Real-world data from patient-reported outcomes (PRO) suggest that axicabtagene ciloleucel (axi-cel; Yescarta) is associated with a temporary worsening of quality of life (QOL) with statistically and clinically significant improvements within 1 year after infusion, according to findings presented in a poster presented at the ASH 2022 Annual Meeting.1
To collect data on quality of life and symptoms, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30A) was used. Questionnaires were completed at baseline before conditioning therapy before axi-cel and at follow-up 14, 30, 60, 90, 180, and 360 days after infusion. EORTC data were available for patients at the following time points: baseline (n=53), day 14 (n=37), day 30 (n=41), day 60 (n=39), day 90 (n=39). = 39), day 180 (n = 29), and day 360 (n = 18).
The investigators reported that 1 year after axi-cel infusion, global health scores improved among patients 50 to 70 years of age compared to general population norms. At baseline, these scores were matched. Additionally, physical functioning, role functioning, and social functioning were initially reported to be below normal for cancer patients and returned or improved from baseline at day 360.1
Of note, emotional functioning was better than the general population at baseline, but worsened from day 30 to day 180. However, improvements were observed over time, exceeding general population norms by day 360 after The infussion.
Regarding symptomatology, the investigators reported that adverse effects, including fatigue, insomnia, loss of appetite, and constipation, improved significantly from baseline to day 360. Improvements were also seen in pain and financial problems; however, by day 180 these effects worsened.1
“Real-world data suggest that axi-cel is associated with a transient worsening of QoL and symptoms at day 14, with subsequent significant improvements in overall QoL and several functional and symptom domains in the year post-treatment.” “, the study’s lead author, Heather SL Jim, PhD, said in a presentation of the data. “Notably, 1 year after treatment, participants reported an overall QoL comparable to the general population.”
“There are limited data regarding the PROs of [chimeric antigen receptor] CAR T-cell therapies without published longitudinal studies to the best of our knowledge of patients treated as standard of care,” added Jim, who is co-leader of the Health Behavior and Outcomes Program at the H. Lee Moffitt Cancer Center and Research Institute. in Tampa, Florida. “The aim of the current study was to report actual changes in quality of life and symptoms during the first year after axi-cel treatment.”
“Higher scores on the QOL subscales indicate better QOL, and higher scores on the symptom items indicate more symptomatology,” Lim explained. Clinically significant change was defined as a 10-point difference and scores were compared with normative data from the general population and patients with advanced cancer.two
The analysis included 53 patients with a mean age of 63.23 years (SD, 12.76). Most of the patients were white (94%) and 20 were women. Eligible patients were English-speaking adults who were scheduled to receive axi-cel as standard of care at Moffit Cancer Center for FDA-approved indications. Most patients had diffuse large B-cell lymphoma (n = 36), transformed follicular lymphoma (n = 7), or follicular lymphoma (n = 7). Patients had no documented or observable psychiatric or neurological diagnoses that would interfere with study participation and were able to give informed consent.1
“Participants were identified through clinical programs and tumor boards in consultation with the treating oncologist who were recruited between March 2020 and June 2022,” Lim added.
As a point of comparison with previously published data from the Phase 1/2 ZUMA-1 study (NCT02348216), the investigators noted that 64% of patients would have been eligible for trial enrollment.3
Jim concluded by noting that data collected at later times may have been influenced by subsequent treatments or other health conditions for some patients.
References
- Lim HASL, Hoogland AI, Logue JM, et al. Real-world patient-reported results among recipients of axicabtagene ciloleucel for relapsed/refractory large B-cell lymphoma. Blood. 2022;140 (Supplement 1):5190-5191. doi:10.1182/blood-2022-162337
- Quinten C, Coens C, Ghislain I, et al; RESEARCH; EORTC Clinical Groups. The effects of age on health-related quality of life in cancer populations: a pooled analysis of randomized controlled trials using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 with 6024 cancer patients. Eur J Cancer. 2015;51(18):2808-2819. doi:10.1016/j.ejca.2015.08.027
- Locke FL, Neelapu SS, Bartlett NL, et al. ZUMA-1 Phase 1 Results: A Multicenter Study of KTE-C19 Anti-CD19 CAR T Cell Therapy in Refractory Aggressive Lymphoma. molether. 2017;25(1):285-295. doi:10.1016/j.ymthe.2016.10.020
