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Increasing single epirubicin doses in advanced soft tissue sarcomas
Massimo Lopez1, Patrizia Vici, Luigi Di Lauro
1Division of Medical Oncology B, Regina Elena Institute for Cancer Research, Rome, Italy. lopez@ifo.it
Epirubicin at 160 mg/m(2) every 3 weeks is effective for advanced soft tissue sarcoma, showing a 44% response rate. The maximum-tolerated dose was 180 mg/m(2), but 160 mg/m(2) is recommended with hematopoietic support.
Area of Science:
- Oncology
- Pharmacology
Background:
- Soft tissue sarcoma is a rare cancer with limited treatment options.
- Epirubicin is an anthracycline chemotherapy agent used in various cancers.
Purpose of the Study:
- To determine the maximum-tolerated dose (MTD) of epirubicin in advanced soft tissue sarcoma.
- To evaluate the clinical efficacy and safety of epirubicin in this patient population.
Main Methods:
- A dose-escalation study involving 61 patients with advanced soft tissue sarcoma.
- Patients received epirubicin at doses of 140, 160, or 180 mg/m(2) every 3 weeks.
- Dose-limiting toxicity (DLT) was monitored to establish the MTD.
Main Results:
- The overall response rate was 44%, with a dose-response relationship observed (P=.02).
- Median response duration, time to progression, and overall survival were 10, 8, and 15 months, respectively.
- Myelosuppression, particularly grade 3/4 neutropenia (79%), was the most common toxicity.
Conclusions:
- The MTD of epirubicin was determined to be 180 mg/m(2).
- A dose of 160 mg/m(2) every 3 weeks with hematopoietic support is recommended for clinical use.
- Single high-dose epirubicin demonstrates efficacy as first-line treatment for advanced soft tissue sarcoma.
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