Final results of a phase II study of CHOEP plus lenalidomide as initial therapy for patients with stage II-IV peripheral T-cell lymphoma.
T-cell lymphoma
clinical trials
lymphomas
malignant lymphomas
non-Hodgkins lymphoma
trials
Journal
British journal of haematology
ISSN: 1365-2141
Titre abrégé: Br J Haematol
Pays: England
ID NLM: 0372544
Informations de publication
Date de publication:
08 2023
08 2023
Historique:
revised:
13
05
2023
received:
19
03
2023
accepted:
15
05
2023
medline:
26
7
2023
pubmed:
23
5
2023
entrez:
22
5
2023
Statut:
ppublish
Résumé
There remains no one standard induction for nodal-based peripheral T-cell lymphoma (PTCL). We conducted a phase II study of lenalidomide plus CHOEP as a novel induction strategy. Patients received CHOEP at standard doses in combination with 10 mg of lenalidomide on days 1-10 of a 21-day cycle for six cycles of therapy followed by observation, high-dose therapy with autologous stem cell rescue, or maintenance lenalidomide per provider preference. Among 39 patients evaluable for efficacy, the objective response rate after six cycles was 69%, with complete response in 49%, partial response in 21%, stable disease in 0% and progressive disease in 13%. Thirty-two patients (82%) completed full induction, and seven patients (18%) discontinued for toxicity, primarily hematologic. Any grade hematologic toxicity occurred in over 50% of patients, with grade 3 or 4 febrile neutropenia occurring in 35% of patients despite mandated growth factors. With a median followup of surviving patients of 21.3 months, the estimated 2-year progression-free and overall survival were 55% (95% CI 37%-70%) and 78% (95% CI 59%-89%), respectively. In sum, six cycles of lenalidomide plus CHOEP resulted in a modest response rate primarily due to hematologic toxicity, which prevented all patients from completing planned induction.
Substances chimiques
Lenalidomide
F0P408N6V4
Types de publication
Clinical Trial, Phase II
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
525-529Informations de copyright
© 2023 British Society for Haematology and John Wiley & Sons Ltd.
Références
Vose J, Armitage J, Weisenburger D, International T-Cell Lymphoma Project. International peripheral T-cell and natural killer/T-cell lymphoma study: pathology findings and clinical outcomes. J Clin Oncol. 2008;26(25):4124-30.
Morschhauser F, Fitoussi O, Haioun C, Thieblemont C, Quach H, Delarue R, et al. A phase 2, multicentre, single-arm, open-label study to evaluate the safety and efficacy of single-agent lenalidomide (Revlimid) in subjects with relapsed or refractory peripheral T-cell non-Hodgkin lymphoma: the EXPECT trial. Eur J Cancer. 2013;49(13):2869-76.
Toumishey E, Prasad A, Dueck G, Chua N, Finch D, Johnston J, et al. Final report of a phase 2 clinical trial of lenalidomide monotherapy for patients with T-cell lymphoma. Cancer. 2015;121(5):716-23.
Savage KJ, Chhanabhai M, Gascoyne RD, Connors JM. Characterization of peripheral T-cell lymphomas in a single North American institution by the WHO classification. Ann Oncol. 2004;15(10):1467-75.
Schmitz N, Trümper L, Ziepert M, Nickelsen M, Ho AD, Metzner B, et al. Treatment and prognosis of mature T-cell and NK-cell lymphoma: an analysis of patients with T-cell lymphoma treated in studies of the German High-Grade Non-Hodgkin Lymphoma Study Group. Blood. 2010;116(18):3418-25.
Brink M, Meeuwes FO, Van Der Poel MWM, Kersten MJ, Wondergem M, Mutsaers PGNJ, et al. Impact of etoposide and ASCT on survival among patients aged <65 years with stage II to IV PTCL: a population-based cohort study. Blood. 2022;140(9):1009-19.
Lemonnier F, Safar V, Beldi-Ferchiou A, Cottereau AS, Bachy E, Cartron G, et al. Integrative analysis of a phase 2 trial combining lenalidomide with CHOP in angioimmunoblastic T-cell lymphoma. Blood Adv. 2021;5(2):539-48.
Pfreundschuh M, Trümper L, Kloess M, Schmits R, Feller AC, Rudolph C, et al. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of elderly patients with aggressive lymphomas: results of the NHL-B2 trial of the DSHNHL. Blood. 2004;104(3):634-41.
Castellino A, Chiappella A, LaPlant BR, Pederson LD, Gaidano G, Macon WR, et al. Lenalidomide plus R-CHOP21 in newly diagnosed diffuse large B-cell lymphoma (DLBCL): long-term follow-up results from a combined analysis from two phase 2 trials. Blood Cancer J. 2018;8:108.
Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, et al. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomized, phase 3 trial. Lancet. 2019;393(10168):229-40.
d'Amore F, Leppä S, da SMG, Silva MG, Relander T, Lauritzsen GF, et al. Final analysis of the front-line phase III randomized ACT-1 trial in younger patients with systemic peripheral T-cell lymphoma treated with CHOP chemotherapy with or without alemtuzumab and consolidated by autologous hematopoietic stem cell transplant. Blood. 2018;132(Supplement 1):998-8.
Wulf GG, Altmann B, Ziepert M, D'Amore F, Held G, Greil R, et al. Alemtuzumab plus CHOP versus CHOP in elderly patients with peripheral T-cell lymphoma: the DSHNHL2006-1B/ACT-2 trial. Leukemia. 2021;35(1):143-55.
Bachy E, Camus V, Thieblemont C, Sibon D, Casasnovas RO, Ysebaert L, et al. Romidepsin plus CHOP versus CHOP in patients with previously untreated peripheral T-cell lymphoma: results of the Ro-CHOP phase III study (conducted by LYSA). J Clin Oncol. 2022;40(3):242-51.
Chiappella A, Dodero A, Evangelista A, Re A, Orsucci L, Usai SV, et al. Romidepsin-CHOEP followed by high-dose chemotherapy and stem-cell transplantation in untreated Peripheral T-Cell Lymphoma: results of the PTCL13 phase Ib/II study. Leukemia. 2023;37(2):433-40.
Ruan J, Moskowitz AJ, Mehta-Shah N, Sokol L, Chen Z, Kotlov N, et al. Multicenter phase 2 study of oral azacytidine (CC-486) plus CHOP as initial treatment for peripheral T-cell lymphoma. Blood. 2023;141(18):2194-205.