Phase II Trial of Doxorubicin Plus Escalated High-Dose Ifosfamide in Patients With Advanced Soft Tissue Sarcomas of the Adult: A Study of the Spanish Group for Research on Sarcomas (GEIS)

• Published in: Sarcoma Vol. 2006; pp. 18 - 25
• Main Authors: Buesa, J.M, Garcia del Muro, J, Cruz, J, Montalar, J, Escudero, P, Martin, J, Maurel, J, Lopez-Pousa, A, de las Penas, R, Casado, A
• Format: Journal Article
• Language: English
• Published: Egypt Hindawi Limiteds 2006; John Wiley & Sons, Inc; Hindawi Publishing Corporation; Hindawi Limited
• Subjects: Care and treatment; Clinical Study; Dosage and administration; Ifosfamide; Sarcoma; Spain
• ISSN: 1357-714X; 1369-1643
• DOI: 10.1155/SRCM/2006/26986

Background. To explore the tolerance and the activity of high-dose ifosfamide (IFOS) combined with doxorubicin (DXR) at 50 mg/m(2) every 4 weeks in patients with soft tissue sarcomas. Methods. DXR was given IV bolus and IFOS by continuous infusion at 2 g/m(2)/day. Initial IFOS dose (12 g/m(2)) was adjusted to 10, 13, or 14 g/m(2) according to toxicity. Results. Seventy patients received 277 cycles (median 3 cycles, range 1-10), 34% with IFOS dose increased, 30% decreased, and 48% delivered at 12 g/m(2). Toxicity grade 4 occurred on granulocytes (67% of patients) or platelets (19%), 54% had febrile neutropenia, 31% grade 3/4 asthenia, and 26% abandoned the study due to toxicity. Three toxic deaths occurred. In 57 non-GIST patients objective activity was 45.6% (95% CI, 32 to 58%). Conclusion. At least 4 cycles were tolerated by 71% of patients, most receiving DXR 50 mg/m(2) plus IFOS 10-12 g/m(2), with substantial toxicity.