Abstract 1582P
Background
Immune checkpoint inhibitors (ICIs) are integral to the treatment of many cancers, often leading to improved survival outcomes and durable response. Immune-related adverse events (irAEs) differ in presentation and management from adverse events associated with other cancer therapies. This study describes the characteristics and management of irAEs in the community setting.
Methods
This retrospective cohort study used electronic health record data from 2 community health systems (30+ hospitals, 500+ sites) from the Syapse Learning Health Network. Patients (pts) first exposed to ICIs between 1/1/2015 and 2/28/2019 were included with data cutoff of 3/1/2020. Pts with irAEs were identified using a 2-step screening process with a target cohort of ∼400 pts. Step 1: Technology-enabled screening using medication names, ICD codes, ER/hospitalization records and abnormal clinical labs. Step 2: Chart review by certified tumor registrars to confirm and characterize irAEs (attribution, severity, management and outcomes), with adjudication by a medical oncologist.
Results
1382 pts were reviewed from a pool of 2129 pts with suspected irAEs, resulting in a cohort of 403 pts with irAEs. Lung cancer (60%) and melanoma (16%) were the most common histologies. The median time to irAE onset was 77 days. 91 pts (23%) had an ER/hospitalization visit due to irAE, with 43% of visits due to gastrointestinal irAE. irAE-related deaths occurred in 7 pts (1.7% of irAE cases). Systemic steroid use was documented in 236 pts (59%; duration of use 31 days).) Pts treated with steroids ≤24 hours of irAE onset had a higher resolution proportion at 3 months (0.7; 95% CI 0.6-0.8) than pts treated >72 hours (0.5; 95% CI 0.5-0.6). Of 78 pts with irAE related treatment discontinuation who were retreated with ICIs, half developed irAE recurrence. Table: 1582P
| ICI Monotherapy (N = 328) | ICI + Chemotherapy (N = 29) | ICI + ICI (N = 46) | All (N = 403) | |
| ICI initiation to irAE onset, days, median (IQR) | 84 (41-170) | 99 (13-140) | 24 (11-60) | 77 (33-150) |
| Most common irAEs | ||||
| Endocrine | 115 (35%) | 6 (21%) | 16 (35%) | 137 (34%) |
| Dermatologic | 77 (23%) | 7 (24%) | 21 (46%) | 105 (26%) |
| GI | 81 (25%) | 11 (38%) | 25 (54%) | 117 (29%) |
| Pulmonary | 45 (14%) | 3 (10%) | 1 (2%) | 49 (12%) |
| ER/hospitalization | 68 (21%) | 10 (34%) | 13 (28%) | 91 (23%) |
| Most common irAEs (ER/hospitalization patients) | ||||
| GI | 27 (40%) | 4 (40%) | 8 (62%) | 39 (43%) |
| Pulmonary | 23 (34%) | 2 (20%) | 0 (0%) | 25 (27%) |
| Treated with steroids | 188 (57%) | 16 (55%) | 32 (70%) | 236 (59%) |
| Retreated with ICI | 62 (19%) | 2 (7%) | 14 (30%) | 78 (19%) |
| Death (among patients with irAE) | 6 (2%) | 0 (0%) | 1 (2%) | 7 (2%) |
Conclusions
Pts with prompt recognition and management of irAEs experienced superior irAE resolution in a community setting.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Bristol Myers Squibb.
Funding
Bristol Myers Squibb.
Disclosure
D.B. Johnson: Financial Interests, Personal: Bristol-Myers Squibb. D. Bruno: Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, Novartis, Tempus, Eli Lilly, Mirati Therapeutics, Daiichi Sankyo; Financial Interests, Institutional, Funding: AstraZeneca; Non-Financial Interests, Principal Investigator: Eli Lilly. M. Rioth: Financial Interests, Personal, Full or part-time Employment: Syapse; Financial Interests, Personal, Stocks/Shares: Syapse. C. Zhang: Financial Interests, Personal, Full or part-time Employment: Syapse; Financial Interests, Personal, Stocks/Shares: Syapse. J. Palaia: Financial Interests, Personal, Full or part-time Employment, Employee at BMS: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares, own BMS stocks: Bristol Myers Squibb. R. Pisupati: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. C. Bond: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. L.C. Rosenblatt: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. R.G. Broome: Financial Interests, Personal, Employee: Syapse; Financial Interests, Personal, Stocks/Shares: Syapse. H. Kluger: Financial Interests, Personal: Bristol-Myers Squibb. All other authors have declared no conflicts of interest.