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

Cancer Science

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 】

Abstract

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.

【 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.

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