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Increasing Single Epirubicin Doses in Advanced Soft Tissue Sarcomas

From the Division of Medical Oncology B, Regina Elena Institute for Cancer Research, Rome, Italy.

Address reprint requests to Massimo Lopez, MD, Division of Medical Oncology B, Regina Elena Institute for Cancer Research, Via E. Chianesi, 53, 00144, Rome, Italy; email: lopez{at}ifo.it

PURPOSE: To evaluate the maximum-tolerated dose and the clinical efficacy of epirubicin in patients with advanced soft tissue sarcoma.

PATIENTS AND METHODS: Sixty-one patients were treated at three different epirubicin dose levels: 140 mg/m² (six patients), 160 mg/m² (52 patients), and 180 mg/m² (three patients). Cycles were repeated every 3 weeks for a maximum of eight cycles. The first two dose levels proved to be feasible and safe without dose-limiting toxicity (DLT). Because the first three patients entering the third dose level experienced DLT, subsequent patients received the next lower dose level.

RESULTS: The overall response rate was 44% (95% confidence interval, ± 12%), with six complete (10%) and 21 partial (34%) responses. Responses seemed related to epirubicin dose level, because the response rate was 17%, 44%, and 100% for the three dose levels (² test for trend, P = .02). Median response duration, median time to progression, and median overall survival were 10, 8, and 15 months, respectively. Myelosuppression was the most frequent side effect, with grade 3 or 4 neutropenia occurring in 79% of the patients; 31% of patients were febrile. Nonhematologic toxicity was mainly grades 1 and 2. The mean epirubicin dose-intensity was 49 mg/m² per week.

CONCLUSION: The third epirubicin dose level (180 mg/m²) was the maximum-tolerated dose. The recommended drug dose for clinical use is 160 mg/m² every 3 weeks with hematopoietic support. Single high-dose epirubicin is effective as first-line treatment and should be preferentially used whenever a high response rate is important to allow the resection of an otherwise unresectable disease or whenever it might result in a significant symptomatic benefit.

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