Patient-centered outcomes with post-approval nivolumab in metastatic NSCLC at the Cleveland Clinic Taussig Cancer Institute (TCI).

Abstract

29 Background: Patient-centered outcomes are important quality metrics of value-based cancer care. For NSCLC, these include chemotherapy administration within 30 days of death and end of life hospitalizations. Nivolumab was initially FDA approved in March 2015 for second-line therapy of squamous NSCLC and subsequently for non-squamous NSCLC. To evaluate the impact of post-approval nivolumab use on patient-centered outcomes, a retrospective review was performed of patients (pts) with metastatic NSLCC receiving nivolumab at TCI main campus and regional centers. Methods: All pts with NSCLC receiving nivolumab from 3/4/15 to 10/5/15 were identified (cohort A) and treatment characteristics were collected from pharmacy, billing, and tumor registry databases and manual chart review. Similar data for a cohort of NSCLC pts (cohort B) initiating care with 4 academic thoracic and 12 community TCI oncologists from 1/1/12 to 7/1/13 and who received second-line therapy were used for comparison. Results: 113 cohort A pts received nivolumab with a median follow up of 101 days. 82 (73%) were alive at the time of evaluation. 70 (62%) received ≤ 1 prior chemotherapy regimens for metastatic disease. 19 of 52 (37%) cohort A pts completing nivolumab received drug within 30 days of death, 13 (68%) of whom had received ≤ 1 prior chemotherapy regimens. 3 of 50 (6%) cohort B pts completing second-line therapy received drug within 30 days of death. In patients with a known date of death, median time from first dose of nivolumab in cohort A and second-line therapy in cohort B and death was 41 and 145 days respectively. 28 (25%) cohort A pts and 18 (36%) cohort B pts were hospitalized at a TCI facility during therapy. Conclusions: This study shows the brisk uptake of nivolumab to clinical practice, but with potential for inappropriate utilization. Continued evaluation of practice patterns is necessary including cost analysis. Further research is needed to better understand outcomes in patients with EGOG PS ≥ 2, front-line use, and cost effectiveness.