Efficacy of Adjuvant Radiation Therapy in the Treatment of Soft Tissue Sarcoma of the Extremity: 20-year Follow-up of a Randomized Prospective Trial

Background: 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).

Methods: 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.

Results: 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 17.9 years. 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).

Conclusions: 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.