relapsed (BR) prostate cancer (PC) patients (pts) (M&lt;sub&gt;0&lt;/sub&gt;) after local treatment (LT). J Clin Oncol; 2009 May 20;27(15_suppl):5130

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • Pts were randomized to either 5 or 25 mg/day(d), PO, d 1-21 (28-d cycles); then stratified by PSADT (< 3, 3-8.9, ≥ 9 mos), LT and prior ADT.
  • Eligible pts had: rising PSA (≥1 ng/mL), M<sub>0</sub> disease, testosterone > 150 ng/mL, adequate bone marrow, renal, and hepatic function.
  • Baseline and Q 2 mos PSA's were processed after Q 6 mos of L, along with CT and bone scan.
  • Primary endpoints are safety and progression after 6 mo of L (defined by a confirmed ↑ in PSA > 25% over the baseline value or mets).
  • A sample size of 30 pts/arm provides an 85% power to detect a PSA progression rate of 40% (compared to 80% predicted ) with a Type I error = 0.05 (Fishers exact test).
  • 16 pts had PSADT <3 mos, 26 from 3-8.9 mos, and 17 ≥ 9 mos.
  • 22 /44 who completed 6 mos of L remained on L > 6 mos ( 7<sup>+</sup>-30<sup>+</sup> mos); including 7 pts ≥ 24 mos.
  • Of 44 pts, blinded evaluation of PSA's at 6 mos: 4 pts had ≥ 50% ↓, 22 had stable PSA,17 had PD, 1 too early .
  • Rash was DLT. Other Gr toxicities: appendicitis, abd pain, neck pain, venous thrombolic disease, fatigue, pruritus.
  • CONCLUSIONS: Preliminary data prior to unblinding the study treatment arms, from pooled data, suggest that L may be administered > 6 mos with acceptable toxicity, and is associated with PSA declines and long term stabilization in pts with BR.

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  • (PMID = 27964411.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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70. Bengala C, Bettelli S, Fontana A, Bertolini F, Sartori G, Malavasi N, Losi L, Del Giovane C, Luppi G, Conte P: EGFR gene copy number, KRAS and BRAF status, PTEN and AKT expression analysis in patients with metastatic colon cancer treated with anti-EGFR monoclonal antibodies ± chemotherapy. J Clin Oncol; 2009 May 20;27(15_suppl):e15055

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • So far EGFR GCN is available on 55 pts, KRAS and BRAF on 63 pts, PTEN in primary tumor (PT) on 36 pts and in metastatic (MTS) site on 24 pts, AKT on 19 pts.
  • It was 4.2 vs. 2.3 mos in pts with WT and mutated KRAS respectively (p: 0.001).
  • Median OS was 9.7 mos (2.03-49.0) and no statistically significant differences were observed according to the biomarkers status.
  • However a trend was observed for pts with KRAS WT 10.6 vs. 7.8 mos and for PTEN positive in PT: 9.0 vs. 5.67 mos.

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  • (PMID = 27964545.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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71. Gandara D, Kim ES, Herbst RS, Moon J, Redman MW, Dakhil SR, Hirsch F, Mack PC, Franklin W, Kelly K: S0536: Carboplatin, paclitaxel, cetuximab, and bevacizumab followed by cetuximab and bevacizumab maintenance in advanced non-small cell lung cancer (NSCLC): A SWOG phase II study. J Clin Oncol; 2009 May 20;27(15_suppl):8015

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] S0536: Carboplatin, paclitaxel, cetuximab, and bevacizumab followed by cetuximab and bevacizumab maintenance in advanced non-small cell lung cancer (NSCLC): A SWOG phase II study.
  • METHODS: Eligibility: treatment-naïve advanced stage non-squamous cell NSCLC, no requirement for EGFR positivity, PS 0-1, no brain metastases or hemoptysis.
  • Primary endpoint: feasibility defined by the frequency and severity of ≥grade 4 hemorrhagic toxicities.
  • Primary endpoint was met: grade ≥4 hemorrhage: 2% (95% CI: 0-7%).
  • Partial response (PR): 51/95 assessable (54%; 43%-64%); Stable disease (SD): 22/95 (23%).
  • Disease control rate (PR+SD): 77%.
  • With median follow up of 15 months (mos), PFS is 7 mos (18 pts remain progression-free) and OS is 14 mos.
  • EGFR IHC by H score (>0 vs 0) showed a nonsignificant trend toward improved survival: 15 vs 11 mos (p=0.14).
  • S0819, a Phase III trial of CB/P ± CX (plus B in eligible pts) is under development and is designed to validate EGFR FISH as a predictive biomarker.

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  • (PMID = 27962808.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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72. Natale RB, Natale RB: Concurrent chemotherapy immediately following erlotinib (E) or gefitinib (G) induced apoptosis in previously untreated patients with advanced or metastatic non-small cell lung cancer (NSCLC). J Clin Oncol; 2009 May 20;27(15_suppl):e19014

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Concurrent chemotherapy immediately following erlotinib (E) or gefitinib (G) induced apoptosis in previously untreated patients with advanced or metastatic non-small cell lung cancer (NSCLC).
  • However, a subset analysis of TRIBUTE pts with a never smoking history suggested that improved survival may occur when the pt population is partially enriched to increase the proportion with an EGFR-TKI induced apoptotic effect (Miller VA.
  • RESULTS: With a median follow-up of 24 mos, the median TTPs are 21+ mos and 7 mos and the median survivals are 31+ and 12 mos in groups A and B, respectively.
  • CONCLUSIONS: These data suggest that EGFR-TKI induced apoptosis may act synergistically with concurrent 1<sup>st</sup> line chemotherapy in pts with advanced or metastatic NSCLC and a new paradigm for incorporation of biologically targeted agents into chemotherapy regimens.

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  • (PMID = 27962621.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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73. Salerrno May KS, Yang GY, Iyer RV, Chandrasekhar R, Wilding G, Khushalani NI, Yendamuri SS, Gibbs JF, Fakih M: Renal atrophy secondary to chemoradiation treatment of abdominal malignancies. J Clin Oncol; 2009 May 20;27(15_suppl):e15532

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • Primary disease sites were pancreas (61.5%), periampullary (16.1%), stomach (10.8%), gastroesophageal junction (10%), and retroperitoneum (1.5%).
  • Median follow up was 9.4 months (range 0-55.4 mos).
  • Compensatory hypertrophy of the non-PK was not seen.

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  • (PMID = 27962316.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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74. Meyerhardt JA, Jackson McCleary N, Niedzwiecki D, Hollis D, Venook A, Mayer R, Goldberg R: Impact of age and comorbidities on treatment effect, tolerance, and toxicity in metastatic colorectal cancer (mCRC) patients treated on CALGB 80203. J Clin Oncol; 2009 May 20;27(15_suppl):4038

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • Median follow-up was 23 mos.

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  • (PMID = 27961542.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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75. Ramanarayanan J, Pahuja S, Elefante AN, Hernandez-Ilizaliturri FJ: Abrogation of tumor necrosis alpha (TNF-alpha) pathway by anti-TNF therapy in hematological malignancies. J Clin Oncol; 2009 May 20;27(15_suppl):7093

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • METHODS: We reviewed the English literature by conducting systematic MEDLINE using the terms TNF-, infliximab, adalimumab, etanercept, cancer therapy, hematologic malignancies, myelodysplastic syndrome (MDS), multiple myeloma (MM), myeloproliferative disease (MPD), chronic lymphocytic leukemia (CLL), and lymphoma from January 2001 to August 2008.
  • As a single agent, etanercept did not yield significant responses.
  • Improvement in constitutional symptoms were noted in at least 50% of patients with myelofibrosis(MF)/Ph- MPD.

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  • (PMID = 27961263.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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76. Tannir N, Wong Y, Kollmannsberger C, Ernstoff MS, Perry DJ, Appleman LJ, Posadas E, Qian J, Ricker JL, Michaelson DM: Phase II trial of ABT-869 in advanced renal cell cancer (RCC) after sunitinib failure: Efficacy and safety results. J Clin Oncol; 2009 May 20;27(15_suppl):5036

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • Eligibility criteria included progressive disease (PD) within 100 days of enrollment after at least 2 cycles of sunitinib, prior nephrectomy, and adequate organ function.
  • The primary endpoint was objective response rate (ORR) per RECIST by central imaging.
  • Median TTP was 4.9 mos [95% CI: 3.5-6.8] per central imaging.

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  • (PMID = 27962936.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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77. Fischbach NA, Spigel D, Brahmer J, Garst J, Robles R, Chung C, Wang L, Sing A, Lynch T, ARIES Investigators: Preliminary safety and effectiveness of bevacizumab (BV) based treatment in subpopulations of patients (pts) with non-small cell lung cancer (NSCLC) from the ARIES study: A bevacizumab (BV) treatment observational cohort study (OCS). J Clin Oncol; 2009 May 20;27(15_suppl):8040

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Preliminary safety and effectiveness of bevacizumab (BV) based treatment in subpopulations of patients (pts) with non-small cell lung cancer (NSCLC) from the ARIES study: A bevacizumab (BV) treatment observational cohort study (OCS).
  • Median F/U is 7.5 mos.

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  • (PMID = 27962849.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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78. Zhang W, Dahlberg SE, Yang D, Sandler AB, Brahmer JR, Schiller JH, Carbone DP, Johnson DH, Lenz H: Genetic variants in angiogenesis pathway associated with clinical outcome in NSCLC patients (pts) treated with bevacizumab in combination with carboplatin and paclitaxel: Subset pharmacogenetic analysis of ECOG 4599. J Clin Oncol; 2009 May 20;27(15_suppl):8032

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • Multivariable Cox models adjusted for gender, PS, stage, adrenal, liver and bone mets were separately fitted for each SNP to obtain estimates of hazard ratios.
  • RESULTS: Median OS for the 133 patients was 10.3 mos (8.2-15.6) for PC and 13.0 mos (10.2-16.6) for BPC.
  • Median PFS was 4.6 mos (3.6-5.6) for PC & 6.5 mos (5.4-8.3) for BPC.

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  • (PMID = 27962832.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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79. Higano C, Alumkal J, Ryan CJ, Yu EY, Beer TM, Chandrawansa K, Katz T, Youssoufian H, Schwartz J, Prostate Cancer Clinical Trials Consortium: A phase II study evaluating the efficacy and safety of single agent IMC A12, a monoclonal antibody (MAb), against the insulin-like growth factor-1 receptor (IGF-IR), as monotherapy in patients with metastastic, asymptomatic castration-resistant prostate cancer (CRPC). J Clin Oncol; 2009 May 20;27(15_suppl):5142

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • METHODS: Pts received IMC-A12 10 mg/kg IV every 2 wks; until evidence of progressive disease (PD), intolerable toxicity, or other withdrawal criteria were met.
  • PD by bone scan required at least 2 new lesions with confirmation at subsequent imaging per PCWG2.
  • 9 of 31 pts experienced disease stabilization for ≥6 mos (range: 7.4-12.5 mos), 5 pts (3 with PSA reduction) continue on IMC-A12.
  • Disease stabilization for > 6 months in 9 of 31 pts suggests that IMC- A12 may have modest antitumor activity.

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  • (PMID = 27964448.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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80. Kamoi K, Kawauchi A, Miki T, Aron M, Remer E, Haber G, Berger A, Crouzet S, Ricardo B, Gill I: Laparoscopic renal cryoablation: Risk factor analysis to predict oncologic outcomes with minimum 5-year follow-up. J Clin Oncol; 2009 May 20;27(15_suppl):5094

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • In the 69 patients with biopsy-proven renal cell cancer (median follow-up 81 mos; range 60-132 mos), 5-year overall, disease-specific, and disease- free survival was 75%, 92%, and 82%, respectively, while 10-year overall, disease-specific, and disease-free survival was 46%, 83%, and 79%, respectively.
  • Relative risk of patients who has a history of radical nephrectomy for RCC treatment was 4.1 (95% CIs, 1.2 to 13.4), and 5.4 (95% CIs, 1.2 to 27.7) for disease-free survival and disease-specific survival, respectively.
  • Disease-specific survival of 92% at 5-years and 83% at 10-years is possible.
  • Preceding radical nephrectomy for RCC treatment was the only independent predicting factor for both disease-free and disease-specific survival.

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  • (PMID = 27964294.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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81. Scher K, Tisnado DM, Rose-Ash D, Rastegar A, Adams J, Ko CY, Ganz PA, Kahn KL: Physician and practice characteristics influencing tumor board attendance: Results from the provider survey of the Los Angeles Women's Health Study. J Clin Oncol; 2009 May 20;27(15_suppl):e17501

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • METHODS: This cross-sectional study utilizes data obtained by surveying physicians of a population-based sample of women with incident breast cancer.
  • Physicians were queried regarding tumor board attendance, specialty (medical oncologist [MO], radiation oncologist [RO], surgeon indicating that the hospital at which most breast cancer surgeries are performed has an American College of Surgeons accredited program [ACOSSg] and surgeon without such affiliation [non-ACOSSg]), physician characteristics (gender, race, teaching involvement, patient volume, number of offices, ownership interest), and practice setting (practice type, size, reimbursement).
  • Weekly participation was reported by 63%, 92%, 47%, and 32% of MOs, ROs, ACOSSgs, and non-ACOSSgs (p < 0.01).
  • In comparison to the most prevalent specialty category (low volume ACOSSgs), high volume MOs attend more (p = 0.01), and low volume non-ACOSSgs attend less frequently (p = 0.00).
  • Tumor board agendas and formalized institution wide policies could be designed to further engage low frequency attendees as a means to promote multidisciplinary care and improve health outcomes.

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  • (PMID = 27963245.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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82. Arellano ML, Winton E, Pan L, Souza L, Sunay S, Lima L, McLemore M, Heffner LT, Langston A, Khoury HJ: Prognostic significance of leukopenia at the time of diagnosis in acute myeloid leukemia (AML). J Clin Oncol; 2009 May 20;27(15_suppl):7070

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Prognostic significance of leukopenia at the time of diagnosis in acute myeloid leukemia (AML).
  • : 7070 Background: In contrast to the poor prognosis associated with hyperleukocytosis, the prognostic significance of leukopenia at the time of diagnosis of AML is unknown.
  • Simultaneously obtained peripheral blood and marrow blasts were analyzed for cell surface expression of CD34, cKit, CXCR4, PCAM, VLA-2, VLA-3, VLA-4, VLA-5, and FLT3 using flow cytometry.
  • RESULTS: Patients' characteristics (gender, secondary vs. de novo, and cytogenetic [CTG] risk) were comparable between the 2 groups.
  • Leukopenic AML pts were older (median 56 vs. 53 years, p = 0.02), and had lower induction complete remission [CR] rates: 63% vs. 81% (p = 0.03) by univariate analysis.
  • Induction mortality was 0% for leukopenic and 5% for non-leukopenic pts.
  • In primary refractory pts, median survival was longer for leukopenic (11) vs. non-leukopenic (34) pts: 137 vs. 81 d (p = 0.026).
  • Median follow-up was 22 mos.
  • Event-free (EFS), disease-free (DFS), and overall survivals (OS) were lower in the leukopenic group: 12 vs. 14; 14 vs. 17; and 17 vs. 19 mos, respectively; but did not reach statistical significance.
  • The level of expression of cell surface adhesion molecules on blood and marrow blasts was comparable for the 2 groups.

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  • (PMID = 27961453.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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83. Vergote I, Finkler NJ, Hall JB, Melnyk O, Edwards RP, Jones M, Meng L, Brown GL, Rankin EM, Burke JJ 2nd, Rose PG: Randomized phase III study of canfosfamide (C, TLK286) plus pegylated liposomal doxorubicin (PLD) versus PLD as second-line therapy in platinum (P) refractory or resistant ovarian cancer (OC). J Clin Oncol; 2009 May 20;27(15_suppl):5552

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • METHODS: 244 pts were planned with P refractory or resistant (progression within 6 mos. after P) OC following ≤ 2 P regimens, and measurable disease (RECIST).
  • Randomization was stratified by ECOG PS, best prior P response and bulky disease (≥ 5cm).
  • The 65/60 pts were well-balanced for disease characteristics and received a median 3/3.5 cycles per patient (range 1-11/0-17) of C + PLD/PLD, 35 pts (21/14) discontinued study treatment(s) due to the hold, respectively.
  • Non-hematologic AEs were similar for both arms, except the incidence of Grade 2-3 Palmar-Plantar Erythrodysesthesia (PPE) (9% vs. 21%) and stomatitis (17% vs. 23%) was lower and less severe with C+PLD vs. PLD.
  • Overall median PFS, the primary endpoint, was 5.6 mos. for C + PLD and 3.7 mos. for PLD (p = 0.7243, HR = 0.92).
  • In a planned analysis, 75 pts (40 /35) who were P refractory or primary P resistant observed a median PFS of 5.6 mos. for C + PLD vs. 2.9 mos. for PLD (p = 0.0425, HR = 0.55).
  • ORR for C + PLD was 15.0% (with 1 CR) vs. 5.7% for PLD.
  • Stable disease was observed 42.5% on C + PLD and 37.1% on PLD; median duration of SD was 7.4 mos. and 4.1 mos., respectively (p = 0.0439, HR = 0.49).
  • The median time to response was 2.8 mos. on C + PLD vs. 4.8 mos. on PLD.
  • In the P refractory or primary P resistant population, the median PFS was significantly longer for C+PLD than PLD alone.

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  • (PMID = 27962542.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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84. Rixe O, Dutcher J, Motzer R, Wilding G, Stadler WM, Garrett M, Pithavala Y, Kim S, Tarazi J, Rini BI: Diastolic blood pressure (dBP) and pharmacokinetics (PK) as predictors of axitinib efficacy in metastatic renal cell cancer (mRCC). J Clin Oncol; 2009 May 20;27(15_suppl):5045

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • RESULTS: The median overall survival (mOS) for mRCC pts with at least 1 dBP measurement ≥90 mmHg (n = 59) during axitinib therapy was 130 weeks vs. 42 weeks (p < 0.01) for pts without any dBP ≥90 mmHg (n = 50).
  • The mOS of pts with an AUC below the median (605 ng.hr/ml; n = 54) was 69 weeks vs. 88 weeks (p > 0.05) for pts with an AUC above the median (n = 55).
  • Among pts with dBP ≥90 mmHg, mOS was 120 weeks and 131 weeks (p > 0.05) for pts with AUC below and above the median (n = 23 and 36), respectively.
  • Among pts without dBP ≥90 mmHg, mOS was 42 weeks and 43 weeks (p > 0.05) for pts with AUC below and above the median (n = 31 and 19), respectively.
  • An 82% increase in probability of a partial response was predicted for a 10 mmHg higher dBP during therapy.

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  • (PMID = 27962952.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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85. Kaseb AO, Iwasaki M, Javle M, Onicescu G, Garrett-Mayer E, Abbruzzese JL, Thomas MB: Biological activity of bevacizumab and erlotinib in patients with advanced hepatocellular carcinoma (HCC). J Clin Oncol; 2009 May 20;27(15_suppl):4522

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • Current standard of care for advanced HCC is sorafenib based on median survival (MS) of 10.7 months (mos), median time to progression 5.5 mos.
  • RESULTS: The primary endpoint was the percent of pts alive and progression-free after 16 weeks of therapy (PFS<sub>16</sub>) based on historic median PFS of 3 to 5 mos.
  • Of the 57 pts enrolled, 14 (28%) had confirmed partial responses, 31 (62%) had stable disease and 5 (10%) had progressive disease.
  • The median PFS is 7.9 mos (95% CI 5.7, 9.5) and the OS is 12.8 mos, 95% CI (9.5, 17.9).

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  • (PMID = 27962725.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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86. Cabanillas ME, Waguespack SG, Bronstein Y, Williams M, Feng L, Sherman SI, Busaidy NL: Treatment (tx) with tyrosine kinase inhibitors (TKIs) for patients (pts) with differentiated thyroid cancer (DTC): The M. D. Anderson Cancer Center (MDACC) experience. J Clin Oncol; 2009 May 20;27(15_suppl):6060

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • Until recently, tx for pts with progressive, RAI negative disease was limited.
  • METHODS: Adult pts with a diagnosis of DTC treated with single agent sorafenib (SOR) or sunitinib (SUN), and who had a baseline and at least 1 follow-up (f/u) scan after 3 months (mos) of therapy, were included.
  • 15 pts met inclusion criteria: 9 women, 6 men.
  • No pts were excluded due to progression or death before 3 mos.
  • Most patients had RAI negative disease.
  • Four pts had bone mets: 2 had XRT and had SD in bone, while the other 2 did not have XRT and had PD in bone.
  • At 12 mos PFS was 65% and OS was 85%.
  • Median f/u time was 16 mos.
  • Log (TG) significantly correlated with response to tx and therefore may have value as a surrogate marker of response.

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  • (PMID = 27961926.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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87. Finn RS, Press M, Dering J, Florance A, Platek G, Arbushites M, Koehler M, Johnston S: Progression-free survival (PFS) of patients with HER2-negative, estrogen-receptor (ER)-low metastatic breast cancer (MBC) with the addition of lapatinib to letrozole: Biomarker results of EGF30008. J Clin Oncol; 2009 May 20;27(15_suppl):1018

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • We report a blinded analysis of HER-2, ER, and progesterone receptor (PR) expression for patients (pts) with HR+ MBC at first diagnosis or post-adjuvant relapse and response to Lap + Let versus Let.
  • The primary endpoint was PFS in HR+, HER-2+ MBC pts; secondary endpoints included PFS in the intent-to-treat population.
  • RESULTS: In 219/1286 (17%) HER-2+ (FISH+ or IHC3+) pts, a significant improvement in median PFS was observed for Lap + Let versus Let (8.2 v 3.0 mos, HR = 0.71, 95% CI 0.53, 0.96, p = 0.019).
  • No significant difference in median PFS was seen in 952 (74%) HER-2-negative pts (13.4 v 13.7 mos, HR = 0.90, 95% CI 0.77, 1.05, p = 0.188).
  • Pts with the lowest quartile of ER expression (H-score <160, n = 207) had a significant improvement in median PFS (13.6 mos v 6.6 mos, HR = 0.65, 95% CI 0.47, 0.9, p < 0.005).

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  • (PMID = 27960731.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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88. Madan S, Kumar S, Lacy MQ, Dispenzieri A, Hayman SR, Buadi FK, Dingli D, Rajkumar SV, Gertz MA: Natural history of multiple myeloma (MM) relapsing after autologous stem cell transplantation (ASCT). J Clin Oncol; 2009 May 20;27(15_suppl):e19513

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : e19513 Background: The outcome of patients with MM relapsing after ASCT used early in the disease course or after failure of initial therapy, is not well defined.
  • RESULTS: We studied 487 patients who had relapsed following a single ASCT, of whom 351 (72%) had an early SCT (≤ 12 mos from diagnosis).
  • The median estimated follow up for all patients was 27 mos, 50 mos and 69 mos from relapse, SCT and diagnosis respectively.
  • The median overall survival (OS) from the time of relapse was 30 mos for the early SCT group and 21 months for the late SCT group.
  • The median time to relapse following transplant was 15 mos (3-119) among early SCT group and 12 mos (3-76) among the late SCT group.
  • Among the early group, nearly a third of the patients achieved a PR or better to first salvage therapy (Table), with another third achieving stable disease and 25% of patients did not have response data.
  • The median progression free survival for the first salvage regimen was 8 mos; 18 mos for those with PR or better and 5 mos for those with SD as the best response.
  • Those with a durable response to transplant and those not requiring initiation of therapy for long periods after disease relapse have favorable disease biology and have prolonged survival after relapse.
  • The natural history of the disease provides a valuable benchmark for evaluation of newer treatment approaches.

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  • (PMID = 27960950.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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89. Sloan JA, Liu H, Sargent DJ, Satele D, Schaefer PL, Halyard MY, Grothey A, Garces YI, Brown PD, Loprinzi CL, Buckner JC: A patient-level pooled analysis of the prognostic significance of baseline fatigue for overall survival (OS) among 3,915 patients participating in 43 North Central Cancer Treatment Group (NCCTG) and Mayo Clinic Cancer Center (MC) oncology clinical trials. J Clin Oncol; 2009 May 20;27(15_suppl):9599

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : 9599 Background: We have previously identified overall a single-item measure for baseline quality of life (QOL) as a strong prognostic factor for survival (Tan, ASCO 2008), and that fatigue was an important component of patient QOL (Sloan, 2007).
  • Cox proportional hazards models adjusted for the effects of overall QOL, performance score, race, disease site, age and gender.
  • RESULTS: Baseline fatigue was a strong predictor of OS for the entire patient cohort (CDF vs. nCDF: 31.5 mos vs >83.9 mos, p<0.0001).
  • The effect sizes were consistent across different disease sites (GI, esophageal, head and neck, prostate, lung, breast and others).

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  • (PMID = 27963750.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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90. Carlson RW, O'Neill A, Vidaurre T, Gomez HL, Badve S, Sledge G, Eastern Cooperative Oncology Group: Randomized phase II trial of gefitinib plus anastrozole or fulvestrant in postmenopausal, metastatic breast cancer. J Clin Oncol; 2009 May 20;27(15_suppl):1013

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • METHODS: This multi-institutional, single-stage, non-comparative, randomized phase II study tested the EGFR tyrosine kinase inhibitor gefitinib 250 mg daily PO plus endocrine therapy with either anastrozole 1 mg/day PO (AG Arm) versus fulvestrant 250 mg IM every 4-weeks (FG Arm).
  • Eligible pts were postmenopausal women with ER+ and/or PgR+ measurable metastatic breast cancer with no prior endocrine therapy for metastatic disease, no prior adjuvant AI or fulvestrant, no more than two chemotherapy regimens for metastatic disease, ECOG status 0-2, no CNS metastasis, and adequate bone marrow, liver, and renal function.
  • Primary endpoint was RECIST determined clinical benefit (CR+PR+SD for ≥6 mos) and secondary endpoints were toxicity and interaction of biomarkers with clinical benefit.
  • Treatment groups were balanced for race, age, ECOG status, and sites of disease.
  • Median follow-up is 35 mos.
  • Treatment was terminated for disease progression in 74% v 75%, toxicity 7% v 10%, death 1% v 3%, withdrawal 8% v 1%, and other 3% v 7% in the AG v FG arms, respectively.
  • Response rates are CR 3% v 4%, PR 21% v 17%, SD for ≥6 mos 18% v 17% for AG v FG.
  • Median PFS is 5.7 mos v 5.2 mos and median OS is 30.2 mos v 23.8 mos for AG v FG, respectively.

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  • (PMID = 27960741.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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91. Wu Y, Kwok Y, Mirmiran A, Goloubeva O, Mannuel H, Dawson N, Amin P, Hussain A: Weekly paclitaxel (P) with concurrent external beam radiation (EBRT) and androgen deprivation therapy (ADT) in high-risk prostate cancer (PC) patients with or without prior prostatectomy (RP). J Clin Oncol; 2009 May 20;27(15_suppl):5122

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : 5122 Background: EBRT with ADT (4 mos to 2-3 yrs) is standard treatment for high risk PC.
  • Treatment included ADT (4 or 24 mos, preplanned based on clinical presentation), P (40, 50, or 60 mg/m2/wk) x 7 with EBRT, and whole pelvis EBRT 45 Gy with 19.8 Gy boost (total 64.8 Gy) to prostate bed in RP pts and 25.2 Gy boost (total 70.2 Gy) to prostate in LAPC pts.
  • ADT for 4 mos was given in 29 pts and for 24 mos in 30 pts.
  • Median duration of f/u was 75.3 mos, OS 78%, biochemical progression 24/59 (41%) pts, clinical progression 11/59 (19%) pts.
  • Time to biochemical progression was similar between RP vs. LAPC (p = 0.17), between ADT 4 mos vs. 24 mos (p = 0.61), and between AA vs. W (p = 0.54).

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  • (PMID = 27964408.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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92. Ougari KE, Taneja C, Sofrygin O, Kaura S, Delea T: Cost-effectiveness of zoledronic (ZOL) acid plus endocrine therapy (ET) in premenopausal women with early breast cancer (EBC) from a Canadian perspective. J Clin Oncol; 2009 May 20;27(15_suppl):557

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : 557 Background: The Austrian Breast and Colorectal Cancer Study Group Trial 12 (ABCSG-12) examined the efficacy of 3 years (yrs) of treatment with goserelin in combination with ET (anastrozole or tamoxifen) with or without ZOL 4 mg q6 mos in 1,803 premenopausal women with EBC (median age 45 yrs).
  • After a median follow-up of 47.8 mos (max 84 mos), risk of disease-free survival (DFS) events was reduced by 36% (HR = 0.64; p = 0.01) in patients (pts) who received ZOL (ZOL+ET) compared with those who did not (ET).
  • A Canadian healthcare system perspective and a lifetime timeframe were used.

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  • (PMID = 27960672.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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93. Arnold R, Müller H, Schade-Brittinger C, Rinke A, Klose K, Barth P, Wied M, Mayer C, Aminossadati B, PROMID Study Group: Placebo-controlled, double-blind, prospective, randomized study of the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: A report from the PROMID study group. J Clin Oncol; 2009 May 20;27(15_suppl):4508

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • METHODS: Treatment-naïve patients with histologically confirmed locally inoperable or metastasized well-differentiated NETs and a Karnofsky index >60 were randomized to receive either octreotide LAR 30 mg/month (mo) or placebo for 18 mos, or until tumor progression or death.
  • The primary endpoint was median time to tumor progression.
  • Secondary endpoints included objective tumor response rate (WHO criteria), measured every 3 mos, as well as symptom control and overall survival.
  • Median time to tumor progression in the octreotide LAR and placebo groups were 14.3 mos and 6 mos, respectively (HR: 0.34; 95% CI: 0.20-0.59; P=0.000072).
  • After 6 mos of treatment, stable disease was seen in 67% and 37.2% of patients treated with octreotide LAR and placebo, respectively.
  • Octreotide LAR demonstrates substantial tumor control and shows a more favorable antiproliferative response than placebo as two-thirds of patients treated with octreotide LAR achieved stable disease at 6 mos.

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  • (PMID = 27962687.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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94. Obasaju CK, Raju RN, Stinchcombe T, Couch LS, Jotte R, Kocs DM, Wang Y, Bromund J, Treat J, Socinski MA: Final results of a randomized phase II trial of pemetrexed (P) + carboplatin (Cb) ± enzastaurin (E) versus docetaxel (D) + Cb as first-line treatment of patients (pts) with stage IIIB/IV non-small cell lung cancer (NSCLC). J Clin Oncol; 2009 May 20;27(15_suppl):8037

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Final results of a randomized phase II trial of pemetrexed (P) + carboplatin (Cb) ± enzastaurin (E) versus docetaxel (D) + Cb as first-line treatment of patients (pts) with stage IIIB/IV non-small cell lung cancer (NSCLC).
  • In the TAX 326 trial, D + cisplatin was associated with a median survival of 11.3 mos vs. 10.1 mos for vinorelbine + cisplatin (P=.04).
  • Pts were equally randomized to 3 arms: (A) P 500 mg/m<sup>2</sup> and Cb AUC 6 every 3 wks × 6 cycles with E given orally as a loading dose of 1200 mg or 1125 mg followed by 500 mg daily until disease progression;.
  • CONCLUSIONS: First-line treatment with PCb was associated with a significantly longer overall survival than DCb in advanced or metastatic NSCLC.

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  • (PMID = 27962857.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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95. Renouf DJ, Lim HJ, Speers C, Villa D, Gill S, Blanke CD, O'Reilly SE, Kennecke H: Impact of bevacizumab (bev) on overall survival (OS) in patients (pts) with metastatic colorectal cancer (MCRC): A population-based study. J Clin Oncol; 2009 May 20;27(15_suppl):4114

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • The primary endpoint was OS of all pts within each cohort.
  • Median age at diagnosis of MCRC was 68y in 2003/04 and 69y in 2006.
  • Median follow up time was 47.3 and 21.4 mos respectively.
  • Median OS significantly improved for the entire cohort (13.8 to 17.3 mos, p<0.001).
  • Median OS for pts who received ST for MCRC improved (18.6 to 23.6 mos, p=0.001).
  • Median OS for pts who did not receive ST did not change (6.1 to 5.9 mos, p=0.65).
  • Median OS for pts <70 who received ST for MCRC improved (20.3 to 26.5 mos, p = 0.002).
  • Median OS for pts ≥70 who received ST for MCRC improved (16.5 to 19.9 mos), but this was not significant (p=0.16).
  • The improvement in survival appears to be limited to pts treated with ST for metastatic disease.
  • On a population basis, the addition of bev to CT is associated with a significant improvement in OS in MCRC.

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  • (PMID = 27961224.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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96. Wanebo HJ, Begossi G, Belliveau J, Gustafson E: Isolated chemotherapeutic perfusion as neoadjuvant therapy for advanced/unresectable pelvic malignancy. J Clin Oncol; 2009 May 20;27(15_suppl):2555

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • METHODS: 42 patients had advanced (irradiated) rectal cancer, 8 pts had advanced anorectal cancer, 5 patients had sarcoma.
  • Other cancers included melanoma (M 4pts), endometrial cancer (EC) 2, ovarian cancer (OC) 2, and bladder cancer (BC) 1.
  • RESULTS: Palliative IPP for advanced rectal cancer pts provided significant pain control (1-4 months) in 11 of 14 pts with narcotic resistant pain and induced tumor regression in 6 pts.
  • Preoperative perfusion in 26 advanced rectal cancer pts induced a complete path response (in pelvis) in 2 pts and significant regression in 11 pts rendering them resectable.
  • 7 had RO resection with clear margins: of the other pts 1 had a path CR negating resection, 3 refused pelvic resection, 2 became inoperable.
  • Median survival post IPP was 24 mos in 12 patients considered resectable vs. 8 mos in 12 patients considered non resectable p<0.05.
  • It was 30 months in 8 pts with advanced anorectal squamous cancer (1pt survived >90 mos), 20 months in 4 patients with endometrial/ovarian recurrence, (1 died NED >48 mos), 13 mos in 4 melanoma pts and only 5 months in 5 pts pelvic sarcoma (4-34 mos-NED).

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  • (PMID = 27961873.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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97. Vij R, Wang M, Orlowski R, Stewart AK, Jagannath S, Kukreti V, Le MH, Kunkel L, Siegel D, Multiple Myeloma Research Consortium (MMRC): PX-171-004, a multicenter phase II study of carfilzomib (CFZ) in patients with relapsed myeloma: An efficacy update. J Clin Oncol; 2009 May 20;27(15_suppl):8537

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • PX-171-004 is an ongoing Phase II study evaluating safety and efficacy of CFZ in MM patients with relapsed disease after 1-3 prior therapies.
  • The primary endpoint was ORR, defined as Partial Response (PR) or better.
  • Of the BTZ-exposed cohort, 2 subjects received BTZ exclusively as a single agent, 6 had BTZ in a chemotherapy combination, and 9 received BTZ in a transplant regime.
  • In BTZ-naïve patients, CFZ achieved an ORR of 57%; median DOR of 8.6 mos (range >1.9 to >9.7 mos).
  • The median follow-up was 10 mos and the median TTP has not been reached.
  • For the BTZ- exposed group, CFZ achieved an ORR of 18%; median DOR not yet reached (>8.5 mos) (range >1 d to >8.5 mos).
  • Median follow-up and TTP were 9.2 and 8.9 mos, respectively.

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  • (PMID = 27960932.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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98. Piovesan C, Fumagalli E, Coco P, Palassini E, Dileo P, Morosi C, Gronchi A, Casali P: Response to sirolimus in combination to tirosine kinase inhibitors (TKI) in three cases of PDGFRA-D842V metastatic gastrointestinal stromal tumor (GIST). J Clin Oncol; 2009 May 20;27(15_suppl):10565

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • We therefore used the mTOR inhibitor sirolimus in three pts with a PDGFRA-D842V metastatic GIST.
  • RESULTS: Two pts had a Choi's response 6 and 3 mos, respectively, after starting the combination.
  • Disease was stable at 2 mos, although clinical improvement was noticed, and therapy is ongoing.
  • The first pt underwent surgery of residual peritoneal disease after 13 mos, and is now continuing therapy being surgically NED.
  • The other pt had a tumor progression after 9 mos from starting therapy and 6 mos from tumor response (with a negative PET scan).

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  • (PMID = 27963816.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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99. Carneiro BA, Bahary N, Lembersky B, Fakih M, Krishnamurthi SS, Lancaster S, Pinkerton R, Crandall T, Potter D, Ramanathan RK: Phase II study of biweekly cetuximab (C) and irinotecan (I) as a second-line regimen for metastatic colorectal cancer (mCRC). J Clin Oncol; 2009 May 20;27(15_suppl):e15088

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase II study of biweekly cetuximab (C) and irinotecan (I) as a second-line regimen for metastatic colorectal cancer (mCRC).
  • Our study investigated the efficacy and safety of a biweekly I + C combination in patients (pts) with mCRC.
  • METHODS: mCRC pts who failed 1st line fluoropyrimidine/oxaliplatin regimens and had not received I or C, were eligible for this open label phase II trial with response rate (RR) as the primary end-point and planned sample size of 31 patients to achieve a 25% RR with 80% power.
  • Median OS 11.1 mos (95% CI 6.0-15.1) and TTP 2.4 mos (95% CI 1.4-NA).
  • The OS and TTP are consistent with those reported previously (Martin et al Brit J Cancer 2008, Pfeiffer P et al Ann Oncol 2008), supporting biweekly I + C as a convenient second-line regimen in mCRC.

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  • (PMID = 27964555.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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100. Wesolowski R, Shealy AG, Tao J, Moore HC: Differential outcomes in patients treated with endocrine therapy for early or locally advanced breast cancer based on BRCA mutation status. J Clin Oncol; 2009 May 20;27(15_suppl):e22065

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • METHODS: Through an IRB approved registry, breast cancer patients tested for BRCA1 and BRCA2 mutations and treated with endocrine therapy for hormone-receptor positive non-metastatic disease were identified.
  • Primary and secondary endpoints were overall survival (OS) and progression-free survival (PFS) respectively.
  • RESULTS: Of 115 breast cancer patients tested for BRCA mutations, 63 met the inclusion criteria of whom 16 patients were BRCA 1 or 2 mutation positive and 47 were negative.
  • In the BRCA(+) group, 14 patients (87.5%) had stage I-III disease at diagnosis.
  • In the BRCA(-) group, 5 patients (10.6%) had stage 0 disease while 41 patients (87.2%) had stage I-III disease at diagnosis.
  • Stage at diagnosis was unavailable for 2 BRCA(+) and 1 BRCA(-) patients.
  • Both groups were similar with respect to Her-2 expression status, history of ovarian suppression, age of diagnosis, and age of menopause.
  • Median follow up was 76.1 mos in BRCA(+) and 62.9 mos in BRCA(-) group.

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  • (PMID = 27963208.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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