title: 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.
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/m(2) ) 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/m(2) nab-paclitaxel on days 1, 8, and 15 with 80 mg/m(2) 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.
authors: Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.
authors: Junji
authors: J
authors: Tsurutani
authors: Department of Breast Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
authors: Katsumasa
authors: K
authors: Kuroi
authors: Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.
authors: Tsutomu
authors: T
authors: Iwasa
authors: Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.
authors: Masaki
authors: M
authors: Miyazaki
authors: Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.
authors: Shinichi
authors: S
authors: Nishina
authors: Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.
authors: Chihiro
authors: C
authors: Makimura
authors: Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.
authors: Junko
authors: J
authors: Tanizaki
authors: Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.
authors: Kunio
authors: K
authors: Okamoto
authors: Department of Breast Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
authors: Toshinari
authors: T
authors: Yamashita
authors: Department of Breast Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
authors: Tomoyuki
authors: T
authors: Aruga
authors: Department of Breast Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
authors: Takashi
authors: T
authors: Shigekawa
authors: Department of Surgery, Kindai University Faculty of Medicine, Osaka, Japan.
authors: Yoshifumi
authors: Y
authors: Komoike
authors: Department of Breast Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
authors: Toshiaki
authors: T
authors: Saeki
authors: Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.
authors: Kazuhiko
authors: K
authors: Nakagawa
mesh_terms: D000328:Adult; D000368:Aged; D000418:Albumins / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000737:chemistry / Q000188:drug therapy* / Q000401:mortality; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis*; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics
chemical_list: D000418:Albumins; D004338:Drug Combinations; D010094:Oxonic Acid; D017239:Paclitaxel; D018719:Erb-b2 Receptor Tyrosine Kinases; D005641:Tegafur; C520255:130-nm albumin-bound paclitaxel; C079198:S 1 (combination); C508053:ERBB2 protein, human
keywords: Combination chemotherapy; S-1; metastatic breast cancer; nab-paclitaxel; phase I study