Driving restrictions for blood cancer patients undergoing chimeric antigen receptor (CAR)-T cell therapy may need reconsideration, according to research presented by Rahul Banerjee, MD, FACP, of the University of Washington Fred Hutchinson Cancer Center, at the 66th ASH Annual Meeting and Exposition.
Current package inserts from the US Food and Drug Administration universally recommend blood cancer patients refrain from driving for eight weeks post-infusion, yet there is no clear evidence to justify these restrictions, the investigators wrote.
Dr. Banerjee and colleagues specifically highlighted CAR-T therapies used to treat multiple myeloma such as idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel).
Dr. Banerjee and colleagues analyzed data from 553 CAR-T recipients who had received either cilta-cel (n=224) or ide-cel (n=329) to assess the prevalence of side effects such as cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or other neurotoxicity during weeks five to eight post-therapy. The study found that after the fourth week, severe side effects were exceedingly rare: only one patient (0.2%) experienced grade 2 CRS, and no new cases of ICANS were reported beyond day 28.
Additionally, physician surveys revealed a significant shift in attitudes toward driving restrictions: while 73% supported restrictions during weeks zero to four, only 14% endorsed extending them to weeks five to eight.
Universal eight-week restrictions impose unnecessary burdens on patients and caregivers, particularly those in remote areas, the investigators noted.
“Narrowing universal driving restrictions to weeks 0-4 following CAR-T therapy would constitute an evidence-based modification to the package inserts for ide-cel and cilta-cel,” they wrote.
Limitations of the study include the absence of patient-reported data, which the authors intentionally omitted to avoid questioning patients about activities potentially undertaken against medical advice.
Reference
Banerjee R, Richards A, Khouri A. Post-CAR-T driving restrictions after week 4 appear unnecessary: data from the United States Myeloma Immunotherapy Consortium. Abstract #3765. Presented at the 66th American Society of Hematology Annual Meeting and Exposition; San Diego, California; December 7-10.
