Neoadjuvant Chemotherapy in High-Grade Myxoid Liposarcoma: Results of the Expanded Cohort of a Randomized Trial From Italian (ISG), Spanish (GEIS), French (FSG), and Polish Sarcoma Groups (PSG).

Autor:	Gronchi A; Department of Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy., Palmerini E; Osteoncologia, Sarcomi dell'osso e dei tessuti molli, e Terapie Innovative, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy., Quagliuolo V; Department of Surgery, IRCCS Humanitas Research Hospital, Rozzano, Italy., Martin Broto J; Medical Oncology Department, Fundación Jimenez Diaz University Hospital, Madrid, Spain.; University Hospital General de Villalba, Madrid, Spain.; Instituto de Investigacion Sanitaria Fundacion Jimenez Diaz (IIS/FJD, UAM), Madrid, Spain., Lopez Pousa A; Department of Cancer Medicine, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain., Grignani G; Department of Cancer Medicine, Ospedale Città della Scienza e della Salute, Torino, Italy., Brunello A; Department of Oncology, Medical Oncology 1 Unit, Istituto Oncologico Veneto IOV, IRCCS, Padova, Italy., Blay JY; Department of Cancer Medicine, Centre Léon Bérard Cancer Center, UNICANCER & Université Claude Bernard, Lyon, France., Tendero O; Department of Surgery, Hospital Universitari Son Espases, Palma de Mallorca, Spain., Diaz Beveridge R; Department of Cancer Medicine, Hospital Universitari i Politècnic La Fe, Valencia, Spain., Ferraresi V; Department of Cancer Medicine, Istituto Regina Elena, Rome, Italy., Lugowska I; Department of Soft Tissue/Bone Sarcoma and Melanoma, Centrum Onkologii, Instytutim, Marii Sklodowskiej-Curie, Warszawa, Poland., Pizzamiglio S; Unit of Bioinformatics and Biostatistics, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy., Verderio P; Unit of Bioinformatics and Biostatistics, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy., Fontana V; Department of Epidemiology, Clinical Trial Center, IRCCS Ospedale Policlinico San Martino, IST Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy., Donati DM; Orthopaedic Oncology Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy., Palassini E; Department of Cancer Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy., Sanfilippo R; Department of Cancer Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy., Bianchi G; Orthopaedic Oncology Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy., Bertuzzi A; Department of Cancer Medicine, IRCCS Humanitas Research Hospital, Rozzano, Italy., Morosi C; Department of Radiology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy., Pasquali S; Department of Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy., Stacchiotti S; Department of Cancer Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy., Bagué S; Department of Pathology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain., Coindre JM; Department of Pathology, Institut Bergonié, Bordeaux, France., Miceli R; Unit of Biostatistics for Clinical Research, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy., Dei Tos AP; Department of Pathology, University of Padua, Padova, Italy., Casali PG; Department of Cancer Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.
Jazyk:	angličtina
Zdroj:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2024 Mar 10; Vol. 42 (8), pp. 898-906. Date of Electronic Publication: 2024 Jan 17.
DOI:	10.1200/JCO.23.00908
Abstrakt:	Purpose: A randomized trial was conducted to compare neoadjuvant standard (S) anthracycline + ifosfamide (AI) regimen with histology-tailored (HT) regimen in selected localized high-risk soft tissue sarcoma (STS). The results of the trial demonstrated the superiority of S in all STS histologies except for high-grade myxoid liposarcoma (HG-MLPS) where S and HT appeared to be equivalent. To further evaluate the noninferiority of HT compared with S, the HG-MLPS cohort was expanded. Patients and Methods: Patients had localized high-grade (cellular component >5%; size ≥5 cm; deeply seated) MLPS of extremities or trunk wall. The primary end point was disease-free survival (DFS). The secondary end point was overall survival (OS). The trial used a noninferiority Bayesian design, wherein HT would be considered not inferior to S if the posterior probability of the true hazard ratio (HR) being >1.25 was <5%. Results: From May 2011 to June 2020, 101 patients with HG-MLPS were randomly assigned, 45 to the HT arm and 56 to the S arm. The median follow-up was 66 months (IQR, 37-89). Median size was 107 mm (IQR, 84-143), 106 mm (IQR, 75-135) in the HT arm and 108 mm (IQR, 86-150) in the S arm. At 60 months, the DFS and OS probabilities were 0.86 and 0.73 (HR, 0.60 [95% CI, 0.24 to 1.46]; log-rank P = .26 for DFS) and 0.88 and 0.90 (HR, 1.20 [95% CI, 0.37 to 3.93]; log-rank P = .77 for OS) in the HT and S arms, respectively. The posterior probability of HR being >1.25 for DFS met the Bayesian monitoring cutoff of <5% (4.93%). This result confirmed the noninferiority of trabectedin to AI suggested in the original study cohort. Conclusion: Trabectedin may be an alternative to standard AI in HG-MLPS of the extremities or trunk when neoadjuvant treatment is a consideration.
Databáze:	MEDLINE
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