AI Article Synopsis
- REFLECT is a groundbreaking study examining the effectiveness and safety of Sandoz biosimilar rituximab (SDZ-RTX) as a first-line treatment for patients with diffuse large B-cell lymphoma (DLBCL).
- The real-world study involved 169 treatment-naïve patients receiving SDZ-RTX in combination with R-CHOP therapy, demonstrating a complete response rate of 65.1% and an overall response rate of 94.7%.
- The study found that after two years, progression-free survival was 78.5%, but also indicated that a significant number of patients (84.6%) experienced at least one adverse event during treatment.
Article 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 CD20‑positive 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.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10363888 | PMC |
| http://dx.doi.org/10.1177/20406207231183765 | DOI Listing |
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