Association between patient-reported symptoms and clinical outcomes in R/R CLL.

Abstract

The ALPINE trial was a randomized, open-label study comparing the efficacy and safety of zanubrutinib versus ibrutinib monotherapy in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL). Using patient-reported outcome (PRO) data from the ALPINE trial, the current study aimed to investigate the association between disease-specific patient-reported symptoms and the clinical outcomes of progression-free survival (PFS) and duration of response (DoR). After adjusting for baseline stratification factors, zanubrutinib was associated with lower PRO-based recurrent symptomatic deterioration compared to ibrutinib. Zanubrutinib also demonstrated significantly lower risk of disease progression and better DoR across all disease-specific patient-reported symptoms. Compared to ibrutinib, zanubrutinib demonstrated a 28%-33% reduction in the risk of a PFS event after adjusting for global health status, physical functioning, role functioning, fatigue, pain, nausea and vomiting, diarrhea, and constipation (all P < .02). Similarly, zanubrutinib demonstrated a 31%-51% reduced risk of shortened DoR after adjusting for the patient-reported scores (all P < .02). These are crucial aspects in clinical decision-making, as they highlight zanubrutinib's association with improved clinical outcomes and patient-reported symptomatology. These findings reinforce the enhanced efficacy profile of zanubrutinib in patients with R/R CLL/SLL by demonstrating its lower patient-reported symptom deterioration in addition to increased PFS and better DoR.