Second Primary Malignancies Represent Small Proportion of Adverse Events After CAR T-Cell Therapy
By Elana Gotkine HealthDay Reporter
WEDNESDAY, March 20, 2024 -- Second primary malignancies (SPMs) represent a small proportion of adverse events (AEs) reported by patients receiving chimeric antigen receptor T-cell (CAR T-cell) therapy, according to a letter to the editor published online March 14 in Blood.
Noting that CAR T-cell-eligible patients are often heavily pretreated and have a higher risk for treatment-related AEs, Magdi Elsallab, M.D., Ph.D., from Harvard Medical School in Boston, and colleagues analyzed the U.S. Food and Drug Administration AE Reporting System database to quantify reports of SPMs after CAR T-cell therapy.
The researchers identified 12,394 unique reports of CAR T-cell therapy AEs; 2,225 of these were associated with the System Organ Class "Neoplasms benign, malignant, and unspecified." Overall, 536 SPM reports (4.3 percent) were included after application of exclusion criteria. Most of the reports included axicabtagene ciloleucel and tisagenlecleucel (51.7 and 33.0 percent, respectively). By high-level group term, the most frequent SPMs were leukemias (62.1 percent), which represented 2.7 percent of all CAR T-cell therapy reports, followed by skin neoplasms (10.1 percent). Leukemias included myelodysplastic syndromes, acute myeloid leukemias, and T-cell large granular lymphocytic leukemia (208, 106, two cases, respectively).
"We will continue to monitor the data released by the FDA to learn more about CAR T-associated risks," Elsallab said in a statement. "However, it's crucial to stress that the benefits of CAR T-cell therapies still outweigh the risks for the approved indications."
Several authors disclosed ties to the pharmaceutical industry.
Abstract/Full Text (subscription or payment may be required)
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
![](/img/logo/vendor/healthday-logo.png)
© 2024 HealthDay. All rights reserved.
Posted March 2024
Read this next
Vaginal Cancer Incidence Increasing Globally
WEDNESDAY, July 3, 2024 -- The incidence of vaginal cancer is increasing globally, according to a study published online June 25 in BJOG: An International Journal of Obstetrics...
Nudging Both Clinicians, Patients May Increase Serious Illness Conversations
TUESDAY, July 2, 2024 -- Combining clinician- and patient-directed nudges may help to promote serious illness conversations (SICs) in cancer care, according to a study published...
Perioperative Chemo Improves Progression-Free Survival in Pancreatic Cancer
TUESDAY, July 2, 2024 -- For patients with resectable pancreatic ductal adenocarcinoma (PDAC), the 12-month progression-free survival (PFS) may be increased with neoadjuvant...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.