A randomized phase 3 trial of autologous vs allogeneic transplantation as part of first-line therapy in poor-risk peripheral T-NHL

Blood. 2021 May 13;137(19):2646-2656. doi: 10.1182/blood.2020008825.

Abstract

First-line therapy for younger patients with peripheral T-cell non-Hodgkin lymphoma (T-NHL) consists of 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) with or without etoposide (CHOEP), consolidated by high-dose therapy and autologous stem cell transplantation (auto-SCT). We hypothesized that allogeneic stem cell transplantation (allo-SCT) could improve outcomes. 104 patients with peripheral T-cell non-Hodgkin lymphoma, except ALK+ anaplastic large cell lymphoma, 18 to 60 years, all stages, and all age adjusted International Prognostic Index scores, except 0 and stage I, were randomized to 4 cycles of CHOEP and 1 cycle of dexamethasone, cytosine-arabinoside, and platinum (DHAP) followed by high-dose therapy and auto-SCT or myeloablative conditioning and allo-SCT. The primary end point was event-free survival (EFS) at 3 years. After a median follow-up of 42 months, the 3-year EFS after allo-SCT was 43%, as compared with 38% after auto-SCT. Overall survival at 3 years was 57% vs 70% after allo- or auto-SCT, without significant differences between treatment arms. None of the 21 responding patients proceeding to allo-SCT relapsed, as opposed to 13 of 36 patients (36%) proceeding to auto-SCT. Eight of 26 patients (31%) and none of 41 patients died of transplant-related toxicity after allo- and auto-SCT, respectively. The strong graft-versus-lymphoma effect after allo-SCT was counterbalanced by transplant-related mortality. This trial is registered at www.clinicaltrials.gov as #NCT00984412.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Allografts
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Cisplatin / administration & dosage
  • Combined Modality Therapy
  • Consolidation Chemotherapy
  • Cyclophosphamide / administration & dosage
  • Cytarabine / administration & dosage
  • Dexamethasone / administration & dosage
  • Doxorubicin / administration & dosage
  • Etoposide / administration & dosage
  • Female
  • Graft vs Host Disease / etiology
  • Humans
  • Kaplan-Meier Estimate
  • Lymphoma, T-Cell, Peripheral / therapy*
  • Male
  • Middle Aged
  • Myeloablative Agonists / therapeutic use
  • Neoplasms, Second Primary / etiology
  • Peripheral Blood Stem Cell Transplantation*
  • Prednisolone / administration & dosage
  • Prospective Studies
  • Risk
  • Transplantation Conditioning
  • Transplantation, Autologous
  • Vincristine / administration & dosage

Substances

  • Myeloablative Agonists
  • Cytarabine
  • Vincristine
  • Etoposide
  • Dexamethasone
  • Doxorubicin
  • Cyclophosphamide
  • Prednisolone
  • Cisplatin

Supplementary concepts

  • CHOEP protocol
  • DHAP protocol

Associated data

  • ClinicalTrials.gov/NCT00984412