Efficacy of adjuvant radiation therapy in the treatment of soft tissue sarcoma of the extremity: 20-year follow-up of a randomized prospective trial.

Abstract

This update of a randomized, prospective study presents the effect of external beam radiation therapy (EBRT) on long-term overall survival, local control, and limb function following limb-sparing surgery (LSS) for the treatment extremity soft tissue sarcoma (STS). Following LSS, patients with extremity STS were randomized to receive EBRT or surgery alone. All patients with high-grade STS received adjuvant chemotherapy. Long-term follow-up was obtained through telephone interviews using a questionnaire based on validated methods. Overall survival (OS) was determined by Kaplan-Meier method. A total of 141 patients with extremity STS were randomized to receive adjuvant EBRT (n=70) or LSS alone (n=71). Median follow-up was 17.9years. The 10- and 20-year survival was 77% (95% CI 66-85%) and 64% (95% CI 52-75%) for patients receiving LSS alone and 82% (95% CI 72-90%) and 71% (95% CI 59-81%) for patients receiving EBRT (p=0.22). Of the 54 patients who completed telephone interviews, the incidence of local recurrence during the follow-up period was 4% (1 of 24) in the LSS alone cohort compared with 0% (0 of 30) in those who received EBRT (p=0.44). Patients treated with EBRT tended to have more wound complications (17 vs. 12.5%, p=0.72), clinically significant edema (25 vs. 12%, p=0.31), and functional limb deficits (15 vs. 12%, p=0.84). Adjuvant EBRT following surgery for STS of the extremity provides excellent local control with acceptable treatment-related morbidity and no statistically significant improvement in overall survival.