SwePub
Sök i LIBRIS databas

  Utökad sökning

WFRF:(Benedetti Andrea)
 

Sökning: WFRF:(Benedetti Andrea) > Ibrutinib combined ...

LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00008769naa a2200733 4500
001oai:lup.lub.lu.se:9b9b00ca-3492-4083-854f-8af5d1f729bb
003SwePub
008240531s2024 | |||||||||||000 ||eng|
0247 a https://lup.lub.lu.se/record/9b9b00ca-3492-4083-854f-8af5d1f729bb2 URI
0247 a https://doi.org/10.1016/S0140-6736(24)00184-32 DOI
040 a (SwePub)lu
041 a engb eng
042 9 SwePub
072 7a art2 swepub-publicationtype
072 7a ref2 swepub-contenttype
1001 a Dreyling, Martinu University Hospital Munich4 aut
2451 0a 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
264 1c 2024
300 a 14 s.
520 a 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.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Cancer och onkologi0 (SwePub)302032 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Cancer and Oncology0 (SwePub)302032 hsv//eng
7001 a Doorduijn, Jeanetteu Erasmus University Medical Center4 aut
7001 a Giné, Evau Hospital Clínic of Barcelona4 aut
7001 a Jerkeman, Matsu 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, Lund4 aut0 (Swepub:lu)onk-mje
7001 a Walewski, Janu The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology4 aut
7001 a Hutchings, Martinu Copenhagen University Hospital4 aut
7001 a Mey, Ulrichu Cantonal Hospital Graubunden4 aut
7001 a Riise, Jonu Oslo university hospital4 aut
7001 a Trneny, Mareku Charles University in Prague4 aut
7001 a Vergote, Vibekeu University Hospitals Leuven4 aut
7001 a Shpilberg, Oferu Ariel University,Assuta Medical Center4 aut
7001 a Gomes da Silva, Mariau Portuguese Institute Of Oncology4 aut
7001 a Leppä, Sirpau University of Helsinki4 aut
7001 a Jiang, Linmiaou Ludwig-Maximilian University of Munich4 aut
7001 a Stilgenbauer, Stephanu University Hospital of Ulm4 aut
7001 a Kerkhoff, Andreau University Hospital Münster4 aut
7001 a Jachimowicz, Ron D.u University Hospital of Cologne4 aut
7001 a Celli, Melania4 aut
7001 a Hess, Georgu Universitätsmedizin Mainz4 aut
7001 a Arcaini, Lucau University of Pavia,Policlinico San Matteo Pavia Fondazione4 aut
7001 a Visco, Carlou Verona University Medical School,Ospedale San Bortolo4 aut
7001 a van Meerten, Tomu University Medical Center Groningen4 aut
7001 a Wirths, Stefanu University Hospital of Tubingen4 aut
7001 a Zinzani, Pier Luigiu St. Orsola-Malpighi University Hospital,University of Bologna4 aut
7001 a Novak, Urbanu Bern University Hospital4 aut
7001 a Herhaus, Peteru Technical University of Munich4 aut
7001 a Benedetti, Fabiou University of Verona4 aut
7001 a Sonnevi, Kristinau Karolinska Institute4 aut
7001 a Hanoun, Christineu University Hospital Essen4 aut
7001 a Hänel, Matthias4 aut
7001 a Dierlamm, Judith4 aut
7001 a Pott, Christianeu University Medical Center Schleswig-Holstein4 aut
7001 a Klapper, Wolframu University Medical Center Schleswig-Holstein4 aut
7001 a Gözel, Döndüu University Hospital Munich4 aut
7001 a Schmidt, Christianu University Hospital Munich4 aut
7001 a Unterhalt, Michaelu University Hospital Munich4 aut
7001 a Ladetto, Marcou University of Eastern Piedmont4 aut
7001 a Hoster, Evau Ludwig-Maximilian University of Munich4 aut
7102 a University Hospital Munichb Erasmus University Medical Center4 org
7730 t The Lancetg 403:10441, s. 2293-2306q 403:10441<2293-2306x 0140-6736
8564 u http://dx.doi.org/10.1016/S0140-6736(24)00184-3x freey FULLTEXT
8564 8u https://lup.lub.lu.se/record/9b9b00ca-3492-4083-854f-8af5d1f729bb
8564 8u https://doi.org/10.1016/S0140-6736(24)00184-3

Hitta via bibliotek

Till lärosätets databas

Kungliga biblioteket hanterar dina personuppgifter i enlighet med EU:s dataskyddsförordning (2018), GDPR. Läs mer om hur det funkar här.
Så här hanterar KB dina uppgifter vid användning av denna tjänst.

 
pil uppåt Stäng

Kopiera och spara länken för att återkomma till aktuell vy