Toxicity monitoring periods could be halved for patients who receive CAR-T therapy for diffuse large B-cell lymphoma (DLBCL), according to a new study.
The treatment is associated with two serious side-effects, cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Now, researchers report in Blood Advances that incidents of toxicity are “extremely rare” after two weeks.
US guidance requires that patients stay within a two-hour distance of their treatment centre for four weeks, and recommend patients do not drive for eight weeks. Treatment centres often implement stricter rules, ensuring that patients stay with a specified carer, and within an hour’s distance of the centre.
This can cause problems for patients and could create a barrier to accessing CAR-T cell therapy, according to study leader Dr Nausheen Ahmed, medical director of the bone marrow transplant survivorship programme at the University of Kansas, USA.
Dr Ahmed obtained data from nine treatment centres and analysed outcomes for 475 patients. Most of the patients – just under 70% – received CAR-T as a third line therapy.
Within seven days of CAR-T cell infusion, 57% of patients experienced CRS while 25% experienced ICANS. Within the next seven days, incidence reduced to 5.4% of patients suffering CRS for the first time and 9.3% suffering ICANS for the first time. After two weeks post-infusion, just one patient suffered ICANS for the first time.
Dr Ahmed reports that infection was the most serious threat to patients. Two patients died from infection within 28 days while five patients died from infection after 28 days.
She said: “We are learning that infection may be driving a lot of the non-relapse mortality and toxicity within the first few months after CAR-T infusion, so we have to shift our focus to preventing and managing infections after those two weeks.
“Instead of the authorised treatment centre trying to keep the patient locally for a long time, we could collaborate with and train community haematologists/oncologists and referring physicians to identify, initiate treatment for, and collaborate with the treatment centre to manage infections and other less common side effects.”
Source:
Ahmed N, Wesson W, Lutfi F, Porter DL, Bachanova V, Nastoupil LJ, Perales MA, Maziarz RT, Brower J, Shah GL, Chen AI, Oluwole OO, Schuster SJ, Bishop MR, McGuirk JP, Riedell PA. (2024) “Optimizing the Post-CAR T Monitoring Period for Axicabtagene Ciloleucel, Tisagenlecleucel, and Lisocabtagene Maraleucel.” Blood Advances, 23 July 2024, doi: 10.1182/bloodadvances.2023012549.
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