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Cosmos Study

One in Twenty Diagnosed with Secondary Cancer One Year After CAR T-Cell Therapy

October 8, 2024
Dual-Team Study
Team A:Kersten Bartelt, RNJoe Deckert, PhD
Team B:Joel Jones, PharmDEmily Higgs

Key Findings

  • 5.2% of patients who have undergone CAR T-cell therapy develop secondary cancer within a year, including both metastatic cancers and second primary cancers, with small variations by medication. 
  • Skin, respiratory organ, and digestive organ cancers were the most common types of secondary cancer after CAR T-cell therapy. 

Chimeric antigen receptor (CAR) T-cell therapy is a type of immunotherapy that uses altered T cells to fight cancers such as lymphoma, leukemia, and multiple myeloma when other treatments have not been successful.1 In April 2024, the U.S. Food and Drug Administration (FDA) required a boxed warning for the risk of T-cell malignancies following CAR T-cell therapy and recommended lifelong monitoring for secondary cancers.2 However, others have reported that secondary cancers after CAR T-cell therapy are rare.3,4 

To understand the rate of secondary cancer among patients who received CAR T-cell therapy, we studied 3,296 patients treated with CAR T-cell therapy between January 1, 2017, and August 1, 2023. Secondary cancers included both metastatic cancers and second primary cancers. Overall, we found that 5.2% of treated patients had a new cancer diagnoses three weeks to one year after the start of CAR T-cell therapy, as seen in Figure 1. When we stratified the data by the specific CAR T-cell therapy, we found small variations in the rate of secondary cancer, though no specific treatment was significantly different from the overall rate. 

Figure 1
Secondary Cancer Rates After CAR T-Cell Therapy by Type
Secondary Cancer Rates After CAR T-Cell Therapy by Type
Figure 1. The rates of secondary cancer after CAR T-cell therapy by the type of therapy used.

Skin, respiratory organ, and digestive organ cancers were the most diagnosed types of secondary cancers for patients who had received CAR T-cell therapy, as seen in Figure 2. 

Figure 2
Secondary Cancer Rate by Type After CAR T-Cell Therapy
Secondary Cancer Rate by Type After CAR T-Cell Therapy
Figure 2. The rate of secondary cancers by type after CAR T-cell therapy.

These data come from Cosmos, a dataset created in collaboration with a community of Epic health systems representing more than 274 million patient records from 1,500 hospitals and more than 36,000 clinics from all 50 states, Lebanon, and Saudi Arabia. This study was completed by two teams that worked independently, each composed of a clinician and research scientists. The two teams came to similar conclusions. Graphics by Brian Olson. 

References

  1. CAR T-cell therapy and its side effects. American Cancer Society. Published March 1, 2022. https://www.cancer.org/cancer/managing-cancer/treatment-types/immunotherapy/car-t-cell1.html. Accessed August 28, 2024. 
  2. FDA Requires Boxed Warning for T cell Malignancies Following Treatment with BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies. U.S. Food & Drug Administration. Published April 18, 2024. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-requires-boxed-warning-t-cell-malignancies-following-treatment-bcma-directed-or-cd19-directed. Accessed August 28, 2024. 
  3. Conger K. Risk of secondary cancers after CAR-T cell therapy low, according to large Stanford Medicine study. Stanford Medicine. Published June 12, 2024. https://med.stanford.edu/news/all-news/2024/06/car-t-secondary-cancer.html. Accessed August 28, 2024. 
  4. Raeke M. Secondary cancers following CAR T cell therapy are rare. Penn Medicine. Published January 24, 2024. https://www.pennmedicine.org/news/news-releases/2024/january/secondary-cancers-following-car-t-cell-therapy-are-rare. Accessed August 28, 2024.