Introduction
Chronic lymphocytic leukaemia, a common blood cancer in adults, particularly affects the elderly and is marked by the accumulation of B lymphocytes. While therapeutic options have expanded, the fludarabine, cyclophosphamide, and rituximab (FCR) regimen remains the standard first-line treatment for fit patients in the Brazilian public health system.
Aim
This systematic review aimed to assess the efficacy and safety of ibrutinib plus rituximab (IR) as a first-line therapy for chronic lymphocytic leukaemia.
Methods
Following PRISMA guidelines and registered in PROSPERO (CRD42023494868), searches were conducted in multiple databases in December 2023 to identify relevant randomized controlled trials comparing the IR and FCR regimens. Eligible studies reported at least one of the following outcomes: progression-free survival, overall survival, severe adverse events, or quality of life.
Results
Two double-blind randomized controlled trials (FLAIR and E1912) totalling 1300 patients met inclusion criteria. Meta-analysis showed that the IR regimen significantly improved progression-free survival compared to the FCR regimen (Hazard ratio: 0.41; 95% CI: 0.31–0.53) with moderate certainty of evidence. However, overall survival did not differ substantially (Hazard ratio: 0.71; 95% CI: 0.33–1.49), and the certainty of the evidence was very low. Quality of life data were unavailable. Due to variations in follow-up, results for severe adverse events were not pooled and the individual studies reported results with low certainty of evidence. The global risk of bias was rated as there was some concern due to the lack of concealed allocation in all outcomes.
Conclusion
The IR regimen demonstrated superior progression-free survival and comparable safety to the FCR regimen suggesting it is an effective and safe option for first-line treatment of chronic lymphocytic leukaemia.
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