Hermine, Olivier ORCID: 0000-0003-2574-3874, Hoster, Eva ORCID: 0000-0002-0749-1389, Walewski, Jan ORCID: 0000-0003-4247-2674, Bosly, Andre, Stilgenbauer, Stephan, Thieblemont, Catherine ORCID: 0000-0002-9941-2448, Szymczyk, Michal, Bouabdallah, Reda, Kneba, Michael, Hallek, Michael, Salles, Gilles ORCID: 0000-0002-9541-8666, Feugier, Pierre, Ribrag, Vincent, Birkmann, Josef, Forstpointner, Roswitha, Haioun, Corinne, Haenel, Mathias, Casasnovas, Rene Olivier, Finke, Juergen, Peter, Norma, Bouabdallah, Kamal, Sebban, Catherine, Fischer, Thomas, Duehrsen, Ulrich, Metzner, Bernd, Maschmeyer, Georg, Kanz, Lothar, Schmidt, Christian, Delarue, Richard, Brousse, Nicole, Klapper, Wolfram, Macintyre, Elizabeth, Delfau-Larue, Marie-Helene, Pott, Christiane, Hiddemann, Wolfgang, Unterhalt, Michael and Dreyling, Martin (2016). Addition of high-dose cytarabine to immunochemotherapy before autologous stem-cell transplantation in patients aged 65 years or younger with mantle cell lymphoma (MCL Younger): a randomised, open-label, phase 3 trial of the European Mantle Cell Lymphoma Network. Lancet, 388 (10044). S. 565 - 576. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1474-547X

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Abstract

Background Mantle cell lymphoma is characterised by a poor long-term prognosis. The European Mantle Cell Lymphoma Network aimed to investigate whether the introduction of high-dose cytarabine to immunochemotherapy before autologous stem-cell transplantation (ASCT) improves outcome. Methods This randomised, open-label, parallel-group, phase 3 trial was done in 128 haemato-oncological hospital departments or private practices in Germany, France, Belgium, and Poland. Patients aged 65 years or younger with untreated stage II IV mantle cell lymphoma were centrally randomised (1:1), with computer-assisted random block selection, to receive either six courses of R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) followed by myeloablative radiochemotherapy and AS CT (control group), or six courses of alternating R-CHOP or R-DHAP (rituximab plus dexamethasone, high-dose cytarabine, and cisplatin) followed by a high-dose cytarabine-containing conditioning regimen and AS CT (cytarabine group). Patients were stratified by study group and international prognostic index. The primary outcome was time to treatment failure from randomisation to stable disease after at least four induction cycles, progression, or death from any cause. Patients with stage II IV mantle cell lymphoma were included in the primary analysis if treatment was started according to randomisation. For safety analyses, patients were assessed according to the treatment actually started. This study is registered with ClinicalTrials.gov, number NCT00209222. Findings Of 497 patients (median age 55 years [IQR 49-60]) randomised from July 20,2004, to March 18,2010,234 of 249 in the control group and 232 of 248 in the cytarabine group were included in the primary analysis. After a median follow-up of 6.1 years (95% CI 5.4-6.4), time to treatment failure was significantly longer in the cytarabine group (median 9.1 years [95% CI 6.3 not reached], 5 year rate 65% [95% CI 57-71]) than in the control group (3 9 years [3.2-4 4], 40% [33-46]; hazard ratio 0.56; p=0.038). During induction immunochemotherapy, patients who received high-dose cytarabine had increased grade 3 or 4 haematological toxicity (haemoglobin 71 [29%] of 241 vs 19 [8%] of 227 controls; platelets 176 [73%] of 240 vs 21 [9%] of 225), grade 3 or 4 febrile neutropenia (39 [17%] of 230 vs 19 [8%] of 224), and grade 1 or 2 renal toxicity (creatinine 102 [43%] of 236 vs 22 [10%] of 224). The number of AS CT-related deaths was similar (eight [3.4%]) in both groups. Interpretation Immunochemotherapy containing high-dose cytarabine followed by ASCT should be considered standard of care in patients aged 65 years or younger with mantle cell lymphoma.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Hermine, OlivierUNSPECIFIEDorcid.org/0000-0003-2574-3874UNSPECIFIED
Hoster, EvaUNSPECIFIEDorcid.org/0000-0002-0749-1389UNSPECIFIED
Walewski, JanUNSPECIFIEDorcid.org/0000-0003-4247-2674UNSPECIFIED
Bosly, AndreUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stilgenbauer, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Thieblemont, CatherineUNSPECIFIEDorcid.org/0000-0002-9941-2448UNSPECIFIED
Szymczyk, MichalUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bouabdallah, RedaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kneba, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hallek, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Salles, GillesUNSPECIFIEDorcid.org/0000-0002-9541-8666UNSPECIFIED
Feugier, PierreUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ribrag, VincentUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Birkmann, JosefUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Forstpointner, RoswithaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haioun, CorinneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haenel, MathiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Casasnovas, Rene OlivierUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Finke, JuergenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Peter, NormaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bouabdallah, KamalUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sebban, CatherineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fischer, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Duehrsen, UlrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Metzner, BerndUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Maschmeyer, GeorgUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kanz, LotharUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmidt, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Delarue, RichardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Brousse, NicoleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Klapper, WolframUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Macintyre, ElizabethUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Delfau-Larue, Marie-HeleneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pott, ChristianeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hiddemann, WolfgangUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Unterhalt, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dreyling, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-266753
DOI: 10.1016/S0140-6736(16)00739-X
Journal or Publication Title: Lancet
Volume: 388
Number: 10044
Page Range: S. 565 - 576
Date: 2016
Publisher: ELSEVIER SCIENCE INC
Place of Publication: NEW YORK
ISSN: 1474-547X
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
1ST-LINE TREATMENT; RESPONSE CRITERIA; PLUS RITUXIMAB; FREE SURVIVAL; FOLLOW-UP; THERAPY; CHOP; INDOLENT; TEMSIROLIMUS; MULTICENTERMultiple languages
Medicine, General & InternalMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/26675

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