Yutaka Yamamoto1, Hiroyasu Yamashiro2, Uhi Toh3, Naoto Kondo4,5, Rikiya Nakamura6, Masahiro Kashiwaba7, Masato Takahashi8, Koichiro Tsugawa9, Takashi Ishikawa10, Takahiro Nakayama11, Shoichiro Ohtani12, Toshimi Takano13, Tomomi Fujisawa14, Tatsuya Toyama5, Hidetoshi Kawaguchi15, Kojiro Mashino16, Yuichi Tanino17, Satoshi Morita18, Masakazu Toi19, Shinji Ohno20. 1. Department of Breast and Endocrine Surgery, Graduate School of Medical Sciences, Kumamoto University, 1-1-1 Honjo, Chuo-ku, Kumamoto, 860-8556, Japan. yyamamoto@kumamoto-u.ac.jp. 2. Department of Breast Surgery, Tenri Yorozu Hospital, Nara, Japan. 3. Department of Surgery, Kurume University School of Medicine, Fukuoka, Japan. 4. Department of Breast Oncology, Aichi Cancer Center Hospital, Aichi, Japan. 5. Department of Breast Surgery, Nagoya City University Graduate School of Medical Sciences, Aichi, Japan. 6. Division of Breast Surgery, Chiba Cancer Center, Chiba, Japan. 7. Department of Breast Surgery, Sagara Hospital, Kagoshima, Japan. 8. Department of Breast Surgery, NHO Hokkaido Cancer Center, Hokkaido, Japan. 9. Department of Breast Surgery, St. Marianna University School of Medicine, Kanagawa, Japan. 10. Department of Breast Surgery, Tokyo Medical University, Tokyo, Japan. 11. Department of Breast Surgery, Osaka International Cancer Institute, Osaka, Japan. 12. Department of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan. 13. Department of Medical Oncology, Toranomon Hospital, Tokyo, Japan. 14. Department of Breast Oncology, Gunma Prefectural Cancer Center, Gunma, Japan. 15. Department of Breast Surgery, Matsuyama Red Cross Hospital, Ehime, Japan. 16. Department of Surgery (Breast Surgery), Oita Prefectural Hospital, Oita, Japan. 17. Department of Breast and Endocrine Surgery, Kobe University Hospital, Hyogo, Japan. 18. Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan. 19. Department of Breast Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan. 20. Breast Oncology Center, Cancer Institute Hospital, Tokyo, Japan.
Abstract
PURPOSE: To investigate the effectiveness and safety of bevacizumab-paclitaxel combination therapy as first- or second-line chemotherapy for HER2-negative locally advanced or metastatic breast cancer in daily clinical practice. METHODS: In this prospective multicenter observational study, bevacizumab-paclitaxel was administered at the discretion of attending physicians. Cohorts A and B had hormone receptor-positive and triple-negative breast cancer (TNBC), respectively. Primary endpoint was overall survival (OS). Multivariate analyses were conducted to identify prognostic factors. RESULTS: Between November 2012 and October 2014, 767 patients were enrolled from 155 institutions across Japan. Effectiveness was analyzed in 754 eligible patients (cohort A, 539; cohort B, 215) and safety in 750 treated patients (median observation period, 19.7 months). Median OS (95% CI) was 21.7 (19.8-23.6) months in eligible patients; 25.2 (22.4-27.4) months and 13.2 (11.3-16.6) months in cohorts A and B, respectively; and 24.4 (21.9-27.2) months and 17.6 (15.2-20.0) months in patients receiving first- and second-line therapy, respectively. Factors affecting OS (hazard ratio 95% CI) were TNBC (1.75, 1.44-2.14), second-line therapy (1.35, 1.13-1.63), ECOG performance status ≥ 1 (1.28, 1.04-1.57), taxane-based chemotherapy (0.65, 0.49-0.86), cancer-related symptoms (0.56, 0.46-0.68), and visceral metastasis (0.52, 0.40-0.66). Incidences of grade ≥ 3 AEs hypertension, neutropenia, peripheral neuropathy, proteinuria, and bleeding were 35.7%, 27.2%, 7.2%, 3.7%, and 0.3%, respectively. CONCLUSIONS: In Japanese clinical practice, combined bevacizumab-paclitaxel was as effective as in previous studies. Factors that independently predicted poor prognosis in the present study are consistent with those identified previously. TRIAL REGISTRATION: Trial no. UMIN000009086.
PURPOSE: To investigate the effectiveness and safety of bevacizumab-paclitaxel combination therapy as first- or second-line chemotherapy for HER2-negative locally advanced or metastatic breast cancer in daily clinical practice. METHODS: In this prospective multicenter observational study, bevacizumab-paclitaxel was administered at the discretion of attending physicians. Cohorts A and B had hormone receptor-positive and triple-negative breast cancer (TNBC), respectively. Primary endpoint was overall survival (OS). Multivariate analyses were conducted to identify prognostic factors. RESULTS: Between November 2012 and October 2014, 767 patients were enrolled from 155 institutions across Japan. Effectiveness was analyzed in 754 eligible patients (cohort A, 539; cohort B, 215) and safety in 750 treated patients (median observation period, 19.7 months). Median OS (95% CI) was 21.7 (19.8-23.6) months in eligible patients; 25.2 (22.4-27.4) months and 13.2 (11.3-16.6) months in cohorts A and B, respectively; and 24.4 (21.9-27.2) months and 17.6 (15.2-20.0) months in patients receiving first- and second-line therapy, respectively. Factors affecting OS (hazard ratio 95% CI) were TNBC (1.75, 1.44-2.14), second-line therapy (1.35, 1.13-1.63), ECOG performance status ≥ 1 (1.28, 1.04-1.57), taxane-based chemotherapy (0.65, 0.49-0.86), cancer-related symptoms (0.56, 0.46-0.68), and visceral metastasis (0.52, 0.40-0.66). Incidences of grade ≥ 3 AEs hypertension, neutropenia, peripheral neuropathy, proteinuria, and bleeding were 35.7%, 27.2%, 7.2%, 3.7%, and 0.3%, respectively. CONCLUSIONS: In Japanese clinical practice, combined bevacizumab-paclitaxel was as effective as in previous studies. Factors that independently predicted poor prognosis in the present study are consistent with those identified previously. TRIAL REGISTRATION: Trial no. UMIN000009086.
Entities:
Keywords:
Bevacizumab; First line; Locally advanced breast cancer; Metastatic breast cancer; Overall survival; Paclitaxel; Second line
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