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Naruto Taira
Department Kawasaki Medical School Kawasaki Medical School, Department of Breast and Thyroid Surgery, Position Professor |
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| Article types | 原著 |
| Language | English |
| Peer review | Peer reviewed |
| Title | Switch maintenance endocrine therapy plus bevacizumab after bevacizumab plus paclitaxel in advanced or metastatic oestrogen receptor-positive, HER2-negative breast cancer (BOOSTER): a randomised, open-label, phase 2 trial. |
| Journal | Formal name：The Lancet. Oncology Abbreviation：Lancet Oncol ISSN code：14745488/14702045 |
| Domestic / Foregin | Foregin |
| Volume, Issue, Page | 23(5),pp.636-649 |
| Author and coauthor | Saji Shigehira, Taira Naruto, Kitada Masahiro, Takano Toshimi, Takada Masahiro, Ohtake Tohru, Toyama Tatsuya, Kikawa Yuichiro, Hasegawa Yoshie, Fujisawa Tomomi, Kashiwaba Masahiro, Ishida Takanori, Nakamura Rikiya, Yamamoto Yutaka, Toh Uhi, Iwata Hiroji, Masuda Norikazu, Morita Satoshi, Ohno Shinji, Toi Masakazu |
| Authorship | 2nd author |
| Publication date | 2022/05 |
| Summary | BACKGROUND:Anticancer treatment regimens typically cause unpleasant side-effects. We aimed to investigate the benefit of switch maintenance endocrine therapy plus bevacizumab after fixed cycles of first-line induction chemotherapy with weekly paclitaxel plus bevacizumab in patients with oestrogen receptor (ER)-positive, HER2-negative advanced or metastatic breast cancer.METHODS:BOOSTER was a prospective, open-label, multicentre, randomised, controlled, phase 2 study done in 53 hospitals in Japan. Eligible patients were women aged 20-75 years, with an Eastern Cooperative Oncology Group performance status of 0-1, who had not received chemotherapy for ER-positive, HER2-negative advanced or metastatic breast cancer. All patients received four to six cycles (in which 4 weeks of treatment constitute one cycle) of weekly paclitaxel plus bevacizumab induction therapy (weekly paclitaxel 90 mg/m2, administered intravenously on days 1, 8, and 15 of each cycle, plus bevacizumab 10 mg/kg administered intravenously on days 1 and 15 of each cycle; first registration). Patients with a complete response, partial response, or stable disease after induction therapy (responders) were then randomly assigned (1:1) using the randomisation enrolment form to either continue weekly paclitaxel plus bevacizumab or switch to maintenance endocrine therapy (an aromatase inhibitor or fulvestrant with or without ovarian-function suppression) plus bevacizumab. Randomisation was stratified by induction therapy period, response to induction therapy, age, history of endocrine therapy, and study site. Patients could receive weekly paclitaxel plus bevacizumab reinduction if they had disease progression with maintenance endocrine therapy plus bevacizumab. The primary endpoint was time to failure of strategy (TFS). Efficacy and safety analyses were done in all treated patients (full analysis set). This study is registered with ClinicalTrials.gov, NCT01989780, and registration and follow-up are closed.FINDI |
| DOI | 10.1016/S1470-2045(22)00196-6 |
| PMID | 35405087 |