Randomized study of systemic chemotherapy following complete excision of nonosseous sarcomas.

Abstract

Between June 1975 and April 1981, 61 of the 177 eligible patients whose nonosseous sarcomas of extremity or trunk origin had been completely excised primarily or after local recurrences agreed to participate in a randomized study of adjvant chemotherapy. Dermatofibrosarcoma, lymphomas, myeloma, Kaposi''s sarcoma and embryonal rhabdomyosarcoma were excluded as were patients with significant 2nd primary cancers and those who received preoperative or postoperative radiation therapy. After stratification by anatomic status of disease, site of origin and histologic grade, a random 1/2 of the 61 paticipants began alternating courses of vincristine/cyclophosphamide/dactinomycin, and vincristine/doxorubicin/dacarbazine at 6 wk intervals for 1 yr. The control group was evaluated at 6 wk intervals without adjuvant chemotherapy, but these patients were offered this chemotherapy later if they had progressive disease excised. Although 30% of the 61 patients experienced local recurrence of disease within the first 5 yr after randomization, and only 54% were continuously disease free for .gtoreq. 5 yr, 82% were surviving at 5 yr (Kaplan-Meier calculations) with a median follow-up of 64.3 mo. Partial suppression of distant metastasis by adjuvant chemotherapy was apparent in the overall study, in the extremity tumor category and in the subgroup of patients who had received limb-sparing surgery; however, no survival advantage for chemotherapy-treated patients was demonstrated. The 30 adjuvant chemotherapy-treated patients received a total of 3 thoracotomies as compared with 17 salvage thoracotomies for the 31 control patients; however, salvage surgery for local recurrences was similar in the 2 groups. Recent improvement in the survival of patients with soft-tissue sarcomas is not necessarily a result of adjuvant chemotherapy or radiation therapy.