Vinorelbine plus cisplatin vs. observation in resected non-small-cell lung cancer
Vinorelbine plus cisplatin vs. observation in resected non-small-cell lung cancer
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DOI：
10.1056/nejmoa043623
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发表时间：
2005-06-23
影响因子：
158.5
通讯作者：
Shepherd, F
中科院分区：
文献类型：
--
作者：
Winton, T;Livingston, R;Shepherd, F
背景我们致力于确定长春瑞滨联合顺铂是否延长了早期完全切除的非小细胞肺癌患者的总生存期。方法我们随机将完全切除的IB期或II期非小细胞肺癌患者分为长春瑞滨联合顺铂组或观察组。结果共482例患者接受了长春瑞滨联合顺铂(242例)或观察组(240例)的随机分组，其中45%的患者为病理IB期疾病，55%为II期患者，所有患者的东部合作肿瘤组表现状态评分均为0或1。两组患者的中位年龄均为61岁，其中65%为男性，53%为腺癌。化疗导致88%的患者中性粒细胞减少(包括7%的3级发热性中性粒细胞减少症)，两名患者死于毒性反应(0.8%)。化疗的非血液毒性反应有乏力(81%的患者)、恶心(80%)、食欲减退(55%)、呕吐(48%)、神经病变(48%)和便秘(47%)，但严重(3级或以上)毒性反应并不常见(
BackgroundWe undertook to determine whether adjuvant vinorelbine plus cisplatin prolongs overall survival among patients with completely resected early-stage non-small-cell lung cancer.MethodsWe randomly assigned patients with completely resected stage IB or stage II non-small-cell lung cancer to vinorelbine plus cisplatin or to observation. The primary end point was overall survival; principal secondary end points were recurrence-free survival and the toxicity and safety of the regimen.ResultsA total of 482 patients underwent randomization to vinorelbine plus cisplatin (242 patients) or observation (240); 45 percent of the patients had pathological stage IB disease and 55 percent had stage II, and all had an Eastern Cooperative Oncology Group performance status score of 0 or 1. In both groups, the median age was 61 years, 65 percent were men, and 53 percent had adenocarcinomas. Chemotherapy caused neutropenia in 88 percent of patients (including grade 3 febrile neutropenia in 7 percent) and death from toxic effects in two patients (0.8 percent). Nonhematologic toxic effects of chemotherapy were fatigue (81 percent of patients), nausea (80 percent), anorexia (55 percent), vomiting (48 percent), neuropathy (48 percent), and constipation (47 percent), but severe (grade 3 or greater) toxic effects were uncommon (