Cancer Science | |
Phase I study of weekly nab‐paclitaxel combined with S‐1 in patients with human epidermal growth factor receptor type 2‐negative metastatic breast cancer | |
Junji Tsurutani4  Katsumasa Kuroi2  Tsutomu Iwasa4  Masaki Miyazaki4  Shinichi Nishina4  Chihiro Makimura4  Junko Tanizaki4  Kunio Okamoto4  Toshinari Yamashita2  Tomoyuki Aruga2  Takashi Shigekawa2  Yoshifumi Komoike1  Toshiaki Saeki3  | |
[1] Department of Surgery, Kindai University Faculty of Medicine, Osaka, Japan;Department of Breast Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan;Department of Breast Oncology, Saitama Medical University International Medical Center, Saitama, Japan;Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan | |
关键词: Combination chemotherapy; metastatic breast cancer; nab‐paclitaxel; phase I study; S‐1; | |
DOI : 10.1111/cas.12658 | |
来源: Wiley | |
【 摘 要 】
We conducted a phase I study of a weekly nab-paclitaxel and S-1 combination therapy in patients with human epidermal growth factor receptor type 2-negative metastatic breast cancer. The primary objective was to estimate the maximum tolerated and recommended doses. Each treatment was repeated every 21 days. Levels 1, 2a, 2b, and 3 were set depending on the S-1 dose (65 or 80 mg/m2) and nab-paclitaxel infusion schedule (days 1 and 8 or days 1, 8, and 15). Fifteen patients were enrolled. Dose-limiting toxicity was observed in one patient at Level 3 (100 mg/m2 nab-paclitaxel on days 1, 8, and 15 with 80 mg/m2 S-1 daily for 14 days, followed by 7 days of rest). Although the maximum tolerated dose was not reached, the recommended dose was determined to be Level 3. Neutropenia was the most frequent grade 3–4 treatment-related adverse event. For patients with measurable lesions, the response rate was 50.0% and the median time to treatment failure and median progression-free survival was 13.2 and 21.0 months, respectively. The present results show the feasibility and potential for long-term administration of this combination therapy.Abstract
【 授权许可】
CC BY-NC-ND
© 2015 The Authors. Cancer Science published by Wiley Publishing Asia Pty Ltd on behalf of Japanese Cancer Association.
Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
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