A randomized, prospective trial of adjuvant chemotherapy in adults with soft tissue sarcomas of the head and neck, breast, and trunk

Since 1977, 31 patients were entered in a randomized, prospective study testing the efficacy of adjuvant chemotherapy after aggressive local treatment of high‐grade sarcomas of the head, neck, breast, and trunk (excluding retroperitoneal sarcomas). All patients had complete resection of gross tumor and underwent postoperative radiotherapy (6000–6300 rads over 7–8 weeks). Seventeen patients received adjuvant chemotherapy consisting of doxorubicin (⩽550 mg/m²), cyclophosphamide (⩽5500 mg/m²), and methotrexate (⩽1000 mg/kg). Three‐year actuarial disease‐free survival in the chemotherapy arm was 77%, compared to 49% in the no‐chemotherapy arm (P = 0.075). Three‐year overall actuarial survivals in the two treatment arms, however, were 68% and 58%, respectively (P = 0.38). Considering only patients with tumors of the trunk (22 patients), 3‐year actuarial disease‐free survival in the chemotherapy arm was 92%, compared to 47% in the no‐chemotherapy arm (P = 0.006). Actuarial 3‐year overall survival in the chemotherapy arm was 82%, compared to 61% in the no‐chemotherapy arm (P = 0.18). An additional 26 patients were treated in an identical fashion, but were not part of the randomized trial because of contraindications to chemotherapy, refusal to enter the randomized trial, or because they were treated before 1977 in a trial in which all patients received chemotherapy. Considering the entire group of 57 patients, follow‐up ranged from 10 to 86 months (median, 35 months). Local control was achieved in 46 patients (81%); 3‐year actuarial disease‐free and overall survivals were 67% and 77%, respectively. A tendency toward improved disease‐free survival was apparent among patients treated with chemotherapy (P = 0.018), but there was no statistically significant improvement in overall actuarial survival (P = 0.46). The subgroup of patients with sarcomas of the trunk (39 patients) demonstrated the greatest benefit from chemotherapy, with regard to disease‐free survival (P < 0.001). The most significant toxicity associated with chemotherapy was doxorubicin‐induced cardiomyopathy, which resulted in clinically apparent congestive heart failure in five patients. Thus, the use of chemotherapy when combined with aggressive local measures appears to improve disease‐free survival, but additional patients and longer follow‐up are necessary to determine if improved overall survival will result. Cancer 55:1206‐1214, 1985.