Role of adjuvant chemotherapy in the treatment of surgically resected pediatric nonrhabdomyosarcomatous soft tissue sarcomas: A pediatric oncology group study

purpose: To prospectively study the value of adjuvant chemotherapy in pedia tric patients with surgically resected nonrhabdomyosarcomatous soft tissue sarcomas (NRSTS). Patients and Methods: From June 1986 to May 1992, after complete surgical r esection(+/-radiotherapy) of their NRSTS, 81 eligible patients either recei ved adjuvant chemotherapy comprising vincristine, dactinomycin, cyclophosph amide, and doxorubicin or were observed. Only 30 patients accepted randomiz ation, and 15 were assigned to each regimen. Of the remaining 51 patients, 19 elected adjuvant chemotherapy and 32 elected observation. Results: Patients were predominantly male, and 69% of all patients were whi te. The median age at diagnosis was 12.3 years (range, 9.2 to 20.7 years). For the 81 eligible patients, the 5-year overall survival estimate was 84.5 % +/- 4.4% and event-free survival was 72.2% +/- 5.4%. Among randomized pat ients, the 5-year estimated overall survival rate was 93.3% +/- 7%, and the event-free survival rate was 86.7% +/- 9.5% for the observation group, com pared with 69.2% +/- 13% and 40.7% +/- 14%, respectively, for those who rec eived chemotherapy. The significantly worse outcome of patients who receive d adjuvant chemotherapy disappeared when survival was stratified by tumor g rade. Among all patients, a grade 3 lesion conferred a significant disadvan tage with respect to event-free survival (P =.0001). Conclusion: The administration of adjuvant chemotherapy according to the sc hedule and dosages used in our trial did not improve the outcome of childre n with resected NRSTS. In this study, tumor grade was the most important pr edictor of clinical outcome in patients with resected NRSTS, and this facto r should be incorporated into the stratification of patients in future tria ls. (C) 1999 by American Society of Clinical Oncology.