TREATMENT OF OLIGOMETASTATIC PARENCHYMAL LESIONS IN OVARIAN CANCER WITH STEREOTACTIC ABLATIVE RADIOTHERAPY: A MULTICENTER PROSPECTIVE PHASE II TRIAL (MITO RT3/RAD).
Gabriella Macchia, Donato Pezzulla, Maura Campitelli, Simona Lucci, Lorena Draghini, Donatella Russo, Andrei Fodor, Giuseppe Roberto D'Agostino, Vittoria Balcet, Marinella Tamburo, Lucia Giaccherini, Francesca Tortoreto, Antonietta Augurio, Edy Ippolito, Aida Di Stefano, Mara Fanelli, Lella Petrella, Savino Cilla, Francesco Cosentino, Claudia Marchetti, Vanda Salutari, Alessio Giuseppe Morganti, Maria Antonietta Gambacorta, Anna Fagotti, Sandro Pignata, Giovanni Scambia, Gabriella Ferrandina, Francesco Deodato
{"title":"TREATMENT OF OLIGOMETASTATIC PARENCHYMAL LESIONS IN OVARIAN CANCER WITH STEREOTACTIC ABLATIVE RADIOTHERAPY: A MULTICENTER PROSPECTIVE PHASE II TRIAL (MITO RT3/RAD).","authors":"Gabriella Macchia, Donato Pezzulla, Maura Campitelli, Simona Lucci, Lorena Draghini, Donatella Russo, Andrei Fodor, Giuseppe Roberto D'Agostino, Vittoria Balcet, Marinella Tamburo, Lucia Giaccherini, Francesca Tortoreto, Antonietta Augurio, Edy Ippolito, Aida Di Stefano, Mara Fanelli, Lella Petrella, Savino Cilla, Francesco Cosentino, Claudia Marchetti, Vanda Salutari, Alessio Giuseppe Morganti, Maria Antonietta Gambacorta, Anna Fagotti, Sandro Pignata, Giovanni Scambia, Gabriella Ferrandina, Francesco Deodato","doi":"10.1016/j.ijrobp.2025.03.032","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>The results of stereotactic body radiotherapy (SBRT) for parenchymal lesions in the setting of oligometastatic ovarian cancer are reported in the context of the prospective multicenter Phase II MITO-RT3/RAD trial (NCT04593381).</p><p><strong>Methods: </strong>The primary endpoint was the complete response (CR) rate, secondary endpoints included local control (LC), progression-free survival (PFS), overall survival (OS), treatment-free interval (TFI), and toxicity rates. Sample size was based on a previous study reporting an average 40.0% CR with SBRT. The study was powered to detect an improvement in the CR rate from 40.0% to 55.0%, with an α error of 0.05 (one-side) and a β error of 0.1.</p><p><strong>Results: </strong>The study met its primary endpoint of a statistically significant improvement of CR. 88 patients with 127 lesions were enrolled across fifteen Institutions from May 2019 to November 2023. CRs were observed in 71 lesions (55.9%), partial response in 37 (29.1%), stable disease in 14 (11.0%), and progressive disease in five lesions (4.0%). The objective response rate was 85.0%, with an overall clinical benefit rate of 96.0%. The overall 12-month LC was 81.6%, with CR lesions exhibiting a significantly higher rate than partial or not responding lesions (12-month LC: 96.3% versus 61.4%, p<0.001). The 12-month actuarial rates for PFS and for OS were 34.9% and 91.5%, respectively. The median actuarial Treatment-free interval was 9 months (range 2.5-15.4 months), while the 12-month actuarial rate was 44.1%. No Grade 3 or higher toxicity was reported. In particular, 15 (20.5%) patients experienced mild acute toxicity (≤ Grade 2). There were 12 Grade 1 events and 6 Grade 2 events, the latter mostly represented by pain flare (N=2). Late toxicity was reported in 4 patients (4.5%) accounting for 4 events, mostly Grade 1, except for one case of moderate asthenia (Grade 2).</p><p><strong>Conclusions: </strong>Parenchymal oligometastatic lesions showed a high rate of complete response and encouraging long-term outcomes for patients achieving CR, including a substantial period of systemic therapy-free survival after radiotherapy. The observed toxicity was minimal, strengthening the safety of ablative SBRT as a non-invasive alternative to surgical resection for parenchymal metastases in high-risk areas.</p>","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":" ","pages":""},"PeriodicalIF":6.4000,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Radiation Oncology Biology Physics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.ijrobp.2025.03.032","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Purpose: The results of stereotactic body radiotherapy (SBRT) for parenchymal lesions in the setting of oligometastatic ovarian cancer are reported in the context of the prospective multicenter Phase II MITO-RT3/RAD trial (NCT04593381).
Methods: The primary endpoint was the complete response (CR) rate, secondary endpoints included local control (LC), progression-free survival (PFS), overall survival (OS), treatment-free interval (TFI), and toxicity rates. Sample size was based on a previous study reporting an average 40.0% CR with SBRT. The study was powered to detect an improvement in the CR rate from 40.0% to 55.0%, 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 of CR. 88 patients with 127 lesions were enrolled across fifteen Institutions from May 2019 to November 2023. CRs were observed in 71 lesions (55.9%), partial response in 37 (29.1%), stable disease in 14 (11.0%), and progressive disease in five lesions (4.0%). The objective response rate was 85.0%, with an overall clinical benefit rate of 96.0%. The overall 12-month LC was 81.6%, with CR lesions exhibiting a significantly higher rate than partial or not responding lesions (12-month LC: 96.3% versus 61.4%, p<0.001). The 12-month actuarial rates for PFS and for OS were 34.9% and 91.5%, respectively. The median actuarial Treatment-free interval was 9 months (range 2.5-15.4 months), while the 12-month actuarial rate was 44.1%. No Grade 3 or higher toxicity was reported. In particular, 15 (20.5%) patients experienced mild acute toxicity (≤ Grade 2). There were 12 Grade 1 events and 6 Grade 2 events, the latter mostly represented by pain flare (N=2). Late toxicity was reported in 4 patients (4.5%) accounting for 4 events, mostly Grade 1, except for one case of moderate asthenia (Grade 2).
Conclusions: Parenchymal oligometastatic lesions showed a high rate of complete response and encouraging long-term outcomes for patients achieving CR, including a substantial period of systemic therapy-free survival after radiotherapy. The observed toxicity was minimal, strengthening the safety of ablative SBRT as a non-invasive alternative to surgical resection for parenchymal metastases in high-risk areas.
期刊介绍：
International Journal of Radiation Oncology • Biology • Physics (IJROBP), known in the field as the Red Journal, publishes original laboratory and clinical investigations related to radiation oncology, radiation biology, medical physics, and both education and health policy as it relates to the field.
This journal has a particular interest in original contributions of the following types: prospective clinical trials, outcomes research, and large database interrogation. In addition, it seeks reports of high-impact innovations in single or combined modality treatment, tumor sensitization, normal tissue protection (including both precision avoidance and pharmacologic means), brachytherapy, particle irradiation, and cancer imaging. Technical advances related to dosimetry and conformal radiation treatment planning are of interest, as are basic science studies investigating tumor physiology and the molecular biology underlying cancer and normal tissue radiation response.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
