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Title: Frontline bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) versus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in transplantation-ineligible patients with newly diagnosed mantle cell lymphoma: final overall survival results of a randomised, open-label, phase 3 study
Authors: Tadeusz Robak
Jie Jin
Halyna Pylypenko
Gregor Verhoef
Noppadol Siritanaratkul
Johannes Drach
Markus Raderer
Jiri Mayer
Juliana Pereira
Gayane Tumyan
Rumiko Okamoto
Susumu Nakahara
Peter Hu
Carlos Appiani
Sepideh Nemat
Franco Cavalli
Achiel Van Hoof
Adriana Sheliga
Adriana Teixeira
Akihiro Tomita
Albert Oriol Rocafiguera
Alexander Suvorov
Alexy Kuzmin
Ali Khojasteh
Amel Mezlini
Anatoly Golenkov
Andre Bosly
Andrew Belch
Ann Van De Velde
Árpád Illes
Ashis Mukhopadhyay
Balkis Meddeb
Bernard De Prijck
Bernardo Garichochea
Bulent Undar
Caballero Gabarrón
Carmen Cao
Carmino Souza
Charles Farber
Cheol Won Suh
Cristina Ileana Burcoveanu
Cristina Ligia Cebotaru
Cristina Ligia Truica
Dai Maruyama
David Belada
Dina Ben Yehuda
Dmitry Udovitsa
Enrica Morra
Ernst Späth-Schwalbe
Eva Gonzalez-Barca
Evgenii Osmanov
Francisco Javier Capote
Fritz Offner
Galvez Cardenas
Georg Heß
Georgii Manikhas
Govind Babu
Grigoriy Rekhtman
Guiseppe Rossi
Herlander Marques
Horia Bumbea
Huaqing Wang
Huiqiang Huang
Ilseung Choi
Irina Bulavina
Irina Lysenko
Irit Avivi
Iryna Kryachok
Jan Maciej Zaucha
Jan Novak
Joaquín Díaz
Judit Demeter
Julia Alexeeva
Jun Zhu
Kateryna Vilchevskaya
Kenichi Ishizawa
Kenny Mauricio
Kensei Tobinai
Kiyoshi Ando
Kudrat Abdulkadryrov
Lee Yung Shih
Lyudmila Kuzina
Mahmut Gumus
Maike De Wit
Marcelo Capra
Margarida Marques
Marina Golubeva
Mario Ojeda-Uribe
Maryna Kyselyova
Masafumi Taniwaki
Massimo Federico
Michael Crump
Michele Baccarani
Michinori Ogura
Miklós Egyed
Miklos Udvardy
Mitsutoshi Kurosawa
Naokuni Uike
Nuriet Khuageva
The First Affiliated Hospital, Zhejiang University School of Medicine
Cherkassy Regional Oncology Center
Janssen Research & Development
N.N. Blokhin Russian Cancer Research Center, Russian Academy of Medical Sciences
KU Leuven– University Hospital Leuven
Masaryk University
Allgemeines KrankenHaus Wien
Ospedale San Giovanni
Medizinische Universitat Wien
Faculty of Medicine, Siriraj Hospital, Mahidol University
Universidade de Sao Paulo - USP
Medical University of Lodz
Janssen Pharmaceutical
Chibanishi General Hospital
Keywords: Medicine
Issue Date: 1-Nov-2018
Citation: The Lancet Oncology. Vol.19, No.11 (2018), 1449-1458
Abstract: © 2018 Elsevier Ltd Background: In the LYM-3002 study, the efficacy and safety of frontline bortezomib plus rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) and rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) were compared in transplant-ineligible patients with untreated, newly diagnosed, mantle cell lymphoma. We report the final overall survival and safety outcomes for patients in the long-term follow-up phase after the primary progression-free-survival endpoint was met. Methods: LYM-3002 was a randomised, open-label, phase 3 study done at 128 clinical centres in 28 countries in Asia, Europe, North America, and South America. Adult patients with confirmed stage II–IV previously untreated mantle cell lymphoma, Eastern Cooperative Oncology Group performance status score of 2 or less, who were ineligible for bone marrow transplantation, were randomly assigned (1:1) to receive six or eight 21-day cycles of VR-CAP (intravenous rituximab 375 mg/m2, cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, and bortezomib 1·3 mg/m2, plus oral prednisone 100 mg/m2) or R-CHOP (intravenous vincristine 1·4 mg/m2 [2 mg maximum], rituximab 375 mg/m2, cyclophosphamide 750 mg/m2, and doxorubicin 50 mg/m2, plus oral prednisone 100 mg/m2). Randomisation was done according to a computer-generated randomisation schedule prepared by the sponsor; permuted blocks central randomisation was used (block size of 4), and was stratified by International Prognostic Index score and disease stage at diagnosis. The primary endpoint of this final analysis was overall survival, which was analysed in the intention-to-treat population. This study is registered with, number NCT00722137, and is closed to new participants with follow-up completed. Findings: Between May 22, 2008, and Dec 5, 2011, 487 patients were enrolled and randomly assigned. 268 patients (140 in the VR-CAP group and 128 in the R-CHOP group) were included in the follow-up analysis, which included patients with data available after the primary analysis clinical cutoff date of Dec 2, 2013. After median follow-up of 82·0 months (IQR 74·1–94·2), median overall survival was significantly longer in the VR-CAP group than in the R-CHOP group (90·7 months [95% CI 71·4 to not estimable] vs 55·7 months [47·2 to 68·9]; hazard ratio 0·66 [95% CI 0·51–0·85]; p=0·001). Three new adverse events were reported since the primary analysis cutoff (one each of grade 4 lung adenocarcinoma and grade 4 gastric cancer in the VR-CAP group, and one case of grade 2 pneumonia in the R-CHOP group). 103 (42%) of 243 patients in the VR-CAP group, and 138 (57%) of 244 in the R-CHOP group died; the most common cause of death was progressive disease. Interpretations: Compared with R-CHOP, VR-CAP was associated with significantly longer survival, and had a manageable and expected safety profile. Our results support further assessment of VR-CAP in patients with previously untreated mantle cell lymphoma. Funding: Janssen Research & Development.
ISSN: 14745488
Appears in Collections:Scopus 2018

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