Long-term results of the MCL01 phase II trial of rituximab plus HyperCVAD alternating with high-dose cytarabine and methotrexate for the initial treatment of patients with mantle cell lymphoma.
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols
/ administration & dosage
Autografts
Cyclophosphamide
/ administration & dosage
Cytarabine
/ administration & dosage
Dexamethasone
/ administration & dosage
Disease-Free Survival
Doxorubicin
/ administration & dosage
Female
Follow-Up Studies
Humans
Lymphoma, Mantle-Cell
/ drug therapy
Male
Methotrexate
/ administration & dosage
Middle Aged
Rituximab
/ administration & dosage
Stem Cell Transplantation
Survival Rate
Vincristine
/ administration & dosage
Hyper-CVAD-AM
long-term analysis
mantle cell lymphoma
second malignancies
survival
Journal
British journal of haematology
ISSN: 1365-2141
Titre abrégé: Br J Haematol
Pays: England
ID NLM: 0372544
Informations de publication
Date de publication:
03 2021
03 2021
Historique:
revised:
10
04
2020
received:
21
02
2020
accepted:
12
04
2020
pubmed:
16
5
2020
medline:
3
8
2021
entrez:
16
5
2020
Statut:
ppublish
Résumé
Mantle cell lymphoma is a rare and incurable lymphoproliferative disorder. In the MCL01 trial, patients were treated with the R-HCVAD regimen [rituximab plus HyperCVAD (hyperfractionated cyclophosphamide, vincristine, doxorubicin, dexamethasone; R-CVAD) alternating with high-dose methotrexate and cytarabine (AM)] for four cycles followed by autologous stem cell transplantation (ASCT) for those who reached only a partial response. After a median follow-up of 10·5 years, we reported 10-year progression-free and overall survival rates of 35% and 61% respectively, with a 10-years cumulative incidence rate of second malignancies of 10·6%. Mature results of the MCL01 trial confirmed the efficacy of HyperCVAD-AM as a frontline regimen for younger patients (≤65 years).
Substances chimiques
Cytarabine
04079A1RDZ
Rituximab
4F4X42SYQ6
Vincristine
5J49Q6B70F
Dexamethasone
7S5I7G3JQL
Doxorubicin
80168379AG
Cyclophosphamide
8N3DW7272P
Methotrexate
YL5FZ2Y5U1
Types de publication
Clinical Trial, Phase II
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1011-1014Subventions
Organisme : Gr.A.D.E. Onlus (Gruppo Amici Dell'Ematologia-Onlus)
Organisme : Associazione Angela Serra per la Ricerca sul Cancro
Informations de copyright
© 2020 British Society for Haematology and John Wiley & Sons Ltd.
Références
Dreyling M, & European Mantle Cell Lymphoma Network Mantle Cell lymphoma: biology, clinical presentation, and therapeutic approaches. Am Soc Clin Oncol Educat Book. 2014:191-8.
Chihara D, Cheah CY, Westin JR, Fayad LE, Rodriguez MA, Hagemeister FB, et al. Rituximab plus hyper-CVAD alternating with MTX/Ara-C in patients with newly diagnosed mantle cell lymphoma: 15-year follow-up of a phase II study from the MD Anderson Cancer Center. Br J Haematol. 2016;172:80-8.
Geisler CH, Kolstad A, Laurell A, Andersen NS, Pedersen LB, Jerkeman M, et al. Long-term progression-free survival of mantle cell lymphoma after intensive front-line immunochemotherapy with in vivo-purged stem cell rescue: a nonrandomized phase 2 multicenter study by the Nordic Lymphoma Group. Blood. 2008;112:2687-93.
Merli F, Luminari S, Ilariucci F, Petrini M, Visco C, Ambrosetti A, et al. Rituximab plus HyperCVAD alternating with high dose cytarabine and methotrexate for the initial treatment of patients with mantle cell lymphoma, a multicentre trial from Gruppo Italiano Studio Linfomi. Br J Haematol. 2012;156:346-53.
Romaguera J, Hagemeister FB. Lymphoma of the colon. Curr Opin Gastroenterol. 2005;21:80-4.
Visco C, Chiappella A, Nassi L, Patti C, Ferrero S, Barbero D, et al. Rituximab, bendamustine, and low-dose cytarabine as induction therapy in elderly patients with mantle cell lymphoma: a multicentre, phase 2 trial from Fondazione Italiana Linfomi. The Lancet. Haematology. 2017;4:e15-e23.
Flinn IW, van der Jagt R, Kahl B, Wood P, Hawkins T, MacDonald D, et al. First-line treatment of patients with indolent non-hodgkin lymphoma or mantle-cell lymphoma with bendamustine plus rituximab versus R-CHOP or R-CVP: results of the BRIGHT 5-year follow-up study. J Clin Oncol. 2019;37:984-91.
Kluin-Nelemans HC, Hoster E, Hermine O, Walewski J, Trneny M, Geisler CH, et al. Treatment of older patients with mantle-cell lymphoma. New Engl J Med. 2012;367:520-31.
Robak T, Huang H, Jin J, Zhu J, Liu T, Samoilova O, et al. Bortezomib-based therapy for newly diagnosed mantle-cell lymphoma. New Engl J Med. 2015;372:944-53.
Rummel, M, Kaiser, U, Balser, C, Stauch, M, Brugger, W, Welslau, M, et al. & Study Group Indolent Lymphomas. Bendamustine plus rituximab versus fludarabine plus rituximab for patients with relapsed indolent and mantle-cell lymphomas: a multicentre, randomised, open-label, non-inferiority phase 3 trial. Lancet Oncol. 2016;17:57-66.
Romaguera JE, Fayad LE, Feng L, Hartig K, Weaver P, Rodriguez MA, et al. Ten-year follow-up after intense chemoimmunotherapy with Rituximab-HyperCVAD alternating with Rituximab-high dose methotrexate/cytarabine (R-MA) and without stem cell transplantation in patients with untreated aggressive mantle cell lymphoma. Br J Haematol. 2010;150:200-8.
Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, et al. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007;25:579-86.
Eskelund CW, Kolstad A, Jerkeman M, Räty R, Laurell A, Eloranta S, et al. 15-year follow-up of the Second Nordic Mantle Cell Lymphoma trial (MCL2): prolonged remissions without survival plateau. Br J Haematol. 2016;175:410-8.
Hermine O, Hoster E, Walewski J, Bosly A, Stilgenbauer S, Thieblemont C, et al. 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 N. Lancet (London, England). 2016;388:565-75.
Visco C, Tisi MC, Evangelista A, Di Rocco A, Zoellner A-K, Zilioli VR, et al. Time to progression of mantle cell lymphoma after high-dose cytarabine-based regimens defines patients risk for death. Br J Haematol. 2019;185:940-4.