Incidence of venous thromboembolism with immune checkpoint inhibitors in a community setting: A single-center retrospective study.

Authors

null

Madhan Srinivasan Kumar

Saint Vincent Hospital, Worcester, MA

Madhan Srinivasan Kumar , Vidit Majmundar , Sumukh Arun Kumar , Chidambaram Ramasamy , Kala Seetharaman

Organizations

Saint Vincent Hospital, Worcester, MA, Saint Vincent Cancer and Wellness Center, Worcester, MA

Research Funding

No funding received
None.

Background: Immune activation and inflammation caused by immune checkpoint inhibitors (ICIs) are critical pathobiological drivers for venous thromboembolism (VTE). There is a paucity of data about VTE risk in cancer patients receiving ICI. We aimed to describe the incidence of VTE in cancer patients receiving ICI in a community setting. Methods: We conducted a single center, retrospective cohort study at Saint Vincent Hospital. The study cohort was created using our center's pharmacy database of patients who received any of the five ICIs (ipilimumab, nivolumab, pembrolizumab, atezolizumab, or durvalumab) between Jan 2017 and Dec 2022. VTE events including deep venous thrombosis, splanchnic vein thrombosis, and pulmonary embolism, were identified by chart review. We used a self-controlled risk-interval design, with "control period" and "at-risk period" being 6 months before and after the initiation of ICI treatment respectively. VTE events were also analyzed for subgroups: Single-agent ICI therapy (IA), Dual ICI therapy (IB), and ICI + chemotherapy (IC). Descriptive statistics and cox regression were used for statistical analysis. Results: Study population included 170 patients, with 75, 14, and 81 patients in subgroups IA, IB, and IC respectively. The mean age of the patients was 69.51 ± 10.05 years with a majority being males (62.4%). The most common cancer observed was non-small cell lung cancer (43.5%) followed by small cell lung cancer (6.9%), and malignant melanoma (5.7%). Pembrolizumab (55.3%) was the most common ICI used and nivolumab + ipilimumab (7.64%) was the most common dual ICI used. We noted a 1.25-fold higher incidence of VTE post-ICI use (Incidence rate ratio [IRR]: 11.76 per 100 person-year) compared to pre-ICI use (IRR: 9.41 per 100 person-year) at 6 months. On subgroup analysis, Group IB had the highest risk for VTE at 6 months (IRR: 28.57 per 100 person-year), followed by group IC and IA (IRR: 14.12 and 8.0 per 100 person-year respectively). IRR decreased to 6.62 per 100 person-year at 12-month interval indicating increased VTE risk in the first 6 months of ICI exposure. Type of ICI, adjuvant chemotherapy or type of cancer was not able to predict VTE risk on multivariate analysis. Conclusions: ICI treatment was associated with an increased incidence of VTE in our study cohort with the highest risk among patients on dual ICI followed by ICI + chemotherapy and ICI monotherapy. Future prospective studies are needed to identify risk factors and biomarkers to improve risk stratification and risk-adapted thromboprophylaxis.

VTE - IRR expressed per 100 person-years and hazard ratio (HR).

All PatientsSub Group IASub Group IBSub Group IC
6 months pre-ICI (IRR)9.418.014.2811.29
6 months post-ICI (IRR)11.768.0 28.5714.12
6 months (HR)1.251.02.01.25
12 months pre-ICI (IRR)4.634.475.04.88
12 months post-ICI (IRR)6.627.4610.06.49
12 months (HR)1.431.672.01.33

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2023 ASCO Annual Meeting

Session Type

Publication Only

Session Title

Publication Only: Developmental Therapeutics—Immunotherapy

Track

Developmental Therapeutics—Immunotherapy

Sub Track

Other Checkpoint Inhibitors (Non-PD1/PDL1, Monotherapy, or Combination)

Citation

J Clin Oncol 41, 2023 (suppl 16; abstr e14681)

DOI

10.1200/JCO.2023.41.16_suppl.e14681

Abstract #

e14681

Abstract Disclosures