REFLECT: prospective multicenter non-interventional study evaluating the effectiveness and safety of Sandoz rituximab (SDZ-RTX; Rixathon®) in combination with CHOP for the treatment of patients with previously untreated CD20-positive diffuse large B-cell lymphoma.
Ther Adv Hematol
; 14: 20406207231183765, 2023.
Article
en En
| MEDLINE
| ID: mdl-37492394
ABSTRACT
Background:
REFLECT is the first prospective study of Sandoz biosimilar rituximab (SDZ-RTX) in patients with diffuse large B-cell lymphoma (DLBCL).Objective:
To evaluate the 2-year effectiveness and safety of SDZ-RTX as first-line treatment for DLBCL.Design:
Real-world, multicenter, open-label, single-arm, non-interventional, post-approval study of SDZ-RTX in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with treatment-naïve CD20positive DLBCL.Methods:
Treatment-naïve, CD20-positive adult patients (⩾18 years) with DLBCL eligible for therapy with R-CHOP were treated with SDZ-RTX-CHOP every 2 or 3 weeks for 6-8 cycles. The effectiveness of SDZ-RTX was measured by the complete response (CR) rate at the end of R-CHOP treatment, as assessed by the treating physician. Progression-free survival (PFS) was assessed at 24 months.Results:
A total of 169 patients [52.1% female, median (range) age 70 (24-94) years] with DLBCL were included in the full analysis set. At baseline, 19.5% and 24.3% of patients had Ann Arbor disease stage III or IV, respectively, and most patients (80.5%) had Eastern Cooperative Oncology Group Performance Status of 0 or 1. A total of 100 (59.2%) patients completed the 24-month observation period. In total, 110 [65.1%; 95% confidence interval (CI) 57.4-72.3] patients achieved CR as best response and 50 (29.6%; 95% CI 22.8-37.1) patients achieved partial response. Overall best response rate was 94.7% (95% CI 90.1-97.5). One-year PFS was 84.9% (95% CI 78.2-89.6), while 2-year PFS was 78.5% (95% CI 70.9-84.4); median PFS was not reached within the observational period. A total of 143 (84.6%) patients experienced ⩾1 adverse event, 53 (31.4%) of which were suspected to be related to study drug.Conclusion:
This real-world, 2-year study reconfirms that first-line treatment of CD20-positive DLBCL with R-CHOP using SDZ-RTX is effective and well tolerated. Registration N/A.
REFLECT A study evaluating Sandoz biosimilar rituximab (Rixathon ® ) in combination with CHOP for the treatment of patients with previously untreated diffuse large B-cell lymphoma Why was this study done? ⢠Biosimilars are biologic medicines that are highly similar to a reference biologic medicine that is already approved and has been used in patients for several years. ⢠The REFLECT study was the first study of a biosimilar medicine (Sandoz biosimilar rituximab) in patients with a type of lymphatic cancer called diffuse large B-cell lymphoma (DLBCL). What did the researchers do? ⢠Sandoz biosimilar rituximab was given as part of the standard treatment (cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP) in patients with DLBCL who had not received treatment before. ⢠The researchers aimed to evaluate how well Sandoz biosimilar rituximab worked over a 2-year period. ⢠The researchers also aimed to look at the safety of Sandoz biosimilar rituximab. ⢠Patients with DLBCL had to be ⩾18 years of age, in need of treatment, and were classed as suitable for treatment with R-CHOP by their doctor. ⢠Patients were treated with R-CHOP including Sandoz biosimilar rituximab every 2 or 3 weeks for 68 cycles. What did the researchers find? ⢠A total of 169 patients with DLBCL were included in the study. ⢠Just over half (52%) were female and the average age was 67 years. ⢠Nearly 6 out of 10 (59%) patients completed the 2-year study. ⢠More than 6 out of 10 (65%) patients achieved complete response and 3 out of 10 (30%) achieved partial response. ⢠The overall response rate was 95%. ⢠One-year progression-free survival was 85%, and 2-year progression-free survival was 79%. ⢠Regarding safety, 85% of patients experienced at least one adverse event; just over 3 out of 10 (31%) of these were suspected to be related to the study drug. What do the findings mean? ⢠This 2-year study shows that R-CHOP including Sandoz biosimilar rituximab is effective and well tolerated as the first treatment given to patients with DLBCL.
Texto completo:
1
Bases de datos:
MEDLINE
Tipo de estudio:
Clinical_trials
/
Observational_studies
Idioma:
En
Revista:
Ther Adv Hematol
Año:
2023
Tipo del documento:
Article
País de afiliación:
Alemania