Vinorelbine plus Cisplatin vs. Observation in Resected Non–Small-Cell Lung Cancerстатья из журнала
Аннотация: We undertook to determine whether adjuvant vinorelbine plus cisplatin prolongs overall survival among patients with completely resected early-stage non-small-cell lung cancer.We 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.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). 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).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.
Год издания: 2005
Авторы: Timothy Winton, Robert B. Livingston, David C. Johnson, James R. Rigas, Michael Johnston, Charles Butts, Yvon Cormier, Greg G. Goss, Richard Inculet, Eric Vallières, Willard A. Fry, Drew Bethune, Joseph Ayoub, Keyue Ding, Lesley Seymour, Barbara Graham, Ming‐Sound Tsao, David R. Gandara, Kenneth A. Kesler, Todd L. Demmy, Frances A. Shepherd
Издательство: Massachusetts Medical Society
Источник: New England Journal of Medicine
Ключевые слова: Lung Cancer Treatments and Mutations, Lung Cancer Diagnosis and Treatment, Lung Cancer Research Studies
Другие ссылки: New England Journal of Medicine (PDF)
New England Journal of Medicine (HTML)
PubMed (HTML)
New England Journal of Medicine (HTML)
PubMed (HTML)
Открытый доступ: bronze
Том: 352
Выпуск: 25
Страницы: 2589–2597