Ibrutinib plus Bendamustine and Rituximab in Untreated Mantle‑Cell Lymphoma

Rákkutatás · Lymphoma

The median progression‑free survival was 80.6 months in the ibrutinib group and 52.9 months in the placebo group (hazard ratio for disease progression or death, 0.75; 95% confidence interval, 0.59 to 0.96; P = 0.01).

The study evaluated the benefit of adding ibrutinib to standard bendamustine‑rituximab therapy in patients aged 65 or older with untreated mantle‑cell lymphoma. 523 patients were randomized to ibrutinib (560 mg daily) or placebo plus six cycles of bendamustine and rituximab. Patients with an objective response received rituximab maintenance every 8 weeks for up to 12 doses. The primary endpoint was progression‑free survival. At median follow‑up of 84.7 months the median PFS was 80.6 months with ibrutinib versus 52.9 months with placebo (hazard ratio 0.75; 95 % CI 0.59‑0.96; P = 0.01). Complete‑remission rates were 65.5 % versus 57.6 % (P = 0.06). Overall survival was similar. Grade 3/4 adverse events occurred in 81.5 % (ibrutinib) versus 77.3 % (placebo). The combination was safe and significantly prolonged PFS.

This study demonstrates that adding the Bruton’s tyrosine‑kinase inhibitor ibrutinib to standard bendamustine‑rituximab chemotherapy markedly improves progression‑free survival for patients with untreated mantle‑cell lymphoma, supporting a new standard of care for older patients.

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