Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens
Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens
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DOI：
10.1200/jco.2000.18.12.2354
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发表时间：
2000-06-01
影响因子：
45.3
通讯作者：
Hammershaimb, L
中科院分区：
文献类型：
--
作者：
Fossella, FV;DeVore, R;Hammershaimb, L
目的：为了证实多西紫杉醇单药治疗晚期非小细胞肺癌(NSCLC)的II期疗效，本研究对化疗失败的晚期非小细胞肺癌(NSCLC)患者进行了这项III期试验。患者和方法：共373例患者随机接受多西紫杉醇100 mg/m(2)(D100)或75 mg/m(2)(D75)治疗，与长春瑞滨或异环磷酰胺(V/I)对照。结果：D100和D75的总有效率分别为10.8%和6.7%，均显著高于V/I的0.8%(P=.001和P=.036)。接受多西紫杉醇治疗的患者进展时间更长(经对数等级检验，P=.046)，26周后无进展存活率更高(经卡方检验，P=.005)。虽然总体存活率在三组之间没有显著差异，但D75组的一年存活率显著高于对照组(32%对19%；经卡方检验，P=.025)。先前暴露于紫杉醇并没有降低对多西紫杉醇的反应的可能性，也没有影响生存。对铂耐药而不是铂耐药的患者，以及功能状态为0或1对2的患者有更好的疗效。D100的毒性最大，但D75组耐受性良好。结论：首次随机试验表明，每3周一次的D75对晚期非小细胞肺癌患者具有临床意义，这些患者的疾病在以铂为基础的化疗后复发或进展。J Clin Oncol18：2354-2362，(C)2000，美国临床肿瘤学会。
Purpose: To confirm the promising phase II results of docetaxel monotherapy, this phase III trial was conducted of chemotherapy for patients with advanced non-small-cell lung cancer (NSCLC) who had previously failed platinum-containing chemotherapy.Patients and Methods: A total of 373 patients were randomized to receive either docetaxel 100 mg/m(2) (D100) or 75 mg/m(2) (D75) versus a control regimen of vinorelbine or ifosfamide (V/I). The three treatment groups were well-balanced for key patient characteristics.Results: Overall response rates were 10.8% with D100 and 6.7% with D75, each significantly higher than the 0.8% response with V/I (P = .001 and P = .036, respectively). patients who received docetaxel had a longer time to progression (P = .046, by log-rank test) and a greater progression-free survival at 26 weeks (P = .005, by chi(2) test). Although overall survival was not significantly different between the three groups, the 1-year survival was significantly greater with D75 than with the control treatment (32% v 19%; P = .025, by chi(2) test). Prior exposure to paclitaxel did not decrease the likelihood of response to docetaxel, nor did it impact survival. There was a trend toward greater efficacy in patients whose disease was platinum-resistant rather than platinum-refractory and in patients with performance status of 0 or 1 verses 2. Toxicity was greatest with D100, but the D75 arm was well-tolerated.Conclusion: This first randomized trial in this setting demonstrates that D75 every 3 weeks can offer clinically meaningful benefit to patients with advanced NSCLC whose disease has relapsed or progressed after platinum-based chemotherapy. J Clin Oncol 18:2354-2362, (C) 2000 by American Society of Clinical Oncology.