Journal Article 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

108 ( 5 )  , pp.987 - 994 , 2017-05 , Wiley-Blackwell
ISSN:1347-9032
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/m2 nab-paclitaxel once per week for 3 of 4 weeks; n = 100) or docetaxel (75 mg/m2 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/m2 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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