Authors:
Background:ICIs were approved for first line (1L) therapy in aMel. However, pts with renal or hepatic dysf are often excluded from clinical trials; little is known about usage or outcomes for these pts.Methods:We retrospectively analyzed de-identified real-world data aggregated by Flatiron Health from US community oncology practices. Pts had confirmed aMel, a documented order/administration of an ICI as 1L therapy from 1/1/11 to 12/1/17 and ≥1 hepatic or renal lab value up to 30 days before 1L start. Renal [serum creatinine (cr)] and hepatic [total bilirubin (Tbili), aspartate aminotransferase (AST), and alanine aminotransferase (ALT)] function labs were graded by Common Terminology Criteria for Adverse Events v4.03. Dysf was defined as grade 2+. Categorical variables were assessed using Chi-square test; continuous variables with Kruskal-Wallis test; therapy duration and OS with log-rank test.Results:1475 pts with relevant data were identified (Table).Conclusions:In this real-world aMel cohort, <3% of ICI-treated pts had baseline hepatic or renal dysf. Relative to pts with normal organ function, pts with baseline renal dysf were more often male and were more likely to be older. Although only hepatic dysf was significantly associated with shorter ICI duration, both renal and hepatic dysf pts had significantly shorter median OS. The OS findings may reflect competing risk from underlying comorbidities, practice patterns, tolerance (renal dysf), toxicity and/or ICI efficacy in the setting of organ dysf. Additional research is needed to better understand ICI treatment for real-world pts with baseline renal or hepatic dysf.
Sources:
ASCO Annual Meeting