P3.15-12 Survival Impact of Patient Enrollment in Antineoplastic Drug Trials for Stage IV Non-Small Cell Lung Cancer (NSCLC)

Abstract

Patient enrollment in antineoplastic drug trials (ADT) is essential for the development of effective therapies in stage IV NSCLC. An open question is whether NSCLC patients derive a survival benefit by enrolling in ADTs. We hypothesized that patient enrollment in ADT is associated with longer overall survival (OS) because of access to novel therapies and closer follow up, compared with no ADT enrollment. We reviewed electronic medical records of 193 patients diagnosed with biopsy-proven, stage IV NSCLC between 01/01/2007 and 12/31/2014, who received treatments at the Seattle Cancer Care Alliance. Other inclusion criteria were age > 18 and receipt of ≥ 1 antineoplastic agent within 180 days from diagnosis. We abstracted patient clinical characteristics, tumor histology, EGFR and ALK mutation status, receipt of chemotherapy, targeted therapies, and immunotherapy up to 5 consecutive lines, participation in ADTs, and OS from diagnosis to death. We fitted multivariate Cox regression models to estimate the risk-adjusted effect of ADT participation on survival, compared with no trial participation. Patients’ mean age was 63.4; 53.9% were female; 28.5% were never smokers; 75.1% had ECOG PS of 0-1; 95.3% had non-squamous histology; 27.5% had brain metastases; 20.7% and 4.1% had EGFR+ and ALK+ NSCLC. Fifty-three (27.5%) enrolled in ≥ 1 ADT, of whom 17 (32.0%) received trial drug(s) that later became FDA approved, and 44 (83.0%) and 13 (24.5%) enrolled in phases I/II or III trials. Adjusting for ECOG PS, smoking, EGFR mutation status, type of first line therapy, and number of treatment lines, participation in ≥ 1 ADT was associated with a hazard ratio for death of 0.62 (P = 0.02; Table 1). Participation in therapeutic trials is associated with longer OS in NSCLC. Besides supporting drug development, trial enrollment may improve patient outcomes. Efforts should focus on increasing patient enrollment in drug trials.