LONG-TERM RESULTS OF A PROSPECTIVE RANDOMIZED TRIAL OF ADJUVANT BRACHYTHERAPY IN THE MANAGEMENT OF COMPLETELY RESECTED SOFT-TISSUE SARCOMASOF THE EXTREMITY AND SUPERFICIAL TRUNK

Purpose: A prospective randomized trial evaluating adjuvant brachyther apy for soft tissue sarcomas was conducted between July 1982 and July 1987. Methods and Materials: One hundred twenty-six patients with soft tissue sarcoma of the extremity or superficial trunk (STS) underwent grossly complete resection with limb-sparing surgery. Intra-operativel y, patients were randomized to receive either adjuvant brachytherapy ( BRT) or no further therapy (no BRT). BRT consisted of an Iridium-192 i mplant which delivered 4200-4500 cGy over 4-6 days. Total hospital sta y for combined surgery and BRT was 10-14 days. Patients in each group were well matched with respect to age, sex, site, tumor size, depth, h istologic type, and grade. Median follow-up is 66.5 months for all liv ing patients. Results: At 5 years, local control was 82% in the BRT gr oup vs. 67% in the no BRT group (p = .049). When analyzed by histologi c grade, high grade tumors had local control of 90% with BRT vs. 65% w ith no BRT (p = .013). There was no difference in local control in the low grade patients in either arm. At 5 years, the proportion free of distant metastases was approximately 76% in both arms, with no differe nce between BRT and no BRT. When analyzed by grade, high grade patient s had a similar proportion free of distant metastasis in the BRT vs. n o BRT arms despite improved local control in those receiving BRT. Simi larly, the disease-specific survival for all patients at 5 years was 8 1% for BRT vs. 80% for no BRT (p = NS). When analyzed by grade, and tr eatment (BRT vs. no BRT), 5-year disease-specific survival for high gr ade was the same in both groups.Conclusions: Adjuvant BRT significantl y improves local control in completely resected STS. This improvement is confined to patients with high grade histology. BRT provides excell ent local control in this group, and significantly shortens the treatm ent time when compared to adjuvant external beam radiation. However, t he improved local control does not translate into either decreased dis tant metastasis or increased disease-specific survival.