Efficacy of Metronomic Oral Vinorelbine, Cyclophosphamide, and Capecitabine vs Weekly Intravenous Paclitaxel in Patients With Estrogen Receptor–Positive, ERBB2-Negative Metastatic Breast Cancer

作者：Elisabetta Munzone, Meredith M. Regan, Saverio Cinieri, Emilia Montagna, Laura Orlando, Ruichao Shi, Enrico Campadelli, Lorenzo Gianni, Michela Palleschi, Fausto Petrelli, Carmelo Bengala, Daniele Generali, Elena Collovà, Fabio Puglisi, Elisabetta Cretella, Claudio Zamagni, Claudio Chini, Barbara Ruepp, Sherene Loi, Marco Angelo Colleoni, International Breast Cancer Study Group (IBCSG), Angelo Di Leo, Rolf Arno Stahel, Stefan Paul Aebi, Paul Baas, Richard D. Gelber, Keith Matthew McGregor, Solange Peters, Sanjay Popat, Rafael Rosell, Anita Hiltbrunner, G Achille, Anne Carrer-Wagner, Daniela Celotto, Carmen Comune, Adriana Gasca, Nino Giacomelli, Roswitha Kammler, Rita Pfister, Heidi Roschitzki, Monica Ruggeri, Elizabeth Rugiati, Mirjam Schneider, Judith Schroeder, Sandra Troesch, Colleen Bouzan, Subrina Farah, Zhuoxin Sun, Holly Shaw, L. J. Blacher, Colleen King, Leslie Mundy, Dorene Polizzi, Mónica Greco, Karolyn Scott, Robert Starkweather, Raffaella Ghisini, Roberto Masetti, Laura Amaducci, Ugo De Giorgi, Graziella Pinotti, Michela Donadio, Aron Goldhirsch · 发表于：JAMA Oncology · 年份：2023 · DOI：10.1001/jamaoncol.2023.2150 · 被引用次数：37 · 研究领域：Advanced Breast Cancer Therapies、Cancer Treatment and Pharmacology、Breast Cancer Treatment Studies

Importance: In spite of the effectiveness of endocrine therapy plus cyclin-dependent kinase (CDK) 4/6 inhibitors as the first-line treatment for estrogen receptor (ER)-positive, erb-b2 receptor tyrosine kinase 2 (ERBB2 [formerly HER2/neu])-negative (ER+/ERBB2-) metastatic breast cancer (MBC), patients eventually develop resistance, and eventually most will receive chemotherapy. The METEORA-II trial compared a metronomic all-oral treatment with intravenous (IV) chemotherapy. Objective: To compare the efficacy of the oral vinorelbine plus cyclophosphamide plus capecitabine (VEX) regimen vs weekly IV paclitaxel among patients with ER+/ERBB2- MBC who are candidates for chemotherapy. Design, Setting, and Participants: This phase 2 randomized clinical trial including 140 women 18 years and older (randomized 1:1) with ER+/ERBB2- MBC was carried out from September 13, 2017, to January 14, 2021 at 15 centers in Italy. Eligible patients could have received 1 prior line of chemotherapy for MBC and/or 2 lines of endocrine therapy (including CDK4/6 inhibitors). Interventions: In 4-week cycles, patients received either metronomic oral VEX or weekly IV paclitaxel. Main Outcomes and Measures: The primary end point was investigator-assessed time to treatment failure (TTF) defined as the interval between the date of randomization to the end of treatment (because of disease progression or lack of tolerability or because further trial treatment was declined). Secondary end points included progre...