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Adding a targeted tablet to first-line chemotherapy gave older people with mantle cell lymphoma about two and a half more years before relapse, without helping them live longer.
A randomised trial in patients aged 65 or over with untreated mantle-cell lymphoma. 523 patients received ibrutinib 560 mg orally once daily until progression or unacceptable toxicity (261) or placebo (262), plus six cycles of bendamustine 90 mg per square metre and rituximab 375 mg per square metre. Responders received rituximab maintenance every eight weeks for up to twelve additional doses. The primary endpoint was investigator-assessed progression-free survival.
At a median follow-up of 84.7 months, median progression-free survival was 80.6 months with ibrutinib against 52.9 months with placebo (hazard ratio for progression or death 0.75, 95 per cent confidence interval 0.59 to 0.96, p = 0.01). Complete response occurred in 65.5 against 57.6 per cent (p = 0.06). Overall survival was similar in the two groups. Grade 3 or 4 adverse events during treatment occurred in 81.5 against 77.3 per cent.
Twenty-eight extra months of progression-free survival, with no survival gain and a high rate of severe adverse events in both arms. It set up the two trials that followed: ECHO, which substituted a more selective inhibitor, and ENRICH, which removed the chemotherapy.
Shares Martin Dreyling, Michael L. Wang, A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL, SHINE and the tag lymphoma-evidence.
Shares SHINE, CCND1, ENRICH, Maintenance therapy and the tag lymphoma-evidence.
Shares CCND1, Maintenance therapy, CD20, Rituximab and the tag lymphoma-evidence.
Shares CCND1, Maintenance therapy, CD20, Rituximab and the tag lymphoma-evidence.
Shares B-cell receptor / BTK signalling (to NF-κB), BTK (Bruton tyrosine kinase), Older and multimorbid patients are excluded and undertreated, CD20 and the tag lymphoma-evidence.
Shares ENRICH, BTK (Bruton tyrosine kinase), Ibrutinib, CD20 and the tag lymphoma-evidence.
Shares B-cell receptor / BTK signalling (to NF-κB), BTK (Bruton tyrosine kinase), Ibrutinib, Older and multimorbid patients are excluded and undertreated and the tag lymphoma-evidence.
Shares Older and multimorbid patients are excluded and undertreated, CD20, Rituximab, Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting and the tag lymphoma-evidence.