Smoking Behavior in Patients With Early-Stage NSCLC: A Report From ECOG-ACRIN 1505 Trial.

Abstract Background Smoking cessation has been reported to benefit patients even after a diagnosis of lung cancer. We studied the smoking behavior of patients who participated in a phase 3 trial of adjuvant therapy following resection of stages IB-IIIA non-small cell lung cancer (NSCLC). Methods ECOG-ACRIN 1505 was conducted to determine whether the addition of bevacizumab to adjuvant chemotherapy would improve overall survival (OS) for patients with early stage NSCLC. Studying the association between smoking status and OS was a secondary endpoint. Patients completed a questionnaire about their smoking habits at baseline, 3, 6, 9 and 12 months. Results 1501 patients were enrolled and 99.8%, 95%, 94%, 93%, and 93% responded to the questionnaire at baseline, 3, 6, 9 and 12 months, respectively. 90% reported a current or previous history of cigarette smoking. 60% of non-smokers at enrollment reported smoking after diagnosis (before randomization); however, 1% of them reported smoking at 12 months. 94% of respondents smoked none/fewer cigarettes daily at 12 months. The incidence of grades 3-5 toxicity on treatment was 68%, 76%, and 72% in never, former, and current smokers, respectively (p=0.05). The disease-free survival (DFS) for never-smokers relative to current and former smokers was (HR 0.93, p=0.64, HR 1.05, p=0.72), and OS was (adjusted HR for death 0.54, p=0.005, adjusted HR for death 0.68, p=0.03), respectively. Conclusion This is the first comprehensive, prospective report of smoking habits in NSCLC patients from a phase III early stage trial. There was a high rate of smoking reduction and cessation following study entry. DFS did not differ significantly between smokers and never smokers, though there were less grade 3-5 toxicities and more favorable OS in never-smokers.