Influence of Gastrointestinal Tract Cancer History on the Outcomes of Lung Cancer Surgery: Extended Inclusion Criteria for Clinical Trials

Abstract

ABSTRACT Aim: Clinical trials often exclude patients with a history of cancer treatment during the 5 years preceding the investigation. This study aims to evaluate whether a history of gastrointestinal (GI) tract cancer affects the prognosis of patients who undergo surgery for non-small cell lung cancer (NSCLC) to extend inclusion criteria for clinical trials. Methods: Multi-institutional, individual data from patients with NSCLC resected between 2000 and 2013 were collected. The patients were divided into 2 groups: those with a history of GI tract cancer (GI group) and those without any history (non-GI group). We compared the outcomes with well-matched groups using propensity scoring to minimize bias related to the nonrandomness. The influence of GI tract cancer stage, disease-free interval (DFI), and treatment method for GI tract cancer on the outcome of NSCLC was examined. Results: We analyzed 196 patients in the GI group and 3732 in the non-GI group. In unmatched cohort, multivariate analyses showed that a history of GI tract cancer did not affect overall survival (OS: hazard ratio [HR] 0.95; 95% confidence interval [CI] 0.68-1.32) or recurrence-free survival (RFS: HR 0.94; 95%CI 0.71-1.25). Independent predictors of poor prognosis included older age, male sex, high carcinoembryonic antigen levels, and advanced clinical stage of NSCLC. The two groups in matched cohort demonstrated equivalent OS (OS: HR 0.90; 95%CI 0.60-1.33) and RFS (RFS: HR 0.84; 95%CI 0.60-1.18), even in patients with clinical stage I. GI tract cancer stage, DFI, and treatment method for GI tract cancer were not associated with outcomes. Conclusions: Patients with well-controlled GI tract cancer treated during the last 5 years can be included in randomized controlled trials for NSCLC.Patients with well-controlled GI tract cancer treated during the last 5 years can be included in randomized controlled trials for NSCLC. Disclosure: All authors have declared no conflicts of interest.