Stereotactic Ablative Radiation Therapy for Oligometastatic Ovarian Cancer Lymph Node Disease: The MITO-RT3/RAD Phase II Trial.

Autor:	Macchia G; Radiation Oncology Unit, Responsible Research Hospital, Campobasso, Molise, Italy. Electronic address: macchiagabriella@gmail.com., Campitelli M; UOC di Radioterapia, Dipartimento di Scienze Radiologiche, Radioterapiche ed Ematologiche, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy., Pezzulla D; Radiation Oncology Unit, Responsible Research Hospital, Campobasso, Molise, Italy., Lucci S; UOC di Radioterapia, Dipartimento di Scienze Radiologiche, Radioterapiche ed Ematologiche, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy., Fodor A; Department of Radiation Oncology, IRCCS San Raffaele Scientific Institute, Milan, Italy., Russo D; Radiotherapy Unit, Ospedale 'Vito Fazzi,' Lecce, Italy., Balcet V; UOC Radioterapia, Nuovo Ospedale degli Infermi, Biella, Italy., Bonome P; Radiation Oncology Unit, Responsible Research Hospital, Campobasso, Molise, Italy., Durante S; Division of Radiation Oncology, IEO European Institute of Oncology IRCCS, and Department of Oncology and Hemato-Oncology, University of Milan, Italy., Draghini L; Radiation Oncology Center, S Maria Hospital, Terni, Italy., Titone F; Department of Radiation Oncology, University Hospital Udine, Italy., D'Agostino GR; Radiotherapy and Radiosurgery Department, Humanitas Clinical and Research Center-IRCCS, Rozzano, Milan, Italy., Tamburo M; U.O.C. di Radioterapia, Azienda Ospedaliera 'Cannizzaro' - Catania, Italy., Ferioli M; Radiation Oncology, Azienda USL - IRCCS di Reggio Emilia, Italy., Ippolito E; Department of Radiation Oncology, Campus Bio-Medico University, Roma, Italy., Tortoreto F; UOC di Radioterapia Fatebenefratelli Isola Tiberina. Gemelli Isola, Rome, Italy., Caravatta L; Department of Radiation Oncology, SS Annunziata Hospital, Chieti, Italy., De Felice F; Department of Radiotherapy, Policlinico Umberto I, Department of Radiological, Oncological and Pathological Sciences, 'Sapienza' University of Rome, Rome, Italy., Stefano AD; Medical Oncology Unit, Responsible Research Hospital, Campobasso, Molise, Italy., Fanelli M; Research Laboratories, Responsible Research Hospital, Campobasso, Molise, Italy., Cilla S; Medical Physics Unit, Responsible Research Hospital, Campobasso, Molise, Italy., Cosentino F; Department of Gynecologic Oncology, Responsible Research Hospital and Università degli studi del Molise, Campobasso, Italy., Marchetti C; UOC Ginecologia Oncologica, Dipartimento Scienze della Salute della Donna e del Bambino, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy., Salutari V; UOC Ginecologia Oncologica, Dipartimento Scienze della Salute della Donna e del Bambino, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy., Boccia S; UOC Ginecologia Oncologica, Dipartimento Scienze della Salute della Donna e del Bambino, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy., Morganti AG; Radiation Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna; Radiation Oncology, Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy., Gambacorta MA; UOC di Radioterapia, Dipartimento di Scienze Radiologiche, Radioterapiche ed Ematologiche, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy; Istituto di Radiologia, Università Cattolica del Sacro Cuore Roma, Italy., Fagotti A; UOC Ginecologia Oncologica, Dipartimento Scienze della Salute della Donna e del Bambino, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy., Pignata S; Oncologia Clinica Sperimentale Uroginecologica Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, Italy., Scambia G; UOC Ginecologia Oncologica, Dipartimento Scienze della Salute della Donna e del Bambino, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy., Ferrandina G; UOC Ginecologia Oncologica, Dipartimento Scienze della Salute della Donna e del Bambino, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy., Deodato F; Radiation Oncology Unit, Responsible Research Hospital, Campobasso, Molise, Italy; Istituto di Radiologia, Università Cattolica del Sacro Cuore Roma, Italy.
Jazyk:	angličtina
Zdroj:	International journal of radiation oncology, biology, physics [Int J Radiat Oncol Biol Phys] 2024 Sep 24. Date of Electronic Publication: 2024 Sep 24.
DOI:	10.1016/j.ijrobp.2024.09.036
Abstrakt:	Purpose: MITO-RT3/RAD (NCT04593381) is a prospective multicenter phase 2 trial designed to assess the effectiveness and safety of stereotactic body radiation therapy (SBRT) in patients who received diagnoses of oligometastatic ovarian cancer. In this report, we provide the results of the trial in the setting of lymph node disease. Methods and Materials: The primary endpoint was the complete response (CR) rate, secondary endpoints included local control (LC), progression-free survival (PFS), overall survival, treatment-free interval, and toxicity rates. The sample size was based on a previous study reporting an average 70.0% CR with SBRT. The study was powered to detect an improvement in the CR rate from 70.0% to 85.0%, with an α error of 0.05 (one-side) and a β error of 0.1. Results: The study met its primary endpoint of a statistically significant improvement in CR. One hundred thirty-five patients with 249 lesions were enrolled across 15 institutions from May 2019 to November 2023. CRs were observed in 194 lesions (77.9%), partial responses in 40 (16.1%), stable disease in 14 (5.6%), and progressive disease in 1 lesion (0.4%). The objective response rate was 94%, with an overall clinical benefit rate of 99.6%. CR lesions exhibited a significantly higher LC rate than partial or not responding lesions (12-month LC: 92.7% vs 63.1%, P < .001). The 12-month actuarial rates for PFS and for overall survival were 36.6% (CR, 38.3% vs not-CR, 18.8%; P, .022) and 97.2% (CR, 97.8% vs not-CR, 93.8%; P, .067), respectively. The 12-month actuarial rate for treatment-free interval was 52.7% (CR, 58.4% vs not-CR, 24.4%; P, .004). CR was substantially associated with higher PFS (P, .036) and treatment-free interval (P, .006) rates in the univariate analysis. Twenty-three patients (17.0%) experienced mild acute toxicity. Late toxicity was reported in 9 patients (6.7%), mostly grade 1. Conclusions: This trial confirms the efficacy of ablative SBRT, with minimal toxicity observed. SBRT offered a high CR rate, promising long-term outcomes, and a significant systemic therapy-free survival period for complete responders. (Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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