A randomized prospective trial using postoperative adjuvant chemotherapy (Adriamycin) in high-grade extremity soft-tissue sarcoma

From March 1981 to December 1984 119 patients with primary grade III extremity soft-tissue sarcoma were randomized postoperatively to single agent Adriamycin (57) or to control, no adjuvant chemotherapy (62). Adjuvant therapy was begun within 6 weeks of surgery, and consisted of Adriamycin 90 mg/m² given over 2 days, once a month for 5 months. All patients had received preoperative intraarterial Adriamycin, radiation therapy (1,750 cGy) and subsequent surgical excision. At a median follow-up of 28 months there was no difference between the two groups in overall survival (Adriamycin=84%, control=80%), local tumor recurrence, or in the disease-free survival (Adriamycin=58%, control=54%). This study indicates that the use of single-agent Adriamycin as postoperative adjuvant chemotherapy has no significant clinical benefit in patients with high-grade extremity soft-tissue sarcoma treated with preoperative Adriamycin, radiation, and surgical excision. Although the Adriamycin postoperative adjuvant chemotherapy did not significantly benefit the experimental group relative to the control group, both groups of patients had an improved disease-free and overall survival rate compared to historical controls.