In:
Chemotherapy, S. Karger AG, Vol. 62, No. 5 ( 2017), p. 307-313
Abstract:
〈 b 〉 〈 i 〉 Background: 〈 /i 〉 〈 /b 〉 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. 〈 b 〉 〈 i 〉 Methods: 〈 /i 〉 〈 /b 〉 In this multicenter, phase II, single-arm study, patients with recurrent or metastatic HER2-negative breast cancer were administered gemcitabine (1,200 mg/m 〈 sup 〉 2 〈 /sup 〉 ) and vinorelbine (25 mg/m 〈 sup 〉 2 〈 /sup 〉 ) 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. 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 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. 〈 b 〉 〈 i 〉 Conclusion: 〈 /i 〉 〈 /b 〉 The combination of gemcitabine and vinorelbine is an effective and tolerable regimen for HER2-negative, taxane-pretreated, metastatic breast cancer patients in Japan.
Type of Medium:
Online Resource
ISSN:
0009-3157
,
1421-9794
Language:
English
Publisher:
S. Karger AG
Publication Date:
2017
detail.hit.zdb_id:
1482111-4
SSG:
15,3
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