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- W2789826025 abstract "Abstract In the Asia‐Pacific region, treatment options are limited for patients with relapsed/refractory chronic lymphocytic leukemia ( CLL )/small lymphocytic lymphoma ( SLL ). Rituximab is widely used in this setting when purine analog‐based therapies are not appropriate. We evaluated the efficacy and safety of ibrutinib compared with rituximab in a randomized, open‐label phase 3 study in predominantly Asian patients with relapsed/refractory CLL / SLL . Patients ( N = 160) were randomly assigned 2:1 to receive 420 mg ibrutinib ( n = 106) until disease progression ( PD ) or unacceptable toxicity or up to six cycles of rituximab ( n = 54). The primary endpoint was investigator‐assessed progression‐free survival ( PFS ); key secondary endpoints were overall response rate ( ORR ), overall survival ( OS ), and safety. Rituximab‐treated patients could crossover to receive ibrutinib after confirmed PD . At data cutoff, median treatment duration was 16.4 months for ibrutinib and 4.6 months for rituximab. Ibrutinib significantly improved PFS (hazard ratio [ HR ] = 0.180, 95% confidence interval [ CI ]: 0.105–0.308). ORR was significantly higher ( P < 0.0001) with ibrutinib (53.8%) than with rituximab (7.4%). At a median follow‐up of 17.8 months, ibrutinib improved OS compared with rituximab ( HR = 0.446; 95% CI : 0.221–0.900; P = 0.0206). Overall incidence of adverse events ( AE s) was similar between treatments and was not exposure‐adjusted. With ibrutinib, most common AE s were diarrhea and platelet count decreased; with rituximab, most common AE s were neutrophil count decreased and platelet count decreased. Grade ≥3 AE s were reported in 82.7% of ibrutinib‐treated patients and 59.6% of rituximab‐treated patients. Ibrutinib improved PFS , ORR , and OS compared with rituximab and displayed a manageable safety profile in Asian patients with relapsed/refractory CLL / SLL ." @default.
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- W2789826025 date "2018-03-13" @default.
- W2789826025 modified "2023-10-16" @default.
- W2789826025 title "Ibrutinib versus rituximab in relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma: a randomized, open-label phase 3 study" @default.
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- W2789826025 doi "https://doi.org/10.1002/cam4.1337" @default.
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