In a dialog with CancerNetwork®, Nausheen Ahmed, MD, spoke about optimizing monitoring methods for sufferers with B-cell non-Hodgkin lymphoma who endure therapy with CAR T-cell remedy.
Ahmed, an affiliate professor within the Division of Hematologic Malignancies and Mobile Therapeutics on the College of Kansas Medical Heart, mentioned the potential of providing extra versatile monitoring durations for sufferers within the context of findings from a real-world examine revealed in Blood Advances.1 Knowledge from her examine confirmed that the incidence of recent onset cytokine launch syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) was uncommon at greater than 2 weeks following CAR T-cell remedy infusion. Moreover, late non-relapse mortality typically resulted from infectious issues.
The FDA carried out a Danger Analysis and Mitigation Technique (REMS) to assist handle the danger of extreme CRS and ICANS by requiring sufferers to reside inside 2 hours of a certified therapy heart for 4 weeks following CAR T-cell remedy infusion.2 In keeping with the examine authors, this mitigation technique might create vital limitations to CAR T-cell remedy entry amongst sure sufferers and caregivers who have to relocate as a part of a therapy plan.
Findings from Ahmed’s examine supported the event of individualized monitoring methods relying on the soundness of the affected person. She and her coauthors proposed a 2-week monitoring interval for sufferers whereas permitting for an elective enhance to 4 weeks based mostly on elements resembling doctor consolation and availability of local people oncology help. As Ahmed emphasised in the course of the dialogue, having flexibility in these monitoring durations might assist mitigate monetary and geographic obstacles stopping satisfactory entry to CAR T-cell remedy amongst sufferers.
“There needs to be extra of a hybrid mannequin of care. There needs to be extra involvement of our referring medical doctors or neighborhood medical doctors in detecting and managing these infections or working with the specialised heart as a way to bypass the [emergency room] and different methods to assist these sufferers,” Ahmed mentioned. “If there’s sufficient information to say that the sufferers don’t want further restrictions past 2 weeks, which is what our research present, then reconsidering the necessities can be one step in direction of lowering disparities in entry.”
References
- Ahmed N, Wesson W, Lutfi F, et al. Optimizing the post-CAR T monitoring interval in recipients of axicabtagene ciloleucel, tisagenlecleucel, and lisocabtagene maraleucel. Blood Advances. Revealed on-line July 24, 2024. doi:10.1182/bloodadvances.2023012549
- Danger Analysis and Mitigation Methods (REMS) for autologous chimeric antigen receptor (CAR) T cell immunotherapies modified to attenuate burden on healthcare supply system. FDA. June 26, 2024. Accessed July 23, 2024. https://tinyurl.com/2m284rjy
