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Prospective observational study of bevacizumab combined with paclitaxel as first- or second-line chemotherapy for locally advanced or metastatic breast cancer: the JBCRG-C05 (B-SHARE) study
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, bevacizuma...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer Japan
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7796874/ https://www.ncbi.nlm.nih.gov/pubmed/32715420 http://dx.doi.org/10.1007/s12282-020-01138-4 |
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author | Yamamoto, Yutaka Yamashiro, Hiroyasu Toh, Uhi Kondo, Naoto Nakamura, Rikiya Kashiwaba, Masahiro Takahashi, Masato Tsugawa, Koichiro Ishikawa, Takashi Nakayama, Takahiro Ohtani, Shoichiro Takano, Toshimi Fujisawa, Tomomi Toyama, Tatsuya Kawaguchi, Hidetoshi Mashino, Kojiro Tanino, Yuichi Morita, Satoshi Toi, Masakazu Ohno, Shinji |
author_facet | Yamamoto, Yutaka Yamashiro, Hiroyasu Toh, Uhi Kondo, Naoto Nakamura, Rikiya Kashiwaba, Masahiro Takahashi, Masato Tsugawa, Koichiro Ishikawa, Takashi Nakayama, Takahiro Ohtani, Shoichiro Takano, Toshimi Fujisawa, Tomomi Toyama, Tatsuya Kawaguchi, Hidetoshi Mashino, Kojiro Tanino, Yuichi Morita, Satoshi Toi, Masakazu Ohno, Shinji |
author_sort | Yamamoto, Yutaka |
collection | PubMed |
description | 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s12282-020-01138-4) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-7796874 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Springer Japan |
record_format | MEDLINE/PubMed |
spelling | pubmed-77968742021-01-19 Prospective observational study of bevacizumab combined with paclitaxel as first- or second-line chemotherapy for locally advanced or metastatic breast cancer: the JBCRG-C05 (B-SHARE) study Yamamoto, Yutaka Yamashiro, Hiroyasu Toh, Uhi Kondo, Naoto Nakamura, Rikiya Kashiwaba, Masahiro Takahashi, Masato Tsugawa, Koichiro Ishikawa, Takashi Nakayama, Takahiro Ohtani, Shoichiro Takano, Toshimi Fujisawa, Tomomi Toyama, Tatsuya Kawaguchi, Hidetoshi Mashino, Kojiro Tanino, Yuichi Morita, Satoshi Toi, Masakazu Ohno, Shinji Breast Cancer Original Article 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s12282-020-01138-4) contains supplementary material, which is available to authorized users. Springer Japan 2020-07-26 2021 /pmc/articles/PMC7796874/ /pubmed/32715420 http://dx.doi.org/10.1007/s12282-020-01138-4 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Original Article Yamamoto, Yutaka Yamashiro, Hiroyasu Toh, Uhi Kondo, Naoto Nakamura, Rikiya Kashiwaba, Masahiro Takahashi, Masato Tsugawa, Koichiro Ishikawa, Takashi Nakayama, Takahiro Ohtani, Shoichiro Takano, Toshimi Fujisawa, Tomomi Toyama, Tatsuya Kawaguchi, Hidetoshi Mashino, Kojiro Tanino, Yuichi Morita, Satoshi Toi, Masakazu Ohno, Shinji Prospective observational study of bevacizumab combined with paclitaxel as first- or second-line chemotherapy for locally advanced or metastatic breast cancer: the JBCRG-C05 (B-SHARE) study |
title | Prospective observational study of bevacizumab combined with paclitaxel as first- or second-line chemotherapy for locally advanced or metastatic breast cancer: the JBCRG-C05 (B-SHARE) study |
title_full | Prospective observational study of bevacizumab combined with paclitaxel as first- or second-line chemotherapy for locally advanced or metastatic breast cancer: the JBCRG-C05 (B-SHARE) study |
title_fullStr | Prospective observational study of bevacizumab combined with paclitaxel as first- or second-line chemotherapy for locally advanced or metastatic breast cancer: the JBCRG-C05 (B-SHARE) study |
title_full_unstemmed | Prospective observational study of bevacizumab combined with paclitaxel as first- or second-line chemotherapy for locally advanced or metastatic breast cancer: the JBCRG-C05 (B-SHARE) study |
title_short | Prospective observational study of bevacizumab combined with paclitaxel as first- or second-line chemotherapy for locally advanced or metastatic breast cancer: the JBCRG-C05 (B-SHARE) study |
title_sort | prospective observational study of bevacizumab combined with paclitaxel as first- or second-line chemotherapy for locally advanced or metastatic breast cancer: the jbcrg-c05 (b-share) study |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7796874/ https://www.ncbi.nlm.nih.gov/pubmed/32715420 http://dx.doi.org/10.1007/s12282-020-01138-4 |
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