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Enrico Tiacci, MD, discusses safety and efficacy results of a trial evaluating the BRAF inhibitor vemurafenib combined with rituximab in hairy cell leukemia.
Enrico Tiacci, MD, associate professor of hematology, University and Hospital of Perugia, Italy, discusses safety and efficacy results of a trial evaluating the BRAF inhibitor vemurafenib (Zelboraf) combined with rituximab (Rituxan) in hairy cell leukemia (HCL).
The phase II trial included 31 patients with relapsed or refractory HCL. Patients received vemurafenib twice daily for 8 weeks and rituximab every 2 weeks. After finishing vemurafenib, patients received rituximab 4 more times, at 2-week intervals.
Out of 31 patients, 27 were evaluable and all except 1 of the evaluable patients achieved complete remission (CR), according to Tiacci. About 63% of patients achieved CR after 2 cycles of the combination. About 65% of patients were negative for minimal residual disease in the bone marrow, and the rate of progression-free survival was 83% at a median follow-up of 29.5 months.
The combination did not create any new toxicities, according to Tiacci. The adverse events (AEs) were mostly grade 1/2 and reversible, and common AEs included rash, arthritis, phototoxicity, and increase of pancreatic enzymes.