In a study reported in a research letter in JAMA Oncology, Storgard et al identified the risk of T-cell malignant neoplasms and any second primary malignant neoplasms in patients receiving chimeric antigen receptor (CAR) T-cell therapy for hematologic malignancies.
Study Details
The study used the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) postmarketing surveillance database to identify second primary malignant neoplasm reports for six commercially available CAR T-cell products between September 2017 and September 2023. Second primary malignant neoplasm reports from patients with hematologic malignant neoplasms who did not receive CAR T-cell therapy were used as a reference group.
Key Findings
Of a total of 8,964,773 adverse event reports in FAERS, 8,455 (0.1%) involved patients treated with CAR T-cell therapy. Among the 8,455 reports, 386 (4.6%) were second primary malignant neoplasms; most reported were myeloid neoplasms (n = 220, 57.0%) followed by solid tumors (n = 112, 29.0%), with T-cell malignant neoplasms accounting for 11 reports (2.8%). A disproportionate increase in second primary malignant neoplasm reporting was observed among patients with hematologic malignant neoplasms who were treated vs not treated with CAR T-cell therapy (reporting odds ratio [OR] = 2.63. 95% confidence interval [CI] = 2.34–2.95).
Among 11 T-cell malignant neoplasm reports after CAR T-cell therapy, large B-cell lymphoma was the most common indication for CAR T-cell therapy (n = 8, 72.7%). A disproportionate increase in T-cell malignant neoplasm reporting was observed among patients with hematologic malignant neoplasms who were treated vs not treated with CAR T-cell therapy (reporting OR = 3.03, 95% CI = 1.49–5.53). Death occurred in six of the T-cell malignant neoplasm cases.
The investigators stated: “As CAR [T-cell] therapies expand, characterizing their long-term adverse effects has become a priority. We found higher-than-expected reporting of second primary malignant neoplasms and T-cell malignant neoplasms after CAR [T-cell] therapy vs other treatments in patients with hematologic malignant neoplasms. Notably, second primary malignant neoplasms were predominantly of myeloid origin, whereas T-cell malignant neoplasms were rare.”
Roni Shouval, MD, PhD, of the Adult Bone Marrow Transplant and Cellular Therapy Service, Memorial Sloan Kettering Cancer Center, is the corresponding author of the JAMA Oncology article.
Disclosure: The study was supported by grants from the National Cancer Institute. For full disclosures of the study authors, visit jamanetwork.com.
