Abstract 311P
Background
This international pooled analysis was conducted to examine the effectiveness and the safety of bevacizumab (BV) plus paclitaxel (PTX) as the 1st line treatment for HER2 negative metastatic breast cancer (MBC) with real-world data. Using the data from this pooled analysis, we tried to verify the usefulness of the prognostic index (PI) for MBC treated with BV-containing regimen previously shown in the ATENA trial.
Methods
A total of 2,474 patients were enrolled from 4 prospective observational studies (B-SHARE (n=419) in Japan, ML21647 (n=214) in Hungary, ML21165 (n=785) and ML22452 (n=1,056) in Germany). Patients receiving BV+PTX as first-line treatment for MBC. The primary endpoint was overall survival (OS). We also validated the prognostic value of the PI developed in the ATENA trial.
Results
Median follow-up time was 10.9 months (M). Median OS was 21.4M (95% confidential interval (CI) 19.8 – 22.7M). In this pooled analysis, 5 factors (disease-free interval < 24 months, liver metastases or ≥ 3 involved organ sites, prior anthracycline or taxane treatment, triple-negative breast cancer, and performance status > 1) identified by the ATENA trial were also identified as independent prognostic factors for OS by multivariate analysis. Low-, intermediate-, and high-risk groups were defined as patients with none or 1 risk factor, two risk factors, and three or more risk factors, respectively. High- (median OS 12.6M[95%CI 11.2 – 14.7M]) and intermediate-risk groups (median OS 18.0M[95%CI 16.5 – 20.1M]) had significantly worse prognosis than low-risk group (median OS 27.4M[95%CI 25.6 – 30.6M]), (p<0.0001).
Conclusions
The usefulness of the PI developed in the ATENA trial in predicting the prognosis among patients receiving BV + PTX was verified in this pooled analysis. New treatment strategies are needed for MBC patients with multiple risk factors to further improve prognosis.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
JBCRG; Japan Brest Cancer Research Group.
Funding
Chugai/Roche.
Disclosure
H. Yamashiro: Honoraria (self): Chugai; Honoraria (self): Daiich-Sankyo; Honoraria (self): Pfizer; Honoraria (self): kyowa Kirin; Honoraria (self): Eisai; Honoraria (self): Eli Lilly; Honoraria (self): Takeda; Honoraria (self): Taiho. Y. Yamamoto: Honoraria (self), Research grant/Funding (institution): Chugai; Honoraria (self): Daiichi-Sankyo; Honoraria (self): Esai; Honoraria (self): Eli Lilly; Honoraria (self): Takeda; Honoraria (self): Sysmex; Honoraria (self): GE Health Care Japan; Honoraria (self): AstraZeneca; Honoraria (self): Pfizer; Honoraria (self): Novartis; Honoraria (self), Research grant/Funding (institution): Nippon Kayaku; Honoraria (institution): Kyowa-Kirin; Officer/Board of Directors: Japanese Breast Cancer Society; Officer/Board of Directors: Japan Breast Cancer Research Group. A. Schneeweiss: Research grant/Funding (institution): Celgene; Research grant/Funding (institution): Roche; Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): Molecular Partner; Speaker Bureau/Expert testimony: Roche; Speaker Bureau/Expert testimony: AstraZeneca; Honoraria (self), Travel/Accommodation/Expenses: Celgene; Honoraria (self), Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche; Honoraria (self), Travel/Accommodation/Expenses: Pfizer; Honoraria (self): AstraZeneca; Honoraria (self): Novartis; Honoraria (self): MSD; Honoraria (self): Tesaro; Honoraria (self): Lilly. V. Müller: Honoraria (self), Honoraria (institution), Advisory/Consultancy, Research grant/Funding (self): Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: Amgen; Speaker Bureau/Expert testimony: AstraZeneca; Advisory/Consultancy, Speaker Bureau/Expert testimony: Daiichi Sankyo; Advisory/Consultancy, Speaker Bureau/Expert testimony: Eisai; Speaker Bureau/Expert testimony: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD; Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Speaker Bureau/Expert testimony: Teva; Speaker Bureau/Expert testimony, Research grant/Funding (institution): Seattle Genetics; Advisory/Consultancy: Genomic Health; Advisory/Consultancy: Hexal; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: ClinSol; Advisory/Consultancy: Eli Lilly; Advisory/Consultancy: Tesaro; Advisory/Consultancy: Nektar; Honoraria (institution): Genentech. O. Gluz: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Celgene. B. Aktas: Honoraria (self): Roche; Honoraria (self): Novartis; Honoraria (self): Pfizer; Honoraria (self): AstraZeneca. M. Toi: Honoraria (self), Research grant/Funding (institution): Chugai; Honoraria (self), Research grant/Funding (institution): Takeda; Honoraria (self), Research grant/Funding (institution): Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Kyowa-Hakko-Kirin; Honoraria (self), Research grant/Funding (institution): Taiho; Research grant/Funding (institution), Officer/Board of Directors: JBCRG association; Honoraria (self), Research grant/Funding (institution): Eisai; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Daiichi-Sankyo; Honoraria (self), Research grant/Funding (institution): AstraZeneca; Honoraria (self): Eli Lilly; Honoraria (self): MSD; Honoraria (self): Genomic Health; Honoraria (self): Novartis; Honoraria (self), Advisory/Consultancy: Konica Minolta; Research grant/Funding (institution): Astellas; Honoraria (institution), Advisory/Consultancy: BMS; Honoraria (self), Research grant/Funding (institution): Shimadzu; Honoraria (self): Yakult; Honoraria (self), Research grant/Funding (institution): Nippon Kayaku; Research grant/Funding (institution): AFI technologies; Advisory/Consultancy: Athenex Oncology; Officer/Board of Directors: Organisation for Oncology and Translational Research; Officer/Board of Directors: Kyoto Breast cancer Research Network. S. Morita: Honoraria (self): AstraZeneca; Honoraria (self): Bristol-Myers Squibb Company; Honoraria (self): Chugai; Honoraria (self): Eisai; Honoraria (self): Eli Lilly; Honoraria (self): MSD; Honoraria (self): Pfizer Japan; Honoraria (self): Taiho. S. Ohno: Honoraria (self): Chugai; Honoraria (self): AstraZeneca; Honoraria (self), Research grant/Funding (institution): Eisai; Honoraria (self), Research grant/Funding (institution): Taiho; Honoraria (self): Pfizer; Honoraria (self): Eli Lilly; Honoraria (self): Kyowa Kirin; Honoraria (self): Nippon Kayaku. All other authors have declared no conflicts of interest.