FUNCTION AND HEALTH STATUS OUTCOMES IN A RANDOMIZED TRIAL COMPARING PRE-OPERATIVE AND POST-OPERATIVE RADIOTHERAPY IN EXTREMITY SOFT TISSUE SARCOMA

Abstract

Introduction Morbidity associated with wound complications may translate into disability and quality-of-life disadvantages for patients treated with radiotherapy (RT) for soft tissue sarcoma (STS) of the extremities. Functional outcome and health status of extremity STS patients randomized in a phase III trial comparing pre-operative versus post-operative RT is described.

Methods One hundred and ninety patients with extremity STS were randomized after stratification by tumor size dichotomized at 10 cm. Function and quality of life were measured by the Musculoskeletal Tumor Society Rating Scale (MSTS), the Toronto Extremity Salvage Score (TESS), and the Short Form-36 (SF-36) at randomization, six weeks, and three, six, 12, and 24 months after surgery. One hundred and eighty-five patients had function data.

Results Patients treated with post-operative RT had better function with higher MSTS (25.8 v 21.3, P < .01), TESS (69.8 v 60.6, P =.01), and SF-36 bodily pain (67.7 v 58.5, P =.03) scores at six weeks after surgery. There were no differences at later time points. Scores on the physical function, role-physical, and general health sub-scales of the SF-36 were significantly lower than Canadian normative data at all time points. After treatment arm was controlled for, MSTS change scores were predicted by a lower-extremity tumor, a large resection specimen, and motor nerve sacrifice; TESS change scores were predicted by lower-extremity tumor and prior incomplete excision. When wound complication was included in the model, patients with complications had lower MSTS and TESS scores in the first two years after treatment.

Conclusions The timing of RT has minimal impact on the function of STS patients in the first year after surgery. Tumor characteristics and wound complications have a detrimental effect on patient function.