Preoperative versus postoperative radiotherapy in soft-tissue sarcoma of the limbs: A randomised trial

Abstract

Background External-beam radiotherapy has been delivered preoperatively or post-operatively for adjuvant treatment of soft tissue sarcoma of the limbs. Preoperative radiotherapy has been associated with increased wound healing problems but has the potential to increase survival rates and reduce local recurrence. This randomised study aimed to provide a higher level of evidence as to whether preoperative radiotherapy is benefi-cial for most patients. Methods The sarcomas were stratifi ed by size (< or = 10 cm or >10 cm) and then 94 patients randomly allocated to preoperative radiotherapy (50 Gy in 25 fractions) and 96 to postoperative radiotherapy (66 Gy in 33 fractions). The primary endpoint was rate of wound complications within 120 days of surgery. Analyses were per protocol for primary outcomes and by intention to treat for secondary outcomes. Results Median follow-up was 3.3 years (range 0.27-5.6). Four patients, all in the preoperative group, did not undergo protocol surgery and were not evaluable for the primary outcome. Of those patients who were eligible wound complications were recorded in 31 (35 %) of 88 in the preoperative group and 16 (17 %) of 94 in the postoperative group (difference 18 % [95 % CI 5-30], p = 0.01). Tumour size and anatomical site were also signifi cant risk factors in a multivariate analysis. Overall survival was slightly better in patients who had preoperative radiotherapy than in those who had postoperative treatment (p = 0.0481). Conclusions Although patient survival was marginally improved for patients undergoing preoperative radiotherapy, tumour size and location had a bearing on the increased frequency of wound complications in this group and therefore these factors should be borne in mind when considering preoperative radiotherapy.