Cytotherapy · 2026
Real-world outcomes of Axicabtagene Ciloleucel CAR-T therapy in large B-cell lymphoma: a single-center observational study.
СтатьяНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Alsuhaibani Khalid, Hejab Amal, Aljasser Maha, Elhassan Tusneem, Ahmed Syed Osman, Rasheed Walid, Alfayez Mansour, Alamer Abdullah, Alhayli Saud, Alshaibani Alfadel, Alahmari Ali, Haroon Alfadil, Hanbali Amr, Chaudhri Naeem A, Saad Ayman, Alotaibi Shaykhah, Alkhaldi Hanan, Alnughmush Ahmed, Alyamany Ruah, Shaheen Marwan, Alfraih Feras Abdulaziz, Alotaibi Ahmad S, Albanyan Omar, Samarkandi Hadeel, Syed Farhatullah, Alsharif Fahad, Almohareb Fahad, Alzahrani Hazza, Aljurf Mahmoud, El Fakih Riad, Albabtain Abdulwahab
Аннотация
BACKGROUND: Axicabtagene Ciloleucel (Axi-cel) has recently transformed the treatment landscape for relapsed or refractory large B-cell lymphoma (R/R LBCL). Despite promising results in pivotal trials like ZUMA-1 and ZUMA-7, there is limited data on its outcomes in the Middle East and North Africa (MENA) region.
METHODS: This observational study analyzed patients with R/R LBCL treated with Axi-cel at King Faisal Specialist Hospital and Research Center (KFSH and RC), Riyadh, Saudi Arabia, from February 2023 to November 2024. The primary endpoints were overall survival (OS) and progression-free survival. Secondary outcomes included response rates and toxicity.
RESULTS: A total of 77 patients were included. The median age was 53 years. Most patients presented with advanced-stage disease (75% Stage IV) and bone marrow involvement was observed in 34%. The best overall response rate was 78%, with a complete response (CR) rate of 49%. CR rates were comparable between second-line (48%) and third-line or beyond (50%) groups. Median OS was not reached for both the second-line and third-line or beyond, favoring the second-line in OS (hazards ratio [HR] = 2.98, P = 0.03). The estimated 12-month OS was 71.4% for the entire group and 86.2% for the second-line cohort, compared to 57% for the third-line and beyond cohort. The absence of bone marrow involvement (HR = 0.28, P = 0.008) and elevated lactate dehydrogenase (LDH) levels (HR = 2.69, P = 0.041) were significant risk factors on multivariate analysis for OS. The incidence of cytokine release syndrome was 94% (Grade ≥3 in 4%) and immune effector cell-associated neurotoxicity syndrome in 39% of patients (Grade ≥3 in 17%).
CONCLUSION: Real-world data from the MENA region on the safety and efficacy of Axi-cel in patients with R/R LBCL were comparable to those from the registrational ZUMA-1 and ZUMA-7 trials. Bone marrow involvement, elevated LDH and advanced disease emerged as adverse prognostic markers.
METHODS: This observational study analyzed patients with R/R LBCL treated with Axi-cel at King Faisal Specialist Hospital and Research Center (KFSH and RC), Riyadh, Saudi Arabia, from February 2023 to November 2024. The primary endpoints were overall survival (OS) and progression-free survival. Secondary outcomes included response rates and toxicity.
RESULTS: A total of 77 patients were included. The median age was 53 years. Most patients presented with advanced-stage disease (75% Stage IV) and bone marrow involvement was observed in 34%. The best overall response rate was 78%, with a complete response (CR) rate of 49%. CR rates were comparable between second-line (48%) and third-line or beyond (50%) groups. Median OS was not reached for both the second-line and third-line or beyond, favoring the second-line in OS (hazards ratio [HR] = 2.98, P = 0.03). The estimated 12-month OS was 71.4% for the entire group and 86.2% for the second-line cohort, compared to 57% for the third-line and beyond cohort. The absence of bone marrow involvement (HR = 0.28, P = 0.008) and elevated lactate dehydrogenase (LDH) levels (HR = 2.69, P = 0.041) were significant risk factors on multivariate analysis for OS. The incidence of cytokine release syndrome was 94% (Grade ≥3 in 4%) and immune effector cell-associated neurotoxicity syndrome in 39% of patients (Grade ≥3 in 17%).
CONCLUSION: Real-world data from the MENA region on the safety and efficacy of Axi-cel in patients with R/R LBCL were comparable to those from the registrational ZUMA-1 and ZUMA-7 trials. Bone marrow involvement, elevated LDH and advanced disease emerged as adverse prognostic markers.