Ibrutinib plus Bendamustine/Rituximab versus Bendamustine/Rituximab in Patients with Relapsed/Refractory CLL: HRQL Outcomes in the HELIOS Trial
Ibrutinib is a first-in-class, oral, covalent inhibitor of Bruton’s tyrosine kinase (BTK) that is approved for the treatment of patients with previously treated chronic lymphocytic leukemia (CLL) in patients who have received at least 1 prior therapy and in patients with the high-risk deletion 17p cytogenetic feature.1 When added to standard chemoimmunotherapy with bendamustine/rituximab (BR), ibrutinib resulted in a 80% reduction in disease progression or death in patients with previously treated CLL/small lymphocytic leukemia in the randomized, double-blind, placebo-controlled, phase 3 HELIOS trial.2 Given that health-related quality of life (HRQL) is an important consideration for patients with CLL, and that HQRL was studied as a secondary end point, Traina and colleagues reported results of a planned analysis of HRQL and fatigue in the HELIOS trial.3
In this trial, 578 patients with relapsed CLL following ?1 prior therapy were randomized to receive ibrutinib (420 mg daily; n = 289) or placebo (n = 289) plus BR. HRQL and fatigue measures included the FACIT-Fatigue, EORTC QLQ-C30-CLL16, and EQ-5D-5L, as well as fatigue scores by baseline quartile with respect to clinical, sociodemographic, and HRQL factors. Of the 578 patients enrolled, 540 (93%) provided FACIT-Fatigue responses at baseline. In terms of HRQL scores, baseline patient-reported outcome scores indicated relatively good HRQL with minimal room for improvement. However, patients with the worst fatigue at baseline achieved improvements in fatigue score over time for both treatments, with greater magnitude of improvements observed with ibrutinib + BR versus placebo + BR (P <.05 at cycle 10). These improvements in fatigue scores correlated directly with improved mean hemoglobin values. Moreover, a greater proportion of patients treated with ibrutinib + BR who described feeling ill or unwell at baseline reported a return to wellness (50% vs 38% at cycle 19) compared with control. Based on these data, the authors concluded that the addition of ibrutinib to BR did not negatively impact HRQL, and the ibrutinib regimen was associated with greater reductions in fatigue compared with control among patients with the worst fatigue at baseline. The improvements in fatigue appear to be consistent with improvements in hemoglobin.
- Imbruvica (ibrutinib) [Prescribing Information]. 2015.
- Chanan-Khan et al. ASCO 2015. Abstract LBA7005.
- Traina S, et al. ASH 2015. Abstract 267.