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The first trial to show that a chemotherapy-free first-line combination beats immunochemotherapy in older people with mantle cell lymphoma.
A randomised, open-label, phase 2/3 superiority trial at 66 sites in the United Kingdom, Sweden, Norway, Finland and Denmark. Patients aged 60 or over with untreated mantle-cell lymphoma, Ann Arbor stage II to IV and performance status 0 to 2, were randomised 1 to 1, stratified by the investigator's pre-chosen immunochemotherapy, between that immunochemotherapy with rituximab and ibrutinib 560 mg daily with six to eight cycles of rituximab on the matched schedule. All responders received rituximab maintenance every eight weeks for two years; the ibrutinib group continued ibrutinib until progression or unacceptable toxicity. The trial was registered with EudraCT as 2015-000832-13.
Between 15 February 2016 and 30 June 2021, 397 patients were randomised, 198 to control and 199 to intervention; 107 (27 per cent) were pre-allocated to R-CHOP and 290 (73 per cent) to rituximab-bendamustine. Median age was 74 in both groups, and 296 patients (75 per cent) were male. At a median follow-up of 47.9 months the adjusted hazard ratio for progression-free survival was 0.69 (95 per cent confidence interval 0.52 to 0.90, p = 0.0034). Grade 3 or above adverse events were reported by 67 per cent of the ibrutinib-rituximab group and 70 per cent of the immunochemotherapy group.
The authors' conclusion is that ibrutinib-rituximab should be considered a new standard-of-care option for first-line treatment of older patients with mantle-cell lymphoma. The subgroup split means it is clearly better than R-CHOP and roughly equivalent to bendamustine-rituximab.
Shares SHINE, CCND1, ENRICH, Maintenance therapy and the tag lymphoma-evidence.
Shares SHINE, CCND1, ENRICH, Fixed-duration, chemotherapy-free first-line treatment for the indolent lymphomas and the tag lymphoma-evidence.
Shares R-CHOP (lymphoma chemoimmunotherapy), B-cell receptor / BTK signalling (to NF-κB), BTK (Bruton tyrosine kinase), Older and multimorbid patients are excluded and undertreated and the tag lymphoma-evidence.
Shares R-CHOP (lymphoma chemoimmunotherapy), B-cell receptor / BTK signalling (to NF-κB), BTK (Bruton tyrosine kinase), Ibrutinib and the tag lymphoma-evidence.
Shares R-CHOP (lymphoma chemoimmunotherapy), Prednisone, Vincristine, The Lancet and the tag lymphoma-evidence.
Shares R-CHOP (lymphoma chemoimmunotherapy), Older and multimorbid patients are excluded and undertreated, CD20, Trials do not represent the people who get cancer and the tag lymphoma-evidence.
Shares TRIANGLE: ibrutinib with immunochemotherapy with or without autologous transplant versus immunochemotherapy and transplant in untreated mantle cell lymphoma, CCND1, Maintenance therapy, CD20 and the tag lymphoma-evidence.
Shares Fixed-duration, chemotherapy-free first-line treatment for the indolent lymphomas, R-CHOP (lymphoma chemoimmunotherapy), Bendamustine, CD20 and the tag lymphoma-evidence.