© 2003 by Oxford University Press
© 2003 Oxford University Press
ARTICLE |
Randomized Study of Adjuvant Chemotherapy for Completely Resected Stage I, II, or IIIA Non–Small-Cell Lung Cancer
For the Adjuvant Lung Project Italy/European Organisation for Research Treatment of Cancer–Lung Cancer Cooperative Group Investigators
Affiliations of authors: G. V. Scagliotti, University of Torino, Department of Clinical and Biological Sciences, S. Luigi Hospital, Thoracic Oncology Unit, Orbassano (Torino), Italy; R. Fossati, V. Torri, Laboratory of Clinical Cancer Research, Mario Negri Institute, Milan, Italy; L. Crinò, Division of Medical Oncology, Bellaria Hospital, Bologna, Italy; G. Giaccone, Division of Medical Oncology, Free University Medical Center, Amsterdam, The Netherlands; G. Silvano, Department of Radiation Oncology, Moscati Hospital, Taranto, Italy; M. Martelli, Division of Thoracic Surgery, S. Camillo-Forlanini Hospital, Rome, Italy; M. Clerici, Division of Medical Oncology, S. Giuseppe Hospital, Milan, Italy; F. Cognetti, Division of Medical Oncology A, Regina Elena Cancer Institute, Rome; M. Tonato, Division of Medical Oncology, Policlinico Hospital, Perugia, Italy.
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{at}unito.it).
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.
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- Adjuvant Chemotherapy for Non–Small-Cell Lung Cancer: The End of the Beginning
- Bruce E. Johnson
J Natl Cancer Inst 2003 95: 1422-1424.[Extract] [Full Text] [PDF]
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