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Randomized phase II study of nab‐paclitaxel as first‐line chemotherapy in patients with HER2‐negative metastatic breast cancer

Weekly administration of nanoparticle albumin‐bound paclitaxel (nab‐paclitaxel) has been shown to be a safe and effective treatment for metastatic breast cancer (MBC) in clinical studies. We conducted a multicenter, randomized, open‐label phase II study to compare the efficacy and safety of weekly n...

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Autores principales: Tamura, Kenji, Inoue, Kenichi, Masuda, Norikazu, Takao, Shintaro, Kashiwaba, Masahiro, Tokuda, Yutaka, Iwata, Hiroji, Yamamoto, Naohito, Aogi, Kenjiro, Saeki, Toshiaki, Nakayama, Takahiro, Sato, Nobuaki, Toyama, Tatsuya, Ishida, Takanori, Arioka, Hitoshi, Saito, Mitsue, Ohno, Shinji, Yamauchi, Hideko, Yamada, Kimito, Watanabe, Junichiro, Ishiguro, Hiroshi, Fujiwara, Yasuhiro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5448660/
https://www.ncbi.nlm.nih.gov/pubmed/28256066
http://dx.doi.org/10.1111/cas.13221
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author Tamura, Kenji
Inoue, Kenichi
Masuda, Norikazu
Takao, Shintaro
Kashiwaba, Masahiro
Tokuda, Yutaka
Iwata, Hiroji
Yamamoto, Naohito
Aogi, Kenjiro
Saeki, Toshiaki
Nakayama, Takahiro
Sato, Nobuaki
Toyama, Tatsuya
Ishida, Takanori
Arioka, Hitoshi
Saito, Mitsue
Ohno, Shinji
Yamauchi, Hideko
Yamada, Kimito
Watanabe, Junichiro
Ishiguro, Hiroshi
Fujiwara, Yasuhiro
author_facet Tamura, Kenji
Inoue, Kenichi
Masuda, Norikazu
Takao, Shintaro
Kashiwaba, Masahiro
Tokuda, Yutaka
Iwata, Hiroji
Yamamoto, Naohito
Aogi, Kenjiro
Saeki, Toshiaki
Nakayama, Takahiro
Sato, Nobuaki
Toyama, Tatsuya
Ishida, Takanori
Arioka, Hitoshi
Saito, Mitsue
Ohno, Shinji
Yamauchi, Hideko
Yamada, Kimito
Watanabe, Junichiro
Ishiguro, Hiroshi
Fujiwara, Yasuhiro
author_sort Tamura, Kenji
collection PubMed
description Weekly administration of nanoparticle albumin‐bound paclitaxel (nab‐paclitaxel) has been shown to be a safe and effective treatment for metastatic breast cancer (MBC) in clinical studies. We conducted a multicenter, randomized, open‐label phase II study to compare the efficacy and safety of weekly nab‐paclitaxel and docetaxel in Japanese patients with human epidermal growth factor receptor 2‐negative MBC. The primary endpoint was progression‐free survival (PFS). Patients were randomized to receive nab‐paclitaxel (150 mg/m(2) nab‐paclitaxel once per week for 3 of 4 weeks; n = 100) or docetaxel (75 mg/m(2) docetaxel every 3 weeks; n = 100). The median PFS by independent radiologist assessment was 9.8 months (90% confidence interval [CI]: 8.5–11.2) for nab‐paclitaxel and 11.2 months (90% CI: 8.4–13.8) for docetaxel (hazard ratio: 1.25, P = 0.363), and the median overall survival was 42.4 months and 34.0 months, respectively. The overall response rate was 56.1% for nab‐paclitaxel and 52.5% for docetaxel. Adverse events in both treatment arms were similar to previous reports. Neutropenia was the most common adverse event in both arms, with 35.0% of patients in the nab‐paclitaxel arm and 89.0% in the docetaxel arm experiencing grade 4 neutropenia. Grade 3 peripheral sensory neuropathy occurred in 22.0% of patients in the nab‐paclitaxel and 5.0% in the docetaxel arm. In this study, although weekly nab‐paclitaxel 150 mg/m(2) did not show superiority in PFS compared with docetaxel, efficacy outcomes were similar in patients treated with weekly nab‐paclitaxel and docetaxel.
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spelling pubmed-54486602017-06-01 Randomized phase II study of nab‐paclitaxel as first‐line chemotherapy in patients with HER2‐negative metastatic breast cancer Tamura, Kenji Inoue, Kenichi Masuda, Norikazu Takao, Shintaro Kashiwaba, Masahiro Tokuda, Yutaka Iwata, Hiroji Yamamoto, Naohito Aogi, Kenjiro Saeki, Toshiaki Nakayama, Takahiro Sato, Nobuaki Toyama, Tatsuya Ishida, Takanori Arioka, Hitoshi Saito, Mitsue Ohno, Shinji Yamauchi, Hideko Yamada, Kimito Watanabe, Junichiro Ishiguro, Hiroshi Fujiwara, Yasuhiro Cancer Sci Original Articles Weekly administration of nanoparticle albumin‐bound paclitaxel (nab‐paclitaxel) has been shown to be a safe and effective treatment for metastatic breast cancer (MBC) in clinical studies. We conducted a multicenter, randomized, open‐label phase II study to compare the efficacy and safety of weekly nab‐paclitaxel and docetaxel in Japanese patients with human epidermal growth factor receptor 2‐negative MBC. The primary endpoint was progression‐free survival (PFS). Patients were randomized to receive nab‐paclitaxel (150 mg/m(2) nab‐paclitaxel once per week for 3 of 4 weeks; n = 100) or docetaxel (75 mg/m(2) docetaxel every 3 weeks; n = 100). The median PFS by independent radiologist assessment was 9.8 months (90% confidence interval [CI]: 8.5–11.2) for nab‐paclitaxel and 11.2 months (90% CI: 8.4–13.8) for docetaxel (hazard ratio: 1.25, P = 0.363), and the median overall survival was 42.4 months and 34.0 months, respectively. The overall response rate was 56.1% for nab‐paclitaxel and 52.5% for docetaxel. Adverse events in both treatment arms were similar to previous reports. Neutropenia was the most common adverse event in both arms, with 35.0% of patients in the nab‐paclitaxel arm and 89.0% in the docetaxel arm experiencing grade 4 neutropenia. Grade 3 peripheral sensory neuropathy occurred in 22.0% of patients in the nab‐paclitaxel and 5.0% in the docetaxel arm. In this study, although weekly nab‐paclitaxel 150 mg/m(2) did not show superiority in PFS compared with docetaxel, efficacy outcomes were similar in patients treated with weekly nab‐paclitaxel and docetaxel. John Wiley and Sons Inc. 2017-05-05 2017-05 /pmc/articles/PMC5448660/ /pubmed/28256066 http://dx.doi.org/10.1111/cas.13221 Text en © 2017 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial (http://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Original Articles
Tamura, Kenji
Inoue, Kenichi
Masuda, Norikazu
Takao, Shintaro
Kashiwaba, Masahiro
Tokuda, Yutaka
Iwata, Hiroji
Yamamoto, Naohito
Aogi, Kenjiro
Saeki, Toshiaki
Nakayama, Takahiro
Sato, Nobuaki
Toyama, Tatsuya
Ishida, Takanori
Arioka, Hitoshi
Saito, Mitsue
Ohno, Shinji
Yamauchi, Hideko
Yamada, Kimito
Watanabe, Junichiro
Ishiguro, Hiroshi
Fujiwara, Yasuhiro
Randomized phase II study of nab‐paclitaxel as first‐line chemotherapy in patients with HER2‐negative metastatic breast cancer
title Randomized phase II study of nab‐paclitaxel as first‐line chemotherapy in patients with HER2‐negative metastatic breast cancer
title_full Randomized phase II study of nab‐paclitaxel as first‐line chemotherapy in patients with HER2‐negative metastatic breast cancer
title_fullStr Randomized phase II study of nab‐paclitaxel as first‐line chemotherapy in patients with HER2‐negative metastatic breast cancer
title_full_unstemmed Randomized phase II study of nab‐paclitaxel as first‐line chemotherapy in patients with HER2‐negative metastatic breast cancer
title_short Randomized phase II study of nab‐paclitaxel as first‐line chemotherapy in patients with HER2‐negative metastatic breast cancer
title_sort randomized phase ii study of nab‐paclitaxel as first‐line chemotherapy in patients with her2‐negative metastatic breast cancer
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5448660/
https://www.ncbi.nlm.nih.gov/pubmed/28256066
http://dx.doi.org/10.1111/cas.13221
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