Kosei Kimura1, Mitsuhiko Iwamoto2, Satoru Tanaka3, Daigo Yamamoto4, Katsuhide Yoshidome5, Hiroyuki Ogura6, Risa Terasawa2, Nobuki Matsunami7, Yuko Takahashi8, Toshikatsu Nitta9, Takashi Morimoto10, Hiroya Fujioka2, Kanako Kawaguchi2, Kazuhisa Uchiyama2. 1. Department of Breast and Endocrine Surgery, Osaka Medical College Hospital, 2-7 Daigaku-machi, Takatsuki City, Osaka, 569-8686, Japan. sur121@osaka-med.ac.jp. 2. Department of Breast and Endocrine Surgery, Osaka Medical College Hospital, 2-7 Daigaku-machi, Takatsuki City, Osaka, 569-8686, Japan. 3. Department of Breast Surgery, National Hospital Organization Osaka Minami Medical Center, 2-1 Kidohigashi-machi, Kawachinagano City, Osaka, 586-8521, Japan. 4. Department of Breast Surgery, Kansai Medical University Medical Center, 10-15 Humizono-cho, Moriguchi City, Osaka, 570-8507, Japan. 5. Department of Breast and Endocrine Surgery, Osaka Police Hospital, 10-31 Kitayama-cho, Tennoji-ku, Osaka City, Osaka, 543-0035, Japan. 6. Department of Breast Surgery, Hamamatsu University School of Medicine, 20-1 Handayama-1-chome, Hamamatsu City Higashi-ku, Shizuoka, 431-3192, Japan. 7. Department of Breast Surgery, Osaka Rosai Hospital, 1179-3 Nagasone-cho, Sakai City Kita-ku, Osaka, 591-8025, Japan. 8. Department of Breast and Endocrine Surgery, Hirakata City Hospital, 14-1 Kinnohonmachi-2-chome, Hirakata City, Osaka, 573-1013, Japan. 9. Division of Surgery, Medico Shunju Shiroyama Hospital Breast Center, 8-1 Habikino-2-chome, Habikino City, Osaka, 583-0872, Japan. 10. Department of Breast Surgery, Yao Municipal Hospital, 3-1 Ryugecho-1-chome, Yao City, Osaka, 581-0069, Japan.
Abstract
PURPOSE: Although eribulin is a suitable option for early-line treatment of metastatic breast cancer (MBC), data on first- or second-line use of eribulin for human epidermal growth factor receptor 2 (HER2)-negative MBC are still limited. Therefore, we conducted a phase II trial to investigate the efficacy and safety of eribulin for first- or second-line chemotherapy for HER2-negative MBC. MATERIALS AND METHODS: We performed a phase II, open-label, single-arm, multicenter study in Japan. Eligible patients were women with histologically confirmed HER2-negative MBC without chemotherapy or only one chemotherapy line for MBC. The primary endpoint was the overall response rate (ORR) and the secondary endpoints included the clinical benefit rate (ORR + stable disease for 6 months; CBR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), safety, and health-related quality of life (HRQoL). RESULTS: A total of 35 patients with HER2-negative MBC were enrolled between March 2013 and February 2017 (data cut-off July 31, 2017). The ORR was 37.1% (95% CI 21.1-53.2%). The CBR was 54.3% (95% CI 37.8-70.8%). The median PFS was 6.2 months (95% CI 2.7-9.4 months) and median OS was 21.4 months (95% CI 11.5-32.9 months). Common grade 3/4 adverse events were neutropenia (42.9%) but febrile neutropenia (2.9%). Although the majority of non-hematological adverse events were mild in severity, one patient died of pneumonitis. In HRQoL analysis, eribulin appeared to maintain HRQoL of many patients. CONCLUSIONS: Eribulin as first- or second-line chemotherapy is effective and has manageable toxicity for patients with HER2-negative MBC.
PURPOSE: Although eribulin is a suitable option for early-line treatment of metastatic breast cancer (MBC), data on first- or second-line use of eribulin for human epidermal growth factor receptor 2 (HER2)-negative MBC are still limited. Therefore, we conducted a phase II trial to investigate the efficacy and safety of eribulin for first- or second-line chemotherapy for HER2-negative MBC. MATERIALS AND METHODS: We performed a phase II, open-label, single-arm, multicenter study in Japan. Eligible patients were women with histologically confirmed HER2-negative MBC without chemotherapy or only one chemotherapy line for MBC. The primary endpoint was the overall response rate (ORR) and the secondary endpoints included the clinical benefit rate (ORR + stable disease for 6 months; CBR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), safety, and health-related quality of life (HRQoL). RESULTS: A total of 35 patients with HER2-negative MBC were enrolled between March 2013 and February 2017 (data cut-off July 31, 2017). The ORR was 37.1% (95% CI 21.1-53.2%). The CBR was 54.3% (95% CI 37.8-70.8%). The median PFS was 6.2 months (95% CI 2.7-9.4 months) and median OS was 21.4 months (95% CI 11.5-32.9 months). Common grade 3/4 adverse events were neutropenia (42.9%) but febrile neutropenia (2.9%). Although the majority of non-hematological adverse events were mild in severity, one patient died of pneumonitis. In HRQoL analysis, eribulin appeared to maintain HRQoL of many patients. CONCLUSIONS: Eribulin as first- or second-line chemotherapy is effective and has manageable toxicity for patients with HER2-negative MBC.
Entities:
Keywords:
Eribulin; First or second-line; Metastatic breast cancer; Objective response rate; QOL