Outcomes of stage IV melanoma in the era of immunotherapy: a National Cancer Database (NCDB) analysis from 2014 to 2016

Abstract

Background: To evaluate factors affecting the utilization of immunotherapy and to stratify results based on the approval of ipilimumab in 2011 and programmed death-1 inhibitors in 2014, an analysis of available data from the National Cancer Database (NCDB) was performed.

Methods: The NCDB was analyzed to identify patients with stage IV melanoma from 2004 to 2016. Patients were categorized during the time periods 2004-2010, 2011-2014, and 2015-2016. Overall survival (OS) was analyzed by Kaplan-Meier, log-rank, and Cox proportional hazard models; IO status was analyzed using logistic regression.

Results: 24,544 patients were analyzed. Overall, 5238 patients (21.3%) who received IO had improved median OS compared with those who did not (20.2 months vs 7.4 months; p<0.0001). Between 2004 and 2010, 9.7% received immunotherapy; from 2011 to 2014, 21.9% received immunotherapy; and from 2015 to 2016, 43.5% received immunotherapy. Three-year OS significantly improved in patients treated with IO across treatment years: 31% (95% CI 29% to 34%) from 2004 to 2010, 35% (95% CI 33% to 37%) from 2011 to 2014, and 46% (95% CI 44% to 48%) from 2015 to 2016 (p<0.0001). Survival was worse in patients who did not receive IO during these treatment years: 16% (15%-17%), 21% (20%-22%), and 27% (25%-28%), respectively. In the overall cohort, age <65 years, female gender, private insurance, no comorbidities, residence in metropolitan area, and treatment at academic centers were associated with better OS (p<0.0001 for all). In the multivariate analysis, receipt of IO from 2015 to 2016 was associated with age <65 years (OR 1.27, 95% CI 1.08 to 1.50), African American race (OR 5.88, 95% CI 1.60 to 28.58), lack of comorbidities (OR 1.43, 95% CI 1.23 to 1.66), and treatment at academic centers (OR 1.44, 95% CI 1.26 to 1.65) (p<0.05 for all).

Conclusions: OS improved in patients with stage IV melanoma receiving IO, with the highest OS rate in 2015-2016. Our findings, which represent a real-world population, are slightly lower than recent trials, such as KEYNOTE-006 and CheckMate 067. Significant socioeconomic factors may impact receipt of IO and survival.

Keywords: Immunotherapy; Melanoma.