Gemcitabine as first-line therapy in patients with metastatic breast cancer: A phase II trial
Gemcitabine as first-line therapy in patients with metastatic breast cancer: A phase II trial
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DOI：
10.1159/000048240
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发表时间：
2002-01-01
期刊：
影响因子：
3.5
通讯作者：
Melemed, A
中科院分区：
文献类型：
--
作者：
Blackstein, M;Vogel, CL;Melemed, A
目的：本II期研究旨在评估吉西他滨在转移性乳腺癌（MBC）患者中的疗效和安全性。方法：组织学或细胞学证实的双向可测量的MBC不能通过手术或放疗治疗。既往不允许有转移性疾病的化疗。患者在第1、8和15天接受吉西他滨1200mg /m(2)，每28天3周，最多8个周期。结果：39例患者入组，中位年龄58岁。35例可评估患者的总缓解率为37.1%(95%可信区间[CI]， 21.5-55.1%)， 2例完全缓解，11例部分缓解。中位进展时间和生存期分别为5.1个月（95% CI, 3.5-8.8个月）和21.1个月（95% CI, 11.0-26.9个月）。化疗耐受良好，平均完成4个周期。4级毒性：1例感染，1例肺功能异常。3级中性粒细胞减少症和血小板减少症发生率分别为30.3%和6.3%。最常见的3级非血液学毒性是恶心/呕吐（10.3%）。21例患者中有5例Karnofsky性能状态（KIPS）评分改善。结论：单药吉西他滨作为治疗MBC的一线药物具有良好的疗效和耐受性。版权所有(C) 2002 S. Karger AG，巴塞尔。
Objectives: This phase II study was conducted to evaluate the efficacy and safety of gemcitabine in patients with metastatic breast cancer (MBC). Methods: Women with histologically or cytologically confirmed bidimensionally measurable MBC not amendable to curative surgery or radiation were eligible. Prior chemotherapy for metastatic disease was not permitted. Patients received gemcitabine 1,200 mg/m(2) on days 1, 8 and 15 for 3 weeks every 28 days for a maximum of 8 cycles. Results: Thirty-nine patients, with a median age of 58 years, were enrolled. The overall response rate for the 35 evaluable patients was 37.1% (95% confidence interval [CI], 21.5-55.1%), with 2 complete responses and 11 partial responses. Median time to progression and survival were 5.1 months (95% CI, 3.5-8.8 months) and 21.1 months (95% CI, 11.0-26.9 months), respectively. Chemotherapy was well tolerated, with a median of 4 cycles completed. Grade 4 toxicities were 1 infection and 1 abnormal pulmonary function. Grade 3 neutropenia and thrombocytopenia occurred in 30.3% and 6.3% of patients, respectively. The most common grade 3 non-hematologic toxicity was nausea/vomiting (10.3%). Five of 21 patients had improved Karnofsky performance status (KIPS) scores. Conclusion: Single-agent gemcitabine is active and well tolerated as first-line treatment in patients with MBC. Copyright (C) 2002 S. Karger AG, Basel.