タイラ　ナルト   Naruto Taira   平　成人    所属   川崎医科大学  医学部 臨床医学　乳腺甲状腺外科学    職種   教授
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	Pertuzumab retreatment for HER2-positive advanced breast cancer: A randomized, open-label phase III study (PRECIOUS).
掲載誌名	正式名：Cancer science 略　 称：Cancer Sci ISSNコード：13497006/13479032
掲載区分	国外
巻・号・頁	113(9),pp.3169-3179
著者・共著者	Yamamoto Yutaka, Iwata Hiroji, Taira Naruto, Masuda Norikazu, Takahashi Masato, Yoshinami Tetsuhiro, Ueno Takayuki, Toyama Tatsuya, Yamanaka Takashi, Takano Toshimi, Kashiwaba Masahiro, Tsugawa Koichiro, Hasegawa Yoshie, Tamura Kenji, Tada Hiroshi, Hara Fumikata, Fujisawa Tomomi, Niikura Naoki, Saji Shigehira, Morita Satoshi, Toi Masakazu, Ohno Shinji
発行年月	2022/09
概要	No standard options existed for human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer that progresses after second-line trastuzumab emtansine therapy before 2020. The purpose of this study was to examine the efficacy of pertuzumab retreatment after disease progression following pertuzumab-containing therapy for HER2-positive locally advanced or metastatic breast cancer for the first time. This randomized, open-label, multicenter phase III trial was undertaken in 93 sites in Japan. Eligible patients with HER2-positive breast cancer who had received pertuzumab, trastuzumab, and chemotherapy as first- and/or second-line therapy were randomly assigned (1:1) to: (i) pertuzumab, trastuzumab, and physician's choice chemotherapy (PTC), or (ii) trastuzumab and physician's choice chemotherapy (TC). The primary end-point was investigator-assessed progression-free survival (PFS). Between August 1, 2015 and December 31, 2018, 219 patients were randomized to PTC (n = 110) or TC (n = 109). Median follow-up was 14.2 months (interquartile range, 9.0-22.2), and median PFS was 5.3 months (95% confidence interval [CI], 4.0-6.6) with PTC and 4.2 months (95% CI, 3.2-4.8) with TC (stratified hazard ratio 0.76 [95% CI upper limit 0.967]; p = 0.022). Progression-free survival was improved by adding pertuzumab in all prespecified subgroups. The PTC arm showed a trend towards better overall survival and duration of response, but similar objective response and health-related quality of life. The incidence of treatment-related adverse events was similar between groups except for diarrhea. Pertuzumab retreatment contributes to disease control for HER2-positive locally advanced or metastatic breast cancer previously treated with pertuzumab-containing regimens.
DOI	10.1111/cas.15474
PMID	35754298