Patients with relapsed or refractory large B-cell lymphoma (LBCL) treated with the chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel (liso-cel) experience better quality of life (QoL) than those treated with standard of care (SOC), according to findings published in Blood Advances. The findings come from the phase III TRANSFORM study, which found superior efficacy for liso-cel compared to SOC, with better event-free survival, complete remission, and progression-free survival.
“Coupled with the superior efficacy results, these data further support the use of liso-cel as a potential new SOC for second-line treatment in patients with early relapsed or refractory LBCL,” according to researchers led by Jeremy Abramson, MD, associate professor of medicine at Harvard Medical School.
Patients in TRANSFORM were no older than 75, had an Eastern Cooperative Oncology Group performance status no higher than 1, and had confirmed LBCL. They either had refractory disease – stable disease, progressive disease, partial response, or complete response with relapse before three months – or relapsed disease within 12 months of initial therapy.
They were randomized to receive either liso-cel or SOC. Those receiving liso-cel underwent apheresis followed by lymphodepletion and subsequent liso-cel infusion. They also could have received bridging therapy for disease control during the manufacturing of liso-cel. The SOC group received up to three cycles of second-line therapy – one of three platinum-based regimens that was decided by the physician.
Those with a complete or partial response to second-line chemotherapy proceeded to high-dose chemotherapy and autologous hematopoietic cell transplant (AHCT).
Health-related QoL was gauged using the 30-item European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and the Functional Assessment of Cancer Therapy-Lymphoma subscale. These assessments were done at baseline and at days 29, 64, and 126 of the treatment period. These were meant to offer an insight into QoL before liso-cel treatment, after the treatment, and after AHCT. The assessments were also performed at six, nine, 12, 18, 24, and 36 months after treatment.
The QoL scales assess physical, emotional, cognitive, and social attributes, symptoms such as fatigue and nausea, financial difficulty, and global health status.
About half of the patients in the treatment arms, which included 92 patients each, completed the questionnaires and were eligible to be included in the QoL analysis.
Researchers found a higher proportion of patients with clinically meaningful improvement in the liso-cel arm compared to the SOC arm in global health and QoL, cognitive functioning, and fatigue, while a lower proportion of the liso-cel arm deteriorated. Results for pain scores trended toward improvement in the liso-cel arm and toward deterioration in the standard treatment arm. The other domains were generally similar between the two arms, researchers reported.
The liso-cel arm outperformed the standard treatment arm in time to deterioration in global health status and QoL, but there was a trend toward a greater risk of deterioration in emotional functioning in the liso-cel arm compared to the standard treatment arm, researchers found. For the other domains, the time to deterioration was generally similar.
The researchers noted that QoL was no longer assessed if treatment failed in either arm once patients received other treatment, which suggests that the QoL data for the SOC treatment arm are mainly for patients who responded and tolerated those treatments well.
“The study was designed to compare the entire sequence and burden of treatments in each study arm over time for the two treatment modalities, and the results demonstrate that the overall burden is lesser with liso-cel versus SOC,” they said. “Treatment with liso-cel . . . did not have a detrimental effect on most health-related QoL measures. In many domains, patients in the liso-cel arm reported more favorable health-related QoL results compared with those in the SOC arm.”
Any conflicts of interest declared by the authors can be found in the original article.
Reference
Abramson JS, Johnston PB, Kamdar M, et al. Health-related quality of life with lisocabtagene maraleucel vs standard of care in relapsed or refractory LBCL [published online, 2022 Sept 23]. Blood Adv. doi: 10.1182/bloodadvances.2022008106.
