Comorbidity in clinical trial patients with advanced or metastatic non-small cell lung cancer (NSCLC).

Abstract

e20606 Background: Co-morbid conditions can have an impact on the natural course of lung cancer, as well as on treatment efficacy and safety outcomes. It is important to understand the difference in co-morbidity between clinical trial patients and the general population in order to remain vigilant for an altered safety and efficacy in the post-approval setting. We did a retrospective review of the prevalence of co-morbidity in patients with advanced or metastatic NSCLC enrolled in clinical trials conducted by PSI-CRO over a decade. Methods: A retrospective review of the prevalence of co-morbidities in NSCLC patients enrolled in clinical trials conducted by PSI-CRO from 2005 to 2015 was done. A total of 8 clinical studies involving 1,355 patients were identified. Results: The median age was 60 years with 30% of patients being 65 or older. More than two-thirds (72%) were men. About one-fifth (19%) had ECOG PS of 0 with remaining four-fifths (81%) having PS of 1. Only a small subset (9%) did not have any co-morbid conditions while more than three-quarters (77%) presented with at least 2 comorbidities. The most common comorbidities were hypertension (41%), coronary artery disease (24%), and chronic obstructive pulmonary disease (COPD) (13%). Only 1.4% of patients had malignancies in the past, which could be explained by their routine exclusion from clinical trials. Also the prevalence of diabetes mellitus (2.7%) and neurologic diseases (4%) is noted to be small. Conclusions: The prevalence of hypertension and cardiovascular co-morbidity in patients with advanced or metastatic NSCLC enrolled in clinical trial is in line with that in general population. In contrast, the prevalence of COPD, diabetes, neurologic diseases, and previous malignancies was significantly lower. The differences in prevalence in some of the co-morbidities might be explained by the restrictive inclusion criteria as well as a resulting lower PS leading to ineligibility for clinical trials. Our findings suggest that with certain co-morbidities, difference exists between the general population and those enrolled in clinical trials. This may have a potential impact on post-approval drug efficacy and safety outcomes.