Feasibility and activity of concurrent neoadjuvant chemotherapy and radiation therapy in patients with high-risk soft tissue sarcoma.

Authors

Elena Palassini, Sara Pizzamiglio, Emanuela Palmerini, Vittorio Quagliuolo, Javier Martin-Broto, Antonio Lopez Pousa, Sandra Aliberti, Antonella Brunello, Jean-Yves Blay, Oscar Tendero, Robert Diaz Beveridge, Virginia Ferraresi, Iwona Lugowska, Claudia Sangalli, Sandro Pasquali, Valeria Duroni, Giuseppe Bianchi, Davide Maria Donati, Andrea Marrari, Jean Michel Coindre, Silvia Bagué, Valeria Fontana, Carlo Morosi, Silvia Stacchiotti, Angelo Paolo Dei Tos, Paolo Verderio, Paolo Giovanni Casali, Alessandro Gronchi

Published in

Clinical cancer research : an official journal of the American Association for Cancer Research. Jul 30, 2026. Epub Jul 30, 2026.

Abstract

The ISG-STS 1001 was an international, randomized, phase III, trial for localized, high-risk, STS comparing neoadjuvant ChT with epirubicin and ifosfamide (EI) versus a histology-tailored regimen. The trial included also a cohort of patients not randomized but just registered and treated with EI. Herein, we analyzed tolerability and activity of concurrent EI and RT in the ISG-STS 1001.
EI was made up of epirubicin 120 mg/m² plus ifosfamide 9 g/m² per cycle. RT was delivered at a dose of 44-50 Gy pre-operatively or 60-66 Gy post-operatively. ChT dose-intensity (DI), grade ≥3 hematological toxicities, acute RT-related toxicities, post-operative local complications, and radiological response by RECIST were compared between the group of patients receiving concurrent pre-operative ChT and RT (ChT/RT group) and the group receiving pre-operative ChT alone (ChT group).
Among the 548 patients enrolled in the ISG-STS 1001, 287 were included in the current analysis (146 received pre-operative RT). Median ChT DI was >90% in both groups. Hematological toxicities were comparable between the two groups. Concerning post-operative 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 to the ChT group. A statistically significant association between RECIST response and pre-operative RT was found (20.3% and 9.8% in the ChT/RT group and in the ChT group, respectively, p = 0.02).
Concurrent EI and RT is feasible and safe, resulting in increased proportion of dimensional responses.

PMID:
42531374
Bibliographic data and abstract were imported from PubMed on 31 Jul 2026.

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