Functional status and treatment-related toxicities in cancer patients treated with immune checkpoint inhibitors

Authors: Zhang D, Braithwaite D, Shah N,.Atkins BM

Category: Survivorship & Health Outcomes/Comparative Effectiveness Research
Conference Year: 2020

Abstract Body:
Purpose: To describe toxicities induced by immune checkpoint inhibitors (ICIs) and explore their association with functional status at treatment initiation via a cross-sectional analysis. Methods: The Georgetown MedStar immune-oncology (I-O) dataset, which was derived based on 10 DC-Baltimore based MedStar Health network hospitals, was used for analysis. A centralized research data warehouse was developed for this dataset. Demographic data, lifestyle factors, comorbidity, ICI use, toxicities, and functional status were extracted from medical records, labs, pathology, radiology, and Cancer Registry data. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at ICI initiation was treated as an ordinal variable to reflect functional status (0, 1, and ≥2). We descriptively summarized demographic, health-related factors, and ECOG PS by toxicities. A multivariable logistic regression adjusting for age, race, gender, obesity, smoking status, number of comorbidities, steroid hormone usage, lines of therapy, metastasis, ICI type, ICI dose, and cancer type was used to investigate association between ECOG PS at ICI initiation and prevalence of having 1 or more toxicities. Results: A total of 684 stage III or IV cancer patients were included for analysis (lung: 269, melanoma: 204, other: 211). The mean age was 64.1 years (16-99, SD: 13.5) and over half were male (N=394, 57.6%). A total of 424 patients (62.0%) were white, 182 (26.6%) were black, and 78 (11.4%) were categorized as “other” race/ethnicity. The ECOG PS at ICI initiation suggested most patients had impaired functional status (0: 189, 1: 348, ≥2: 147). A total of 288 (42.1%) patients developed toxicities after ICI treatment. Common toxicities included colitis (N=69, 10.1%), hepatitis (N=67, 9.8%), and skin rash (N=112, 16.4%). People with worse ECOG PS tended to have a lower rate of toxicities (0: 60.3%, 1: 41.7%, ≥2: 19.7%). The multivariable logistic regression yielded consistent results (aOR (ECOG PS ≥2 vs. 0)=0.35, 95% CI=0.19-0.63; aOR (ECOG PS =1 vs. 0)=0.75, 95% CI=0.49-1.16). Conclusions: Our results suggest that in cancer patients receiving ICI therapy in the real world setting, the likelihood of toxicities appears to be higher in patients with better functional status.

Keywords: immunotherapy; functional status; treatment toxicities; epidemiology