title: Randomized phase III trial of vinorelbine plus cisplatin compared with observation in completely resected stage IB and II non-small-cell lung cancer: updated survival analysis of JBR-10.
abstract: PURPOSE Adjuvant cisplatin-based chemotherapy (ACT) is now an accepted standard for completely resected stage II and III A non-small-cell lung cancer (NSCLC). Long-term follow-up is important to document persistent benefit and late toxicity. We report here updated overall survival (OS) and disease-specific survival (DSS) data. PATIENTS AND METHODS Patients with completely resected stage IB (T2N0, n = 219) or II (T1-2N1, n = 263) NSCLC were randomly assigned to receive 4 cycles of vinorelbine/cisplatin or observation. All efficacy analyses were performed on an intention-to-treat basis. Results Median follow-up was 9.3 years (range, 5.8 to 13.8; 33 lost to follow-up); there were 271 deaths in 482 randomly assigned patients. ACT continues to show a benefit (hazard ratio [HR], 0.78; 95% CI, 0.61 to 0.99; P = .04). There was a trend for interaction with disease stage (P = .09; HR for stage II, 0.68; 95% CI, 0.5 to 0.92; P = .01; stage IB, HR, 1.03; 95% CI, 0.7 to 1.52; P = .87). ACT resulted in significantly prolonged DSS (HR, 0.73; 95% CI, 0.55 to 0.97; P = .03). Observation was associated with significantly higher risk of death from lung cancer (P = .02), with no difference in rates of death from other causes or second primary malignancies between the arms. CONCLUSION Prolonged follow-up of patients from the JBR.10 trial continues to show a benefit in survival for adjuvant chemotherapy. This benefit appears to be confined to N1 patients. There was no increase in death from other causes in the chemotherapy arm.
authors.affiliation: Cross Cancer Institute, 11560 University Ave, Edmonton, Alberta, Canada, T6G 1Z2. charlesb@cancerboard.ab.ca
authors.forename: Charles A
authors.initials: CA
authors.lastname: Butts
authors.forename: Keyue
authors.initials: K
authors.lastname: Ding
authors.forename: Lesley
authors.initials: L
authors.lastname: Seymour
authors.forename: Philip
authors.initials: P
authors.lastname: Twumasi-Ankrah
authors.forename: Barbara
authors.initials: B
authors.lastname: Graham
authors.forename: David
authors.initials: D
authors.lastname: Gandara
authors.forename: David H
authors.initials: DH
authors.lastname: Johnson
authors.forename: Kenneth A
authors.initials: KA
authors.lastname: Kesler
authors.forename: Mark
authors.initials: M
authors.lastname: Green
authors.forename: Mark
authors.initials: M
authors.lastname: Vincent
authors.forename: Yvon
authors.initials: Y
authors.lastname: Cormier
authors.forename: Glenwood
authors.initials: G
authors.lastname: Goss
authors.forename: Brian
authors.initials: B
authors.lastname: Findlay
authors.forename: Michael
authors.initials: M
authors.lastname: Johnston
authors.forename: Ming-Sound
authors.initials: MS
authors.lastname: Tsao
authors.forename: Frances A
authors.initials: FA
authors.lastname: Shepherd
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin; D005260:Female; D011905:Genes, ras; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009154:Mutation; D009367:Neoplasm Staging; D016609:Neoplasms, Second Primary / Q000209:etiology; D014747:Vinblastine / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine