Vinorelbine plus Cisplatin vs. Observation in Resected Non-Small-Cell Lung Cancer

Vinorelbine plus Cisplatin vs. Observation in Resected Non-Small-Cell Lung Cancer

June 23, 2005 | Timothy Winton, M.D., Robert Livingston, M.D., David Johnson, M.D., James Rigas, M.D., Michael Johnston, M.D., Charles Butts, M.D., Yvon Cormier, M.D., Glenwood Goss, M.D., Richard Inculet, M.D., Eric Vallieres, M.D., Willard Fry, M.D., Drew Bethune, M.D., Joseph Ayoub, M.D., Keyue Ding, Ph.D., Lesley Seymour, M.D., Ph.D., Barbara Graham, R.N., Ming-Sound Tsao, M.D., David Gandara, M.D., Kenneth Kesler, M.D., Todd Demmy, M.D., and Frances Shepherd, M.D., for the National Cancer Institute of Canada Clinical Trials Group and the National Cancer Institute of the United States Intergroup JBR.10 Trial Investigators
A randomized trial compared adjuvant vinorelbine plus cisplatin with observation in patients with completely resected early-stage non–small-cell lung cancer (NSCLC). The study enrolled 482 patients (242 in the chemotherapy group and 240 in the observation group). The primary endpoint was overall survival, with recurrence-free survival and toxicity as secondary endpoints. Chemotherapy was well tolerated, with neutropenia in 88% of patients and two treatment-related deaths. Overall survival was significantly prolonged in the chemotherapy group (94 months vs. 73 months in the observation group; hazard ratio, 0.69; P=0.04), as was recurrence-free survival (not reached vs. 46.7 months; hazard ratio, 0.60; P<0.001). Five-year survival rates were 69% and 54%, respectively (P=0.03). Adjuvant vinorelbine plus cisplatin was associated with an acceptable level of toxicity and improved survival in patients with completely resected early-stage NSCLC. The study found that adjuvant chemotherapy with vinorelbine plus cisplatin significantly improved survival and recurrence-free survival compared to observation in patients with completely resected early-stage NSCLC. The regimen was well tolerated, with manageable toxicity. The results suggest that adjuvant vinorelbine plus cisplatin should be considered as a standard of care for patients with early-stage NSCLC. The study also highlights the importance of further research into the role of ras mutations in NSCLC survival and the potential benefits of adjuvant chemotherapy in different patient subgroups.A randomized trial compared adjuvant vinorelbine plus cisplatin with observation in patients with completely resected early-stage non–small-cell lung cancer (NSCLC). The study enrolled 482 patients (242 in the chemotherapy group and 240 in the observation group). The primary endpoint was overall survival, with recurrence-free survival and toxicity as secondary endpoints. Chemotherapy was well tolerated, with neutropenia in 88% of patients and two treatment-related deaths. Overall survival was significantly prolonged in the chemotherapy group (94 months vs. 73 months in the observation group; hazard ratio, 0.69; P=0.04), as was recurrence-free survival (not reached vs. 46.7 months; hazard ratio, 0.60; P<0.001). Five-year survival rates were 69% and 54%, respectively (P=0.03). Adjuvant vinorelbine plus cisplatin was associated with an acceptable level of toxicity and improved survival in patients with completely resected early-stage NSCLC. The study found that adjuvant chemotherapy with vinorelbine plus cisplatin significantly improved survival and recurrence-free survival compared to observation in patients with completely resected early-stage NSCLC. The regimen was well tolerated, with manageable toxicity. The results suggest that adjuvant vinorelbine plus cisplatin should be considered as a standard of care for patients with early-stage NSCLC. The study also highlights the importance of further research into the role of ras mutations in NSCLC survival and the potential benefits of adjuvant chemotherapy in different patient subgroups.
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