Increasing 4'-epidoxorubicin and fixed ifosfamide doses plus granulocyte-macrophage colony-stimulating factor in advanced soft tissue sarcomas: a pilot study

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
S FrustaciS Monfardini

Abstract

To determine the maximum-tolerated dose (MTD) of 4'-epidoxorubicin (EPI) in combination with full dose of ifosfamide (IFO) when granulocyte-macrophage colony-stimulating factor (GM-CSF) was used, to estimate its clinical efficacy, and to evaluate the mobilization of hematopoietic progenitors. Previously untreated advanced patients were treated with fixed doses of IFO at 1.8 g/m2/d for 5 days and escalating doses of EPI. The starting dose level of EPI was 50 mg/m2 bolus on days 1 and 2; subsequent levels were 60 mg/m2 and 70 mg/ m2 given on days 1 and 2. GM-CSF (5 micrograms/kg/d) was administered from days +6 to +19. Clinical evaluation of response was performed after three consecutive cycles. Mobilization of hematopoietic progenitors was evaluated as day 14 CFU-GM after the first cycle only. Overall, six, 18, and 13 assessable patients were entered onto each EPI dose level, respectively. The first and the second EPI level were considered feasible. Conversely, at the third level, only six of 13 patients [46%] tolerated full EPI doses at the scheduled time. Therefore, the dose-intensity of the three levels was 100%, 99.7%, and 86.1%, respectively. Overall, 20 of 37 patients (54%) obtained an objective response. The response rate...Continue Reading

Citations

Mar 7, 2001·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·S FrustaciP Picci
Mar 1, 2002·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Massimo LopezSilvia Carpano
Feb 1, 2006·Expert Review of Anticancer Therapy·Eugene T H Ek, Peter F M Choong
Dec 21, 2000·Current Oncology Reports·P Picci
Dec 28, 1999·Medical and Pediatric Oncology·J FelgenhauerJ S Miser
Oct 13, 2006·British Journal of Cancer·S LeyvrazUNKNOWN Swiss Group for Clinical Cancer Research (SAKK)
Feb 28, 2006·Annals of Oncology : Official Journal of the European Society for Medical Oncology·S LeyvrazUNKNOWN Swiss Group for Clinical Cancer Research
Mar 18, 2011·Medicina clínica·Xavier García Del MuroUNKNOWN Grupo Español de Investigación en Sarcomas (GEIS)

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