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Ibrutinib combined ...
Ibrutinib combined with immunochemotherapy with or without autologous stem-cell transplantation versus immunochemotherapy and autologous stem-cell transplantation in previously untreated patients with mantle cell lymphoma (TRIANGLE) : a three-arm, randomised, open-label, phase 3 superiority trial of the European Mantle Cell Lymphoma Network
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- Dreyling, Martin (author)
- University Hospital Munich
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- Doorduijn, Jeanette (author)
- Erasmus University Medical Center
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- Giné, Eva (author)
- Hospital Clínic of Barcelona
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- Jerkeman, Mats (author)
- Lund University,Lunds universitet,Medicinsk onkologi,Sektion I,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Lymfom - Klinisk forskning,Forskargrupper vid Lunds universitet,LUCC: Lunds universitets cancercentrum,Övriga starka forskningsmiljöer,Onkologi övergripande,Institutionen för kliniska vetenskaper, Lund,Medical oncology,Section I,Department of Clinical Sciences, Lund,Faculty of Medicine,Lymphoma - Clinical Research,Lund University Research Groups,LUCC: Lund University Cancer Centre,Other Strong Research Environments,Oncology corporate,Department of Clinical Sciences, Lund
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- Walewski, Jan (author)
- The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
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- Hutchings, Martin (author)
- Copenhagen University Hospital
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- Mey, Ulrich (author)
- Cantonal Hospital Graubunden
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- Riise, Jon (author)
- Oslo university hospital
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- Trneny, Marek (author)
- Charles University in Prague
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- Vergote, Vibeke (author)
- University Hospitals Leuven
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- Shpilberg, Ofer (author)
- Assuta Medical Center,Ariel University
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- Gomes da Silva, Maria (author)
- Portuguese Institute Of Oncology
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- Leppä, Sirpa (author)
- University of Helsinki
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- Jiang, Linmiao (author)
- Ludwig-Maximilian University of Munich
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- Stilgenbauer, Stephan (author)
- University Hospital of Ulm
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- Kerkhoff, Andrea (author)
- University Hospital Münster
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- Jachimowicz, Ron D. (author)
- University Hospital of Cologne
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Celli, Melania (author)
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- Hess, Georg (author)
- Universitätsmedizin Mainz
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- Arcaini, Luca (author)
- University of Pavia,Policlinico San Matteo Pavia Fondazione
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- Visco, Carlo (author)
- Ospedale San Bortolo,Verona University Medical School
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- van Meerten, Tom (author)
- University Medical Center Groningen
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- Wirths, Stefan (author)
- University Hospital of Tubingen
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- Zinzani, Pier Luigi (author)
- University of Bologna,St. Orsola-Malpighi University Hospital
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- Novak, Urban (author)
- Bern University Hospital
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- Herhaus, Peter (author)
- Technical University of Munich
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- Benedetti, Fabio (author)
- University of Verona
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- Sonnevi, Kristina (author)
- Karolinska Institute
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- Hanoun, Christine (author)
- University Hospital Essen
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Hänel, Matthias (author)
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Dierlamm, Judith (author)
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- Pott, Christiane (author)
- University Medical Center Schleswig-Holstein
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- Klapper, Wolfram (author)
- University Medical Center Schleswig-Holstein
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- Gözel, Döndü (author)
- University Hospital Munich
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- Schmidt, Christian (author)
- University Hospital Munich
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- Unterhalt, Michael (author)
- University Hospital Munich
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- Ladetto, Marco (author)
- University of Eastern Piedmont
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- Hoster, Eva (author)
- Ludwig-Maximilian University of Munich
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(creator_code:org_t)
- 2024
- 2024
- English 14 s.
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In: The Lancet. - 0140-6736. ; 403:10441, s. 2293-2306
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Abstract
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- Background: Adding ibrutinib to standard immunochemotherapy might improve outcomes and challenge autologous stem-cell transplantation (ASCT) in younger (aged 65 years or younger) mantle cell lymphoma patients. This trial aimed to investigate whether the addition of ibrutinib results in a superior clinical outcome compared with the pre-trial immunochemotherapy standard with ASCT or an ibrutinib-containing treatment without ASCT. We also investigated whether standard treatment with ASCT is superior to a treatment adding ibrutinib but without ASCT. Methods: The open-label, randomised, three-arm, parallel-group, superiority TRIANGLE trial was performed in 165 secondary or tertiary clinical centres in 13 European countries and Israel. Patients with previously untreated, stage II–IV mantle cell lymphoma, aged 18–65 years and suitable for ASCT were randomly assigned 1:1:1 to control group A or experimental groups A+I or I, stratified by study group and mantle cell lymphoma international prognostic index risk groups. Treatment in group A consisted of six alternating cycles of R-CHOP (intravenous rituximab 375 mg/m2 on day 0 or 1, intravenous cyclophosphamide 750 mg/m2 on day 1, intravenous doxorubicin 50 mg/m2 on day 1, intravenous vincristine 1·4 mg/m2 on day 1, and oral prednisone 100 mg on days 1–5) and R-DHAP (or R-DHAOx, intravenous rituximab 375 mg/m2 on day 0 or 1, intravenous or oral dexamethasone 40 mg on days 1–4, intravenous cytarabine 2 × 2 g/m2 for 3 h every 12 h on day 2, and intravenous cisplatin 100 mg/m2 over 24 h on day 1 or alternatively intravenous oxaliplatin 130 mg/m2 on day 1) followed by ASCT. In group A+I, ibrutinib (560 mg orally each day) was added on days 1–19 of R-CHOP cycles and as fixed-duration maintenance (560 mg orally each day for 2 years) after ASCT. In group I, ibrutinib was given the same way as in group A+I, but ASCT was omitted. Three pairwise one-sided log-rank tests for the primary outcome of failure-free survival were statistically monitored. The primary analysis was done by intention-to-treat. Adverse events were evaluated by treatment period among patients who started the respective treatment. This ongoing trial is registered with ClinicalTrials.gov, NCT02858258. Findings: Between July 29, 2016 and Dec 28, 2020, 870 patients (662 men, 208 women) were randomly assigned to group A (n=288), group A+I (n=292), and group I (n=290). After 31 months median follow-up, group A+I was superior to group A with 3-year failure-free survival of 88% (95% CI 84–92) versus 72% (67–79; hazard ratio 0·52 [one-sided 98·3% CI 0–0·86]; one-sided p=0·0008). Superiority of group A over group I was not shown with 3-year failure-free survival 72% (67–79) versus 86% (82–91; hazard ratio 1·77 [one-sided 98·3% CI 0–3·76]; one-sided p=0·9979). The comparison of group A+I versus group I is ongoing. There were no relevant differences in grade 3–5 adverse events during induction or ASCT between patients treated with R-CHOP/R-DHAP or ibrutinib combined with R-CHOP/R-DHAP. During maintenance or follow-up, substantially more grade 3–5 haematological adverse events and infections were reported after ASCT plus ibrutinib (group A+I; haematological: 114 [50%] of 231 patients; infections: 58 [25%] of 231; fatal infections: two [1%] of 231) compared with ibrutinib only (group I; haematological: 74 [28%] of 269; infections: 52 [19%] of 269; fatal infections: two [1%] of 269) or after ASCT (group A; haematological: 51 [21%] of 238; infections: 32 [13%] of 238; fatal infections: three [1%] of 238). Interpretation: Adding ibrutinib to first-line treatment resulted in superior efficacy in younger mantle cell lymphoma patients with increased toxicity when given after ASCT. Adding ibrutinib during induction and as maintenance should be part of first-line treatment of younger mantle cell lymphoma patients. Whether ASCT adds to an ibrutinib-containing regimen is not yet determined. Funding: Janssen and Leukemia & Lymphoma Society.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
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Dreyling, Martin
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Doorduijn, Jeane ...
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Giné, Eva
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Jerkeman, Mats
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Walewski, Jan
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Hutchings, Marti ...
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Mey, Ulrich
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Riise, Jon
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Trneny, Marek
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Vergote, Vibeke
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Shpilberg, Ofer
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Gomes da Silva, ...
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Leppä, Sirpa
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Jiang, Linmiao
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Stilgenbauer, St ...
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Kerkhoff, Andrea
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Jachimowicz, Ron ...
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Celli, Melania
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Hess, Georg
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Arcaini, Luca
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Visco, Carlo
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van Meerten, Tom
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Wirths, Stefan
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Zinzani, Pier Lu ...
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Novak, Urban
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Herhaus, Peter
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Benedetti, Fabio
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Sonnevi, Kristin ...
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Hanoun, Christin ...
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Hänel, Matthias
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Dierlamm, Judith
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Pott, Christiane
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Klapper, Wolfram
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Gözel, Döndü
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Schmidt, Christi ...
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Unterhalt, Micha ...
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Ladetto, Marco
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Hoster, Eva
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The Lancet
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Lund University
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Karolinska Institutet