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Clinical Trial
. 2005 Jun 23;352(25):2589-97.
doi: 10.1056/NEJMoa043623.

Vinorelbine plus cisplatin vs. observation in resected non-small-cell lung cancer

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Free article
Clinical Trial

Vinorelbine plus cisplatin vs. observation in resected non-small-cell lung cancer

Timothy Winton et al. N Engl J Med. .
Free article

Abstract

Background: We undertook to determine whether adjuvant vinorelbine plus cisplatin prolongs overall survival among patients with completely resected early-stage non-small-cell lung cancer. VSports手机版.

Methods: We randomly assigned patients with completely resected stage IB or stage II non-small-cell lung cancer to vinorelbine plus cisplatin or to observation V体育安卓版. The primary end point was overall survival; principal secondary end points were recurrence-free survival and the toxicity and safety of the regimen. .

Results: A 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 (<10 percent) V体育ios版. Overall survival was significantly prolonged in the chemotherapy group as compared with the observation group (94 vs. 73 months; hazard ratio for death, 0. 69; P=0. 04), as was relapse-free survival (not reached vs. 46. 7 months; hazard ratio for recurrence, 0. 60; P<0. 001). Five-year survival rates were 69 percent and 54 percent, respectively (P=0. 03). .

Conclusions: Adjuvant vinorelbine plus cisplatin has an acceptable level of toxicity and prolongs disease-free and overall survival among patients with completely resected early-stage non-small-cell lung cancer VSports最新版本. .

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