Organ Dysfunction in Patients with Advanced Melanoma Treated with Immune Checkpoint Inhibitors

Author:

Spillane Susan1,Baxi Shrujal2,Torres Aracelis Z.2,Lenis David3,Freedman Andrew N.4,Mariotto Angela B.4,Sharon Elad5

Affiliation:

1. Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, Maryland, USA

2. Flatiron Health Inc, New York, New York, USA

3. Covera Health, New York, New York, USA

4. Cancer Control and Population Sciences, National Cancer Institute, Bethesda, Maryland, USA

5. Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland, USA

Abstract

Abstract Background Real-world data enables evaluation of immune checkpoint inhibitor (ICI) use in advanced melanoma management. We examined characteristics and outcomes of ICI-treated patients with advanced melanoma and organ dysfunction (baseline and emergent). Materials and Methods This retrospective observational study used electronic health records derived from a nationwide data set to examine advanced melanoma patients treated with first-line ICIs (2011–2018). Clinical characteristics, real-world time to treatment discontinuation (rwTTD), and overall survival (OS) were analyzed for patients with normal organ function and those with organ dysfunction prior to ICI initiation. Patients with emergent dysfunction in the 90 days following ICI initiation were identified, and potentially associated characteristics were explored. Results Of 2,407 patients included, 1,884 and 1,717 had evaluable renal and hepatic laboratory values, respectively. Patients with baseline renal dysfunction (2.4%) were older and more frequently male, and less frequently treated with ICI combinations, than patients with normal renal function. Patients with baseline hepatic dysfunction (2.8%) were similar to patients with normal hepatic function regarding demographics and treatments received. Patients with baseline organ dysfunction displayed shorter rwTTD and OS. Among patients with normal baseline organ function, 4.6% and 7.4% developed renal and hepatic dysfunction within 90 days of ICI initiation, respectively; this was associated with combination ICI treatment. Conclusion Patients with advanced melanoma and baseline organ dysfunction frequently receive ICI treatment but have poorer clinical outcomes than patients with normal organ function. Among patients with normal renal and hepatic function at ICI initiation, emergent organ dysfunction rates in this real-world cohort are similar to those reported in clinical trials. Implications for Practice Real-world data provide an opportunity to understand treatment patterns, toxicity, and clinical outcomes among patients treated outside of clinical trials. This study confirms that patients with advanced melanoma and baseline renal or hepatic dysfunction are being treated with ICI therapy more frequently as monotherapy than in combination therapy. For those real-world patients with normal baseline organ function, emergent renal and hepatic dysfunction are both more common in patients treated with combination versus ICI monotherapy.

Funder

Health Research Board

Publisher

Oxford University Press (OUP)

Subject

Cancer Research,Oncology

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