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Axicabtagen Ciloleucel (Axi-cel) is approved in Europe for the treatment of relapsed and refractory large B-cell lymphoma (R/R LBCL), primary mediastinal B-cell lymphoma (PMBCL) and transforming follicular lymphoma ( tFL) adult patients.
M.
Kwon et al.
analyzed the results of a real-world study on the use of Axi-cel in patients treated in Spain.
The results were announced at the 47th Annual Meeting of the European Association of Blood and Marrow Transplantation (EBMT 2021) in 2021.
The editor organizes the main content as follows for readers.
Research Method The study retrospectively collected data from patients who underwent continuous hemodialysis for Axi-cel treatment from February 2019 to November 2020.
The cytokine release syndrome (CRS) and immune effector cell-related neurotoxic syndrome (ICANS) were graded according to the ASTCT consensus standard, and the remission was assessed according to the Lugano standard.
The results of the study were 106 patients with R/R lymphoma who underwent apheresis.
At the time of the data cutoff, 92 patients (87%) had received the infusion.
Reasons for non-infusion include: progression-related death (12 cases, 86%), tumor lysis syndrome (1 case, 7%), and complete remission after bridging therapy (CR; 1 case, 7%).
It is worth noting that 14 patients received pretreatment chemotherapy and infusion during the peak period of the COVID-19 epidemic in Spain (March to April 2020).
The median time from approval to infusion was 54 days.
Diffuse large B-cell lymphoma (DLBCL) patients accounted for 74%, tFL patients accounted for 11%, and PMBCL patients accounted for 15%.
All patients underwent lymphocyte depletion.
At the time of lymphocyte depletion, the disease status was Progression (PD) accounting for 69%, stable disease (SD) accounting for 22%, and partial remission (PR) accounting for 9%.
The median time from leukocyte separation to the start of lymphocyte clearance was 34 days.
The median time from leukocyte separation to infusion was 39 days.
The median length of hospital stay was 21 days.
86% of patients had any grade of CRS (18% was grade 2 and 6.
5% was grade 3-4).
Among them, 58% of CRS patients used tocilizumab and 19% of patients used corticosteroids.
42.
5% of patients developed ICANS (10% were grade 2 and 15% were grade 3-4).
The treatment of ICANS included corticosteroids (78%), tocilizumab (31%), Siltuximab (15%) and Anakinra (twenty one%).
Twenty patients (22%) entered the ICU.
Four patients died from ICANS, one died from CRS, and one died from infection.
Among the 80 patients who could be assessed and rescheduled on day 30, the ORR was 78% (CR: 40%, PR: 38%, PD: 11%, SD or uncertain: 11%).
Of the 58 patients who could be evaluated on day 100, 66% had sustained remission (CR: 48%, PR: 18%).
Of the 23 patients who could be evaluated on day 180, 65% had CR.
Of the 39 patients with PR/SD on day 30, 9 (23%) converted to CR.
After a median follow-up of 6.
3 months, the event-free survival (EFS) rate and overall survival (OS) rate of the infusion population were 55.
5% and 78%, respectively, and the estimated median EFS and OS were 13.
1 months and 7.
3 months, respectively .
In the intention-to-treat analysis of all patients undergoing apheresis, the estimated median OS and EFS were 12.
3 months (95% CI: 8.
9-15.
7) and 6.
6 months (95% CI: 4.
6-8.
5), respectively. Research conclusions This Spanish multi-center retrospective analysis showed that in the real world, patients with relapsed and refractory aggressive B-cell lymphoma have received encouraging results from Axi-cel treatment.
The incidence of major toxic events was lower than that reported in key trials, but toxicity-related deaths occurred.
During the limited follow-up time, the relief was good.
Reference source: M.
Kwon, R.
Bailen, L.
Lopez Corral, et al.
REAL WORLD OF EXPERIENCE AXICABTAGENE CILOLEUCEL FOR THE TREATMENT OF RELAPSED OR REFRACTORY LARGE B-CELL LYMPHOMA IN SPAIN.
The 47th Annual Meeting of the EBMT.
Abstract OS3 -4.
Poke "read the original text", we will make progress together
M.
Kwon et al.
analyzed the results of a real-world study on the use of Axi-cel in patients treated in Spain.
The results were announced at the 47th Annual Meeting of the European Association of Blood and Marrow Transplantation (EBMT 2021) in 2021.
The editor organizes the main content as follows for readers.
Research Method The study retrospectively collected data from patients who underwent continuous hemodialysis for Axi-cel treatment from February 2019 to November 2020.
The cytokine release syndrome (CRS) and immune effector cell-related neurotoxic syndrome (ICANS) were graded according to the ASTCT consensus standard, and the remission was assessed according to the Lugano standard.
The results of the study were 106 patients with R/R lymphoma who underwent apheresis.
At the time of the data cutoff, 92 patients (87%) had received the infusion.
Reasons for non-infusion include: progression-related death (12 cases, 86%), tumor lysis syndrome (1 case, 7%), and complete remission after bridging therapy (CR; 1 case, 7%).
It is worth noting that 14 patients received pretreatment chemotherapy and infusion during the peak period of the COVID-19 epidemic in Spain (March to April 2020).
The median time from approval to infusion was 54 days.
Diffuse large B-cell lymphoma (DLBCL) patients accounted for 74%, tFL patients accounted for 11%, and PMBCL patients accounted for 15%.
All patients underwent lymphocyte depletion.
At the time of lymphocyte depletion, the disease status was Progression (PD) accounting for 69%, stable disease (SD) accounting for 22%, and partial remission (PR) accounting for 9%.
The median time from leukocyte separation to the start of lymphocyte clearance was 34 days.
The median time from leukocyte separation to infusion was 39 days.
The median length of hospital stay was 21 days.
86% of patients had any grade of CRS (18% was grade 2 and 6.
5% was grade 3-4).
Among them, 58% of CRS patients used tocilizumab and 19% of patients used corticosteroids.
42.
5% of patients developed ICANS (10% were grade 2 and 15% were grade 3-4).
The treatment of ICANS included corticosteroids (78%), tocilizumab (31%), Siltuximab (15%) and Anakinra (twenty one%).
Twenty patients (22%) entered the ICU.
Four patients died from ICANS, one died from CRS, and one died from infection.
Among the 80 patients who could be assessed and rescheduled on day 30, the ORR was 78% (CR: 40%, PR: 38%, PD: 11%, SD or uncertain: 11%).
Of the 58 patients who could be evaluated on day 100, 66% had sustained remission (CR: 48%, PR: 18%).
Of the 23 patients who could be evaluated on day 180, 65% had CR.
Of the 39 patients with PR/SD on day 30, 9 (23%) converted to CR.
After a median follow-up of 6.
3 months, the event-free survival (EFS) rate and overall survival (OS) rate of the infusion population were 55.
5% and 78%, respectively, and the estimated median EFS and OS were 13.
1 months and 7.
3 months, respectively .
In the intention-to-treat analysis of all patients undergoing apheresis, the estimated median OS and EFS were 12.
3 months (95% CI: 8.
9-15.
7) and 6.
6 months (95% CI: 4.
6-8.
5), respectively. Research conclusions This Spanish multi-center retrospective analysis showed that in the real world, patients with relapsed and refractory aggressive B-cell lymphoma have received encouraging results from Axi-cel treatment.
The incidence of major toxic events was lower than that reported in key trials, but toxicity-related deaths occurred.
During the limited follow-up time, the relief was good.
Reference source: M.
Kwon, R.
Bailen, L.
Lopez Corral, et al.
REAL WORLD OF EXPERIENCE AXICABTAGENE CILOLEUCEL FOR THE TREATMENT OF RELAPSED OR REFRACTORY LARGE B-CELL LYMPHOMA IN SPAIN.
The 47th Annual Meeting of the EBMT.
Abstract OS3 -4.
Poke "read the original text", we will make progress together
