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29 maart 2018: Bron: Cancer Medicine: 13 March 2018

Ook uit een Aziatische studie blijkt dat Ibrutinib (Imbruvica) superieure resultaten geeft in vergelijking met Rituximab bij recidief van CLL - Chronische Lymfatische Leukemie en SLL, een vorm van lymfklierkanker. (Zie ook in gerelateerde artikelen bv deze studie)

Na een mediane studiefollow-up van 17,8 maanden blijkt de ziektevrije tijd (OOR) al een verschil te geven van plus 45 procent en ook de overall overleving (OS) was al significant beter. 

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).

Hier de grafiek uit het studierapport: Ibrutinib versus rituximab in relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma: a randomized, open‐label phase 3 study

en ik geef maar geen verdere vertaling van de details want deze zijn duidelijk lijkt mij. Ga naar het volledige studierapprot en bekjk alle grafieken enz. Onderaan de grafiek staat het abstract met referentielijst.


In the updated analysis, 64 PFS events were reported (26 [24.5%] in the ibrutinib arm and 38 [70.4%] in the rituximab arm). PFS was significantly improved for patients in the ibrutinib arm compared with the rituximab arm (HR = 0.180, 95% CI: 0.105–0.308; P < 0.0001). The median PFS was not reached in the ibrutinib arm; median PFS for the rituximab arm was 8.3 months (range, 0–22.6 months). At the 18‐month landmark, the estimated PFS rate in the ibrutinib arm was 74.0%, and in the rituximab arm, it was 11.9% (Fig. 1A).

(A) Kaplan–Meier Curves for Progression‐Free Survival (ITT Population). The median progression‐free survival (PFS) was not reached in the ibrutinib arm. The median PFS for the rituximab arm was 8.34 months (95% confidence interval: 8.21–9.03 months). (B) Kaplan–Meier Curves for Overall Survival (ITT Population). With a median follow‐up of 17.84 months, overall survival was significantly improved in the ibrutinib arm compared with the rituximab arm.
Hier het abstract plus referentielijst:

Ibrutinib significantly improved PFS, ORR, and OS compared with rituximab; the results were robust and internally consistent. Ibrutinib displayed a manageable safety profile with no new or unexpected events reported.

Original Research

Ibrutinib versus rituximab in relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma: a randomized, open‐label phase 3 study

First published: 13 March 2018


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  = 0.180, 95% confidence interval : 0.105–0.308). ORR was significantly higher (< 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; = 0.0206). Overall incidence of adverse events (AEs) was similar between treatments and was not exposure‐adjusted. With ibrutinib, most common AEs were diarrhea and platelet count decreased; with rituximab, most common AEs were neutrophil count decreased and platelet count decreased. Grade ≥3 AEs 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.


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