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1. El-Haddad AM, Ibrahim MF, El-Wakil MA, El-Bolkainy TN, Farahat IG: Pediatric Non Metastatic Non Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTSS): Five Years Experience from NCI-Egypt. J Egypt Natl Canc Inst; 2008 Dec;20(4):395-402

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Pediatric Non Metastatic Non Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTSS): Five Years Experience from NCI-Egypt.
  • PURPOSE: Evaluation of demographic, pathological, and clinical patterns in addition to treatment outcome of pediatric NRSTS patients treated at the NCI, Egypt.
  • PROCEDURE: 21 pediatric patients of NRSTS between 2001 and 2006 were included.
  • Patients' cohort formed of 3 treatment groups. (1) Patients who underwent complete surgical resection with no adjuvant therapies. (2) Patients who received chemotherapy and complete surgical resection, and group (3) Patients with localized unrersectable tumors for whom systemic chemotherapy only was given.
  • Demographic, clinicopathological variables, and treatment modalities were statistically evaluated and compared with the outcome.
  • RESULTS: Tumors of unknown histiogenesis followed by MPNST and myxofibrosarcoma were the most frequent tumor subtypes.
  • Low tumor grade was in favor of better outcome.
  • With a median follow up of 2-years; respectively 100% and 81.1% of patients who had complete surgical resection of a localized disease with or without chemotherapy entered in CR (p=0.01).
  • CONCLUSIONS: Complete surgical resection with or without chemotherapy is the mainstay of therapy for localized NRSTS.
  • Tumor grade and surgical resection of NRSTS are 2 important predictors of prognosis.
  • KEY WORDS: Nonrhabdomyosarcoma - Soft tissue sarcoma - Pediatric.

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  • (PMID = 20571598.001).
  • [ISSN] 1110-0362
  • [Journal-full-title] Journal of the Egyptian National Cancer Institute
  • [ISO-abbreviation] J Egypt Natl Canc Inst
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Egypt
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2. Benz MR, Czernin J, Allen-Auerbach MS, Tap WD, Dry SM, Elashoff D, Chow K, Evilevitch V, Eckardt JJ, Phelps ME, Weber WA, Eilber FC: FDG-PET/CT imaging predicts histopathologic treatment responses after the initial cycle of neoadjuvant chemotherapy in high-grade soft-tissue sarcomas. Clin Cancer Res; 2009 Apr 15;15(8):2856-63
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  • [Title] FDG-PET/CT imaging predicts histopathologic treatment responses after the initial cycle of neoadjuvant chemotherapy in high-grade soft-tissue sarcomas.
  • PURPOSE: In patients with soft-tissue sarcoma (STS), the early assessment of treatment responses is important.
  • Using positron emission tomography/computed tomography (PET/CT) with [(18)F]fluorodeoxyglucose (FDG), we determined whether changes in tumor FDG uptake predict histopathologic treatment responses in high-grade STS after the initial cycle of neoadjuvant chemotherapy.
  • EXPERIMENTAL DESIGN: From February 2006 to March 2008, 50 patients with resectable high-grade STS scheduled for neoadjuvant therapy and subsequent tumor resection were enrolled prospectively.
  • FDG-PET/CT before (baseline), after the first cycle (early follow-up), and after completion of neoadjuvant therapy (late follow-up) was done.
  • Tumor FDG uptake and changes were measured by standardized uptake values.
  • Histopathologic examination of the resected specimen provided an assessment of treatment response.
  • Patients with > or = 95% pathologic necrosis were classified as treatment responders.
  • CONCLUSION: A 35% reduction in tumor FDG uptake at early follow-up is a sensitive predictor of histopathologic tumor response.
  • Early treatment decisions such as discontinuation of chemotherapy in nonresponding patients could be based on FDG-PET criteria.

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  • (PMID = 19351756.001).
  • [ISSN] 1078-0432
  • [Journal-full-title] Clinical cancer research : an official journal of the American Association for Cancer Research
  • [ISO-abbreviation] Clin. Cancer Res.
  • [Language] ENG
  • [Grant] United States / NCI NIH HHS / CA / P01 CA132681; United States / NCI NIH HHS / CA / P50 CA086306; United States / NCI NIH HHS / CA / 5 P50 CA086306
  • [Publication-type] Journal Article; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, Non-P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0W860991D6 / Deoxycytidine; 0Z5B2CJX4D / Fluorodeoxyglucose F18; 80168379AG / Doxorubicin; B76N6SBZ8R / gemcitabine; UM20QQM95Y / Ifosfamide
  • [Other-IDs] NLM/ NIHMS586551; NLM/ PMC4068269
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3. Lewis JJ, Leung D, Espat J, Woodruff JM, Brennan MF: Effect of reresection in extremity soft tissue sarcoma. Ann Surg; 2000 May;231(5):655-63
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  • [Title] Effect of reresection in extremity soft tissue sarcoma.
  • OBJECTIVE: To determine whether reresection affects survival in patients with inadequately resected, primary extremity soft tissue sarcoma.
  • SUMMARY BACKGROUND DATA: Soft tissue sarcomas are rare neoplasms, with an incidence of approximately 6,000 per year in the United States.
  • Because these tumors are rare and benign soft tissue tumors are common, many are initially thought to be benign and are excised without wide margins.
  • METHODS: Patients who underwent treatment for primary tumors from July 1982 to June 1999 at a single institution were the subject of study.
  • Two groups of patients were analyzed: those who underwent one definitive resection (one operation) and those whose tumors were previously resected and who were then referred for subsequent reresection (two operations).
  • Patients were given adjuvant radiation or chemotherapy according to the standard of care.
  • RESULTS: Of 1,092 patients with primary extremity soft tissue sarcoma underwent resection, 685 underwent definitive radical resection and 407 underwent reresection after undergoing excisional resection elsewhere.
  • The 5-year disease-free survival rate of the definitive resection (one operation) group was 70%; that of the reresection (two operations) group was 88%.
  • On multivariate analysis, reresection was adjusted and controlled for age, grade, depth, size, histology, and margins.
  • In all stages there was a trend toward improved outcome; this was most marked for those with stage III disease (>5 cm, high-grade, and deep).
  • CONCLUSIONS: Patients with extremity soft tissue sarcoma who undergo reresection with two "primary" operations have an improved survival compared with those who undergo one operation.
  • This suggests that where indicated and possible, reresection should be liberally applied in patients with primary extremity soft tissue sarcoma.

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  • (PMID = 10767786.001).
  • [ISSN] 0003-4932
  • [Journal-full-title] Annals of surgery
  • [ISO-abbreviation] Ann. Surg.
  • [Language] ENG
  • [Grant] United States / NCI NIH HHS / CA / P01 CA047179; United States / NCI NIH HHS / CA / CA47179
  • [Publication-type] Journal Article; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Other-IDs] NLM/ PMC1421052
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4. Issels RD, Lindner LH, Verweij J, Wust P, Reichardt P, Schem BC, Abdel-Rahman S, Daugaard S, Salat C, Wendtner CM, Vujaskovic Z, Wessalowski R, Jauch KW, Dürr HR, Ploner F, Baur-Melnyk A, Mansmann U, Hiddemann W, Blay JY, Hohenberger P, European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group (EORTC-STBSG), European Society for Hyperthermic Oncology (ESHO): Neo-adjuvant chemotherapy alone or with regional hyperthermia for localised high-risk soft-tissue sarcoma: a randomised phase 3 multicentre study. Lancet Oncol; 2010 Jun;11(6):561-70
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  • [Title] Neo-adjuvant chemotherapy alone or with regional hyperthermia for localised high-risk soft-tissue sarcoma: a randomised phase 3 multicentre study.
  • BACKGROUND: The optimum treatment for high-risk soft-tissue sarcoma (STS) in adults is unclear.
  • Regional hyperthermia concentrates the action of chemotherapy within the heated tumour region.
  • Phase 2 studies have shown that chemotherapy with regional hyperthermia improves local control compared with chemotherapy alone.
  • We designed a parallel-group randomised controlled trial to assess the safety and efficacy of regional hyperthermia with chemotherapy.
  • Patients with localised high-risk STS (> or = 5 cm, Fédération Nationale des Centres de Lutte Contre le Cancer [FNCLCC] grade 2 or 3, deep to the fascia) were randomly assigned to receive either neo-adjuvant chemotherapy consisting of etoposide, ifosfamide, and doxorubicin (EIA) alone, or combined with regional hyperthermia (EIA plus regional hyperthermia) in addition to local therapy.
  • All patients were included in the analysis of the primary endpoint, and 332 patients who received at least one cycle of chemotherapy were included in the safety analysis.
  • The treatment response rate in the group that received regional hyperthermia was 28.8%, compared with 12.7% in the group who received chemotherapy alone (p=0.002).
  • In a pre-specified per-protocol analysis of patients who completed EIA plus regional hyperthermia induction therapy compared with those who completed EIA alone, overall survival was better in the combined therapy group (HR 0.66, 95% CI 0.45-0.98, p=0.038).
  • Leucopenia (grade 3 or 4) was more frequent in the EIA plus regional hyperthermia group compared with the EIA-alone group (128 of 165 vs 106 of 167, p=0.005).
  • Two deaths were attributable to treatment in the combined treatment group, and one death was attributable to treatment in the EIA-alone group.
  • INTERPRETATION: To our knowledge, this is the first randomised phase 3 trial to show that regional hyperthermia increases the benefit of chemotherapy.
  • Adding regional hyperthermia to chemotherapy is a new effective treatment strategy for patients with high-risk STS, including STS with an abdominal or retroperitoneal location.
  • FUNDING: Deutsche Krebshilfe, Helmholtz Association (HGF), European Organisation of Research and Treatment of Cancer (EORTC), European Society for Hyperthermic Oncology (ESHO), and US National Institute of Health (NIH).
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Hyperthermia, Induced. Neoadjuvant Therapy. Sarcoma / therapy
  • [MeSH-minor] Adolescent. Adult. Aged. Combined Modality Therapy. Disease-Free Survival. Doxorubicin / administration & dosage. Etoposide / administration & dosage. Female. Humans. Ifosfamide / administration & dosage. Male. Middle Aged. Neoplasm Recurrence, Local. Retroperitoneal Neoplasms. Survival Rate. Young Adult

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  • [Copyright] Copyright 2010 Elsevier Ltd. All rights reserved.
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  • (PMID = 20434400.001).
  • [ISSN] 1474-5488
  • [Journal-full-title] The Lancet. Oncology
  • [ISO-abbreviation] Lancet Oncol.
  • [Language] eng
  • [Databank-accession-numbers] ClinicalTrials.gov/ NCT00003052
  • [Grant] United States / NCI NIH HHS / CA / P01 CA042745; United States / NCI NIH HHS / CA / P01 CA042745-23; United States / NCI NIH HHS / CA / P01 CA42745
  • [Publication-type] Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 6PLQ3CP4P3 / Etoposide; 80168379AG / Doxorubicin; UM20QQM95Y / Ifosfamide; AVI protocol
  • [Other-IDs] NLM/ NIHMS322633; NLM/ PMC3517819
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5. Blay JY, von Mehren M, Samuels BL, Fanucchi MP, Ray-Coquard I, Buckley B, Gilles L, Lebedinsky C, Elsayed YA, Le Cesne A: Phase I combination study of trabectedin and doxorubicin in patients with soft-tissue sarcoma. Clin Cancer Res; 2008 Oct 15;14(20):6656-62
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  • [Title] Phase I combination study of trabectedin and doxorubicin in patients with soft-tissue sarcoma.
  • PURPOSE: To determine the dose of trabectedin plus doxorubicin with granulocyte colony-stimulating factor support associated with manageable neutropenia and acceptable dose-limiting toxicities (DLT) in patients with recurrent or persistent soft-tissue sarcoma.
  • METHODS: In this phase I, open-label, multicenter trial, patients previously treated with 0-1 prior chemotherapy regimens excluding doxorubicin, an Eastern Cooperative Oncology Group performance status 0-1, and adequate organ function received a 10- to 15-min i.v. infusion of doxorubicin 60 mg/m(2) immediately followed by a 3-h i.v. infusion of trabectedin 0.9 to 1.3 mg/m(2) on day 1 of a 3-week cycle.
  • Adverse events, tumor response, and survival were assessed.
  • RESULTS: Patients (N = 41) received a median of six cycles of treatment (range, 2-13).
  • Common grade 3/4 treatment-emergent adverse events were neutropenia (71%), alanine aminotransferase increase (46%), and thrombocytopenia (37%).
  • CONCLUSION: The combination of doxorubicin 60 mg/m(2) followed by trabectedin 1.1 mg/m(2) every 21 days is safe and active in patients with soft-tissue sarcoma.

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  • (PMID = 18927308.001).
  • [ISSN] 1078-0432
  • [Journal-full-title] Clinical cancer research : an official journal of the American Association for Cancer Research
  • [ISO-abbreviation] Clin. Cancer Res.
  • [Language] ENG
  • [Grant] United States / NCI NIH HHS / CA / P30 CA006927; None / None / / P30 CA006927-46; United States / NCI NIH HHS / CA / P30 CA006927-46
  • [Publication-type] Clinical Trial, Phase I; Journal Article; Multicenter Study
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Dioxoles; 0 / Tetrahydroisoquinolines; 114899-77-3 / trabectedin; 143011-72-7 / Granulocyte Colony-Stimulating Factor; 80168379AG / Doxorubicin
  • [Other-IDs] NLM/ NIHMS113333; NLM/ PMC2777645
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6. Soriano AO, Thompson MA, Admirand JH, Fayad LE, Rodriguez AM, Romaguera JE, Hagemeister FB, Pro B: Follicular dendritic cell sarcoma: a report of 14 cases and a review of the literature. Am J Hematol; 2007 Aug;82(8):725-8
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  • [Title] Follicular dendritic cell sarcoma: a report of 14 cases and a review of the literature.
  • The natural history and response to different treatments have not been well established.
  • Histologically, four cases showed low-grade features, three cases showed low-grade features with focal high-grade features, and five cases showed high-grade features.
  • Information on initial treatment was available in 11 patients, which included surgery alone in one patient, surgery and radiation in two, surgery and chemotherapy in one, chemotherapy alone in three, chemotherapy and radiation in one, surgery followed by radiation and chemotherapy in three patients.
  • In eight patients the initial chemotherapy regimen was cyclophosphamide, doxorubicin, vincristine, and prednisone.
  • Follicular sarcoma is an aggressive neoplasm.
  • Although most of the patients initially responded to treatment, the majority of them (81%) relapsed.
  • A better understanding of the biology of FDCS could guide our efforts in the development of new treatment modalities for this rare disease.
  • [MeSH-major] Dendritic Cells, Follicular / pathology. Sarcoma / pathology
  • [MeSH-minor] Adult. Aged. Female. Humans. Male. Middle Aged. Neoplasm Staging. Treatment Outcome

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  • (PMID = 17373675.001).
  • [ISSN] 0361-8609
  • [Journal-full-title] American journal of hematology
  • [ISO-abbreviation] Am. J. Hematol.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA16672
  • [Publication-type] Case Reports; Journal Article; Research Support, N.I.H., Extramural; Review
  • [Publication-country] United States
  • [Number-of-references] 18
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7. Grobmyer SR, Maki RG, Demetri GD, Mazumdar M, Riedel E, Brennan MF, Singer S: Neo-adjuvant chemotherapy for primary high-grade extremity soft tissue sarcoma. Ann Oncol; 2004 Nov;15(11):1667-72
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  • [Title] Neo-adjuvant chemotherapy for primary high-grade extremity soft tissue sarcoma.
  • BACKGROUND: The purpose of this study was to retrospectively analyze the relationship between neo-adjuvant chemotherapy (NAC) and outcome in patients with high-grade extremity sarcomas.
  • PATIENTS AND METHODS: Inclusion criteria were high-grade, deep, >5 cm extremity soft tissue sarcomas.
  • CONCLUSION: NAC with AIM was associated with a significant improvement in disease-specific survival in patients with high-grade extremity soft tissue sarcomas >10 cm.
  • These data emphasize the need for further prospective clinical studies of neo-adjuvant or adjuvant chemotherapy for patients with large high-grade extremity sarcomas.

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  • (PMID = 15520069.001).
  • [ISSN] 0923-7534
  • [Journal-full-title] Annals of oncology : official journal of the European Society for Medical Oncology
  • [ISO-abbreviation] Ann. Oncol.
  • [Language] ENG
  • [Grant] United States / NCI NIH HHS / CA / P01CA47179
  • [Publication-type] Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] England
  • [Chemical-registry-number] NR7O1405Q9 / Mesna; UM20QQM95Y / Ifosfamide
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8. Wunder JS, Healey JH, Davis AM, Brennan MF: A comparison of staging systems for localized extremity soft tissue sarcoma. Cancer; 2000 Jun 15;88(12):2721-30
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  • [Title] A comparison of staging systems for localized extremity soft tissue sarcoma.
  • BACKGROUND: Staging systems for soft tissue sarcoma (STS) are important to identify patients with similar systemic risk who might benefit from specific treatments.
  • This study compared four commonly used staging systems for predicting systemic outcomes of patients with localized extremity STS, as proposed by the fourth and fifth editions of the American Joint Committee on Cancer/International Union Against Cancer (AJCC/UICC) staging system, the Memorial Sloan-Kettering Cancer Center (MSK) system, and the Surgical Staging System (SSS) of the Musculoskeletal Tumor Society.
  • RESULTS: Compartment status, depth, grade, and size were all independent predictors of outcome within their respective staging systems.
  • However, when compared with one another, only depth, grade, and size retained their prognostic significance.
  • CONCLUSIONS: Staging systems such as the MSK system or the fifth edition of the AJCC/UICC system, which include tumor depth, grade, and size as prognostic factors, are the most predictive of systemic relapse in patients presenting with localized extremity STS.
  • Both of these systems identify the same group of patients at the highest risk who would be the most suitable for adjuvant chemotherapy trials.
  • [MeSH-major] Neoplasm Staging / methods. Sarcoma / pathology. Soft Tissue Neoplasms / pathology
  • [MeSH-minor] Adolescent. Adult. Aged. Aged, 80 and over. Chemotherapy, Adjuvant. Female. Humans. Male. Middle Aged. Multivariate Analysis. Neoplasm Metastasis. Prognosis. Retrospective Studies. Risk Factors

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  • [Copyright] Copyright 2000 American Cancer Society.
  • (PMID = 10870054.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA-47179
  • [Publication-type] Comparative Study; Journal Article; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] UNITED STATES
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9. Ryan CW, Dolan ME, Brockstein BB, McLendon R, Delaney SM, Samuels BL, Agamah ES, Vokes EE: A phase II trial of O6-benzylguanine and carmustine in patients with advanced soft tissue sarcoma. Cancer Chemother Pharmacol; 2006 Nov;58(5):634-9
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  • [Title] A phase II trial of O6-benzylguanine and carmustine in patients with advanced soft tissue sarcoma.
  • PURPOSE: Tumor resistance to alkylating agents such as carmustine (BCNU) has been found to be associated with intracellular expression of O6-methylguanine-DNA methyltransferase (MGMT).
  • Administration of O6-benzylguanine (O6-BG), a substrate that inactivates MGMT, may help overcome chemotherapy resistance.
  • We performed a phase II study to explore the activity of O6-BG in combination with BCNU in patients with advanced soft tissue sarcoma.
  • EXPERIMENTAL DESIGN: Informed consent was obtained from patients with metastatic soft tissue sarcoma naïve to systemic chemotherapy (adjuvant chemotherapy allowed).
  • Treatment was repeated every 6 weeks until disease progression or development of unacceptable toxicity.
  • The most common grade 3-4 toxicities were neutropenia, thrombocytopenia, and anemia.
  • Immunohistochemical estimation of MGMT expression from archival tissue ranged from 20 to 99% positive staining cells.
  • Further development of this regimen and dose for the treatment of soft tissue sarcoma is not warranted due to the lack of objective responses.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Sarcoma / drug therapy
  • [MeSH-minor] Adult. Aged. Anemia / chemically induced. Carmustine / administration & dosage. Carmustine / adverse effects. Enzyme Inhibitors / administration & dosage. Enzyme Inhibitors / adverse effects. Female. Gastrointestinal Stromal Tumors / drug therapy. Guanine / administration & dosage. Guanine / adverse effects. Guanine / analogs & derivatives. Humans. Immunohistochemistry. Infant. Injections, Intravenous. Leiomyosarcoma / drug therapy. Male. Middle Aged. O(6)-Methylguanine-DNA Methyltransferase / antagonists & inhibitors. O(6)-Methylguanine-DNA Methyltransferase / metabolism. Survival Analysis. Tachycardia, Supraventricular / chemically induced. Thrombocytopenia / chemically induced. Treatment Outcome

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  • (PMID = 16520986.001).
  • [ISSN] 0344-5704
  • [Journal-full-title] Cancer chemotherapy and pharmacology
  • [ISO-abbreviation] Cancer Chemother. Pharmacol.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / U01CA63187
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Research Support, N.I.H., Extramural
  • [Publication-country] Germany
  • [Chemical-registry-number] 0 / Enzyme Inhibitors; 19916-73-5 / O(6)-benzylguanine; 5Z93L87A1R / Guanine; EC 2.1.1.63 / O(6)-Methylguanine-DNA Methyltransferase; U68WG3173Y / Carmustine
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10. Dewhirst MW, Poulson JM, Yu D, Sanders L, Lora-Michiels M, Vujaskovic Z, Jones EL, Samulski TV, Powers BE, Brizel DM, Prosnitz LR, Charles HC: Relation between pO2, 31P magnetic resonance spectroscopy parameters and treatment outcome in patients with high-grade soft tissue sarcomas treated with thermoradiotherapy. Int J Radiat Oncol Biol Phys; 2005 Feb 1;61(2):480-91
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  • [Title] Relation between pO2, 31P magnetic resonance spectroscopy parameters and treatment outcome in patients with high-grade soft tissue sarcomas treated with thermoradiotherapy.
  • PURPOSE: In a prior study, the combination of (31)P magnetic resonance spectroscopy (MRS)-based intracellular pH (pHi) and T2 relaxation time was highly predictive of the pathologic complete response (pCR) rate in a small series of patients with soft tissue sarcomas (STSs) treated with thermoradiotherapy.
  • METHODS AND MATERIALS: Patients with high-grade STSs were enrolled in an institutional review board-approved Phase II thermoradiotherapy trial.
  • All tumors received daily external beam radiotherapy (1.8-2.0 Gy, five times weekly) to a total dose of 30-50 Gy.
  • Hyperthermia followed radiotherapy by <1 h and was given two times weekly.
  • The MRS/MRI parameters included (31)P metabolite ratios, pHi, and T2 relaxation time.
  • Currently, 50% of all STS patients with high-grade tumors develop distant metastasis even when excellent local control is achieved.
  • Parameters that could help select for patients who need adjuvant chemotherapy could have significant clinical benefit.
  • [MeSH-major] Hyperthermia, Induced. Sarcoma / secondary. Sarcoma / therapy


11. Arnold SM, Horn J, Eckardt JR, Rinehart JJ, DeSimone P, Fields SZ, Kee BK, Moscow JA, Houchins JC, Leggas M: Clinical and pharmacokinetic (PK) findings in a phase I study of 7-t-butyldimethylsilyl-10-hydroxycamptothecin (AR-67) in patients with refractory solid tumors. J Clin Oncol; 2009 May 20;27(15_suppl):2534

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • PK was performed on the 1<sup>st</sup> and 4<sup>th</sup> day of cycle 1.
  • Toxicity and response were assessed using NCI CTC (v3) grading scale and RECIST.
  • Median age 62 (range 31-79), 15M/11F, median prior therapies 3 (range 1 to 6).
  • Tumor types included: colorectal (8), non-small cell lung (NSCLC) (4), small cell lung (3), soft tissue sarcoma, (3), head and neck (2), prostate (2), and other (4).
  • 21 subjects completed 2 or more cycles of therapy, 5 subjects received 1 cycle of therapy and had rapid disease progression (1 received 2d of drug prior to PD), 1 subject is still under treatment after 9 cycles.
  • Common C1 worst-grade drug related toxicities (CTC I/II % vs III/IV %): Hg (27/8), WBC (11/19), ANC (19/8), platelets (19/12), fatigue (15/8) insomnia (8/0), flushing (15//0), constipation (8/0), nausea (23/0), ALT elevation (12/0), hiccups (8/0).
  • The lactone form was predominant in plasma (>85% of AUC) at all time points.
  • This work was supported by R21-CA-123867 and Arno Therapeutics.

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  • (PMID = 27961852.001).
  • [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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12. Cioffi A, LeCesne A, Blay J, Delaloge S, Yovine A, Maki R, Nieto A, Jiao JJ, Demetri GD: Trabectedin phase II clinical trials: Pooled analysis of safety in patients with solid tumors. J Clin Oncol; 2009 May 20;27(15_suppl):e13510

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • Its unique antitumor properties, attributed to specific binding to the small groove of DNA, have been demonstrated activity against soft-tissue sarcoma (STS), ovarian, breast and prostate cancer.
  • Trabectedin treatment has been authorized by EMEA for STS after failure of standard treatment and shows efficacy in relapsed ovarian cancer in a phase III study.
  • MedDRA and NCI-CTC v1.0/2.0 were used to code and grade treatment-emergent adverse events (AEs).
  • Diagnosis included sarcoma (56%), ovary (26%) and breast (7%) cancer, for which 90% of pts had received chemotherapy, 37.5% radiotherapy, and 96.0% surgery.
  • Fifteen drug-related deaths (1.3%) occurred.
  • CONCLUSIONS: Single-agent trabectedin was reasonably well tolerated, with low rates of drug-related discontinuations and deaths.
  • Sustained clinical benefit in the absence of relevant cumulative toxicities allows its administration to patients for prolonged periods of time.

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  • (PMID = 27961298.001).
  • [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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13. van Erp N, Gelderblom H, van Glabbeke M, Van Oosterom A, Verweij J, Guchelaar HJ, Debiec-Rychter M, Peng B, Blay JY, Judson I: Effect of cigarette smoking on imatinib in patients in the soft tissue and bone sarcoma group of the EORTC. Clin Cancer Res; 2008 Dec 15;14(24):8308-13
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  • [Title] Effect of cigarette smoking on imatinib in patients in the soft tissue and bone sarcoma group of the EORTC.
  • PURPOSE: Smoking is a potent inducer of cytochrome P450 (CYP) 1A2 and may affect the pharmacokinetics of CYP1A2 metabolized drugs.
  • EXPERIMENTAL DESIGN: Imatinib pharmacokinetics, safety, and efficacy was analyzed in 45 patients with gastrointestinal stromal tumors (GIST) or soft-tissue sarcoma included in two European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group trials, including 15 smokers and 30 nonsmokers.
  • Smokers experienced more grade 2/3 anemia (P = 0.010) and fatigue (P = 0.011) and those with GIST had a significantly shorter overall survival (P = 0.037) and time to progression (P = 0.052).
  • Smokers with GIST have a shorter overall survival and time to progression.
  • [MeSH-major] Antineoplastic Agents / pharmacokinetics. Bone Neoplasms / drug therapy. Piperazines / pharmacokinetics. Pyrimidines / pharmacokinetics. Sarcoma / drug therapy. Smoking. Soft Tissue Neoplasms / drug therapy

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  • (PMID = 19088049.001).
  • [ISSN] 1078-0432
  • [Journal-full-title] Clinical cancer research : an official journal of the American Association for Cancer Research
  • [ISO-abbreviation] Clin. Cancer Res.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / 2U10 CA11488-36; United States / NCI NIH HHS / CA / 5U10 CA011488-38
  • [Publication-type] Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Benzamides; 0 / Piperazines; 0 / Pyrimidines; 8A1O1M485B / Imatinib Mesylate
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14. Olmos D, Postel-Vinay S, Molife LR, Okuno SH, Schuetze SM, Paccagnella ML, Batzel GN, Yin D, Pritchard-Jones K, Judson I, Worden FP, Gualberto A, Scurr M, de Bono JS, Haluska P: Safety, pharmacokinetics, and preliminary activity of the anti-IGF-1R antibody figitumumab (CP-751,871) in patients with sarcoma and Ewing's sarcoma: a phase 1 expansion cohort study. Lancet Oncol; 2010 Feb;11(2):129-35
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  • [Title] Safety, pharmacokinetics, and preliminary activity of the anti-IGF-1R antibody figitumumab (CP-751,871) in patients with sarcoma and Ewing's sarcoma: a phase 1 expansion cohort study.
  • Preclinical data suggest a dependence on insulin-like growth-factor signalling for sarcoma subtypes, including Ewing's sarcoma, and early reports show antitumour activity of IGF-1R-targeting drugs in these diseases.
  • The first cohort (n=15) included patients with multiple sarcoma subtypes, age 18 years or older, and the second cohort (n=14) consisted of patients with refractory Ewing's sarcoma, age 9 years or older.
  • Secondary endpoints included pharmacokinetic profiling and preliminary antitumour activity (best response by Response Evaluation Criteria in Solid Tumours [RECIST]) in evaluable patients who received at least one dose of medication.
  • FINDINGS: 29 patients, 16 of whom had Ewing's sarcoma, were enrolled and received a total of 177 cycles of treatment (median 2, mean 6.1, range 1-24).
  • Grade 3 deep venous thrombosis, grade 3 back pain, and grade 3 vomiting were each noted once in individual patients; one patient had grade 3 increases in aspartate aminotransferase and gammaglutamyltransferase concentrations.
  • This patient also had grade 4 increases in alanine aminotransferase concentrations.
  • The only other grade 4 adverse event was raised concentrations of uric acid, noted in one patient.
  • Pharmacokinetics were comparable between patients with sarcoma and those with other solid tumours.
  • 28 patients were assessed for response; two patients, both with Ewing's sarcoma, had objective responses (one complete response and one partial response) and eight patients had disease stabilisation (six with Ewing's sarcoma, one with synovial sarcoma, and one with fibrosarcoma) lasting 4 months or longer.
  • INTERPRETATION: Figitumumab is well tolerated and has antitumour activity in Ewing's sarcoma, warranting further investigation in this disease.
  • [MeSH-major] Antibodies, Monoclonal / pharmacokinetics. Antineoplastic Agents / pharmacokinetics. Sarcoma / drug therapy
  • [MeSH-minor] Adolescent. Adult. Child. Cohort Studies. Female. Humans. Immunoglobulins, Intravenous. Male. Middle Aged. Receptor, IGF Type 1 / antagonists & inhibitors. Receptor, IGF Type 1 / immunology. Sarcoma, Ewing / drug therapy. Young Adult


15. Cianfrocca M, Cooley TP, Lee JY, Rudek MA, Scadden DT, Ratner L, Pluda JM, Figg WD, Krown SE, Dezube BJ: Matrix metalloproteinase inhibitor COL-3 in the treatment of AIDS-related Kaposi's sarcoma: a phase I AIDS malignancy consortium study. J Clin Oncol; 2002 Jan 01;20(1):153-9
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  • [Title] Matrix metalloproteinase inhibitor COL-3 in the treatment of AIDS-related Kaposi's sarcoma: a phase I AIDS malignancy consortium study.
  • PURPOSE: Matrix metalloproteinases (MMPs) are involved in tumor invasion and metastasis and are overexpressed in Kaposi's sarcoma (KS) cells.
  • Secondary aims were to evaluate tumor response, pharmacokinetics, and changes in blood levels of MMP-2, MMP-9, vascular endothelial growth factor (VEGF), and basic fibroblast growth factor (bFGF).
  • Patients with symptomatic visceral KS or severe tumor-associated edema were excluded.
  • Antiretroviral therapy was permitted but not required.
  • Study end points were grade 3 or 4 toxicity or progressive KS.
  • Prior KS therapy was reported by 17 patients (94%).
  • COL-3-related grade 3 or 4 adverse events were reported by six patients and included photosensitivity, rash, and headache.
  • There was a significant difference between responders and nonresponders with respect to the change in MMP-2 serum levels from baseline to minimum value on treatment (P =.037).
  • Further evaluation of COL-3 for the treatment of KS is warranted.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Matrix Metalloproteinase Inhibitors. Sarcoma, Kaposi / drug therapy. Tetracycline / therapeutic use
  • [MeSH-minor] Administration, Oral. Adult. Endothelial Growth Factors / blood. Female. Fibroblast Growth Factor 2 / blood. Fibroblast Growth Factor 2 / drug effects. HIV Infections / complications. Humans. Lymphokines / blood. Lymphokines / drug effects. Male. Matrix Metalloproteinase 2 / blood. Matrix Metalloproteinase 2 / drug effects. Matrix Metalloproteinase 9 / blood. Matrix Metalloproteinase 9 / drug effects. Middle Aged. Statistics, Nonparametric. Tetracyclines. Vascular Endothelial Growth Factor A. Vascular Endothelial Growth Factors

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  • (PMID = 11773164.001).
  • [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
  • [Grant] United States / NCRR NIH HHS / RR / RR 00036; United States / NCRR NIH HHS / RR / RR 00533; United States / NCRR NIH HHS / RR / RR 01032; United States / NCI NIH HHS / CA / U01 CA 70019; United States / NCI NIH HHS / CA / U01 CA 70047; United States / NCI NIH HHS / CA / U01 CA 70054; United States / NCI NIH HHS / CA / U01 CA 70062; United States / NCI NIH HHS / CA / U01 CA 70072; United States / NCI NIH HHS / CA / U01 CA 70080; United States / NCI NIH HHS / CA / U01 CA 71375; United States / NCI NIH HHS / CA / U01 CA 83035
  • [Publication-type] Clinical Trial; Clinical Trial, Phase I; Journal Article; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Endothelial Growth Factors; 0 / Lymphokines; 0 / Matrix Metalloproteinase Inhibitors; 0 / Tetracyclines; 0 / Vascular Endothelial Growth Factor A; 0 / Vascular Endothelial Growth Factors; 0 / tetracycline CMT-3; 103107-01-3 / Fibroblast Growth Factor 2; EC 3.4.24.24 / Matrix Metalloproteinase 2; EC 3.4.24.35 / Matrix Metalloproteinase 9; F8VB5M810T / Tetracycline
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16. Trent JC, Patel SS, Zhang J, Araujo DM, Plana JC, Lenihan DJ, Fan D, Patel SR, Benjamin RS, Khakoo AY: Rare incidence of congestive heart failure in gastrointestinal stromal tumor and other sarcoma patients receiving imatinib mesylate. Cancer; 2010 Jan 1;116(1):184-92
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  • [Title] Rare incidence of congestive heart failure in gastrointestinal stromal tumor and other sarcoma patients receiving imatinib mesylate.
  • BACKGROUND: The authors sought to determine the incidence and severity of cardiovascular toxicity caused by imatinib mesylate in gastrointestinal stromal tumor (GIST) and other sarcoma patients, and to explore cardiotoxicity caused by imatinib mesylate using cell culture and in vitro models.
  • METHODS: To determine the incidence and significance of serious cardiac adverse events in GIST and other sarcoma patients receiving imatinib mesylate, the authors performed a retrospective analysis of 219 consecutive patients treated with imatinib mesylate.
  • RESULTS: Grade 3 or 4 potentially cardiotoxic adverse events (mostly edema or effusions) occurred in 8.2% of patients, were manageable with medical therapy, and infrequently required dose reduction or discontinuation of imatinib mesylate.
  • Furthermore, the cardiac consequences of long-term imatinib therapy remain unknown.
  • We therefore recommend treatment of risk factors for cardiovascular disease in imatinib-treated patients in accord with the American Heart Association guidelines for the prevention and treatment of heart failure.

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  • [Copyright] Copyright 2010 American Cancer Society.
  • [CommentIn] Cancer. 2011 Jan 1;117(1):228; author reply 228-9 [20806351.001]
  • (PMID = 19885836.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] ENG
  • [Grant] United States / NCI NIH HHS / CA / K23 CA109060; United States / NCI NIH HHS / CA / K23 CA109060-05; United States / NCI NIH HHS / CA / 1K23CA109060-05
  • [Publication-type] Journal Article; Research Support, N.I.H., Extramural
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Benzamides; 0 / Piperazines; 0 / Pyrimidines; 8A1O1M485B / Imatinib Mesylate
  • [Other-IDs] NLM/ NIHMS149947; NLM/ PMC4306337
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17. Bailey HH, Mahoney MR, Ettinger DS, Maples WJ, Fracasso PM, Traynor AM, Erlichman C, Okuno SH: Phase II study of daily oral perifosine in patients with advanced soft tissue sarcoma. Cancer; 2006 Nov 15;107(10):2462-7
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  • [Title] Phase II study of daily oral perifosine in patients with advanced soft tissue sarcoma.
  • BACKGROUND: A multicenter Phase II study was performed to evaluate the clinical activity of an initial loading (150 mg every 6 hours x 4 doses) dose followed by continuous daily oral dosing (100 mg/day) of perifosine in patients with advanced soft tissue sarcomas (STSs).
  • METHODS: Patients with measurable metastatic STS received perifosine as first-, second-, or third-line treatment and underwent disease assessment every 8 weeks until disease progression, excessive toxicity, or patient refusal.
  • NCI CTC (v2.0) Grade 1 to 2 gastrointestinal toxicity or fatigue were the most common (>50% of subjects) toxicities observed.
  • Prolonged responses in heavily pretreated STS patients continue to be observed with perifosine treatment.
  • Continued assessment of perifosine in STS appears warranted, with special attention to specific histologies or tumor characteristics that might identify a more sensitive population and achieving perifosine Css levels >6 microg/mL.
  • [MeSH-major] Phosphorylcholine / analogs & derivatives. Sarcoma / drug therapy. Soft Tissue Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Antineoplastic Agents / administration & dosage. Antineoplastic Agents / adverse effects. Antineoplastic Agents / blood. Disease-Free Survival. Drug Administration Schedule. Female. Humans. Male. Middle Aged. Survival Rate. Treatment Outcome

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  • (PMID = 17058289.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CM / CM17104
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 107-73-3 / Phosphorylcholine; 2GWV496552 / perifosine
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18. Schwartz CL, Gorlick R, Teot L, Krailo M, Chen Z, Goorin A, Grier HE, Bernstein ML, Meyers P, Children's Oncology Group: Multiple drug resistance in osteogenic sarcoma: INT0133 from the Children's Oncology Group. J Clin Oncol; 2007 May 20;25(15):2057-62
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  • [Title] Multiple drug resistance in osteogenic sarcoma: INT0133 from the Children's Oncology Group.
  • PURPOSE: Multiple drug resistance due to P-glycoprotein (P-gp) expression has been reported to be a cause of disease recurrence in osteosarcoma.
  • Tumor specimens derived from children and young adults with osteosarcoma enrolled onto a national Intergroup trial (INT0133) were analyzed prospectively to determine the role of multiple drug resistance in osteosarcoma.
  • PATIENTS AND METHODS: From October 15, 1992, to November 25, 1997, 685 patients with localized, high-grade osteosarcoma were enrolled onto INT0133.
  • Paraffin-embedded diagnostic tumor specimens were assayed for P-gp using monoclonal antibodies C-494 (139 patients) and JSB-1 (133 patients).
  • Percent necrosis at the time of definitive surgery (NEC), event-free survival (EFS), and overall survival (OS) were evaluated as outcome measures for patients with P-gp-positive disease and were compared with patients with P-gp-negative disease.
  • CONCLUSION: Prospective analysis of the role of multiple drug resistance in localized osteosarcoma did not find that immunohistochemical analysis of P-gp expression predicted outcome for patients treated on INT0133.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Bone Neoplasms / drug therapy. Drug Resistance, Multiple. Drug Resistance, Neoplasm. Osteosarcoma / drug therapy
  • [MeSH-minor] Adolescent. Adult. Antibodies, Monoclonal / immunology. Child. Child, Preschool. Disease-Free Survival. Female. Humans. Infant. Male. P-Glycoprotein / metabolism. Prospective Studies. Survival Rate. Treatment Outcome

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  • [CommentIn] J Clin Oncol. 2007 Oct 20;25(30):4858-60; author reply 4860-1 [17947741.001]
  • (PMID = 17513810.001).
  • [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
  • [Grant] United States / NCI NIH HHS / CA / CA 13539; United States / NCI NIH HHS / CA / CA 30969; United States / NCI NIH HHS / CA / U10 CA 98543
  • [Publication-type] Journal Article; Research Support, N.I.H., Extramural
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / P-Glycoprotein
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19. Hawkins DS, Bradfield S, Whitlock JA, Krailo M, Franklin J, Blaney SM, Adamson PC, Reaman G: Topotecan by 21-day continuous infusion in children with relapsed or refractory solid tumors: a Children's Oncology Group study. Pediatr Blood Cancer; 2006 Nov;47(6):790-4
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  • PROCEDURE: Patients with Ewing sarcoma family of tumors (ESFT), osteosarcoma (OS), soft tissue sarcomas (STS), medulloblastoma (MB)/primitive neuroectodermal tumor (PNET), astrocytoma, or neuroblastoma (NB) recurrent or refractory to conventional therapy, measurable disease, and adequate organ function were treated with topotecan 0.3 mg/m2/day by continuous intravenous infusion for 21 consecutive days, followed by 7 days without therapy prior to response assessment.
  • RESULTS: Fifty-five patients were enrolled; two were ineligible, two were removed from protocol therapy prior to evaluation for response, and one was inevaluable for response, leaving 53 and 50 patients evaluable for toxicity and response, respectively.
  • The most common Grade 3 or 4 toxicities during the first course of therapy were thrombocytopenia (12/53), neutropenia (8/53), and fatigue (7/53).
  • [MeSH-major] Astrocytoma / drug therapy. Neoplasm Recurrence, Local / drug therapy. Neuroblastoma / drug therapy. Neuroectodermal Tumors, Primitive / drug therapy. Sarcoma / drug therapy. Topotecan / administration & dosage
  • [MeSH-minor] Adolescent. Adult. Child. Child, Preschool. Dose-Response Relationship, Drug. Fatigue / chemically induced. Female. Humans. Infusions, Intravenous. Male. Maximum Tolerated Dose. Neutropenia / chemically induced. Recurrence. Survival Rate. Thrombocytopenia / chemically induced. Time Factors. Treatment Outcome

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  • [Copyright] (c) 2006 Wiley-Liss, Inc.
  • (PMID = 16435380.001).
  • [ISSN] 1545-5009
  • [Journal-full-title] Pediatric blood & cancer
  • [ISO-abbreviation] Pediatr Blood Cancer
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA 98543
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Research Support, N.I.H., Extramural
  • [Publication-country] United States
  • [Chemical-registry-number] 7M7YKX2N15 / Topotecan
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20. Maki RG, Kraft AS, Scheu K, Yamada J, Wadler S, Antonescu CR, Wright JJ, Schwartz GK: A multicenter Phase II study of bortezomib in recurrent or metastatic sarcomas. Cancer; 2005 Apr 1;103(7):1431-8
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  • Arm A included patients with osteogenic sarcoma, Ewing sarcoma, and rhabdomyosarcoma.
  • Arm B accrued patients with other types of soft tissue sarcomas.
  • Patients were not allowed to have received previous chemotherapy for metastatic disease.
  • Pharmacodynamic data from 18 patients with complete data collection did not show consistent differences between patients with or without Grade 2 or Grade 3 neuropathy (toxicity graded according the National Cancer Institute Common Toxicity Criteria).
  • CONCLUSIONS: Bortezomib has minimal activity in soft tissue sarcoma as a single agent.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Bone Neoplasms / drug therapy. Boronic Acids / therapeutic use. Proteasome Inhibitors. Pyrazines / therapeutic use. Sarcoma / drug therapy. Soft Tissue Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Bortezomib. Drug Administration Schedule. Fatigue / chemically induced. Female. Humans. Male. Middle Aged. Neoplasm Metastasis / drug therapy. Neoplasm Recurrence, Local / drug therapy. Nervous System Diseases / chemically induced. Treatment Outcome

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  • [Copyright] Copyright 2005 American Cancer Society.
  • (PMID = 15739208.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CM / N01-CM17105; United States / NCI NIH HHS / CA / P01-CA47179
  • [Publication-type] Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Boronic Acids; 0 / Proteasome Inhibitors; 0 / Pyrazines; 69G8BD63PP / Bortezomib
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21. Piura B, Rabinovich A: Doxorubicin and ifosfamide-mesna in advanced and recurrent uterine sarcomas. Eur J Gynaecol Oncol; 2005;26(3):275-8
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  • METHODS: The hospital records of five patients with advanced/recurrent uterine sarcomas who had combination chemotherapy with doxorubicin and ifosfamide-mesna were retrospectively reviewed.
  • Dose intensity, relative dose intensity and average relative dose intensity (ARDI) of chemotherapy were calculated.
  • Toxicity was graded using the National Cancer Institute (NCI) criteria.
  • Toxicity was mainly hematological with grade 3 or 4 leukopenia--four (80%) patients, neutropenia--four (80%), thrombocytopenia--one (20%) and anemia--one (20%).
  • CONCLUSION: Although the combination of doxorubicin and ifosfamide has certain activity in advanced/recurrent uterine sarcomas, the toxicity is of much concern and the results of treatment in terms of response duration and survival are poor.
  • [MeSH-major] Ifosfamide / therapeutic use. Neoplasm Recurrence, Local / drug therapy. Sarcoma / drug therapy. Uterine Neoplasms / drug therapy
  • [MeSH-minor] Adult. Antineoplastic Combined Chemotherapy Protocols. Doxorubicin / administration & dosage. Female. Humans. Mesna / therapeutic use. Middle Aged. Neoplasm Staging. Protective Agents / therapeutic use. Retrospective Studies. Treatment Outcome

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  • (PMID = 15991525.001).
  • [ISSN] 0392-2936
  • [Journal-full-title] European journal of gynaecological oncology
  • [ISO-abbreviation] Eur. J. Gynaecol. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Italy
  • [Chemical-registry-number] 0 / Protective Agents; 80168379AG / Doxorubicin; NR7O1405Q9 / Mesna; UM20QQM95Y / Ifosfamide
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22. Chow WA, Synold TW, Tetef ML, Longmate J, Frankel P, Lawrence J, Al-Khadimi Z, Leong L, Lim D, Margolin K, Morgan RJ Jr, Raschko J, Shibata S, Somlo G, Twardowski P, Yen Y, Doroshow JH: Feasibility and pharmacokinetic study of infusional dexrazoxane and dose-intensive doxorubicin administered concurrently over 96 h for the treatment of advanced malignancies. Cancer Chemother Pharmacol; 2004 Sep;54(3):241-8
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  • [Title] Feasibility and pharmacokinetic study of infusional dexrazoxane and dose-intensive doxorubicin administered concurrently over 96 h for the treatment of advanced malignancies.
  • METHODS: Patients with advanced malignancies received tandem cycles of concurrent 96-h infusions of dexrazoxane 500 mg/m2 and doxorubicin 165 mg/m2, and 24 h after completion of chemotherapy, granulocyte-colony stimulating factor (5 microg/kg) and oral levofloxacin (500 mg) were administered daily until the white blood cell count reached 10,000 microl(-1).
  • Two partial responses were observed in patients with soft-tissue sarcoma.
  • Principal grade 3/4 toxicities included hypotension (two), anorexia (four), stomatitis (four), typhlitis (two), and febrile neutropenia (seven), with documented infection (three).
  • [MeSH-minor] Adult. Drug Administration Schedule. Drug Therapy, Combination. Female. Granulocyte Colony-Stimulating Factor / administration & dosage. Humans. Infusions, Intravenous. Levofloxacin. Male. Middle Aged. Neoplasms / drug therapy. Neutropenia / chemically induced. Ofloxacin / administration & dosage. Sarcoma / drug therapy. Sepsis. Treatment Outcome

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  • (PMID = 15173955.001).
  • [ISSN] 0344-5704
  • [Journal-full-title] Cancer chemotherapy and pharmacology
  • [ISO-abbreviation] Cancer Chemother. Pharmacol.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA 33572; United States / NCI NIH HHS / CA / CA 62505
  • [Publication-type] Clinical Trial; Journal Article; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] Germany
  • [Chemical-registry-number] 0 / Antibiotics, Antineoplastic; 0 / Cardiovascular Agents; 143011-72-7 / Granulocyte Colony-Stimulating Factor; 5AR83PR647 / Razoxane; 6GNT3Y5LMF / Levofloxacin; 80168379AG / Doxorubicin; A4P49JAZ9H / Ofloxacin
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23. Benz MR, Allen-Auerbach MS, Eilber FC, Chen HJ, Dry S, Phelps ME, Czernin J, Weber WA: Combined assessment of metabolic and volumetric changes for assessment of tumor response in patients with soft-tissue sarcomas. J Nucl Med; 2008 Oct;49(10):1579-84
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  • [Title] Combined assessment of metabolic and volumetric changes for assessment of tumor response in patients with soft-tissue sarcomas.
  • By allowing simultaneous measurements of tumor volume and metabolic activity, integrated PET/CT opens up new approaches for assessing tumor response to therapy.
  • The aim of this study was to determine whether combined assessment of tumor volume and metabolic activity improves the accuracy of (18)F-FDG PET for predicting histopathologic tumor response in patients with soft-tissue sarcomas.
  • METHODS: Twenty patients with locally advanced high-grade soft-tissue sarcoma (10 men and 10 women; mean age, 49 +/- 17 y) were studied by (18)F-FDG PET/CT before and after preoperative therapy.
  • CT tumor volume (CTvol) was measured by delineating tumor borders on consecutive slices of the CT scan.
  • Two indices of total lesion glycolysis (TLG) were calculated by multiplying tumor volume by SUVmean (TLGmean) and SUVmax (TLGmax).
  • Changes in CTvol, SUVmean, SUVmax, TLGmean, and TLGmax after chemotherapy were correlated with histopathologic tumor response (> or =95% treatment-induced tumor necrosis).
  • After neoadjuvant therapy, all parameters except CTvol showed a significant decline (DeltaSUVmax = -51%, P < 0.001; DeltaSUVmean = -40%, P < 0.001; DeltaCTvol = -14%, P = 0.37; DeltaTLGmean = -44%, P = 0.006; and DeltaTLGmax = -54%, P = 0.001).
  • In contrast, changes in CTvol did not allow prediction of treatment response (AUC = 0.48).
  • CONCLUSION: In this population of patients with sarcoma, TLG was less accurate in predicting tumor response than were measurements of the intratumoral (18)F-FDG concentration (SUVmax, SUVmean).
  • Further evaluation of TLG in larger patient populations and other tumor types is necessary to determine the value of this conceptually attractive parameter for assessing tumor response.
  • [MeSH-major] Positron-Emission Tomography / methods. Sarcoma / diagnosis. Sarcoma / radionuclide imaging

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  • (PMID = 18794268.001).
  • [ISSN] 0161-5505
  • [Journal-full-title] Journal of nuclear medicine : official publication, Society of Nuclear Medicine
  • [ISO-abbreviation] J. Nucl. Med.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / P01 CA132681
  • [Publication-type] Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Radiopharmaceuticals
  • [Other-IDs] NLM/ NIHMS586558; NLM/ PMC4068272
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24. Sutton G, Brunetto VL, Kilgore L, Soper JT, McGehee R, Olt G, Lentz SS, Sorosky J, Hsiu JG: A phase III trial of ifosfamide with or without cisplatin in carcinosarcoma of the uterus: A Gynecologic Oncology Group Study. Gynecol Oncol; 2000 Nov;79(2):147-53
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  • OBJECTIVE: The aims of this study were to substantiate the previously reported activity of ifosfamide in patients with advanced, persistent, or recurrent carcinosarcoma (mixed mesodermal sarcoma) of the uterus, and to determine whether the addition of cisplatin results in an improved response or survival.
  • METHODS: Patients were randomized to receive ifosfamide (1.5 g/m(2)/day) times 5 days every 3 weeks for eight courses with mesna uroprotection, with or without cisplatin (20 mg/m(2)/day) times 5 days.
  • No patient had received previous chemotherapy.
  • The investigational arms were balanced for age, grade, and Gynecologic Oncology Group performance status.
  • Percentages of adverse effects reported in 191 patients receiving chemotherapy included (ifosfamide/cisplatin-ifosfamide) grade 3 or 4 granulocytopenia (36/60), grade 3 or 4 anemia (8/17), grade 3 or 4 central nervous system toxicity (19/14), and grade 3 or 4 peripheral neuropathy (1/12).
  • Treatment may have contributed to the deaths of 6 patients treated with full doses of ifosfamide and cisplatin for 5 days.
  • The proportion of patients responding to ifosfamide alone versus ifosfamide-cisplatin therapy was (0.36 versus 0.54) overall, 0.47 versus 0.61 for pelvic, 0.21 versus 0.54 for lung, and 0.33 versus 0.40 for "other" metastatic sites of measurable disease.
  • [MeSH-major] Antineoplastic Agents, Alkylating / therapeutic use. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinosarcoma / drug therapy. Ifosfamide / therapeutic use. Uterine Neoplasms / drug therapy

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  • [Copyright] Copyright 2000 Academic Press.
  • [CommentIn] Gynecol Oncol. 2000 Nov;79(2):145-6 [11063635.001]
  • (PMID = 11063636.001).
  • [ISSN] 0090-8258
  • [Journal-full-title] Gynecologic oncology
  • [ISO-abbreviation] Gynecol. Oncol.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA 27469; United States / NCI NIH HHS / CA / CA 37517
  • [Publication-type] Clinical Trial; Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] UNITED STATES
  • [Chemical-registry-number] 0 / Antineoplastic Agents, Alkylating; Q20Q21Q62J / Cisplatin; UM20QQM95Y / Ifosfamide
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25. Okuno S, Ryan LM, Edmonson JH, Priebat DA, Blum RH: Phase II trial of gemcitabine in patients with advanced sarcomas (E1797): a trial of the Eastern Cooperative Oncology Group. Cancer; 2003 Apr 15;97(8):1969-73
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  • BACKGROUND: The current study was conducted to evaluate the antitumor activity and toxicity of gemcitabine in patients with advanced sarcoma.
  • Grade 3-4 toxicities (by CTC criteria) were observed in all 25 patients.
  • No lethal toxicity (Grade 5) related to treatment was found.
  • CONCLUSIONS: The results of the current study demonstrated that gemcitabine given at this schedule and dose in this population of patients with advanced sarcoma had limited activity.
  • [MeSH-major] Antimetabolites, Antineoplastic / therapeutic use. Deoxycytidine / analogs & derivatives. Deoxycytidine / therapeutic use. Sarcoma / drug therapy
  • [MeSH-minor] Adult. Aged. Female. Humans. Male. Middle Aged. Survival Rate. Treatment Outcome

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  • [Copyright] Copyright 2003 American Cancer Society.
  • (PMID = 12673725.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA13650; United States / NCI NIH HHS / CA / CA21115; United States / NCI NIH HHS / CA / CA23318; United States / NCI NIH HHS / CA / CA59307; United States / NCI NIH HHS / CA / CA66636
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antimetabolites, Antineoplastic; 0W860991D6 / Deoxycytidine; B76N6SBZ8R / gemcitabine
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26. Saylors RL 3rd, Stine KC, Sullivan J, Kepner JL, Wall DA, Bernstein ML, Harris MB, Hayashi R, Vietti TJ, Pediatric Oncology Group: Cyclophosphamide plus topotecan in children with recurrent or refractory solid tumors: a Pediatric Oncology Group phase II study. J Clin Oncol; 2001 Aug 01;19(15):3463-9
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  • All patients received filgrastim (5 mcg/kg) daily until the absolute neutrophil count (ANC) was > or = 1,500 microL after the time of the expected ANC nadir.
  • RESULTS: A total of 307 treatment courses were given to the 83 fully assessable patients.
  • Responses (complete response plus partial response) were seen in rhabdomyosarcoma (10 of 15 patients), Ewing's sarcoma (six of 17 patients), and neuroblastoma (six of 13 patients).
  • Partial responses were seen in two of 18 patients with osteosarcoma and in one patient with a Sertoli-Leydig cell tumor.
  • Of 307 courses, 163 (53%) were associated with grade 3 or 4 neutropenia, 84 (27%) with grade 3 or 4 anemia, and 136 (44%) with grade 3 or 4 thrombocytopenia.
  • Despite the severe myelosuppression, only 34 (11%) of 307 courses were associated with grade 3 or 4 infection.
  • CONCLUSION: The combination of cyclophosphamide and topotecan is active in rhabdomyosarcoma, neuroblastoma, and Ewing's sarcoma.
  • The therapy can be given with acceptable hematopoietic toxicity with the use of filgrastim support.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Neoplasm Recurrence, Local / drug therapy. Neoplasms / drug therapy
  • [MeSH-minor] Adolescent. Adult. Bone Neoplasms / drug therapy. Child. Child, Preschool. Cyclophosphamide / administration & dosage. Female. Humans. Infant. Infusions, Intravenous. Male. Neuroblastoma / drug therapy. Osteosarcoma / drug therapy. Rhabdomyosarcoma / drug therapy. Sarcoma, Ewing / drug therapy. Topotecan / administration & dosage

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  • (PMID = 11481351.001).
  • [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
  • [Grant] United States / NCI NIH HHS / CA / CA 05587; United States / NCI NIH HHS / CA / CA 07431; United States / NCI NIH HHS / CA / CA 11233; United States / NCI NIH HHS / CA / CA 15089; United States / NCI NIH HHS / CA / CA 20549; United States / NCI NIH HHS / CA / CA 25408; United States / NCI NIH HHS / CA / CA 28476; United States / NCI NIH HHS / CA / CA 29139; United States / NCI NIH HHS / CA / CA 29293; United States / NCI NIH HHS / CA / CA 29691; United States / NCI NIH HHS / CA / CA 30969; United States / NCI NIH HHS / CA / CA 32053; United States / NCI NIH HHS / CA / CA 33603; United States / NCI NIH HHS / CA / CA 35587; United States / NCI NIH HHS / CA / CA 53128; United States / NCI NIH HHS / CA / CA 69428
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 7M7YKX2N15 / Topotecan; 8N3DW7272P / Cyclophosphamide
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27. Trent JC, Valero V, Booser DJ, Esparza-Guerra LT, Ibrahim N, Rahman Z, Vernillet L, Patel S, David CL, Murray JL, Cristofanilli M, Hortobagyi GN: A Phase I study of docetaxel plus cyclophosphamide in solid tumors followed by a Phase II study as first-line therapy in metastatic breast cancer. Clin Cancer Res; 2003 Jul;9(7):2426-34
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  • [Title] A Phase I study of docetaxel plus cyclophosphamide in solid tumors followed by a Phase II study as first-line therapy in metastatic breast cancer.
  • PURPOSE: In Phase I, the purpose was to determine the maximum tolerated dose and pharmacokinetics of docetaxel plus cyclophosphamide (DC) with and without granulocyte colony-stimulating factor in the treatment of patients with solid tumors.
  • For Phase II, the purpose was to determine the safety and efficacy of this combination as first-line treatment in patients with metastatic breast cancer (MBC).
  • The maximum tolerated dose for DC was 75 mg/m(2)/700 mg/m(2) in solid tumor patients treated previously and 75 mg/m(2)/800 mg/m(2) for patients not treated previously for MBC.
  • Dose escalation of docetaxel >75 mg/m(2) was not tolerated, despite prophylactic granulocyte colony-stimulating factor treatment.
  • In Phase II, 71% of patients received prior anthracycline therapy.
  • One patient had grade 3 neuropathy.
  • The median overall survival was 22 months, and the median time to progression was 6 months.
  • CONCLUSIONS: DC combination therapy is an active regimen with acceptable toxicity and is appropriate regardless of prior anthracycline therapy.
  • [MeSH-major] Breast Neoplasms / drug therapy. Breast Neoplasms / pathology. Cyclophosphamide / therapeutic use. Neoplasms / drug therapy. Taxoids / therapeutic use
  • [MeSH-minor] Adult. Aged. Antibodies, Monoclonal / therapeutic use. Antibodies, Monoclonal, Humanized. Antineoplastic Agents, Phytogenic / therapeutic use. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Cohort Studies. Dose-Response Relationship, Drug. Female. Granulocyte Colony-Stimulating Factor / metabolism. Humans. Male. Middle Aged. Time Factors. Trastuzumab. Treatment Outcome

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  • (PMID = 12855614.001).
  • [ISSN] 1078-0432
  • [Journal-full-title] Clinical cancer research : an official journal of the American Association for Cancer Research
  • [ISO-abbreviation] Clin. Cancer Res.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / T32 CA09666
  • [Publication-type] Clinical Trial; Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Humanized; 0 / Antineoplastic Agents, Phytogenic; 0 / Taxoids; 143011-72-7 / Granulocyte Colony-Stimulating Factor; 15H5577CQD / docetaxel; 8N3DW7272P / Cyclophosphamide; P188ANX8CK / Trastuzumab
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28. Punt SE, Eary JF, O'Sullivan J, Conrad EU: Fluorodeoxyglucose positron emission tomography in leiomyosarcoma: imaging characteristics. Nucl Med Commun; 2009 Jul;30(7):546-9
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  • [Title] Fluorodeoxyglucose positron emission tomography in leiomyosarcoma: imaging characteristics.
  • These tumors, which are derived from mesenchymal tissues, are difficult to diagnose, and treatment options remain controversial.
  • The relatively rare incidence of this soft tissue sarcoma subtype has limited the number of patients available for studies and research.
  • This study examines whether the imaging characteristics of positron emission tomography (PET) with radiolabeled fluorodeoxyglucose (FDG) provide a reliable, noninvasive means to predict tumor behavior in patients with leiomyosarcomas.
  • METHODS: [18F]-FDG-PET was performed on the tumors of participating patients before the neoadjuvant chemotherapy or resection, and a maximum tumor standard uptake value (SUVmax) was calculated.
  • RESULTS: The SUVmax was correlated with tumor grade (P=0.001) and tumor size as greatest dimension (P=0.004).
  • Analysis of these data indicated the potential effectiveness of FDG-PET imaging in predicting tumor grade.
  • CONCLUSION: In leiomyosarcoma, the SUVmax from FDG-PET is a likely predictor of tumor behavior.
  • The results of this study suggest that a large (by greatest dimension) intermediate grade tumor is expected to have the same predicted outcome as a high-grade tumor and should be treated in the same manner, as they share the same prognosis by definition of tumor grade.
  • Improvements made in the clinical treatment of leiomyosarcomas by use of FDG-PET imaging data may lead to an increase in patient survival.

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  • [Cites] J Bone Joint Surg Am. 2004;86-A Suppl 2:98-104 [15691114.001]
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  • (PMID = 19440162.001).
  • [ISSN] 1473-5628
  • [Journal-full-title] Nuclear medicine communications
  • [ISO-abbreviation] Nucl Med Commun
  • [Language] ENG
  • [Grant] United States / NCI NIH HHS / CA / CA065537-13; United States / NCI NIH HHS / CA / R01 CA065537; United States / NCI NIH HHS / CA / R01 CA 65537; United States / NCI NIH HHS / CA / R01 CA065537-13
  • [Publication-type] Clinical Trial; Journal Article; Research Support, N.I.H., Extramural
  • [Publication-country] England
  • [Chemical-registry-number] 0Z5B2CJX4D / Fluorodeoxyglucose F18
  • [Other-IDs] NLM/ NIHMS121746; NLM/ PMC2752415
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29. Evans SM, Fraker D, Hahn SM, Gleason K, Jenkins WT, Jenkins K, Hwang WT, Zhang P, Mick R, Koch CJ: EF5 binding and clinical outcome in human soft tissue sarcomas. Int J Radiat Oncol Biol Phys; 2006 Mar 1;64(3):922-7
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  • [Title] EF5 binding and clinical outcome in human soft tissue sarcomas.
  • PURPOSE: To study the 2-nitroimidazole agent EF5 as a surrogate for measuring hypoxia in a series of patients with soft tissue sarcomas, and to determine whether hypoxia measured with this technique was associated with patient outcome.
  • METHODS AND MATERIALS: Patients with soft tissue sarcomas of the head and neck, extremity, trunk, or retroperitoneum for whom surgical excision was the initial treatment of choice, were given 21 mg/kg EF5 24-48 hours before surgery.
  • There were seven low-grade, one intermediate-grade, and eight high-grade tumors.
  • No relationship was found between EF5 binding and patient age, sex, hemoglobin level, or tumor size.
  • In de novo tumors, the presence of mitoses and histologic grade were positively correlated with hypoxia.
  • High-grade and -stage de novo tumors had higher levels of EF5 binding compared with low-grade and -stage tumors.
  • Patients with de novo tumors containing moderate to severe hypoxia (> or = 20% EF5 binding), high grade, or > or = 7% mitoses were more likely to develop metastases.
  • CONCLUSIONS: Further studies in a larger cohort of patients are necessary to determine whether hypoxia, as measured by EF5 binding, is an independent prognostic factor for outcome in high-grade sarcomas.
  • Such data should be useful to identify high-risk patients for clinical trials to determine whether early chemotherapy will influence the occurrence of metastasis.
  • [MeSH-major] Cell Hypoxia / physiology. Etanidazole / analogs & derivatives. Hydrocarbons, Fluorinated / metabolism. Indicators and Reagents / metabolism. Neoplasm Recurrence, Local / metabolism. Sarcoma / metabolism
  • [MeSH-minor] Adult. Aged. Female. Humans. Male. Middle Aged. Survival Analysis. Treatment Outcome

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  • (PMID = 16458778.001).
  • [ISSN] 0360-3016
  • [Journal-full-title] International journal of radiation oncology, biology, physics
  • [ISO-abbreviation] Int. J. Radiat. Oncol. Biol. Phys.
  • [Language] eng
  • [Grant] United States / NCRR NIH HHS / RR / M01-RR00040; United States / NCI NIH HHS / CA / R01 CA 75285
  • [Publication-type] Journal Article; Research Support, N.I.H., Extramural
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / 2-(2-nitro-1H-imidazol-1-yl)-N-(2,2,3,3,3-pentafluoropropyl)acetamide; 0 / Hydrocarbons, Fluorinated; 0 / Indicators and Reagents; 30DKA3Q1HL / Etanidazole
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30. Guo CC, Punar M, Contreras AL, Tu SM, Pisters L, Tamboli P, Czerniak B: Testicular germ cell tumors with sarcomatous components: an analysis of 33 cases. Am J Surg Pathol; 2009 Aug;33(8):1173-8
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  • The development of sarcomatous component (SC) in testicular germ cell tumor (GCT) is an uncommon phenomenon.
  • All patients underwent radical orchiectomy, which demonstrated a GCT in all patients except for 3 patients who had received neoadjuvant chemotherapy.
  • The SC was observed in primary testicular tumor (n=19), in metastasis (n=11), or in both primary testicular tumor and metastasis (n=3).
  • The most common histologic type of SC was rhabdomyosarcoma (n=24), followed by high-grade unclassified sarcoma (n=5), rhabdomyosarcoma admixed with high-grade unclassified sarcoma (n=2), angiosarcoma (n=1), and low-grade myxoid sarcoma (n=1).

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  • (PMID = 19561445.001).
  • [ISSN] 1532-0979
  • [Journal-full-title] The American journal of surgical pathology
  • [ISO-abbreviation] Am. J. Surg. Pathol.
  • [Language] ENG
  • [Grant] United States / NCI NIH HHS / CA / P50 CA091846; United States / NCI NIH HHS / CA / CA091846-100006; United States / NCI NIH HHS / CA / U01 CA085078-10; United States / NCI NIH HHS / CA / CA085078-10; United States / NCI NIH HHS / CA / U01 CA085078; United States / NCI NIH HHS / CA / P50 CA091846-100006
  • [Publication-type] Journal Article
  • [Publication-country] United States
  • [Other-IDs] NLM/ NIHMS229448; NLM/ PMC3812063
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31. D'Adamo DR, Anderson SE, Albritton K, Yamada J, Riedel E, Scheu K, Schwartz GK, Chen H, Maki RG: Phase II study of doxorubicin and bevacizumab for patients with metastatic soft-tissue sarcomas. J Clin Oncol; 2005 Oct 1;23(28):7135-42
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  • [Title] Phase II study of doxorubicin and bevacizumab for patients with metastatic soft-tissue sarcomas.
  • PURPOSE: To evaluate the antitumor activity and tolerability of bevacizumab and doxorubicin in patients with metastatic soft-tissue sarcoma (STS).
  • PATIENTS AND METHODS: Patients may have had up to one nonanthracycline line of therapy.
  • Two partial responses (12%, 95% CI = 1% to 36%) were observed, lasting seven and 12 cycles of therapy.
  • Six patients developed cardiac toxicity grade 2 or greater, with four patients grade 2 (cumulative doxorubicin 75, 150, 300, 300 mg/m2, respectively), one grade 3 (total doxorubicin 591 mg/m2), and one grade 4 (total doxorubicin 420 mg/m2).
  • One patient with extensive lung disease died of recurrent bilateral pneumothoraces, possibly treatment-related.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Sarcoma / drug therapy. Sarcoma / pathology
  • [MeSH-minor] Adult. Aged. Antibodies, Monoclonal / administration & dosage. Antibodies, Monoclonal, Humanized. Bevacizumab. Doxorubicin / administration & dosage. Female. Humans. Infusions, Intravenous. Injections, Intravenous. Male. Middle Aged. Neoplasm Metastasis. Treatment Outcome

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  • (PMID = 16192597.001).
  • [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
  • [Grant] United States / NCI NIH HHS / CM / N01-CM17105; United States / NCI NIH HHS / CA / P01 CA47179
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Humanized; 2S9ZZM9Q9V / Bevacizumab; 80168379AG / Doxorubicin
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32. Ramnath N, Schwartz GN, Smith P, Bong D, Kanter P, Berdzik J, Creaven PJ: Phase I and pharmacokinetic study of anhydrovinblastine every 3 weeks in patients with refractory solid tumors. Cancer Chemother Pharmacol; 2003 Mar;51(3):227-30
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  • Diagnoses were non-small-cell lung cancer (NSCLC) (11), colorectal cancer (5), soft tissue sarcoma (4), and miscellaneous (4).
  • Patients had had a median of three prior chemotherapy regimens (range one to six).
  • RESULTS: Grade 2 infusional hypertension, anemia, and dizziness were noted at 16.5 mg/m(2).
  • DLT was grade 4 constipation, neutropenia and grade 3 nausea/vomiting.
  • At 21 mg/m(2) one of six evaluable patients had DLT (grade 3 nausea/vomiting).
  • Stable disease was noted in one patient with metastatic sarcoma to the lungs and in three patients with metastatic NSCLC.
  • [MeSH-major] Antineoplastic Agents / adverse effects. Antineoplastic Agents / pharmacokinetics. Neoplasms / drug therapy. Vinblastine / adverse effects. Vinblastine / analogs & derivatives. Vinblastine / pharmacokinetics
  • [MeSH-minor] Adult. Aged. Drug Administration Schedule. Female. Humans. Infusions, Intravenous. Male. Maximum Tolerated Dose. Middle Aged

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  • (PMID = 12655441.001).
  • [ISSN] 0344-5704
  • [Journal-full-title] Cancer chemotherapy and pharmacology
  • [ISO-abbreviation] Cancer Chemother. Pharmacol.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA16056
  • [Publication-type] Clinical Trial; Clinical Trial, Phase I; Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] Germany
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 38390-45-3 / 3',4'-anhydrovinblastine; 5V9KLZ54CY / Vinblastine
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33. Hensley ML, Dizon D, Derosa F, Venkatraman E, Sabbatini P, Chi DS, Dupont J, Colevas AD, Spriggs D, Aghajanian C: A phase I trial of BMS-247550 (NSC# 710428) and gemcitabine in patients with advanced solid tumors. Invest New Drugs; 2007 Aug;25(4):335-41
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  • Dose-limiting toxicity definitions were based on severe myelosuppression, or grade 3 or 4 treatment-related non-hematologic toxicity, or dose delay of greater than 2 weeks due to treatment toxicity observed in the first treatment cycle.
  • Grade 4 neutropenia lasting >or=7 days occurred in one of six patients.
  • Two of three patients in cohort 2 (gemcitabine 900 mg/m2 plus BMS-247550 30 mg/m2) had dose-limiting toxicities of grade 4 neutropenia.
  • At an intermediate dose level (gemcitabine 750 mg/m2 plus BMS-247550 30 mg/m2), two of six patients experienced a dose-limiting toxicity (febrile neutropenia and grade 3 hypophosphatemia in 1, grade 3 hypophosphatemia and grade 3 hyponatremia in (1), and five of six patients experienced dose delays.
  • Treatment-related toxicities included neutropenia, thrombocytopenia, neutropenic fever, hypophosphatemia, and hyponatremia.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Neoplasms / drug therapy
  • [MeSH-minor] Aged. Carcinoma, Small Cell / drug therapy. Cohort Studies. Deoxycytidine / administration & dosage. Deoxycytidine / analogs & derivatives. Dose-Response Relationship, Drug. Epothilones / administration & dosage. Female. Humans. Kidney Neoplasms / drug therapy. Leukopenia / chemically induced. Lung Neoplasms / drug therapy. Male. Melanoma / drug therapy. Middle Aged. Ovarian Neoplasms / drug therapy. Sarcoma / drug therapy. Urinary Bladder Neoplasms / drug therapy. Uterine Neoplasms / drug therapy. Water-Electrolyte Imbalance / chemically induced

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  • (PMID = 17364235.001).
  • [ISSN] 0167-6997
  • [Journal-full-title] Investigational new drugs
  • [ISO-abbreviation] Invest New Drugs
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / U01-CA69856
  • [Publication-type] Clinical Trial, Phase I; Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Epothilones; 0W860991D6 / Deoxycytidine; B76N6SBZ8R / gemcitabine; K27005NP0A / ixabepilone
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34. Bagatell R, Gore L, Egorin MJ, Ho R, Heller G, Boucher N, Zuhowski EG, Whitlock JA, Hunger SP, Narendran A, Katzenstein HM, Arceci RJ, Boklan J, Herzog CE, Whitesell L, Ivy SP, Trippett TM: Phase I pharmacokinetic and pharmacodynamic study of 17-N-allylamino-17-demethoxygeldanamycin in pediatric patients with recurrent or refractory solid tumors: a pediatric oncology experimental therapeutics investigators consortium study. Clin Cancer Res; 2007 Mar 15;13(6):1783-8
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  • [Title] Phase I pharmacokinetic and pharmacodynamic study of 17-N-allylamino-17-demethoxygeldanamycin in pediatric patients with recurrent or refractory solid tumors: a pediatric oncology experimental therapeutics investigators consortium study.
  • We conducted a phase I trial of 17-AAG in pediatric patients with recurrent or refractory neuroblastoma, Ewing's sarcoma, osteosarcoma, and desmoplastic small round cell tumor to determine the maximum tolerated dose, define toxicity and pharmacokinetic profiles, and generate data about molecular target modulation.
  • DLTs were grade 3 transaminitis and hypoxia.
  • Caution should be used in treatment of patients with bulky pulmonary disease.
  • [MeSH-major] Benzoquinones / administration & dosage. Benzoquinones / pharmacokinetics. Lactams, Macrocyclic / administration & dosage. Lactams, Macrocyclic / pharmacokinetics. Neoplasms / drug therapy. Pediatrics
  • [MeSH-minor] Adolescent. Adult. Antineoplastic Agents / administration & dosage. Antineoplastic Agents / adverse effects. Antineoplastic Agents / pharmacokinetics. Biomarkers, Tumor / analysis. Child. Child, Preschool. Female. Humans. Male. Maximum Tolerated Dose. Recurrence. Treatment Failure

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  • [CommentIn] Clin Cancer Res. 2007 Mar 15;13(6):1625-9 [17363512.001]
  • (PMID = 17363533.001).
  • [ISSN] 1078-0432
  • [Journal-full-title] Clinical cancer research : an official journal of the American Association for Cancer Research
  • [ISO-abbreviation] Clin. Cancer Res.
  • [Language] eng
  • [Grant] United States / NCRR NIH HHS / RR / M01 RR-00069; United States / NCRR NIH HHS / RR / M01 RR-00082; United States / NCRR NIH HHS / RR / M01 RR-00095; United States / NCI NIH HHS / CA / U54 CA090821
  • [Publication-type] Clinical Trial, Phase I; Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Benzoquinones; 0 / Biomarkers, Tumor; 0 / Lactams, Macrocyclic; 4GY0AVT3L4 / tanespimycin
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35. Geller JI, Wall D, Perentesis J, Blaney SM, Bernstein M, Pediatric Oncology Group study 9376: Phase I study of paclitaxel with standard dose ifosfamide in children with refractory solid tumors: a Pediatric Oncology Group study (POG 9376). Pediatr Blood Cancer; 2009 Mar;52(3):346-50
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  • RESULTS: Fifteen patients received a combined 46 courses of therapy.
  • The median age was 14.5 years (range, 2-19 years), and diagnoses included sarcoma (7), neuroblastoma (3), and other (5).
  • DLTs occurred in 2/3 patients at 550 mg/m(2) paclitaxel during cycle 1, including grade 3 hypotension and grade 4 anaphylaxis in 1 patient each.
  • CONCLUSION: Paclitaxel hypersensitivity reactions were dose limiting when the drug was administered as a 6-hr infusion.

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  • (PMID = 18989889.001).
  • [ISSN] 1545-5017
  • [Journal-full-title] Pediatric blood & cancer
  • [ISO-abbreviation] Pediatr Blood Cancer
  • [Language] ENG
  • [Grant] United States / NCI NIH HHS / CA / CA057745-09; United States / NCI NIH HHS / CA / U01 CA057745-09
  • [Publication-type] Clinical Trial, Phase I; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] P88XT4IS4D / Paclitaxel; UM20QQM95Y / Ifosfamide
  • [Other-IDs] NLM/ NIHMS123684; NLM/ PMC2744894
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36. Wagner LM, Crews KR, Iacono LC, Houghton PJ, Fuller CE, McCarville MB, Goldsby RE, Albritton K, Stewart CF, Santana VM: Phase I trial of temozolomide and protracted irinotecan in pediatric patients with refractory solid tumors. Clin Cancer Res; 2004 Feb 1;10(3):840-8
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  • We assessed toxicity, the pharmacokinetics of temozolomide and irinotecan, and the DNA repair phenotype in tumor samples.
  • RESULTS: Two patients experienced dose-limiting toxicity (DLT) at the higher dose level; one had grade 4 diarrhea, whereas the other had bacteremia with grade 2 neutropenia.
  • Drug metabolite exposures at the MTD were similar to exposures previously associated with single-agent antitumor activity.
  • One complete response, two partial responses, and one minor response were observed in Ewing's sarcoma and neuroblastoma patients previously treated with stem cell transplant.
  • Responding patients had low or absent O(6)-methylguanine-DNA methyltransferase expression in tumor tissue.
  • Drug clearance was similar to single-agent values, and clinically relevant SN-38 lactone and MTIC exposures were achieved at the MTD.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Camptothecin / administration & dosage. Camptothecin / analogs & derivatives. Dacarbazine / administration & dosage. Dacarbazine / analogs & derivatives. Neoplasms / drug therapy
  • [MeSH-minor] Adolescent. Adult. Area Under Curve. Base Pair Mismatch. Cell Line, Tumor. Child. Child, Preschool. DNA Repair. Female. Humans. Immunohistochemistry. Infant. Male. Maximum Tolerated Dose. O(6)-Methylguanine-DNA Methyltransferase / metabolism. Phenotype. Time Factors

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  • (PMID = 14871959.001).
  • [ISSN] 1078-0432
  • [Journal-full-title] Clinical cancer research : an official journal of the American Association for Cancer Research
  • [ISO-abbreviation] Clin. Cancer Res.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA 21765; United States / NCI NIH HHS / CA / CA 23099; United States / NCI NIH HHS / CA / CA 42014
  • [Publication-type] Clinical Trial; Clinical Trial, Phase I; Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 7673326042 / irinotecan; 7GR28W0FJI / Dacarbazine; 85622-93-1 / temozolomide; EC 2.1.1.63 / O(6)-Methylguanine-DNA Methyltransferase; XT3Z54Z28A / Camptothecin
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37. Kieran MW, Packer RJ, Onar A, Blaney SM, Phillips P, Pollack IF, Geyer JR, Gururangan S, Banerjee A, Goldman S, Turner CD, Belasco JB, Broniscer A, Zhu Y, Frank E, Kirschmeier P, Statkevich P, Yver A, Boyett JM, Kun LE: Phase I and pharmacokinetic study of the oral farnesyltransferase inhibitor lonafarnib administered twice daily to pediatric patients with advanced central nervous system tumors using a modified continuous reassessment method: a Pediatric Brain Tumor Consortium Study. J Clin Oncol; 2007 Jul 20;25(21):3137-43
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  • [Title] Phase I and pharmacokinetic study of the oral farnesyltransferase inhibitor lonafarnib administered twice daily to pediatric patients with advanced central nervous system tumors using a modified continuous reassessment method: a Pediatric Brain Tumor Consortium Study.
  • A modified continual reassessment method (CRM) was used to estimate the MTD based on actual dosages of lonafarnib administered and toxicities observed during the initial 4 weeks of treatment.
  • Both radiographic response (one anaplastic astrocytoma) and stable disease (one medulloblastoma, two high-grade and four low-grade gliomas, one ependymoma, and one sarcoma) were noted, and seven patients remained on treatment for 1 year or longer.
  • [MeSH-major] Central Nervous System Neoplasms / drug therapy. Central Nervous System Neoplasms / mortality. Enzyme Inhibitors / pharmacokinetics. Farnesyltranstransferase / antagonists & inhibitors. Neoplasm Invasiveness / pathology. Piperidines / pharmacokinetics. Pyridines / pharmacokinetics
  • [MeSH-minor] Administration, Oral. Adolescent. Adult. Child. Child, Preschool. Dose-Response Relationship, Drug. Drug Administration Schedule. Female. Follow-Up Studies. Humans. Infant. Infant, Newborn. Male. Maximum Tolerated Dose. Neoplasm Staging. Risk Assessment. Survival Analysis. Treatment Outcome

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  • (PMID = 17634493.001).
  • [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
  • [Grant] United States / NCI NIH HHS / CA / U01 CA81457
  • [Publication-type] Clinical Trial, Phase I; Journal Article; Research Support, N.I.H., Extramural
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Enzyme Inhibitors; 0 / Piperidines; 0 / Pyridines; 193275-84-2 / lonafarnib; EC 2.5.1.29 / Farnesyltranstransferase
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38. Huh WK, Sill MW, Darcy KM, Elias KM, Hoffman JS, Boggess JF, Alvarez RD, Long HJ, O'Malley DM, Birrer MJ: Efficacy and safety of imatinib mesylate (Gleevec) and immunohistochemical expression of c-Kit and PDGFR-beta in a Gynecologic Oncology Group Phase Il Trial in women with recurrent or persistent carcinosarcomas of the uterus. Gynecol Oncol; 2010 May;117(2):248-54
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  • METHODS: Women with measurable uterine carcinosarcoma, who had a performance status of 0, 1, or 2 and had received up to two prior treatment regimens, were eligible and treated with a 600-mg daily oral dose of imatinib mesylate until disease progression or unacceptable toxicity.
  • Endpoints included progression-free survival (PFS) >or=6 months, overall toxicity, PFS, overall survival (OS), and response. c-Kit and PDGFR-beta were evaluated by immunohistochemistry in archival tumor.
  • One subject had a PFS time >or=6 months, yielding the only patient with stable disease.
  • All other patients had progressive disease (n=17) or were inevaluable for tumor response (n=5).
  • Adverse events included grade 4 hypocalcemia (n=1) and grade 3 fatigue, dehydration and anorexia, genitourinary/renal, lymphatic, metabolic, and ocular toxicity (n=1 each, 4%).
  • Positive expression of c-Kit or PDGFR-beta was observed in 88% (14/16) or 40% (6/15) and in 56% (9/16) or 73% (11/15) of cases in the sarcoma and carcinoma component of the tumor, respectively.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Carcinosarcoma / drug therapy. Neoplasm Recurrence, Local / drug therapy. Piperazines / therapeutic use. Proto-Oncogene Proteins c-kit / biosynthesis. Pyrimidines / therapeutic use. Receptor, Platelet-Derived Growth Factor beta / biosynthesis. Uterine Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Benzamides. Disease-Free Survival. Female. Humans. Imatinib Mesylate. Immunohistochemistry. Middle Aged. Proto-Oncogene Proteins c-akt / metabolism. Treatment Outcome

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  • [Copyright] Copyright (c) 2010 Elsevier Inc. All rights reserved.
  • (PMID = 20189232.001).
  • [ISSN] 1095-6859
  • [Journal-full-title] Gynecologic oncology
  • [ISO-abbreviation] Gynecol. Oncol.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA 11479; United States / NCI NIH HHS / CA / CA 27469; United States / NCI NIH HHS / CA / CA 37517; United States / Intramural NIH HHS / /
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, N.I.H., Intramural; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Benzamides; 0 / Piperazines; 0 / Pyrimidines; 8A1O1M485B / Imatinib Mesylate; EC 2.7.10.1 / Proto-Oncogene Proteins c-kit; EC 2.7.10.1 / Receptor, Platelet-Derived Growth Factor beta; EC 2.7.11.1 / AKT2 protein, human; EC 2.7.11.1 / Proto-Oncogene Proteins c-akt
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