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/m2) and vinorelbine (25 mg/m2) 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.
journal_name
Chemotherapyjournal_title
Chemotherapyauthors
Yamamura J,Masuda N,Yamamoto D,Tsuyuki S,Yamaguchi M,Tanaka S,Tsurutani J,Tokunaga S,Yoshidome K,Mizutani M,Aono T,Ooe A,Tanino H,Matsunami N,Yasojima H,Nakayama T,Nishida Ydoi
10.1159/000475879subject
Has Abstractpub_date
2017-01-01 00:00:00pages
307-313issue
5eissn
0009-3157issn
1421-9794pii
000475879journal_volume
62pub_type
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