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Results of Two Consecutive Trials of Dose-Intensive Chemotherapy With Doxorubicin and Ifosfamide in Patients With Sarcomas

Patel, Shreyaskumar R. M.D.; Vadhan-Raj, Saroj M.D.; Burgess, M. Andrew M.D.; Plager, Carl M.D.; Papadopolous, Nicholas M.D.; Jenkins, Jan R.N.; Benjamin, Robert S. M.D.

American Journal of Clinical Oncology: June 1998 - Volume 21 - Issue 3 - p 317-321
Articles

The authors evaluate the efficacy and feasibility of dose-intensive doxorubicin and ifosfamide combination chemotherapy in patients with sarcomas. From January 1995 to April 1996, 33 evaluable patients with either metastatic sarcoma or primary sarcomas with a high-risk for metastases (all except one was previously untreated with chemotherapy) were treated on two consecutive protocols. The median age was 45 years (range, 15-68 years). The first protocol included doxorubicin at 75 mg/m2 given as a 72-hour infusion on days 1 to 3 along with ifosfamide at 2 g/m2/d over 2 hours × 5, days 1 to 5 (protocol AI 75/10). Granulocyte colony-stimulating factor (G-CSF) was used only if indicated according to American Society of Clinical Oncology guidelines. The second protocol included doxorubicin at 90 mg/m2 as a 72-hour continuous infusion and ifosfamide at 2.5 g/m2/d for 4 days (protocol AI 90/10) with prophylactic G-CSF. A median of four cycles were administered (range, 1-6). Three patients achieved a pathologic complete response (CR) and 18 patients achieved a partial response (PR) for a response rate (RR) of 64% (95% confidence interval (CI), 45-80%). Response rate for the subset of patients with soft-tissue sarcomas was 66% (95% CI, 46-82%). Only three patients progressed on therapy. Febrile neutropenia was noted in 31% of cycles at AI 75/10 and in 56% of cycles at AI 90/10. One patient developed reversible grade 3 central nervous system (CNS) toxicity. There was one treatment-related death on AI 90/10 secondary to doxorubicin cardiac toxicity at a cumulative dose of 435 mg/m2. Dose-intensive doxorubicin plus ifosfamide is feasible in appropriately selected patients and appears to be a very active regimen in patients with sarcomas. The authors are currently testing this regimen with G-CSF and thrombopoietin.

From the Departments of Melanoma-Sarcoma Medical Oncology (S.R.P., M.A.B., C.P., N.P., J.J., R.S.B.) and Bioimmunotherapy (S.V.-J.), The University of Texas M.D. Anderson Cancer Center, Houston, Texas, U.S.A.

Address and correspondence and reprint requests to Dr. S. R. Patel, The University of Texas M.D. Anderson Cancer Center, Box 77, 1515 Holcombe Boulevard, Houston, TX 77030, U.S.A.

© Lippincott-Raven Publishers.