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Randomized Study of Adjuvant Chemotherapy for Completely Resected Stage I, II, or IIIA Non–Small-Cell Lung Cancer

Scagliotti, Giorgio V. ; Fossati, Roldano ; Torri, Valter ; Crinò, Lucio ; Giaccone, Giuseppe ; Silvano, Giovanni ; Martelli, Massimo ; Clerici, Maurizia ; Cognetti, Francesco ; Tonato, Maurizio

JNCI : Journal of the National Cancer Institute, 2003-10, Vol.95 (19), p.1453-1461 [Periódico revisado por pares]

Cary, NC: Oxford University Press

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Título:
Randomized Study of Adjuvant Chemotherapy for Completely Resected Stage I, II, or IIIA Non–Small-Cell Lung Cancer
Autor: Scagliotti, Giorgio V. ; Fossati, Roldano ; Torri, Valter ; Crinò, Lucio ; Giaccone, Giuseppe ; Silvano, Giovanni ; Martelli, Massimo ; Clerici, Maurizia ; Cognetti, Francesco ; Tonato, Maurizio
Assuntos: Adult ; Aged ; Antineoplastic agents ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; Biomarkers, Tumor - analysis ; Carcinoma, Non-Small-Cell Lung - drug therapy ; Carcinoma, Non-Small-Cell Lung - pathology ; Carcinoma, Non-Small-Cell Lung - surgery ; Chemotherapy ; Chemotherapy, Adjuvant ; Cisplatin - administration & dosage ; Clinical outcomes ; Clinical trials ; Combined treatments (chemotherapy of immunotherapy associated with an other treatment) ; Disease Progression ; Disease-Free Survival ; Drug Administration Schedule ; Female ; Humans ; Italy ; Lung cancer ; Lung Neoplasms - drug therapy ; Lung Neoplasms - pathology ; Lung Neoplasms - surgery ; Male ; Medical sciences ; Middle Aged ; Mitomycin - administration & dosage ; Multivariate Analysis ; Neoplasm Staging ; Odds Ratio ; Patient Compliance ; Patient Selection ; Pharmacology. Drug treatments ; Proportional Hazards Models ; Prospective Studies ; Survival Analysis ; Treatment Outcome ; Vindesine - administration & dosage
É parte de: JNCI : Journal of the National Cancer Institute, 2003-10, Vol.95 (19), p.1453-1461
Notas: local:0951453
istex:BD4533B77A32881B989D0178842DB1FCAB8E9E7F
Correspondence to: Giorgio V. Scagliotti, MD, PhD, University of Torino, Department of Clinical and Biological Sciences, S. Luigi Hospital, Regione Gonzole 10, 10043 Orbassano (Torino), Italy (e-mail: giorgio.scagliotti@unito.it).
ark:/67375/HXZ-KNDFP7D1-8
PII:1460-2105
Descrição: Background: Surgery is the primary treatment for patients with stage I, II, or IIIA non–small-cell lung cancer (NSCLC). However, long-term survival of NSCLC patients after surgery alone is largely unsatisfactory, and the role of adjuvant chemotherapy in patient survival has not yet been established. Methods: Between January 1994 and January 1999, 1209 patients with stage I, II, or IIIA NSCLC were randomly assigned to receive mitomycin C (8 mg/m2 on day 1), vindesine (3 mg/m2 on days 1 and 8), and cisplatin (100 mg/m2 on day 1) every 3 weeks for three cycles (MVP group; n = 606) or no treatment (control group; n = 603) after complete resection. Randomization was stratified by investigational center, tumor size, lymph-node involvement, and the intention to perform radiotherapy. The primary endpoint was overall survival and secondary endpoints were progression-free survival and toxicity associated with adjuvant treatment. Survival curves were analyzed using the log-rank test. All statistical tests were two-sided. Results: After a median follow-up time of 64.5 months, there was no statistically significant difference between the two patient groups in overall survival (hazard ratio = 0.96, 95% confidence interval = 0.81 to 1.13; P = .589) or progression-free survival (hazard ratio = 0.89, 95% confidence interval = 0.76 to 1.03; P = .128). Only 69% of patients received the three planned cycles of MVP. Grades 3 and 4 neutropenia occurred in 16% and 12%, respectively, of patients in the MVP arm. Radiotherapy was completed by 65% of patients in the MVP arm and by 82% of patients in the control group. In the multivariable analysis, only disease stage and sex were associated with survival. Conclusion: This randomized trial failed to prospectively confirm a statistically significant role for adjuvant chemotherapy in completely resected NSCLC. Given the poor compliance with the MVP regimen used in this study, future studies should explore more effective treatments.
Editor: Cary, NC: Oxford University Press
Idioma: Inglês

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Randomized Study of Adjuvant Chemotherapy for Completely Resected Stage I, II, or IIIA Non–Small-Cell Lung Cancer

Scagliotti, Giorgio V. ; Fossati, Roldano ; Torri, Valter ; Crinò, Lucio ; Giaccone, Giuseppe ; Silvano, Giovanni ; Martelli, Massimo ; Clerici, Maurizia ; Cognetti, Francesco ; Tonato, Maurizio

Cary, NC: Oxford University Press

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