Ibrutinib was superior to chlorambucil in previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma, according to a study of 269 patients with previously untreated CLL or small lymphocytic leukemia, aged 65 years or older. Researchers found:

• During a median 18.4 months of follow-up, ibrutinib resulted in significantly longer progression-free survival vs chlorambucil, with risk of progression or death 84% lower.

• Estimated overall survival rate at 24 months was 98% with ibrutinib versus 85% with chlorambucil

• Relative risk of death was 84% lower in the ibrutinib group.

• Overall response rate was 86% with ibrutinib vs 35% with chlorambucil.

• Rates of sustained increases from baseline values in hemoglobin and platelet levels were higher with ibrutinib.

• Adverse events (≥ 20%) with ibrutinib included diarrhea, fatigue, cough, and nausea, and those with chlorambucil included nausea, fatigue, neutropenia, anemia, and vomiting.

• In the ibrutinib group, 4 patients had a grade 3 hemorrhage and one had a grade 4 hemorrhage.

Citation: Burger JA, Tedeschi A, Barr PM, et al. Ibrutinib as initial therapy for patients with chronic lymphocytic leukemia. [Published online ahead of print December 6, 2015]. NEJM. doi: 10.1056/NEJMoa1509388.