Single-agent versus combination chemotherapy in advanced non-small-cell lung cancer: The Cancer and Leukemia Group B (study 9730)
Single-agent versus combination chemotherapy in advanced non-small-cell lung cancer: The Cancer and Leukemia Group B (study 9730)
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DOI：
10.1200/jco.2005.07.172
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发表时间：
2005-01-01
影响因子：
45.3
通讯作者：
Green, MR
中科院分区：
文献类型：
--
作者：
Lilenbaum, RC;Herndon, JE;Green, MR
目的比较紫杉醇联合卡铂和紫杉醇单药治疗晚期非小细胞肺癌的疗效。方法将561例符合条件的患者随机分为紫杉醇单药治疗组和紫杉醇联合卡铂治疗组。结果紫杉醇组有效率为17%，卡铂-紫杉醇组为30%。臂（P < .0001）。紫杉醇组的中位无失败生存期为2.5个月，卡铂-紫杉醇组为4.6个月（P = 0.0002）。中位生存时间分别为6.7个月（95%CI，5.8 - 7.8）和8.8个月（95%CI，8.0 - 9.9），1年生存率分别为32%（95%CI，27%-38%）和37%（95%CI，32%-43%）。总生存率分布无统计学差异：风险比= 0.91（95% CI，0.77 - 1.17; P = 0.25）。血液学毒性和恶心在联合治疗组中更常见，但两组中发热性中性粒细胞减少和毒性死亡同样低。老年患者的生存率无显著差异。体力状态2组患者联合化疗组生存率高于单药治疗组（P = 0. 019）。结论联合化疗较单药治疗组有效率和无失败生存率提高，但主要终点总生存率差异无统计学意义。老年患者的结果与年轻患者相似。体能状态2例患者在接受联合化疗时具有上级结局。
Purpose We compared the efficacy of combination chemotherapy versus single-agent therapy in patients with advanced non-small-cell lung cancer.Patients and Methods A total of 561 eligible patients were randomly assigned to receive paclitaxel alone or in combination with carboplatin.Results The response rate was 17% in the paclitaxel arm and 30% in the carboplatin-paclitaxel. arm (P < .0001). Median failure-free survival was 2.5 months in the paclitaxel arm and 4.6 months in the carboplatin-paclitaxel arm (P = .0002). Median survival times were 6.7 months (95% CI, 5.8 to 7.8) and 8.8 months (95% CI, 8.0 to 9.9), and 1-year survival rates were 32% (95% CI, 27% to 38%), and 37% (95% CI, 32% to 43%), respectively. The overall survival distributions were not statistically different: hazard ratio = 0.91 (95% CI, 0.77 to 1.17; P = .25). Hematological toxicity and nausea were more frequent in the combination arm, but febrile neutropenia and toxic deaths were equally low in both arms. There was no significant survival difference in elderly patients. Performance status 2 patients treated with combination chemotherapy had a better survival rate than those treated with single-agent therapy (P = .019).Conclusion Combination chemotherapy improves response rate and failure-free survival compared with single-agent therapy, but there was no statistically significant difference in the primary end point of overall survival. The results in elderly patients were similar to younger patients. Performance status 2 patients had a superior outcome when treated with combination chemotherapy.