Fixed-Duration versus Continuous Treatment for Chronic Lymphocytic Leukemia

Rákkutatás · Leukemia

Fixed-duration treatment with venetoclax-obinutuzumab or venetoclax-ibrutinib was noninferior to continuous ibrutinib with regard to investigator-assessed progression‑free survival.

BACKGROUND: Treatment of chronic lymphocytic leukemia (CLL) currently consists of two main approaches – continuous therapy with Bruton's tyrosine kinase inhibitors and fixed‑duration regimens combining venetoclax with either CD20 antibodies or Bruton's tyrosine kinase inhibitors. METHODS: We conducted an investigator‑initiated, phase 3, randomized trial involving patients with previously untreated CLL. Patients were randomly assigned to receive continuous ibrutinib or fixed‑duration venetoclax‑obinutuzumab or venetoclax‑ibrutinib. The primary endpoint was investigator‑assessed progression‑free survival. RESULTS: In this prespecified interim analysis, 3‑year progression‑free survival was 81.1% (venetoclax‑obinutuzumab), 79.4% (venetoclax‑ibrutinib) and 81.0% (ibrutinib), meeting the non‑inferiority criterion. MRD in peripheral blood was undetectable in 73.3% of the venetoclax‑obinutuzumab group compared with 47.2% in the venetoclax‑ibrutinib group and 0% in the ibrutinib group. Three‑year overall survival was 91.5%, 96.0% and 95.7%, respectively. CONCLUSIONS: Fixed‑duration treatment with venetoclax‑obinutuzumab or venetoclax‑ibrutinib is noninferior to continuous ibrutinib with regard to progression‑free survival.

This trial suggests that fixed‑duration regimens can achieve comparable efficacy to continuous therapy, potentially reducing cumulative drug exposure, toxicity, and treatment burden for patients with CLL.

Bizonyítékszint: Irányelv / elfogadott gyakorlat. Magas szintű klinikai elfogadottság.

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