https://meetinglibrary.asco.org/record/163424/abstract
Authors:
Background:ICI trials report varying rates of renal and hepatic toxicity. We evaluated a real-world cohort of aMel pts with normal baseline renal and hepatic labs to identify changes consistent with emergent renal or hepatic dys by drug regimen. Outcomes were also assessed.Methods:We analyzed de-identified real-world data aggregated by Flatiron Health from US community oncology practices. Pts had confirmed aMel, an order/administration of 1L ipilimumab (I), nivolumab (N), or pembrolizumab (P) from 1/1/11 - 12/1/17, normal (grade ≤1) baseline renal & hepatic data (most recent lab within 30 days prior to 1L start), &≥1 renal or hepatic lab within 90 days of 1L start. Renal [serum creatinine] & hepatic [total bilirubin, AST, ALT] function labs were graded by CTCAE score v4. Emergent dys (grade 2+) was based on the highest renal or hepatic lab grade in the follow-up period. Variables were analyzed using Chi2 test (categorical), Kruskal-Wallis test (continuous) & log-rank test (ICI duration, overall survival(OS)).Results:50 pts (4.3%) had emergent renal dys. Renal dys by regimen: I(5.4%); I+N(5.9%); N(2.3%); P(2.8%). 84 pts (7.2%) had emergent hepatic dys. Hepatic dys by regimen: I(7.5%); I+N(14.7%); N(4.6%); P(3.4%). Age-groups with the highest incidence of dys were 65+ (renal: 5.8%), 50-64 (hepatic: 11.7%).Conclusions:A small proportion of patients developed renal and/or hepatic dys within 90 days of 1L ICI start. Pts with emergent renal/hepatic dys had significantly shorter 1L ICI duration. Only renal dys pts had shorter OS. In contrast with renal dys, hepatic dys was prevalent in younger pts. Future adjusted analysis in larger cohorts may identify risk factors and clarify how emergent organ dys impacts OS.
Sources:
ASCO Annual Meeting