Miguel Martín1, Sibylle Loibl2, Gunter von Minckwitz2, Serafín Morales2, Noelia Martinez2, Angel Guerrero2, Antonio Anton2, Bahriye Aktas2, Winfried Schoenegg2, Montserrat Muñoz2, José Ángel Garcia-Saenz2, Miguel Gil2, Manuel Ramos2, Mireia Margeli2, Eva Carrasco2, Cornelia Liedtke2, Grischa Wachsmann2, Keyur Mehta2, Juan R De la Haba-Rodriguez2. 1. Miguel Martín, Instituto de Investigación Sanitaria Gregorio Marañón, Universidad Complutense; Noelia Martinez, University Hospital Ramón y Cajal; José Ángel Garcia-Saenz, University Hospital Clínico San Carlos; Eva Carrasco, Grupo Español de Investigación en Cáncer de Mama, Madrid; Serafín Morales, Hospital Arnau de Vilanova de Lérida, Lérida; Angel Guerrero, Valencian Institute of Oncology, Valencia; Antonio Anton, University Hospital Miguel Servet, Zaragoza; Montserrat Muñoz, University Hospital Clinic i Provincial; Mireia Margeli, Hospital Universitario Germans Trias i Pujol, Barcelona; Miguel Gil, Catalan Institute of Oncology, Hospitalet; Manuel Ramos, Centro Oncológico de Galicia, La Coruña; Juan R. De la Haba-Rodriguez, Instituto Maimonides de Investigación Biomédica de Córdoba (IMIBIC) -Hospital Universitario Reina Sofía, Universidad de Córdoba, Córdoba, Spain; Sibylle Loibl, Gunter von Minckwitz, and Keyur Mehta, German Breast Group, Neu-Isenburg; Sibylle Loibl, Gunter von Minckwitz, and Keyur Mehta, Sana Klinikum Offenbach, Offenbach; Bahriye Aktas, University Women's Hospital Essen, Essen; Winfried Schoenegg, Medical Practice Berlin, Berlin; Cornelia Liedtke, University Women's Hospital Münster, Münster; Cornelia Liedtke, University Hospital Lübeck, Lübeck; and Grischa Wachsmann, Klinikum Böblingen, Böblingen, Germany. mmartin@geicam.org. 2. Miguel Martín, Instituto de Investigación Sanitaria Gregorio Marañón, Universidad Complutense; Noelia Martinez, University Hospital Ramón y Cajal; José Ángel Garcia-Saenz, University Hospital Clínico San Carlos; Eva Carrasco, Grupo Español de Investigación en Cáncer de Mama, Madrid; Serafín Morales, Hospital Arnau de Vilanova de Lérida, Lérida; Angel Guerrero, Valencian Institute of Oncology, Valencia; Antonio Anton, University Hospital Miguel Servet, Zaragoza; Montserrat Muñoz, University Hospital Clinic i Provincial; Mireia Margeli, Hospital Universitario Germans Trias i Pujol, Barcelona; Miguel Gil, Catalan Institute of Oncology, Hospitalet; Manuel Ramos, Centro Oncológico de Galicia, La Coruña; Juan R. De la Haba-Rodriguez, Instituto Maimonides de Investigación Biomédica de Córdoba (IMIBIC) -Hospital Universitario Reina Sofía, Universidad de Córdoba, Córdoba, Spain; Sibylle Loibl, Gunter von Minckwitz, and Keyur Mehta, German Breast Group, Neu-Isenburg; Sibylle Loibl, Gunter von Minckwitz, and Keyur Mehta, Sana Klinikum Offenbach, Offenbach; Bahriye Aktas, University Women's Hospital Essen, Essen; Winfried Schoenegg, Medical Practice Berlin, Berlin; Cornelia Liedtke, University Women's Hospital Münster, Münster; Cornelia Liedtke, University Hospital Lübeck, Lübeck; and Grischa Wachsmann, Klinikum Böblingen, Böblingen, Germany.
Abstract
PURPOSE: To test whether combining bevacizumab, an anti-vascular endothelial growth factor treatment, with endocrine therapy (ET) could potentially delay the emergence of resistance to ET. PATIENTS AND METHODS: A multicenter, randomized, open-label, phase III, binational (Spain and Germany) study added bevacizumab (15 mg/kg every 3 weeks) to ET (ET-B; letrozole or fulvestrant) as first-line therapy in postmenopausal patients with human epidermal growth factor receptor 2 (HER2) -negative and hormone receptor-positive advanced breast cancer. We compared progression-free survival (PFS), overall survival (OS), overall response rate (ORR), response duration (RD), time to treatment failure (TTF), clinical benefit rate (CBR), and safety. RESULTS:From 380 patients recruited (2007 to 2011), 374 were analyzed by intent to-treat (184 patients on ET and 190 patients on ET-B). Median age was 65 years, 270 patients (72%) had Eastern Cooperative Oncology Group performance status of 0, 178 patients (48%) had visceral metastases, and 171 patients (46%) and 195 patients (52%) had received prior chemotherapy or ET, respectively. Median PFS was 14.4 months in the ET arm and 19.3 months in the ET-B arm (hazard ratio, 0.83; 95% CI, 0.65 to 1.06; P = .126). ORR, CBR, and RD with ET versus ET-B were 22% versus 41% (P < .001), 67% versus 77% (P = .041), and 13.3 months versus 17.6 months (P = .434), respectively. TTF and OS were comparable in both arms. Grade 3 to 4 hypertension, aminotransferase elevation, and proteinuria were significantly higher in the ET-B arm. Eight patients (4.2%) receiving ET-B died during study or within 30 days of end of treatment. CONCLUSION: The addition of bevacizumab to ET in first-line treatment failed to produce a statistically significant increase in PFS or OS in women with HER2-negative/hormone receptor-positive advanced breast cancer.
RCT Entities:
PURPOSE: To test whether combining bevacizumab, an anti-vascular endothelial growth factor treatment, with endocrine therapy (ET) could potentially delay the emergence of resistance to ET. PATIENTS AND METHODS: A multicenter, randomized, open-label, phase III, binational (Spain and Germany) study added bevacizumab (15 mg/kg every 3 weeks) to ET (ET-B; letrozole or fulvestrant) as first-line therapy in postmenopausal patients with humanepidermal growth factor receptor 2 (HER2) -negative and hormone receptor-positive advanced breast cancer. We compared progression-free survival (PFS), overall survival (OS), overall response rate (ORR), response duration (RD), time to treatment failure (TTF), clinical benefit rate (CBR), and safety. RESULTS: From 380 patients recruited (2007 to 2011), 374 were analyzed by intent to-treat (184 patients on ET and 190 patients on ET-B). Median age was 65 years, 270 patients (72%) had Eastern Cooperative Oncology Group performance status of 0, 178 patients (48%) had visceral metastases, and 171 patients (46%) and 195 patients (52%) had received prior chemotherapy or ET, respectively. Median PFS was 14.4 months in the ET arm and 19.3 months in the ET-B arm (hazard ratio, 0.83; 95% CI, 0.65 to 1.06; P = .126). ORR, CBR, and RD with ET versus ET-B were 22% versus 41% (P < .001), 67% versus 77% (P = .041), and 13.3 months versus 17.6 months (P = .434), respectively. TTF and OS were comparable in both arms. Grade 3 to 4 hypertension, aminotransferase elevation, and proteinuria were significantly higher in the ET-B arm. Eight patients (4.2%) receiving ET-B died during study or within 30 days of end of treatment. CONCLUSION: The addition of bevacizumab to ET in first-line treatment failed to produce a statistically significant increase in PFS or OS in women with HER2-negative/hormone receptor-positive advanced breast cancer.
Authors: Daneng Li; Linda M McCall; Olwen M Hahn; Clifford A Hudis; Harvey J Cohen; Hyman B Muss; Aminah Jatoi; Jacqueline M Lafky; Karla V Ballman; Eric P Winer; Debu Tripathy; Bryan Schneider; William Barry; Maura N Dickler; Arti Hurria Journal: Breast Cancer Res Treat Date: 2018-05-22 Impact factor: 4.872
Authors: Kathleen I Pritchard; Stephen K Chia; Christine Simmons; Deanna McLeod; Alexander Paterson; Louise Provencher; Daniel Rayson Journal: Oncologist Date: 2016-11-18
Authors: M Martín; S Loibl; T Hyslop; J De la Haba-Rodríguez; B Aktas; C T Cirrincione; K Mehta; W T Barry; S Morales; L A Carey; J A Garcia-Saenz; A Partridge; N Martinez-Jañez; O Hahn; E Winer; A Guerrero-Zotano; C Hudis; M Casas; C Rodriguez-Martin; J Furlanetto; E Carrasco; M N Dickler Journal: Eur J Cancer Date: 2019-07-02 Impact factor: 9.162
Authors: Eva Ciruelos; José Manuel Pérez-García; Joaquín Gavilá; Analía Rodríguez; Juan de la Haba-Rodriguez Journal: Clin Drug Investig Date: 2019-07 Impact factor: 2.859
Authors: Maura N Dickler; William T Barry; Constance T Cirrincione; Matthew J Ellis; Mary Ellen Moynahan; Federico Innocenti; Arti Hurria; Hope S Rugo; Diana E Lake; Olwen Hahn; Bryan P Schneider; Debasish Tripathy; Lisa A Carey; Eric P Winer; Clifford A Hudis Journal: J Clin Oncol Date: 2016-05-02 Impact factor: 44.544