Accès ouvert déclaré 2025 article

Post-CAR-T Driving Restrictions Appear Unnecessary after Week 4: Data from the US Multiple Myeloma Immunotherapy Consortium

Rahul Banerjee, Alicia C. Richards, Jack Khouri, Murali Janakiram, Kara I. Cicero, Danai Dima, Mehmet Hakan Kocoglu, Leyla Osman Shune, Jenny Bhurtel, Tania Jain, Aimaz Afrough, Saurabh Zanwar, Christopher James Ferreri, Oren Pasvolsky, Lekha Mikkilineni, Sneha Purvey, Lauren Cole Peres, Ciara Louise L. Freeman, Shonali Midha, Prof. Amer Beitinjaneh, James A. Davis, Charlotte Burton Wagner, Megan M. Herr, Peter A. Forsberg, Douglas Weston Sborov, Shambavi Richard, Ran Reshef, Binod Dhakal, Veronika Bachanová, Joseph P. McGuirk, Peter Michael Voorhees, Larry D. Anderson Jr., Yi Lin, Thomas G Martin, Surbhi Sidana, Krina K. Patel, Doris K. Hansen, Andrew J. Cowan, Gurbakhash Kaur

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Introduction The FDA package inserts for both idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel) in multiple myeloma (MM) state that patients should universally refrain from driving for 8 weeks following infusion. However, both ide-cel and cilta-cel use 41BB costimulatory domains with a lower risk of adverse events (AE) such as seizures . Because patients typically return to their referring oncologists after Day (D) +28, an additional month of driving restrictions can impose significant burdens and potentially even affect the choice of MM therapy for patients in remote areas. Objectives To understand the risk of driving impairments following CAR-T therapy using patient data and expert opinion. Methods We conducted a two-part study within the US MM Immunotherapy Consortium. Firstly, we analyzed data from commercial CAR-T recipients (pheresis cutoff December 31, 2023) to identify the onset of CRS, ICANS, movement / neurocognitive toxicities (MNT), or any fatal AE between Weeks 5-8 (D+29 to D+56) following CAR-T. Patients with index hospital stays > 4 weeks were excluded given the low likelihood of these patients driving immediately after discharge. Secondly, we surveyed CAR-T-prescribing physicians within the Consortium about impaired driving risk and driving restrictions. Results Of 552 analyzed patients, 40.4% (n=223) had received cilta-cel and 59.6% (n=329) ide-cel with median age 64 (IQR 58-70) and 11.4% (n=63) with ECOG PS ≥2 at infusion. As shown in Table 1 , the development of new AEs during Weeks 5-8 was rare: CRS 0.2% (n=1), ICANS 0.4% (n=2), MNT 0.7% (n=4, all non-Parkinsonian), and any fatal AE 0.4% (n=2, both due to sepsis). Overall, 98.7% of patients (n=545) had no new toxicities during Weeks 5-8. The survey was completed by 47 CAR-T-prescribing physicians (74% response rate). As shown in Table 2 , while 19% (n=9) felt that impaired driving risk was never present during Weeks 1-4, 49% felt so for Weeks 5-8. Conversely, while 43% (n=20) strongly agreed with the rationale for driving restrictions during Weeks 1-4, 2% (n=1) strongly agreed during Weeks 5-8. Differences in response distributions (Weeks 1-4 vs 5-8) were statistically significant (p<0.01) for both questions. Conclusion Our two-part study demonstrates that driving restrictions following Week 4 after CAR-T therapy in MM may not be required. Only 1.3% of CAR-T recipients developed CRS, ICANS, MNT, or fatal AEs during Weeks 5-8. Not all such toxicities would necessarily impair driving, and decisions could likely be made on a case-by-case basis. These findings complement other studies (Wesson, Dima, et al, TCT 2024; Ahmed et al, Blood Advances 2024) reporting the rarity of AEs after the first month of CAR-T therapy. Narrowing universal driving restrictions to Weeks 1-4 following CAR-T therapy in MM would thus constitute an evidence-based modification to the package inserts for ide-cel and cilta-cel.

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DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.

Titre Crossref: Post-CAR-T Driving Restrictions Appear Unnecessary after Week 4: Data from the US Multiple Myeloma Immunotherapy Consortium
Date Crossref: 01/02/2025
Éditeur: Elsevier BV
Type: journal-article

Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.

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Fred Hutch Cancer Center pays non établi dans la notice
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Moffitt Cancer Center pays non établi dans la notice
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Cleveland Clinic pays non établi dans la notice
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City of Hope pays non établi dans la notice
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University of Maryland Department of Internal Medicine pays non établi dans la notice
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U-M Rogel Cancer Center pays non établi dans la notice
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University of Kansas Medical Center pays non établi dans la notice
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Johns Hopkins University pays non établi dans la notice
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Southwestern Medical Center pays non établi dans la notice
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The University of Texas Southwestern Medical Center pays non établi dans la notice
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Mayo Clinic in Arizona pays non établi dans la notice
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Levine Cancer Institute Hematologic Oncology and Blood Disorders pays non établi dans la notice
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Fred Hutch Cancer Center, Moffitt Cancer Center et Cleveland Clinic, avec 9 autres affiliations.

Une affiliation ne permet pas de déduire la nationalité d’un auteur.

Les sujets associés

CAR-T cell therapy researchCancer Immunotherapy and BiomarkersLymphoma Diagnosis and Treatment

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