Demographic composition of lung cancer trials: FDA analysis.

Abstract

9088 Background: Lung cancer is the leading cause of cancer death; in the US non-small cell lung cancer (NSCLC) accounts for 80% of the lung cancer diagnoses. Enrollment of a diverse population in clinical trials (CTs) of new cancer drugs may provide information regarding the safety and efficacy of treatments in demographic subgroups that are disproportionately represented among new cases of, and deaths from, cancer. This analysis characterizes the demographics of patients enrolled in CTs submitted to FDA in support of marketing applications for FDA-approved NSCLC drugs. Methods: Reviewed datasets in the applications of original approval for new NSCLC drugs (2011- 17), and pooled demographic data from CTs that provided primary safety and efficacy data for drug approval. Results: This table illustrates enrollment by demographics at all sites and in the US. Conclusions: Enrollment of females is slightly higher (54%) than predicted based on corresponding incidence rates (48%) for this subgroup in the Surveillance, Epidemiology, and End Results database. Enrollment of younger patients is also higher than predicted based on incidence rate; patients < 65 years comprise 68% of all enrolled patients compared to 28% of new cases. These differences may be attributable, in part, to the number of CTs for new drugs for biomarker-defined NSCLC subtypes that occur more frequently in females and younger patients than in NSCLC in general. In contrast, there is lower representation of racial/ethnic minority patients ( < 1%) and patients ≥ 65 years of age (32%) in these CTs than predicted by incidence rates (65.9, 83.7, 312 and 15 cases per 100,000 in patients who are White male, Black male, > 65 years, and < 65 years, respectively). Targeted enrollment of racial/ethnic minorities and older patients is needed to improve their access to CTs; such efforts may facilitate an assessment of safety and efficacy in these subgroups. All n = 9711% US n = 1149% Age < 65 years 68 72 65-80 years 31 25 > 80 years 2 2 Sex* Female 54 55 Race# American Indian/ Alaskan Nativea < 1 < 1 Asian 43 10 Black/African American < 1 2 Native Hawaiian / Other Pacific Islandera < 1 < 1 Other 2 4 White 50 82 Ethnicity Hispanic 2 3 Not Hispanic 19 21 Other 3 12 Missing/Not Collected 76 65 *Missing ‘Sex’ (n = 2); #Missing ‘race’(n = 484). a (n = 3).