학술논문
The efficacy and safety of pertuzumab plus trastuzumab and docetaxel as a first-line therapy in Japanese patients with inoperable or recurrent HER2-positive breast cancer: the COMACHI study.
Document Type
Academic Journal
Author
Takahashi M; Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.; Ohtani S; Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.; Nagai SE; Breast Oncology, Saitama Cancer Center, Saitama, Japan.; Takashima S; Breast Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.; Yamaguchi M; Breast Surgery, JCHO Kurume General Hospital, 21 Kushihara-machi Kurume, Fukuoka, Japan.; Tsuneizumi M; Breast Surgery, Shizuoka General Hospital, Shizuoka, Japan.; Komoike Y; Surgery, Kindai University Hospital, Osakasayama, Japan.; Osako T; Breast Center, Kumamoto Shinto General Hospital, Kumamoto, Japan.; Ito Y; Breast Medical Oncology, Cancer Institute Hospital of JFCR, Tokyo, Japan.; Ikeda M; Breast and Thyroid Surgery, Fukuyama City Hospital, Hiroshima, Japan.; Ishida K; Surgery, Iwate Medical University, 2-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate Prefecture, 028-3695, Japan.; Nakayama T; Breast and Endocrine Surgery, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan.; Takashima T; Breast and Endocrine Surgery, Osaka City University Graduate School of Medicine, 1-4-3 Asahimachi Abeno-ku, Osaka, 5458585, Japan.; Asakawa T; Clinical Information and Intelligence Department, Chugai Pharmaceutical Co., Ltd, 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku, Tokyo, 103-8324, Japan.; Matsumoto S; Clinical Study Management Department, Chugai Pharmaceutical Co., Ltd, 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku, Tokyo, 103-8324, Japan.; Shimizu D; Clinical Science and Strategy Department, Chugai Pharmaceutical Co., Ltd, 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku, Tokyo, 103-8324, Japan.; Masuda N; Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, Osaka, Japan. nmasuda@alpha.ocn.ne.jp.
Source
Publisher: Kluwer Academic Country of Publication: Netherlands NLM ID: 8111104 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-7217 (Electronic) Linking ISSN: 01676806 NLM ISO Abbreviation: Breast Cancer Res Treat Subsets: MEDLINE
Subject
Language
English
Abstract
Purpose: In the CLEOPATRA study of patients with human epidermal growth factor receptor 2 (HER2)-positive recurrent or metastatic breast cancer, the Japanese patient subgroup did not demonstrate the improved progression-free survival (PFS) of pertuzumab plus trastuzumab and docetaxel vs. placebo that was seen in the overall population. Therefore, COMACHI was conducted to confirm the efficacy and safety of this treatment regimen in this patient subgroup.
Methods: This was a phase IV study of pertuzumab plus trastuzumab and docetaxel in Japanese patients with histologically/cytologically confirmed inoperable or recurrent HER2-positive breast cancer. All patients received pertuzumab, trastuzumab, and docetaxel intravenously every 3 weeks until disease progression/unacceptable toxicity. The primary endpoint was investigator-assessed PFS. Secondary endpoints were overall survival (OS), investigator-assessed objective response rate, and duration of response (DoR). Safety was also assessed.
Results: At final analysis, median investigator-assessed PFS was 22.8 months (95% CI 16.9-37.5). From first dose, OS rate at 1 year was 97.7%; and at 2 and 3 years were 88.5% and 79.1%, respectively. Of the 118 patients with measurable disease at baseline, response rate was 83.9% (95% CI 77.3-90.5) and median investigator-assessed DoR was 26.3 months (95% CI 17.1-not evaluable). Treatment was well tolerated, with no new safety signals detected.
Conclusions: Our results suggest similar efficacy and safety for pertuzumab plus trastuzumab and docetaxel in Japanese patients compared with the overall population of CLEOPATRA, providing further support for this combination therapy as standard of care for Japanese patients with inoperable or recurrent HER2-positive breast cancer.
Methods: This was a phase IV study of pertuzumab plus trastuzumab and docetaxel in Japanese patients with histologically/cytologically confirmed inoperable or recurrent HER2-positive breast cancer. All patients received pertuzumab, trastuzumab, and docetaxel intravenously every 3 weeks until disease progression/unacceptable toxicity. The primary endpoint was investigator-assessed PFS. Secondary endpoints were overall survival (OS), investigator-assessed objective response rate, and duration of response (DoR). Safety was also assessed.
Results: At final analysis, median investigator-assessed PFS was 22.8 months (95% CI 16.9-37.5). From first dose, OS rate at 1 year was 97.7%; and at 2 and 3 years were 88.5% and 79.1%, respectively. Of the 118 patients with measurable disease at baseline, response rate was 83.9% (95% CI 77.3-90.5) and median investigator-assessed DoR was 26.3 months (95% CI 17.1-not evaluable). Treatment was well tolerated, with no new safety signals detected.
Conclusions: Our results suggest similar efficacy and safety for pertuzumab plus trastuzumab and docetaxel in Japanese patients compared with the overall population of CLEOPATRA, providing further support for this combination therapy as standard of care for Japanese patients with inoperable or recurrent HER2-positive breast cancer.