Two treatment regimens for metastatic soft-tissue sarcomas were compared in a randomized trial in the cooperative group setting. Histopathologic diagnosis was affirmed by pathology reference panel review in 72% of the 347 patients. In 21% of patients, the reference panel affirmed the diagnosis of soft-tissue sarcoma but disagreed as to type; 7% of patients were ineligible based upon cell type. Of 298 patients evaluable, measurable tumor regression (partial or complete response) occurred in 17% of patients to doxorubicin (70 mg/mz intravenously) and 18% of patients to doxorubicin (70 mg/mz intravenously) and vindesine (3 mg/mz intravenously), each given every 3 weeks. No difference existed in complete response (4% for doxorubicin, 6% for doxorubicin and vindesine) or median survival (9.4 months for doxorubicin, 9.9 months for doxorubicin and vindesine). Overall, 60% of those patients on doxorubicin and vindesine and 46% on doxorubicin experienced a severe or worse toxicity of treatment (P = 0.01). With greater toxicity and lack of any gains in efficacy, the results do not support use of the combination of doxorubicin and vindesine for metastatic soft-tissue sarcomas. Cancer 66:862-867,1990.
OxoRuBICiN HAS BEEN the single most active agent D for treatment of metastatic soft-tissue sarcoma. It has been commonly used on an every-3-week basis, either alone or in combination with imidazole carboximide (DTIC). When combined with DTIC, doxorubicin resulted in higher overall response frequency but was with-out impact on complete response rate or survival.' Other combinations, while effective in yielding objective response, have also had no impact on either complete response frequency or survival in the cooperative-group setting.2 Because the doxorubicin-DTIC combination resulted in greater frequency of nausea and vomiting, the From the