Long-term results of prospective trial of surgery alone with selective use of radiation for patients with T1 extremity and trunk soft tissue sarcomas.

Objective: We conducted a prospective trial to define the local recurrence rates for selected patients with T1 soft tissue sarcomas (STS) treated by surgery alone.

Summary Background Data: Retrospective data suggest that some patients with small STS can be safely treated by surgery alone. There are no defined criteria to select patients for such treatment.

Methods: Patients with T1 primary STS were treated with function-preserving surgery and microscopic assessment of surgical margins. Postoperative external-beam radiation was employed selectively for patients with microscopically positive (R1) final surgical margins. Patients who underwent resection with microscopically negative (R0) final margins did not receive radiotherapy.

Results: Eighty-eight eligible and evaluable patients were entered on this protocol between March 1996 and April 2002. Tumor sites included the extremities (n=60), and trunk (n=26). Fifty-one patients (58%) had high-grade STS; 60 (68%) had superficial (T1a) disease. Fourteen patients (16%) underwent R1 resection and were treated with postoperative radiation; 74 (84%) underwent R0 resection and were treated by surgery alone. The median follow-up was 75 months. Isolated local recurrences were observed in 11 patients (13%; 6 in R1 arm, 5 in R0 arm). In the R0 surgery-alone arm, the cumulative incidence rates of local recurrence at 5 and 10 years were 7.9% and 10.6%, respectively; and the 5- and 10-year sarcoma-specific death rates were 3.2% and 3.2%.

Conclusion: Selected patients with primary T1 STS of the extremity and trunk can be treated by R0 surgery alone with acceptable local control and excellent long-term survival.