RANDOMIZED PROSPECTIVE-STUDY OF THE BENEFIT OF ADJUVANT RADIATION-THERAPY IN THE TREATMENT OF SOFT-TISSUE SARCOMAS OF THE EXTREMITY

Purpose: This randomized, prospective study assesses the impact of pos toperative external-beam radiation therapy on local recurrence (LR), o verall survival (OS), and quality of life after limb-sparing resection of extremity sarcomas. Patients and Methods: Patients with extremity tumors and a limb-sparing surgical option were randomized to receive o r not receive postoperative adjuvant external-beam radiotherapy. Patie nts with high-grade sarcomas received postoperative adjuvant chemother apy whereas patients with low-grade sarcomas or locally aggressive non malignant tumors were randomized after surgery alone, Results: Ninety- one patients with high-grade lesions were randomized; 47 to receive ra diotherapy (XRT) and 44 to not receive XRT. With a median follow-up of 9.6 years, a highly significant decrease (P-2 = .0028) in the probabi lity of LR was seen with radiation, but no difference in OS was shown, Of 50 patients with low-grade lesions (24 randomized to resection alo ne and 26 to resection and postoperative XRT), there was also a lower probability of LR (P-2 = .016) in patients receiving XRT, again, witho ut a difference in OS. A concurrent quality-of-life study showed that extremity radiotherapy resulted in significantly worse limb strength, edema, and range of motion, but these deficits were often transient an d had few measurable effects on activities of daily life or global qua lity of life, Conclusion: This study indicates that although postopera tive external-beam radiotherapy is highly effective in preventing LRs, selected patients with extremity soft tissue sarcoma who have a low r isk of LR may not require adjuvant XRT after limb-sparing surgery (LSS ). (C) 1998 by American Society of Clinical Oncology.