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- Title
Gemcitabine and Vinorelbine Combination Chemotherapy in Taxane-Pretreated Patients with Metastatic Breast Cancer: A Phase II Study of the Kinki Multidisciplinary Breast Oncology Group (KMBOG) 1015.
- Authors
Yamamura, Jun; Masuda, Norikazu; Yamamoto, Daigo; Tsuyuki, Shigeru; Yamaguchi, Masahide; Tanaka, Satoru; Tsurutani, Junji; Tokunaga, Shinya; Yoshidome, Katsuhide; Mizutani, Makiko; aono, Toyokazu; Ooe, asako; Tanino, Hirokazu; Matsunami, Nobuki; Yasojima, Hiroyuki; Nakayama, Takahiro; Nishida, Yukihiro
- Abstract
Background: This phase II study was conducted to evaluate the efficacy and safety of the chemotherapy combination of gemcitabine and vinorelbine in taxane-pretreated Japanese metastatic breast cancer patients. Methods: In this multicenter, phase II, single-arm study, patients with recurrent or metastatic HER2-negative breast cancer were administered gemcitabine (1,200 mg/m 2 ) and vinorelbine (25 mg/m 2 ) intravenously on days 1 and 8 every 3 weeks. The primary endpoint was the objective response rate, and other endpoints included progression-free survival, overall survival, and safety. Results: A total of 42 patients were enrolled in this study. The objective response rate and clinical benefit rate were 24 and 43%, respectively. The median progression-free survival was 4.0 months. The median overall survival was 11.1 months. Grade 3/4 neutropenia was the most common hematologic toxicity, occurring in 22 patients (54%). Nonhematologic toxicity was moderate and transient, with fatigue (48%) being the most common condition and no severe adverse event reported. Conclusion: The combination of gemcitabine and vinorelbine is an effective and tolerable regimen for HER2-negative, taxane-pretreated, metastatic breast cancer patients in Japan.
- Subjects
CANCER chemotherapy; VINORELBINE; METASTATIC breast cancer; HER2 gene; TAXANES
- Publication
Chemotherapy (0009-3157), 2017, Vol 62, Issue 5, p307
- ISSN
0009-3157
- Publication type
Article
- DOI
10.1159/000475879