Gemcitabine plus paclitaxel versus paclitaxel monotherapy in patients with metastatic breast cancer and prior anthracycline treatment
Gemcitabine plus paclitaxel versus paclitaxel monotherapy in patients with metastatic breast cancer and prior anthracycline treatment
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DOI：
10.1200/jco.2007.11.9362
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发表时间：
2008-08-20
影响因子：
45.3
通讯作者：
O'Shaughnessy, Joyce
中科院分区：
文献类型：
--
作者：
Albain, Kathy S.;Nag, Shona M.;O'Shaughnessy, Joyce
目的：这项III期全球研究的目的是比较吉西他滨联合紫杉醇（GT）与紫杉醇治疗晚期乳腺癌患者的疗效。它被设计为一个关键的研究批准的G乳腺癌治疗indication.Patients和MethodsPatients复发后辅助蒽环类药物被随机分配到吉西他滨，1,250 mg/m2（2）天1和8加紫杉醇，175 mg/m2的第1天，或紫杉醇在第1天相同的剂量（两个手臂每21天给药，揭盲）。主要终点为总生存期（OS），次要终点为疾病进展时间（TTP）、缓解率（RR）、无进展生存期、缓解持续时间和毒性。这最终OS分析计划在380 deaths.ResultsA共266例患者被随机分配到GT和263紫杉醇。GT组的中位生存期为18.6个月，紫杉醇组为15.8个月（对数秩P = .校正后的考克斯风险比为0.78（95%CI，0.64 - 0.96; P = 0.0187）。TTP更长（6.14 v3.98个月;对数秩P = .0002），RR更好（41.4%对26.2%; P = .0002）在GT上有更多的3 - 4级中性粒细胞减少症，在GT上有更多的2 - 4级疲劳和神经病变。结论这项III期研究记录了吉西他滨在晚期乳腺癌中的作用，蒽环类药物为基础的辅助治疗。结果确定GT作为一个合理的选择，妇女谁需要细胞减少与可管理的毒性和验证正在进行的测试GT在辅助设置。
PurposeThe objective of this phase III global study was to compare the efficacy of gemcitabine plus paclitaxel (GT) versus paclitaxel in patients with advanced breast cancer. It was designed as a pivotal study for the approval of G for a breast cancer treatment indication.Patients and MethodsPatients who relapsed after adjuvant anthracyclines were randomly assigned to gemcitabine, 1,250 mg/m(2) days 1 and 8 plus paclitaxel, 175 mg/m2 on day 1; or, to paclitaxel at same dose on day 1 (both arms administered every 21 days, unblinded). The primary end point was overall survival ( OS) and secondary end points were time to progression (TTP), response rate (RR), progression-free survival, response duration, and toxicity. This final OS analysis was planned at 380 deaths.ResultsA total of 266 patients were randomly assigned to GT and 263 to paclitaxel. Median survival on GT was 18.6 months versus 15.8 months on paclitaxel (log-rank P = . 0489), with an adjusted Cox hazard ratio of 0.78 (95% Cl, 0.64 to 0.96; P = .0187). The TTP was longer (6.14 v 3.98 months; log-rank P = .0002) and the RR was better (41.4% v 26.2%; P = .0002) on GT. There was more grade 3 to 4 neutropenia on GT and grade 2 to 4 fatigue and neuropathy were slightly more prevalent on GT.ConclusionThis phase III study documents a role for gemcitabine in advanced breast cancer after anthracycline-based adjuvant therapy. The results establish GT as a reasonable choice for women who require cytoreduction with manageable toxicities and validate ongoing testing of GT in the adjuvant setting.