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Long-term results of the French randomized trial comparing neoadjuvant chemotherapy followed by surgery versus surgery alone in resectable non-small cell lung cancer.
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2010
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Surgical OncologyCancer ManagementMultimodalityFrench Randomized TrialSurgeryOncologySurvival DifferenceClinical TrialsRadiation OncologyCancer ResearchRadiologyHealth SciencesOutcomes ResearchCancer TreatmentLung CancerNeoadjuvant ChemotherapyFiberoptic BronchoscopyBronchial NeoplasmThoracic SurgeryMedicineSurgery Versus Surgery
7003 Background: To evaluate survival beyond 10 years of patients included in the French randomized trialcomparing neoadjuvant chemotherapy (CT-S) versus surgery alone (S) (initial publication: Depierre et al, J Clin Oncol 2002;20:247-53). Methods: Preoperative chemotherapy consisted of two cycles of mitomycin (6 mg/m2, day 1), ifosfamide (1.5 g/m2, days 1 to 3) and cisplatin (30 mg/m2, days 1 to 3), and two additional postoperative cycles for responding patients. Follow-up of patients by CT scan and fiberoptic bronchoscopy was scheduled for 7 years. Annual follow-up was performed thereafter and procedures were left to the investigator's discretion. Results: Three-hundred fifty-five eligible patients were randomized. Median follow-up was 13.8 years. The 10-year survival rate was 20.8% for the S arm and 29.4% for the CT-S arm (p=0.12). Multivariate analysis showed that neoadjuvant chemotherapy (HR=0.78; 95%CI= 0.61-0.99; p= 0.038), age, and the T and N status were significantly correlated with overall survival. The 10- year recurrence-free survival rate was 38.2% in the S arm and 54.6% in the CT-S arm (p = 0.001). The frequency of non-cancer deaths was identical in the 2 arms. The mortality rate from second primary cancer did not differ (6.9% in the S arm and 5% in the CT-S arm). At exploratory subgroup analyses, the 10- year survival rate for patients with stage I and II disease was 23.1% in the S arm and 37.6% in the CT-S arm (p = 0.04). The survival difference for patients with stage IIIa disease was not significant. Chemotherapy significantly increased survival in case of lobectomy (p=0.04) but not in case of a pneumonectomy. Conclusions: Neoadjuvant chemotherapy did not significantly increase long-term survival by univariate analysis. However, a 8% survival benefit in favor of neoadjuvant chemotherapy remained stable beyond 10 years and the multivariate analysis suggested a long-term benefit of neoadjuvant chemotherapy. No significant financial relationships to disclose.