Feasibility and Activity of Concurrent Neoadjuvant Chemotherapy and Radiotherapy in Patients with High-risk Soft-Tissue Sarcoma.

PURPOSE: The ISG-STS 1001 was an international, randomized, phase III trial for localized, high-risk, soft-tissue sarcoma comparing neoadjuvant chemotherapy (ChT) with epirubicin and ifosfamide (EI) versus a histology-tailored regimen. The trial also included a cohort of patients not randomized but just registered and treated with EI. In this study, we analyzed the tolerability and activity of concurrent EI and radiotherapy (RT) in the ISG-STS 1001 trial.

PATIENTS AND

METHODS

EI consisted of epirubicin 120 mg/m2 plus ifosfamide 9 g/m2 per cycle. RT was delivered at a dose of 44 to 50 Gy preoperatively or 60 to 66 Gy postoperatively. ChT dose intensity (DI), grade ≥3 hematologic toxicities, acute RT-related toxicities, postoperative local complications, and radiologic response by RECIST were compared between the group of patients receiving concurrent preoperative ChT and RT (ChT/RT group) and the group receiving preoperative ChT alone (ChT group).

RESULTS

Among the 548 patients enrolled in the ISG-STS 1001 trial, 287 were included in the current analysis (146 received preoperative RT). The median ChT DI was >90% in both groups. Hematologic toxicities were comparable between the 2 groups. With regard to postoperative complications, a higher number of wound dehiscence (9% vs. 3.5%, respectively; P = 0.06) and seroma (10.4% vs. 2.8%, respectively; P = 0.01) were observed in the ChT/RT group compared with the ChT group. A statistically significant association between RECIST response and preoperative RT was found (20.3% and 9.8% in the ChT/RT and ChT groups, respectively; P = 0.02).

CONCLUSIONS

Concurrent EI and RT is feasible and safe, resulting in an increased proportion of dimensional responses.