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

Timothy Winton, Robert Livingston, David Johnson, James Rigas, Michael Johnston, Charles Butts, Yvon Cormier, Glenwood Goss, Richard Inculet, Eric Vallieres, Willard Fry, Drew Bethune, Joseph Ayoub, Keyue Ding, Lesley Seymour, Barbara Graham, Ming Sound Tsao, David R Gandara, Kenneth Kesler, Todd DemmyFrances Shepherd

Research output: Contribution to journalArticle

1427 Citations (Scopus)

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. 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. 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). 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.

Original languageEnglish (US)
Pages (from-to)2589-2597
Number of pages9
JournalNew England Journal of Medicine
Volume352
Issue number25
DOIs
StatePublished - Jun 23 2005
Externally publishedYes

Fingerprint

Non-Small Cell Lung Carcinoma
Cisplatin
Observation
Poisons
Survival
Recurrence
Drug Therapy
vinorelbine
Febrile Neutropenia
Anorexia
Constipation
Random Allocation
Neutropenia
Nausea
Disease-Free Survival
Vomiting
Fatigue
Adenocarcinoma
Survival Rate
Age Groups

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Winton, T., Livingston, R., Johnson, D., Rigas, J., Johnston, M., Butts, C., ... Shepherd, F. (2005). Vinorelbine plus cisplatin vs. observation in resected non-small-cell lung cancer. New England Journal of Medicine, 352(25), 2589-2597. https://doi.org/10.1056/NEJMoa043623

Vinorelbine plus cisplatin vs. observation in resected non-small-cell lung cancer. / Winton, Timothy; Livingston, Robert; Johnson, David; Rigas, James; Johnston, Michael; Butts, Charles; Cormier, Yvon; Goss, Glenwood; Inculet, Richard; Vallieres, Eric; Fry, Willard; Bethune, Drew; Ayoub, Joseph; Ding, Keyue; Seymour, Lesley; Graham, Barbara; Tsao, Ming Sound; Gandara, David R; Kesler, Kenneth; Demmy, Todd; Shepherd, Frances.

In: New England Journal of Medicine, Vol. 352, No. 25, 23.06.2005, p. 2589-2597.

Research output: Contribution to journalArticle

Winton, T, Livingston, R, Johnson, D, Rigas, J, Johnston, M, Butts, C, Cormier, Y, Goss, G, Inculet, R, Vallieres, E, Fry, W, Bethune, D, Ayoub, J, Ding, K, Seymour, L, Graham, B, Tsao, MS, Gandara, DR, Kesler, K, Demmy, T & Shepherd, F 2005, 'Vinorelbine plus cisplatin vs. observation in resected non-small-cell lung cancer', New England Journal of Medicine, vol. 352, no. 25, pp. 2589-2597. https://doi.org/10.1056/NEJMoa043623
Winton T, Livingston R, Johnson D, Rigas J, Johnston M, Butts C et al. Vinorelbine plus cisplatin vs. observation in resected non-small-cell lung cancer. New England Journal of Medicine. 2005 Jun 23;352(25):2589-2597. https://doi.org/10.1056/NEJMoa043623
Winton, Timothy ; Livingston, Robert ; Johnson, David ; Rigas, James ; Johnston, Michael ; Butts, Charles ; Cormier, Yvon ; Goss, Glenwood ; Inculet, Richard ; Vallieres, Eric ; Fry, Willard ; Bethune, Drew ; Ayoub, Joseph ; Ding, Keyue ; Seymour, Lesley ; Graham, Barbara ; Tsao, Ming Sound ; Gandara, David R ; Kesler, Kenneth ; Demmy, Todd ; Shepherd, Frances. / Vinorelbine plus cisplatin vs. observation in resected non-small-cell lung cancer. In: New England Journal of Medicine. 2005 ; Vol. 352, No. 25. pp. 2589-2597.
@article{170905b7244140e69ced94e6ca346fcf,
title = "Vinorelbine plus cisplatin vs. observation in resected non-small-cell lung cancer",
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. 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. 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). 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.",
author = "Timothy Winton and Robert Livingston and David Johnson and James Rigas and Michael Johnston and Charles Butts and Yvon Cormier and Glenwood Goss and Richard Inculet and Eric Vallieres and Willard Fry and Drew Bethune and Joseph Ayoub and Keyue Ding and Lesley Seymour and Barbara Graham and Tsao, {Ming Sound} and Gandara, {David R} and Kenneth Kesler and Todd Demmy and Frances Shepherd",
year = "2005",
month = "6",
day = "23",
doi = "10.1056/NEJMoa043623",
language = "English (US)",
volume = "352",
pages = "2589--2597",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "25",

}

TY - JOUR

T1 - Vinorelbine plus cisplatin vs. observation in resected non-small-cell lung cancer

AU - Winton, Timothy

AU - Livingston, Robert

AU - Johnson, David

AU - Rigas, James

AU - Johnston, Michael

AU - Butts, Charles

AU - Cormier, Yvon

AU - Goss, Glenwood

AU - Inculet, Richard

AU - Vallieres, Eric

AU - Fry, Willard

AU - Bethune, Drew

AU - Ayoub, Joseph

AU - Ding, Keyue

AU - Seymour, Lesley

AU - Graham, Barbara

AU - Tsao, Ming Sound

AU - Gandara, David R

AU - Kesler, Kenneth

AU - Demmy, Todd

AU - Shepherd, Frances

PY - 2005/6/23

Y1 - 2005/6/23

N2 - 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. 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. 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). 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.

AB - 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. 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. 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). 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.

UR - http://www.scopus.com/inward/record.url?scp=20544455590&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=20544455590&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa043623

DO - 10.1056/NEJMoa043623

M3 - Article

C2 - 15972865

AN - SCOPUS:20544455590

VL - 352

SP - 2589

EP - 2597

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 25

ER -