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

doi:10.1056/NEJMoa043623

Volume 352:2589-2597		June 23, 2005		Number 25

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

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., 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

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by Pisters, K. M.W.

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ABSTRACT

Background We undertook to determine whether adjuvant vinorelbineplus cisplatin prolongs overall survival among patients withcompletely resected early-stage non–small-cell lung cancer.

Methods We randomly assigned patients with completely resectedstage IB or stage II non–small-cell lung cancer to vinorelbineplus cisplatin or to observation. The primary end point wasoverall survival; principal secondary end points were recurrence-freesurvival and the toxicity and safety of the regimen.

Results A total of 482 patients underwent randomization to vinorelbineplus cisplatin (242 patients) or observation (240); 45 percentof the patients had pathological stage IB disease and 55 percenthad stage II, and all had an Eastern Cooperative Oncology Groupperformance status score of 0 or 1. In both groups, the medianage was 61 years, 65 percent were men, and 53 percent had adenocarcinomas.Chemotherapy caused neutropenia in 88 percent of patients (includinggrade 3 febrile neutropenia in 7 percent) and death from toxiceffects in two patients (0.8 percent). Nonhematologic toxiceffects of chemotherapy were fatigue (81 percent of patients),nausea (80 percent), anorexia (55 percent), vomiting (48 percent),neuropathy (48 percent), and constipation (47 percent), butsevere (grade 3 or greater) toxic effects were uncommon (<10percent). Overall survival was significantly prolonged in thechemotherapy group as compared with the observation group (94vs. 73 months; hazard ratio for death, 0.69; P=0.04), as wasrelapse-free survival (not reached vs. 46.7 months; hazard ratiofor recurrence, 0.60; P<0.001). Five-year survival rateswere 69 percent and 54 percent, respectively (P=0.03).

Conclusions Adjuvant vinorelbine plus cisplatin has an acceptablelevel of toxicity and prolongs disease-free and overall survivalamong patients with completely resected early-stage non–small-celllung cancer.

Source Information

From the National Cancer Institute of Canada Clinical Trials Group, Kingston, Ont. (T.W., M.J., C.B., Y.C., G.G., R.I., D.B., J.A., K.D., L.S., B.G., M.-S.T., F.S.); Southwest Oncology Group, San Antonio, Tex. (R.L., E.V., D.G.); Eastern Cooperative Oncology Group, Boston (D.J., W.F., K.K.); and Cancer and Leukemia Group B, Chicago (J.R., T.D.).

Address reprint requests to Dr. Winton at 2D2.09 Walter Mackenzie Health Sciences Centre, University of Alberta Hospital, 8440 112th St., Edmonton, AB T6G 2B7, Canada, or at twinton{at}cha.ab.ca.

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Treatment of Resected Non–Small-Cell Lung Cancer
Bria E., Giannarelli D., Terzoli E., Winton T. L., Ding K., Seymour L.
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N Engl J Med 2005; 353:1523-1524, Oct 6, 2005. Correspondence

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