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6. 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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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [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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7. 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
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  • [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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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]
  • [Cites] N Engl J Med. 2000 Apr 27;342(17):1255-65 [10781623.001]
  • [Cites] J Clin Pathol. 1996 May;49(5):428-9 [8707964.001]
  • (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. 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.


10. 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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11. 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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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [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


12. 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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13. 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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4. 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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15. 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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16. 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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17. 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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18. 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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19. 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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20. 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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21. 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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22. 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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23. 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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24. 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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25. 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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26. 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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27. 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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28. 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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29. 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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30. 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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31. 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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32. 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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33. 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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34. 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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35. 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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36. 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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37. 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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38. 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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39. 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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40. 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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41. 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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42. 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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43. 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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44. Krupitskaya Y, Ganjoo K, Lavori PW, Kumar A, Clement-Duchene C, Zhao G, Padda S, San Pedro-Salcedo M, Wakelee HA: A phase II first-line study of gemcitabine, carboplatin, and bevacizumab (GCB) in advanced (adv) stage non-squamous non-small cell lung cancer (NSCLC). J Clin Oncol; 2009 May 20;27(15_suppl):e19024

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase II first-line study of gemcitabine, carboplatin, and bevacizumab (GCB) in advanced (adv) stage non-squamous non-small cell lung cancer (NSCLC).
  • Gemcitabine/carboplatin (GC) has equivalent efficacy to PC with a different toxicity profile.
  • B was then continued q21d until disease progression or unacceptable toxicity.
  • G3/G4 non-hematologic AEs included dyspnea (6%/2%), bacterial pneumonia (4%/0) hypertension (4%/2%), 1G3 wound dehiscence, 1G4 MI, 1G3 transaminitis and hyperbilirubinemia, 1G3 proteinuria and 1G3 leucocyturia.
  • 17/44 (38.6%) pts have died with median overall survival (mOS) not reached but preliminarily estimated at 16.7mo [95%CI 13.4mo-inf].
  • CONCLUSIONS: Treatment with GCB has an acceptable toxicity profile with promising mOS despite a low RR and frequent dose reductions in a population with a high proportion of non-smokers and women.

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  • (PMID = 27962585.001).
  • [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. Hoshimoto S, Shingai T, Wang H, Elashhoff RM, Morton DL, Hoon DS, MMAIT-IV Clinical Trial Group Centers: Validation of a multimarker blood assay for postoperative assessment of stage IV melanoma patients in a prospective international phase III trial. J Clin Oncol; 2009 May 20;27(15_suppl):9045

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Validation of a multimarker blood assay for postoperative assessment of stage IV melanoma patients in a prospective international phase III trial.
  • : 9045 Background: Currently there are no validated prognostic molecular biomarkers for assessment of outcome after complete resection of stage IV melanoma patients.
  • To validate blood molecular biomarkers for prognostic value and monitoring of these patients, we evaluated the clinical utility of a multimarker quantitative reverse-transcription PCR (qRT-PCR) for detecting circulating tumor cells (CTC) of patients blood enrolled in a multicenter international (29 sites) phase III trial of postoperative adjuvant therapy.
  • After complete metastasectomy, AJCC stage IV patients underwent immunotherapy with bacille Calmette-Guerin (BCG) plus placebo or BCG plus melanoma vaccine.
  • Median clinical follow-up time was 21.8 and 24.2 mos. for disease-free survival (DFS) and overall survival (OS), respectively.
  • In serial-bleeds (pretreatment, mos 1 and 3) analysis of 214 patients, biomarker-negative patients had significantly higher OS than patients with 1-2 positive- or 3 positive-biomarkers (risk ratio 2.37, 95% CI 1.14 - 4.94, P=0.021; and risk ratio 2.90, 95% CI 1.28 - 6.53, P=0.01, respectively).
  • CONCLUSIONS: This prospective multicenter blood biomarker validation study demonstrates that multimarker qRT-PCR analysis of CTC has significant clinical utility as a prognostic factor of disease outcome at pretreatment, and as a treatment monitoring prognostic factor in stage IV melanoma patients.

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  • (PMID = 27962113.001).
  • [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. Pishvaian MJ, Marshall JL, Hwang JJ, Malik S, He AR, Deeken JF, Kelso CB, Cotarla I, Berger MS: A phase I trial of GMX1777, an inhibitor of nicotinamide phosphoribosyl transferase (NAMPRT), given as a 24-hour infusion. J Clin Oncol; 2009 May 20;27(15_suppl):3581

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase I trial of GMX1777, an inhibitor of nicotinamide phosphoribosyl transferase (NAMPRT), given as a 24-hour infusion.
  • METHODS: GMX1777 was administered at ascending doses as a 24 hour IV infusion q21 days to successive cohorts of patients with advanced malignancies.
  • Two patients had stable disease for > 4 cycles (6 & 4 mos), and 3 additional patients had SD for ≥ 3 mos.
  • CONCLUSIONS: The MTD for GMX1777 administered as a 24 hour infusion q21 days is 140 mg/m<sup>2</sup>.

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  • (PMID = 27961760.001).
  • [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. Kiel KD, Refaat T, Navanandan N, Sathiaseelan V: Hyperthermia and radiation therapy for locally advanced or recurrent breast cancer. J Clin Oncol; 2009 May 20;27(15_suppl):631

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • RESULTS: Median and mean FU of alive patients was 20 and 32 mos, respectively.
  • Disease volume was microscopic in 11%, less than 3 cm in 11%, and greater than in 78%.
  • CR was seen in 52% and CR/PR in 79% in pts with measurable tumor.
  • Type (primary vs recurrent), location (breast/chest wall/node), extent of disease (3 cm), or prior RT were not associated with LC.
  • All pts with microscopic disease are controlled.
  • 16 pts (12%) are NED (mean 32 mos).

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  • (PMID = 27961438.001).
  • [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. 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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49. 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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50. Kolev V, Mironov S, Mironov O, Moskowitz C, Ishill NM, Gardner GJ, Levine DA, Hricak H, Barakat RR, Chi DS: The prognostic significance of supradiaphragmatic lymphadenopathy identified on preoperative computed tomography scan in patients undergoing primary cytoreduction for advanced stage epithelial ovarian cancer. J Clin Oncol; 2009 May 20;27(15_suppl):e16512

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] The prognostic significance of supradiaphragmatic lymphadenopathy identified on preoperative computed tomography scan in patients undergoing primary cytoreduction for advanced stage epithelial ovarian cancer.
  • METHODS: We performed a retrospective chart review of all patients (pts) with FIGO stage III and IV EOC who had preoperative CT scans of the supradiaphragmatic region and primary cytoreductive surgery at our institution between 1997 and 2004.
  • RESULTS: A total of 212 eligible pts who underwent attempted primary cytoreduction followed by platinum-based systemic chemotherapy were identified for evaluation.
  • With a median follow-up time of 52 mos, there were 135 deaths and a median overall survival of 48 mos (95% CI: 44-53).
  • None of the 44 pts with adenopathy had the enlarged nodes removed at primary cytoreduction.
  • The median survival was 49 mos for pts with and 48 mos for patients without adenopathy (p = 0.46).
  • In total, 155 (73%) patients underwent optimal cytoreduction (residual disease ≤ 1 cm).
  • In the optimally cytoreduced pts, the median survival for the 125 pts without supradiaphragmatic adenopathy was 52 mos (95%CI: 45-59) compared to 51mos (95%CI: 41-58) for the 30 pts with supradiaphragmatic adenopathy (p = 0.33).

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  • (PMID = 27960758.001).
  • [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. Vickers MM, Choueiri TK, Zama I, Cheng T, North S, Knox JJ, Kollmannsberger C, McDermott DF, Rini BI, Heng DY: Failure of initial VEGF-targeted therapy in metastatic renal cell carcinoma (mRCC): What next? J Clin Oncol; 2009 May 20;27(15_suppl):5098

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • RESULTS: 645 patients with mRCC who received initial VEGF-targeted therapy were identified (sunitinib, sorafenib or bevacizumab) and had a median follow-up of 25 mos.
  • Of these, 218 patients (34%) received second-line targeted therapy: the median age was 62 yrs (range, 41-87), median KPS was 90%, 90% had prior nephrectomy, 3.8% had non-clear cell histology, 5.8% had brain metastases and 79% had > 1 metastatic site.
  • Patient characteristics were similar aside from more non-clear cell histology in patients receiving second-line mTOR-inhibiting agents (14% vs 3% p = 0.045).
  • The median time to treatment failure (TTF) of second-line therapy was 4.9 mos for anti-VEGF therapy and 2.5 mos for mTOR inhibitors (p = 0.014).
  • However, patient selection may account for this finding and overall survival was not significantly different.

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  • (PMID = 27964309.001).
  • [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. Van Schil PE, Baas P, Gaafar R, Maat AP, van de Pol M, Hasan B, Klomp HM, Abdelrahman AM, Welch J, Van Meerbeeck J, EORTC Lung Cancer Group: Phase II feasibility trial of induction chemotherapy (ICT) followed by extrapleural pneumonectomy (EPP) and postoperative radiotherapy (PORT) for cT3N1M0 or less malignant pleural mesothelioma (MPM) (EORTC 08031). J Clin Oncol; 2009 May 20;27(15_suppl):7509

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase II feasibility trial of induction chemotherapy (ICT) followed by extrapleural pneumonectomy (EPP) and postoperative radiotherapy (PORT) for cT3N1M0 or less malignant pleural mesothelioma (MPM) (EORTC 08031).
  • : 7509 Background: MPM is a highly lethal disease and the role of EPP in the treatment of early stage, potentially resectable MPM remains controversial.
  • Non-progressing patients (pts) underwent EPP followed by PORT (54Gy, 30 fractions).
  • Primary endpoint was "success of treatment" defined as a patient receiving the full protocol treatment, still alive 90 days after end of treatment without progression and without grade (G) 3-4 toxicity.
  • R0/1/2: 30/10/3, 6 were re-operated, pT0/1/2/3/4: 2/5/19/15/4, pN0/1/2/3: 34/2/6/2, 90-day mortality: 3 pts (6.5%); in 38 pts (83%) postoperative complications occurred.
  • After median follow- up of 19.3 months (mos) median overall survival time was 18.4 mos (95% CI 14.8-NR) and median progression-free survival was 13.9 mos (95% CI 10.9-17.1).
  • Only 24 pts (42%) met the definition of success (one-sided 90% CI 0.36-1.00).

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  • (PMID = 27963479.001).
  • [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. Schwartz GK, Robertson S, Shen A, Wang E, Pace L, Dials H, Mendelson D, Shannon P, Gordon M: A phase I study of XL281, a selective oral RAF kinase inhibitor, in patients (Pts) with advanced solid tumors. J Clin Oncol; 2009 May 20;27(15_suppl):3513

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • The maximum tolerated dose (MTD) was expanded to 10 pts each with colorectal (CRC), melanoma, papillary thyroid (PTC) and NSCLC.
  • One pt with an ocular melanoma demonstrated a cPR of 4 mos duration.
  • Twelve pts had SD (3 -17+ mos), including 2 with I<sup>131</sup>-refractory PTC harboring BRAF V600E mutations (15+ and 17+ mos).
  • At the MTD, paired biopsies from 4 pts (3 melanoma, 1 NSCLC) show an average 72 % decrease in pMEK, 68 % decrease in pERK, 24 % decrease in Ki67 (proliferation) and 64 % increase in TUNEL (apoptosis).
  • Three of 6 evaluable pts in the MTD cohort show SD at first assessment, including 1 melanoma pt with a NRAS Q61R mutation who showed a 20% decrease in target lesions.
  • One cPR occurred in an ocular melanoma subject, and clinical benefit (PR or SD) occurred in 43% (13/30) of pts in the dose-escalation phase.

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  • (PMID = 27961303.001).
  • [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. Karrasch M, Gillespie GY, Braz E, Liechty PG, Nabors LB, Lakeman AD, Palmer CA, Parker JN, Whitley RJ, Markert JM: Treatment of recurrent malignant glioma with G207, a genetically engineered herpes simplex virus-1, followed by irradiation: Phase I study results. J Clin Oncol; 2009 May 20;27(15_suppl):2042

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Treatment of recurrent malignant glioma with G207, a genetically engineered herpes simplex virus-1, followed by irradiation: Phase I study results.
  • Safety and efficacy of intracerebral inoculations of G207 to patients suffering from recurrent malignant gliomas have been demonstrated in previous clinical trials.
  • METHODS: In this phase I clinical trial, a total of 1 x 10<sup>9</sup> plaque forming units (pfu) G207 were administered by five stereotactic injections of 0.2 mL each into regions of recurrent malignant glioma defined by MRI, followed by focal radiation therapy 24 hours post injection.
  • The 2 patients with initial PR (1xGBM, 1xAA) were re-treated with G207/Irradiation at time point of tumor recurrence, showing PR one month after re-treatment again.
  • In patients suffering from relapsed GBM, mOS was 7.4 months, in patients suffering from relapsed AA, mOS was 9.25 months.
  • G207/Irradiation re-treatment was possible and induced anew clinical responses.

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  • (PMID = 27964649.001).
  • [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. Morris RT, Cohn DE, Fowler J, Solomon LA, Vay A, Seward S, Heilbrun L, Smith D, Munkarah AR: Combined weekly docetaxel (D) and gemcitabine (G) for relapsed ovarian cancer (OC) and peritoneal cancer (PC): A multi-institutional phase II study. J Clin Oncol; 2009 May 20;27(15_suppl):5565

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : 5565 Background: Both D and G have demonstrated single-agent activity in OC and PC.
  • The purpose of this study was to prospectively evaluate the efficacy and toxicity for patients (pts) with relapsed platinum-sensitive (Plat-S) and platinum-resistant (Plat-R) OC or PC treated with combination weekly D and G.
  • D (40 mg/m2) and G (800 mg/m2) were administered on days 1 and 8 of a 21 day cycle until progression.
  • There were 2 separate 2-stage designs used, one for each stratum: Plat-R and Plat-S, separately for a total planned sample of 62 pts.
  • The primary endpoint was overall response rate (ORR).
  • Six pts (22%) achieved a complete response (CR), 10 pts (37%) achieved a partial response (PR) and one pt (4%) had stable disease.
  • Progressive disease was noted in 10 pts (37%).
  • Plat-S pts (n = 16) had a 69% ORR (CR = 31%, PR = 38%) and Plat-R pts (n = 11) had an ORR of 45% (CR = 9%, PR = 36%).
  • Median overall survival was 12.7 months (Plat-S = 14.2 mos. and Plat-R = 6.7 mos.).
  • CONCLUSIONS: Weekly D and G combination therapy demonstrates significant activity and moderate toxicity in both Plat-S and Plat-R disease.
  • This non-platinum combination deserves further evaluation and may be considered in pts with Plat-S and Plat-R OC and PC.

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  • (PMID = 27962563.001).
  • [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. Sullivan RJ, Hoshida Y, Brunet J, Tahan S, Aldridge J, Kwabi C, Gardiner E, McDermott D, Golub T, Atkins MB: A single center experience with high-dose (HD) IL-2 treatment for patients with advanced melanoma and pilot investigation of a novel gene expression signature as a predictor of response. J Clin Oncol; 2009 May 20;27(15_suppl):9003

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A single center experience with high-dose (HD) IL-2 treatment for patients with advanced melanoma and pilot investigation of a novel gene expression signature as a predictor of response.
  • : 9003 Background: HD IL-2 remains one of two FDA-approved therapies for the treatment of patients (pts) with advanced melanoma.
  • We present the clinical outcome of pts treated over a recent 2 year period with HD IL-2 at a single institution and an associated retrospective pilot study evaluating the predictive value of a novel tumor gene expression signature.
  • RESULTS: Clinical response occurred in 16 of the 49 pts (32.6%), with 5 pts (10.2%) having a CR.
  • Two other pts had stable disease > 12 mos; 3 pts who progressed after response had resection to NED.
  • 10 pts remain disease/progression free at a minimum of 16 mos following treatment.
  • CONCLUSIONS: The overall and CR rates in a contemporary series of pts with metastatic melanoma treated with HD IL-2 are twice that reported in initial studies suggesting some treatment selection on clinical grounds since the 1990s.
  • This finding requires prospective validation, but suggests immune-related gene expression might contribute to IL-2 responsiveness.

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  • (PMID = 27962351.001).
  • [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. Sperinde J, Ali S, Leitzel K, Fuchs E, Köstler WJ, Paquet A, Weidler J, Huang W, Bates M, Lipton A: Identification of a subpopulation of metastatic breast cancer patients with very high HER2 expression levels and possible resistance to trastuzumab. J Clin Oncol; 2009 May 20;27(15_suppl):1059

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Identification of a subpopulation of metastatic breast cancer patients with very high HER2 expression levels and possible resistance to trastuzumab.
  • METHODS: The HERmark assay was used to measure H2T in formalin-fixed, paraffin-embedded (FFPE) primary breast tumor specimens from 99 women treated with trastuzumab for MBC.
  • At the highest levels of H2T, an abrupt decrease in the PFS rate was observed, consistent with a reduction in susceptibility to trastuzumab.
  • KM analyses demonstrated that patients who were FISH(+), H2T intermediate had a significantly longer PFS than patients who were FISH(-), H2T low (median PFS 12.6 vs. 4.5 mos; HR = 0.34; p < 0.0001).
  • Patients that were FISH(+), H2T high experienced a PFS that was no better than patients that were FISH(-), H2T low (median PFS 4.6 vs. 4.5 mos; HR = 0.87; p = 0.68).
  • MBC patients with very high levels of H2T could represent a sub-group with de novo resistance to trastuzumab who may benefit from combined therapy.

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  • (PMID = 27961126.001).
  • [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. Mayer E, Baurain J, Sparano J, Strauss L, Campone M, Fumoleau P, Rugo H, Awada A, Sy O, Llombart A: Dasatinib in advanced HER2/neu amplified and ER/PR-positive breast cancer: Phase II study CA180088. J Clin Oncol; 2009 May 20;27(15_suppl):1011

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • Subsequent to study initiation, dasatinib demonstrated similar efficacy with a lower incidence of key side-effects at 100 mg once daily in CML and prostate cancer.
  • METHODS: Pts with measurable disease and progression after chemotherapy and other targeted agents were treated with dasatinib on a continuous twice-daily (BID) schedule; RECIST-defined response rate was primary endpoint.
  • RESULTS: Sixty-eight pts, 24 with HER-2-amplified and 44 with HER-2-normal, ER+ and/or PR+ disease, were treated.
  • We observed 3 partial responses lasting 9, 9 and 8+ mos plus 6 stable disease ≥16 weeks (range 24-33 wks).
  • All 9 controlled tumors were ER/PR+, 2 were also HER-2-amplified; thus, disease control rate was 19% in the 47 radiographically-evaluable pts with ER/PR+ disease.
  • Median dose intensity was 136 mg/day at 70 mg BID and 175 mg/day at 100 mg BID; median duration of therapy was 1.8 mos in both dose groups.
  • Most pts (75%) discontinued for disease progression.

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  • (PMID = 27960737.001).
  • [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. 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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60. 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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61. 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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62. 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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63. 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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64. Ahlgren P, Thirlwell M, O'Regan R, Mormont C, Levesque L, Gaspo R, Woloj M, Bello A, Martell B, Leyland-Jones B: An open-label study of sunitinib (SU) plus exemestane (E) in the first-line treatment of hormone receptor (HR)-positive metastatic breast cancer (MBC). J Clin Oncol; 2009 May 20;27(15_suppl):e12019

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • Combining agents that target different signaling pathways may have additive/synergistic activity; combining the AI letrozole with the anti-VEGF agent bevacizumab prolonged progression-free survival to >14 mos as 1st-line therapy for HR+ MBC (Dickler et al. 2008).
  • An open-label, phase I, dose-finding study of first-line SU + E was conducted in HR+ MBC pts.
  • One death occurred on study (non treatment-related Enterobacter sepsis).
  • CONCLUSIONS: These data indicate that SU + E was tolerable with manageable toxicities, with increases in PK parameters and a similar AE profile to that of either single agent alone.

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  • (PMID = 27964247.001).
  • [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. Socinski MA, Stinchcombe TE, Halle JS, Moore DT, Petty WJ, Blackstock AW, Gettinger SN, Decker RH, Khandani AH, Morris DE: Incorporation of bevacizumab (B) and erlotinib (Er) with induction (Ind) and concurrent (Conc) carboplatin (Cb)/paclitaxel (P) and 74 Gy of thoracic radiotherapy in stage III non-small cell lung cancer (NSCLC). J Clin Oncol; 2009 May 20;27(15_suppl):7528

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Incorporation of bevacizumab (B) and erlotinib (Er) with induction (Ind) and concurrent (Conc) carboplatin (Cb)/paclitaxel (P) and 74 Gy of thoracic radiotherapy in stage III non-small cell lung cancer (NSCLC).
  • The primary endpoint is PFS at 1 year.
  • RESULTS: Thus far, 31 eligible PS 0-1 pts have been accrued (med age 62 yrs, range 41-74, 19 non- squamous, 12 SQ, 63% IIIA, 37% IIIB).
  • One gr 5 late (> 2 mos after treatment) PH occurred in a SQ pt.
  • CONCLUSIONS: Preliminarily, we conclude that 1) Incorporation of B and E into this treatment paradigm appears feasible, 2) Esophagitis remains the primary toxicity, 3) Phase II accrual continues but early analysis of survival appears promising.

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  • (PMID = 27963295.001).
  • [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. Dahlberg SE, Sandler AB, Brahmer JR, Schiller JH, Johnson DH: Clinical course of advanced non-small cell lung cancer (NSCLC) patients (pts) experiencing hypertension (HTN) during treatment (TX) with bevacizumab (B) in combination with carboplatin (C) and paclitaxel (P) on E4599. J Clin Oncol; 2009 May 20;27(15_suppl):8042

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Clinical course of advanced non-small cell lung cancer (NSCLC) patients (pts) experiencing hypertension (HTN) during treatment (TX) with bevacizumab (B) in combination with carboplatin (C) and paclitaxel (P) on E4599.
  • Administration of B is thought to decrease nitrous oxide synthesis and lead to HTN, one of the known toxicities associated with PCB on E4599.
  • This side effect may be a physiological sign that the VEGF pathway is more actively being blocked and indicate differential outcomes between hypertensive and non-hypertensive pts.
  • Baseline characteristics of the HTN cohort were similar to those in the non-HTN cohort except for a higher proportion of PS 0 pts (70% vs. 38%, p=0.001) and females (67% vs. 48%, p=0.05).
  • Median follow-up was 54.8 mos.
  • The 6-month cumulative incidence of HTN adjusting for death as a competing risk was 6.2% (95% CI: 3.9-8.6%).
  • Proportional hazards models for OS and PFS adjusting for HTN as a time-varying covariate resulted in an OS HR=0.64 (0.43-0.96, p=0.03) and PFS HR=0.83 (0.57-1.20, p=0.32).
  • The same modeling adjusting for high BP (>150/100) as a time-varying covariate resulted in OS HR=0.60 (0.44-0.82, p=0.002) and PFS HR=0.71 (0.54-0.95, p=0.02).
  • Results for high BP remained statistically significant after adjusting for sex, PS, histology, adrenal, liver and bone mets.

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  • (PMID = 27962851.001).
  • [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. Naik SG, Negrin R, Laport G, Miklos D, Shizuru J, Arai S, Blume K, Wong R, Lowsky R, Johnston L: Long-term outcomes of high-dose therapy using busulfan, etoposide, and cyclophosphamide followed by allogeneic hematopoietic cell transplantation for patients with high-risk or advanced stages of myeloid malignancies. J Clin Oncol; 2009 May 20;27(15_suppl):7033

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Long-term outcomes of high-dose therapy using busulfan, etoposide, and cyclophosphamide followed by allogeneic hematopoietic cell transplantation for patients with high-risk or advanced stages of myeloid malignancies.
  • : 7033 Patients (pts) with high risk (HR) or advanced myeloid malignancies have limited effective treatment options.
  • All pts were treated with a uniform preparatory regimen: busulfan 16.0 mg/kg (d-8 to-5), etoposide 60mg/kg (d-4), cyclophosphamide 60mg/kg (d-2), and graft-versus-host-disease (GVHD) prophylaxis of cyclosporine and prednisone.
  • Disease status at transplantation was induction failure (IF) acute myeloid leukemia (AML) (n = 10), HR AML in 1st complete remission (CR1) n = 11, in CR2 (n = 5), in CR3 (n = 2), relapsed refractory (RR) AML (n = 14), chronic myeloid leukemia (CML) in second chronic phase (n = 6), blast crisis (n = 2), myelofibrosis (n = 6), myeloproliferative disorders (n = 2), and MDS (n = 38).
  • Thirty-six % (n = 35) of pts received bone marrow while 64 % (n = 61) received G-CSF mobilized peripheral blood mononuclear cells (PBMC).
  • With a median follow up of 5.6 yrs (1.6-14.6 yrs) actuarial 5-year overall survival (OS) was 32% (95% CI 22-42%) and 5-year probability for freedom from progression (FFP) was 64% (95% CI 52%-76%).
  • Non-relapse mortality (NRM) was 29 % (95% CI 20%5-38%) at day 100 and 39% (95% CI 29%-49%) at one yr.
  • Cumulative incidence of acute (grade 3-4) and chronic GVHD was 28% (95% CI 19%-37%) and 38% (95% CI 24%-52%), respectively.
  • These results confirm that pts with high-risk or advanced myeloid malignancies can achieve long-term survival following myeloablative allogeneic HCT with aggressive conditioning.

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  • (PMID = 27961395.001).
  • [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. Vogel CL, Burris HA, Limentani S, Borson R, O'Shaughnessy J, Vukelja S, Agresta S, Klencke B, Birkner M, Rugo H: A phase II study of trastuzumab-DM1 (T-DM1), a HER2 antibody-drug conjugate (ADC), in patients (pts) with HER2+ metastatic breast cancer (MBC): Final results. J Clin Oncol; 2009 May 20;27(15_suppl):1017

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : 1017 Background: T-DM1 is an ADC that combines the biological activity of trastuzumab (T) with targeted delivery of a potent antimicrotubule agent, DM1, to HER2-expressing cancer cells.
  • The confirmed objective response rate (ORR) for the 9 pts with measurable disease treated at the MTD was 44%.
  • Primary objectives were assessment of ORR and of safety and tolerability.
  • RESULTS: As of the August 29, 2008, data-cut, 112 patients had enrolled, with baseline median age 54.5 (range 33-82); ECOG PS 2 or 3, 80%; 68.7% with > 3 sites of metastatic disease; median 3 (range 1-14) prior chemotherapy agents for metastatic disease, median 76.3 weeks prior T, and 55.4% with previous lapatinib.
  • With a median follow-up of 4.4 mos, there were 42 (39.3%) ORs (CR or PR), 29 (27.1%) of which have been confirmed by follow-up (F/U) imaging.

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  • (PMID = 27960734.001).
  • [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. 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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70. 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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76. 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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77. 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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78. 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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79. Philip PA, Gupta S, Heilbrun L, Smith D, El-Rayes B, Shields A: &lt;sup&gt;18&lt;/sup&gt;F-Fluorodeoxyglucose positron emission tomography (FDG-PET) as a prognostic and predictive biomarker in metastatic colorectal cancer (mCRC). J Clin Oncol; 2009 May 20;27(15_suppl):e15037

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] <sup>18</sup>F-Fluorodeoxyglucose positron emission tomography (FDG-PET) as a prognostic and predictive biomarker in metastatic colorectal cancer (mCRC).
  • The growing complexity of current therapies and the increasing number of agents to be tested in this disease warrants better understanding of the role of FDG-PET in earlier treatment decisions.
  • 56% and 37% of pts had partial response and stable disease (RECIST criteria), respectively.
  • Median TTP was 13.0 months (90% CI: 10.9 - 16.3 mos), with a median follow-up time for progression of 7.8 months.

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  • (PMID = 27964469.001).
  • [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. Li W, Zhang W, Cai S, Yin J, Li J: Prognostic factors for colorectal cancer patients with pulmonary metastases. J Clin Oncol; 2009 May 20;27(15_suppl):e15107

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : e15107 Background: Pulmonary is the second common metastastic site of CRC with a good survival after metastasectomy, however the general situation of pulmonary metastases from CRC has received little attention, especially for unresectable ones.
  • The aim of this study was to determine factors that may influence survival and disease free interval from primary radical surgery to pulmonary metastases (DFI).
  • METHODS: From 01/2000 to 11/2008, a total of 206 pts with pulmonary metastases (colon72, rectal ca131, 3 unknown) were collected retrospectively and the clinical data were analyzed using Kaplan-Meier survival curves, univariate and multivariate analysis.
  • RESULTS: 128 pts (62.1%) had lung disease as the first metastatic site and 33 pts (26.7%) had synchronous liver involvement.
  • Median survival was 16.0 months (range 12.240-19.760) with a 18% 5-year survival.
  • Of the totally 160 patients who had synchronous pulmonary metastases after radical primary tumor surgery, the mDFI was 20 months (range 16.738-23.262) months.
  • Rectal cancer had a high chance (65%) for lung recurrence with longer DFI (21 vs 14 mo, P=0.02), but no difference of survival was shown compared to colon cancer.
  • The factors influencing the DFI of metachronous pulmonary metastases included primary tumor site, pathological morphology, tumor infiltration stage and regional lymph node stage (P<0.05).
  • There was a trend of better survival of patients receiving resection surgery after pulmonary metastases than receiving chemotherapy alone though no statistical significant was reached (mOS:34 vs 16 mo, P=0.125).
  • The invasive tumor with high stage may have a shorter disease free interval of pulmonary metastases after primary surgery.

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  • (PMID = 27964342.001).
  • [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. Tang P, Gill S, Au HJ, Chen EX, Hedley D, Leroux M, Wang L, Moore MJ: Phase II trial of erlotinib in advanced pancreatic cancer (PC). J Clin Oncol; 2009 May 20;27(15_suppl):4609

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • Benefit from erlotinib (Tarceva), an oral EGFR tyrosine kinase inhibitor has been associated with the presence of a skin rash.
  • METHODS: Erlotinib was given at an initial dose of 150 mg/day to eligible pts with locally advanced (LA) or metastatic PC who had progressed or were unable to tolerate gemcitabine-based chemotherapy.
  • The primary endpoint of this two- stage phase II trial was prolonged disease control (PR + SD > 8 wks) with a rate of >20% assumed to be significant .
  • RESULTS: Fifty pts were accrued (median age 61, M:F = 25:25, ECOG 0:1:2 = 5:41:4, LA:Metastatic = 5:45, prior gemcitabine none:adjuvant:palliative = 2:16:35).
  • Prolonged disease control (SD > 8 wks) was observed in 10/40 evaluable pts, 0.25 (95% CI: 0.12-0.38), which met the primary study endpoint.
  • Median TTP was 1.6 mo (95% CI:1.6-2.1), mOS 4.1 mo (95% CI:3.2-7.3), and 6 mo OS rate was 39% (95%CI: 24-61%).
  • CONCLUSIONS: Erlotinib is associated with prolonged stable disease in a subset of pts with advanced refractory PC.

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  • (PMID = 27964176.001).
  • [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. Fernandes A, Faerber J, Finlay J, Shen J, Lin L, Evans T, Stevenson J, Langer C, Glatstein E, Hahn S, Rengan R: Clinical outcomes of elective nodal irradiation (ENI) compared with involved field radiotherapy (IFRT) in NSCLC. J Clin Oncol; 2009 May 20;27(15_suppl):7541

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : 7541 Background: Local failure rates in patients treated with definitive radiotherapy for non-small cell lung cancer (NSCLC) remain high.
  • IFRT allows higher radiation doses to the primary tumor with the goal of reducing local failure rates while minimizing toxicity.
  • The median follow-up time was 8.4 mos (0.3-43.4) for all pts and 9.7 mos (1.5-40.1) for survivors.
  • CONCLUSIONS: Our data suggest that IFRT does not result in increased nodal failures or decreased survival compared to ENI, and may result in increased local control.

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  • (PMID = 27963317.001).
  • [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. Bedognetti D, Rubagotti A, Conti G, Francesca F, De Cobelli O, Canclini L, Gallucci M, Aragona F, Di Tonno P, Boccardo F: An open, randomized, multicentre, phase III trial comparing the efficacy of two tamoxifen (T) schedules in preventing gynecomastia (gy) induced by bicalutamide monotherapy (BM) in prostate cancer patients (pca pts). J Clin Oncol; 2009 May 20;27(15_suppl):e16080

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • However possible interferences between B and T,especially after prolonged administration, remain a matter of concern.In order to reduce the exposure to T,we considered the putative advantages of a weekly administration based on T effects being dose -dependent and on drug long half-life.
  • METHODS: This was a non inferiority trial.
  • Gy (primary endpoint), breast pain (bp), serum PSA levels and sexual functioning scores were evaluated.
  • RESULTS: At a median F.U. of 24.2 mos (95% CI: 23.7 -24.6) gy developed in 31.7% of pts in d group and in 74.4% of pts in wk group (p < 0.000).
  • There were no major differences among treat. schedules relative to sexual functioning scores, PSA behaviour and disease progression.

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  • (PMID = 27963100.001).
  • [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. Yau CC, Chen PJ, Curtis CM, Murphy PS, Suttle AB, Arumugham T, Hodge JP, Dar MM, Poon R: A phase I study of pazopanib in patients with advanced hepatocellular carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):3561

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • RESULTS: 27 Asian pts have been enrolled at QD doses of 200 (4 pts), 400 (10), 600 (8), 800 (5): median (range) age = 61 (38-76); M/F = 85%/15%; ECOG 0/1 = 59%/41%; 81% with metastatic disease; 67% with Stage IV; 22% with prior systemic therapy, 26% with prior TACE.
  • Best response was PR in 2 pts (7%; 1 at 800mg, 1 at 600 mg) and SD > 4 mos in 11 pts (41%).

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  • (PMID = 27961693.001).
  • [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. 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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86. 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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87. 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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88. 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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89. 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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90. 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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91. 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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92. 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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93. 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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94. 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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95. 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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96. 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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97. 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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98. 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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99. 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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100. 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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