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Publications

Journal Article Ahead of print

PubMed: 42531374 DOI: 10.1158/1078-0432.CCR-26-0400

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

Clin Cancer Res

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

Affiliations

  • Fondazione IRCCS Istituto Nazionale dei Tumori Milan Italy.
  • Fondazione IRCCS Istituto Nazionale dei Tumori Milano Italy.
  • University of Miami Miami, FL United States.
  • IRCCS Humanitas Research Hospital Rozzano (Milano), ITALY Italy.
  • Hospital Universitario Fundación Jiménez Díaz Madrid, Madrid Spain.
  • Institut de Recerca Sant Pau Barcelona, Barcelona Spain.
  • Candiolo Cancer Institute Candiolo, TO Italy.
  • Istituto Oncologico Veneto Padova Italy.
  • Centre Léon Bérard Lyon France.
  • Hospital Universitario Son Espases Spain.
  • Hospital Universitari i Politècnic La Fe Spain.
  • Instituto Nazionale Tumori Regina Elena Rome, Rome Italy.
  • The Maria Sklodowska-Curie National Research Institute of Oncology Warsaw Poland.
  • Istituto Ortopedico Rizzoli Bologna United States.
  • Istituto Ortopedico Rizzoli Bologna, BO Italy.
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Italy.
  • Institut Bergonié Bordeaux France.
  • Hospital de Sant Pau Barcelona, Catalonia Spain.
  • Ospedale Policlinico San Martino Italy.
  • Fondazione IRCCS Istituto Nazionale Tumori Milan Italy.
  • University of Padua Padua, PD Italy.
  • Fondazione IRCCS Istituto Nazionale Tumori Milano Italy.
  • Fondazione IRCCS Istituto Nazionale dei Tumori Italy.

Abstract

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.

MeSH

Radiotherapy, Epirubicin, Ifosfamide, Drug Therapy, Sarcoma, Therapeutics, Tissues, Chemotherapy