Feasibility and activity of concurrent neoadjuvant chemotherapy and radiation therapy in patients with high-risk soft tissue sarcoma
OBJECTIVE: 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. METHODS AND PATIENTS: 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). RESULTS: 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). CONCLUSIONS: Concurrent EI and RT is feasible and safe, resulting in increased proportion of dimensional responses.
Authors
- Robert Díaz Beveridge (ORCID: https://orcid.org/0000-0003-3719-7014)
- Paolo Verderio (ORCID: https://orcid.org/0000-0002-9231-1281)
- Javier Martín‐Broto (ORCID: https://orcid.org/0000-0001-7350-6916)
- Vittorio Quagliuolo (ORCID: https://orcid.org/0000-0002-6102-0000)
- Angelo Paolo Dei Tos (ORCID: https://orcid.org/0000-0002-1228-8940)
- Andrea Marrari (ORCID: https://orcid.org/0000-0001-6363-9299)
- Paolo G. Casali (ORCID: https://orcid.org/0000-0003-4056-8023)
- Virginia Ferraresi (ORCID: https://orcid.org/0000-0001-6419-1668)
- Iwona Ługowska (ORCID: https://orcid.org/0000-0001-9511-178X)
- Jean‐Yves Blay (ORCID: https://orcid.org/0000-0001-7190-120X)
- Giuseppe Bianchi (ORCID: https://orcid.org/0000-0001-6390-9762)
- Jean‐Michel Coindre (ORCID: https://orcid.org/0000-0001-8039-6786)
- Valeria Fontana (ORCID: https://orcid.org/0000-0002-2156-7108)
- Silvia Stacchiotti (ORCID: https://orcid.org/0000-0002-1742-8666)
- Elena Palassini (ORCID: https://orcid.org/0000-0003-2257-4681)
- Claudia Sangalli (ORCID: https://orcid.org/0000-0002-6465-0630)
- Alessandro Gronchi (ORCID: https://orcid.org/0000-0002-4703-3534)
- Oscar Tendero
- Valeria Duroni
- Sílvia Bagué (ORCID: https://orcid.org/0000-0001-9980-7231)
- Sara Pizzamiglio (ORCID: https://orcid.org/0000-0002-7759-0550)
- S. Aliberti (ORCID: https://orcid.org/0000-0001-6990-9341)
- Carlo Morosi (ORCID: https://orcid.org/0000-0003-4940-2185)
- Emanuela Palmerini (ORCID: https://orcid.org/0000-0003-3406-6705)
- Antonella Brunello (ORCID: https://orcid.org/0000-0003-2583-5226)
- Antonio López–Pousa (ORCID: https://orcid.org/0000-0003-1066-3951)
- Davide María Donati (ORCID: https://orcid.org/0000-0002-9170-0576)
- Sandro Pasquali (ORCID: https://orcid.org/0000-0003-4815-6293)
Institutions
- University of Padua (IT)
- University of Miami (US)
- Hospital de Sant Pau (ES)
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT)
- Hospital Universitari i Politècnic La Fe (ES)
- Centre Léon Bérard (FR)
- Istituto Oncologico Veneto (IT)
- National Institute of Oncology (HU)
- Istituto Ortopedico Rizzoli (IT)
- Hospital Universitario Fundación Jiménez Díaz (ES)
- Institut Bergonié (FR)
- Tumori Foundation (US)
- Ospedale Policlinico San Martino (IT)
- The Maria Sklodowska-Curie National Research Institute of Oncology (PL)
- Candiolo Cancer Institute (IT)
- Hospital Universitario Son Espases (ES)
- Fondazione IRCCS Istituto Nazionale dei Tumori (IT)
- IRCCS Humanitas Research Hospital (IT)
Publication Details
- Journal
- Clinical Cancer Research
- Published
- 2026-07-30
- DOI
- https://doi.org/10.1158/1078-0432.ccr-26-0400
- Primary Topic
- Sarcoma Diagnosis and Treatment
- Type
- article
- Field-Weighted Citation Impact
- 0.00