by Melissa Rohman, Northwestern University

Credit: Pixabay/CC0 Public Domain

Patient-reported outcomes from individuals diagnosed with relapsed or refractory large B-cell lymphoma revealed that those who received axicabtagene ciloleucel (axi-cel) immunotherapy experienced higher quality of life than those who received standard care, according to findings published in Blood.

"This data demonstrates that axi-cel not only surpasses standard-of-care autologous stem cell transplantation in therapeutic effect, but also provides a meaningful advantage for patients in their journey to return to functional normalcy," said Reem Karmali, MD, MS, associate professor of Medicine in the Division of Hematology and Oncology and a co-author of the study.

Patients with large B-cell lymphoma—an aggressive type of non-Hodgkin's lymphoma that develops from B-cells in the lymphatic system—who relapse after or are unresponsive to first-line chemoimmunotherapy generally have poor outcomes.

Until recently, standard care for patients who qualified for second-line treatment included high-dose chemotherapy and autologous stem cell transplantation, a process in which healthy blood stem cells from the patient's own body replace damaged bone marrow. However, this combination approach is toxic and is only utilized in patients who have demonstrated a response to chemotherapy and are also free of additional comorbidities.

Still, less than half of patients who undergo stem cell transplantation are cured with this approach. Treatment success rates are even lower for patients who've relapsed within their first year of receiving first-line chemoimmunotherapy.

In the current study, the investigators compared patient-reported outcomes (PRO) from individuals diagnosed with relapsed or refractory large B-cell lymphoma who were enrolled in the phase 3 ZUMA-7 study for second-line treatment.

The ZUMA-7 study had previously demonstrated that patients who received axi-cel—a CD19-targeted CAR T-cell therapy—achieved longer event-free survival compared to patients who received autologous stem cell transplantation as a second-line therapy.

"As a result of ZUMA-7, axi-cel is now approved in the United States for large B-cell lymphoma that is refractory to or that relapses within 12 months of first-line therapy," said Karmali, who is also a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

As part of the study, PRO instruments were used to measure patients' quality of life, including questionnaires that aimed to understand the impact of the patient's disease and treatment on their overall function, symptoms, finances and general quality of life.

Comparative analysis of patient-reported outcomes revealed higher quality of life scores in the axi-cel group compared to the standard care group, with noticeable improvements in physical and social functioning after just three months.

Overall, this data is essential for providers when counseling patients about the benefits and side effects of CAR T-cell therapy, which can be overwhelming for patients deciding their next course of treatment, according to Karmali.

"We find that patients begin to question the reversibility of such symptoms and such reservations pose a barrier to proceeding with this effective therapy. Our findings now serve as a resource during this intake process and effectively provide reassurance," Karmali said.

According to Karmali, next steps will involve a multi-center trial, which will include Northwestern, and enroll front-line large B-cell lymphoma patients at an increased risk for being unresponsive to standard chemoimmunotherapy.  

"We feel that results of ZUMA-7 and the PROs set the benchmark for therapeutic effect and patient experience for clinical trials moving forward for relapsed/refractory large B-cell lymphoma," Karmali said.

More information: Mahmoud Elsawy et al, Patient-reported outcomes in ZUMA-7, a phase 3 study of axicabtagene ciloleucel in second-line large B-cell lymphoma, Blood (2022). DOI: 10.1182/blood.2022015478

Journal information: Blood 

Provided by Northwestern University