Yutaka Yamamoto1, Hiroyasu Yamashiro2, Andreas Schneeweiss3, Volkmar Müller4, Oleg Gluz5, Peter Klare6, Bahriye Aktas7,8, Dank Magdolna9, László Büdi10, Béla Pikó11, László Mangel12, Masakazu Toi13, Satoshi Morita14, Shinji Ohno15. 1. Department of Breast and Endocrine Surgery, Kumamoto University Hospital, 1-1-1, Honjo, Chuo-ku, Kumamoto, 860-8556, Japan. yyamamoto@kumamoto-u.ac.jp. 2. Department of Breast and Endocrine Surgery, Tenri Hospital, Tenri, Japan. 3. Heidelberg University Hospital and German Cancer Research Center, Heidelberg, Germany. 4. Department of Gynecology, Hamburg-Eppendorf University Medical Center, Hamburg, Germany. 5. Breast Center Niederrhein, Evangelical Hospital Johanniter Bethesda, Moenchengladbach, Germany. 6. Clinic for Cancer Medicine for Women/Breast Center, Berlin, Germany. 7. Department of Gynecology and Obstetrics, University of Essen, Essen, Germany. 8. Department of Gynecology, University of Leipzig, Leipzig, Germany. 9. 1st Department of Internal Medicine Division of Oncology, Semmelweis University, Budapest, Hungary. 10. Clinical Oncology and Radiotherapy Center, B-A-Z County Hospital, Miskolc, Hungary. 11. Bekes County Pandy Kalman Hospital, Gyula, Hungary. 12. Medical School, University of Pecs, Pecs, Hungary. 13. Breast Surgery, Kyoto University Graduate School of Medicine, Kyoto, Japan. 14. Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan. 15. Center of Breast Oncology, The Cancer Institute Hospital of JFCR, Tokyo, Japan.
Abstract
BACKGROUND: Bevacizumab (BV) plus paclitaxel (PTX) is a treatment option in patients with HER2-negative metastatic breast cancer (mBC). We conducted an international pooled analysis with individual patient data to evaluate the effectiveness of BV + PTX as a first-line treatment for HER2-negative mBC patients under routine practice. METHODS: A total of 2,474 mBC patients treated with BV + PTX from four prospective observational studies were analyzed. The primary endpoint was overall survival (OS). The other endpoints including identifying independent prognostic factors and validation of the modified Prognostic Factor Index (PFI) developed in the ATHENA trial. RESULTS: Median follow-up time was 10.9 months (M). Median OS were 21.4 M (95% confidential interval 19.8-22.7 M). The seven independent prognostic factors (tumor subtype, age, ECOG performance status (PS), disease-free interval (DFI), liver metastases, number of metastatic organs, and prior anthracycline and/or taxane treatment) for OS found in this analysis included the five risk factors (RFs [DFI < 24 months, ECOG PS 2, liver metastases and/or > 3 metastasis organ sites, TNBC, prior anthracycline and/or taxane therapy]). High- (> 3 RFs [median OS 12.6 M]) and intermediate-risk groups (2 RFs [median OS 18.0 M]) had a significantly worse prognosis than the low-risk group (< 1 RF [median OS 27.4 M]), (p < 0.0001). CONCLUSIONS: This international pooled analysis showed the effectiveness of first-line BV + PTX for HER2-negative mBC patients identifying seven independent prognostic factors as real-world evidence. The usefulness of the modified PFI developed in the ATHENA trial in predicting OS among patients receiving BV + PTX was also verified.
BACKGROUND: Bevacizumab (BV) plus paclitaxel (PTX) is a treatment option in patients with HER2-negative metastatic breast cancer (mBC). We conducted an international pooled analysis with individual patient data to evaluate the effectiveness of BV + PTX as a first-line treatment for HER2-negative mBC patients under routine practice. METHODS: A total of 2,474 mBC patients treated with BV + PTX from four prospective observational studies were analyzed. The primary endpoint was overall survival (OS). The other endpoints including identifying independent prognostic factors and validation of the modified Prognostic Factor Index (PFI) developed in the ATHENA trial. RESULTS: Median follow-up time was 10.9 months (M). Median OS were 21.4 M (95% confidential interval 19.8-22.7 M). The seven independent prognostic factors (tumor subtype, age, ECOG performance status (PS), disease-free interval (DFI), liver metastases, number of metastatic organs, and prior anthracycline and/or taxane treatment) for OS found in this analysis included the five risk factors (RFs [DFI < 24 months, ECOG PS 2, liver metastases and/or > 3 metastasis organ sites, TNBC, prior anthracycline and/or taxane therapy]). High- (> 3 RFs [median OS 12.6 M]) and intermediate-risk groups (2 RFs [median OS 18.0 M]) had a significantly worse prognosis than the low-risk group (< 1 RF [median OS 27.4 M]), (p < 0.0001). CONCLUSIONS: This international pooled analysis showed the effectiveness of first-line BV + PTX for HER2-negative mBC patients identifying seven independent prognostic factors as real-world evidence. The usefulness of the modified PFI developed in the ATHENA trial in predicting OS among patients receiving BV + PTX was also verified.
Authors: S Delaloge; D Pérol; C Courtinard; E Brain; B Asselain; T Bachelot; M Debled; V Dieras; M Campone; C Levy; W Jacot; V Lorgis; C Veyret; F Dalenc; J M Ferrero; L Uwer; P Kerbrat; A Goncalves; M A Mouret-Reynier; T Petit; C Jouannaud; L Vanlemmens; G Chenuc; T Guesmia; M Robain; C Cailliot Journal: Ann Oncol Date: 2016-07-19 Impact factor: 32.976
Authors: I E Smith; J-Y Pierga; L Biganzoli; H Cortés-Funes; C Thomssen; X Pivot; A Fabi; B Xu; D Stroyakovskiy; F A Franke; B Kaufman; P Mainwaring; T Pienkowski; B De Valk; A Kwong; J L González-Trujillo; I Koza; K Petrakova; D Pereira; K I Pritchard Journal: Ann Oncol Date: 2010-09-05 Impact factor: 32.976
Authors: Andreas Schneeweiss; Frank Förster; Hans Tesch; Bahriye Aktas; Oleg Gluz; Matthias Geberth; Martin M Hertz-Eichenrode; Winfried Schönegg; Claudia Schumacher; Andreas Kutscheidt; Claudia Kiewitz; Sandra Klawitter; Marcus Schmidt Journal: Anticancer Res Date: 2016-03 Impact factor: 2.480