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Observe or Treat Early-Stage Chronic Lymphocytic Leukemia?
In the chemotherapy era, clinicians observed patients with asymptomatic, early-stage chronic lymphocytic leukemia (CLL) and did not give anti-CLL therapy until treatment was indicated by symptom onset or clinically significant disease progression. Investigators from Germany now report long-term outcomes with a Bruton tyrosine kinase (BTK) inhibitor in patients with Binet stage A CLL and intermediate-to-high risk for early progression according to a multifactorial risk score.
In this industry-sponsored, prospective, multicenter, double-blind, phase 3 trial, 363 patients received oral ibrutinib (420 mg daily) or placebo until disease progression or treatment intolerance. Another 152 patients with low-risk CLL underwent watchful waiting and regular monitoring of disease status. Findings at a median follow-up of 69 months included:
- Progression to symptomatic disease was significantly delayed with ibrutinib compared with placebo (21.4% vs. 51.4%; hazard ratio, 0.276)
- Ibrutinib showed no 5-year overall survival (OS) benefit compared with placebo (93.3% and 93.6%, respectively). Five-year OS in the low-risk, watch-and-wait group was 97.9%. One of 12 deaths in the ibrutinib arm and 4 of 14 deaths in the placebo arm were due to CLL.
- Toxicity-related events, including arrhythmias, hypertension, and bleeding events, were numerically more frequent in ibrutinib-treated patients.
Comment
Testing the traditional approach to asymptomatic CLL in the era of targeted therapeutics endorsed this watch-and-wait strategy, even in higher-risk patients. Thus, watch and wait remains the standard of care, with the caveat that more-frequent symptom monitoring, examinations, and blood counts are warranted in patients at elevated risk for early progression.
Citation(s)
Author:
Langerbeins P et al.
Title:
Ibrutinib in early-stage chronic lymphocytic leukemia: The randomized, placebo-controlled, double-blind, phase III CLL12 trial.
Source:
J Clin Oncol
2024
Nov
27; [e-pub].
(Abstract/FREE Full Text)
Empfohlen von
Michael E. Williams, MD, ScM