Effects of amphotericin B on combination chemotherapy of metastatic sarcomas

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Abstract
Evaluable patients (94) with metastatic soft tissue and bone sarcomas entered into a prospective randomized trial (SEG 78SAR327) to determine whether amphotericin B (AMB), a membrane-permeabilizing and immunopotentiating agent, could increase the response rates or the survival of patients treated with a 3 drug combination chemotherapy regimen consisting of Adriamycin, cyclophosphamide and methotrexate (ACM). Pretreatment patient characteristics were similar in each arm. In patients treated with ACM there were 4% complete responses and 34% partial responses, compared with only 5% partial responses on ACM + AMB (P < 0.05). However, there was no difference in the median time to progression (5.0 mo. on either arm) or in survival (7.0 mo. on ACM, and 6.0 mo. on ACM + AMB). Myelosuppression was the dose-limiting toxicity, and was equal in each treatment arm. The addition of AMB to dactinomycin during maintenance therapy did not result in any complete or partial responses. Despite definite biologic activity in experimental tumor models, AMB is not useful clinically in potentiating chemotherapeutic drug activity in patients with metastatic sarcomas, and actually results in a decrease in the frequency of objective responses.