TRIANGLE: ibrutinib with immunochemotherapy with or without autologous transplant versus immunochemotherapy and transplant in untreated mantle cell lymphoma
Adding ibrutinib to first-line treatment for younger people with mantle cell lymphoma kept more of them free of treatment failure at three years, and the stem cell transplant that was standard was not shown to add benefit once ibrutinib was used.
Overview
Three-arm open-label phase 3 trial of the European Mantle Cell Lymphoma Network: 870 patients aged 18 to 65 with untreated mantle cell lymphoma were randomised to R-CHOP/R-DHAP and autologous transplant (arm A, 288), the same with ibrutinib in induction and maintenance (arm A+I, 292), or ibrutinib-containing induction and maintenance without transplant (arm I, 290).
After 31 months median follow-up three-year failure-free survival was 88 percent in arm A+I against 72 percent in arm A (hazard ratio 0.52, one-sided p 0.0008); superiority of arm A over arm I (72 against 86 percent) was not shown. Grade 3 to 5 haematological adverse events and infections during maintenance were most frequent after transplant plus ibrutinib.
- Three-year failure-free survival 88 percent (95% CI 84 to 92) in arm A+I versus 72 percent (67 to 79) in arm A; hazard ratio 0.52, one-sided p 0.0008.
- Arm A versus arm I: 72 versus 86 percent (82 to 91); hazard ratio 1.77, superiority of transplant not shown.
- Grade 3 to 5 haematological events during maintenance or follow-up in 50 percent (A+I), 28 percent (I) and 21 percent (A).
Ibrutinib during induction and as maintenance should be part of first-line treatment for younger patients with mantle cell lymphoma; whether transplant adds anything to an ibrutinib-containing regimen is still being followed.
- The A+I against I comparison was not mature at publication.
- Open-label; failure-free survival rather than overall survival was the primary endpoint.
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