title: Up-front autologous stem-cell transplantation in peripheral T-cell lymphoma: NLG-T-01.
abstract: OBJECTIVE
  Systemic peripheral T-cell lymphomas (PTCLs) respond poorly to conventional therapy. To evaluate the efficacy of a dose-dense approach consolidated by up-front high-dose chemotherapy (HDT) and autologous stem-cell transplantation (ASCT) in PTCL, the Nordic Lymphoma Group (NLG) conducted a large prospective phase II study in untreated systemic PTCL. This is the final report, with a 5-year median follow-up, of the NLG-T-01 study.
  
  
  METHODS
  Treatment-naive patients with PTCL age 18 to 67 years (median, 57 years) were included. Anaplastic lymphoma kinase (ALK) -positive anaplastic large-cell lymphoma (ALCL) was excluded. An induction regimen of six cycles of biweekly CHOEP (cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone) was administered (in patients age > 60 years, etoposide was omitted). If in complete or partial remission, patients proceeded to consolidation with HDT/ASCT.
  
  
  RESULTS
  Of 166 enrolled patients, 160 had histopathologically confirmed PTCL. The majority presented with advanced-stage disease, B symptoms, and elevated serum lactate dehydrogenase. A total of 115 underwent HDT/ASCT, with 90 in complete remission at 3 months post-transplantation. Early failures occurred in 26%. Treatment-related mortality was 4%. At 60.5 months of median follow-up, 83 patients were alive. Consolidated 5-year overall and progression-free survival (PFS) were 51% (95% CI, 43% to 59%) and 44% (95% CI, 36% to 52%), respectively. Best results were obtained in ALK-negative ALCL.
  
  
  CONCLUSIONS
  Dose-dense induction followed by HDT/ASCT was well tolerated and led to long-term PFS in 44% of treatment-naive patients with PTCL. This represents an encouraging outcome, particularly considering the high median age and adverse risk profile of the study population. Therefore, dose-dense induction and HDT/ASCT are a rational up-front strategy in transplantation-eligible patients with PTCL.
authors.affiliation: Dept. Hematology, Aarhus University Hospital, DK-8000 Aarhus C, Denmark. frandamo@rm.dk
authors.forename: Francesco
authors.initials: F
authors.lastname: d'Amore
authors.forename: Thomas
authors.initials: T
authors.lastname: Relander
authors.forename: Grete F
authors.initials: GF
authors.lastname: Lauritzsen
authors.forename: Esa
authors.initials: E
authors.lastname: Jantunen
authors.forename: Hans
authors.initials: H
authors.lastname: Hagberg
authors.forename: Harald
authors.initials: H
authors.lastname: Anderson
authors.forename: Harald
authors.initials: H
authors.lastname: Holte
authors.forename: Anders
authors.initials: A
authors.lastname: Österborg
authors.forename: Mats
authors.initials: M
authors.lastname: Merup
authors.forename: Peter
authors.initials: P
authors.lastname: Brown
authors.forename: Outi
authors.initials: O
authors.lastname: Kuittinen
authors.forename: Martin
authors.initials: M
authors.lastname: Erlanson
authors.forename: Bjørn
authors.initials: B
authors.lastname: Østenstad
authors.forename: Unn-Merete
authors.initials: UM
authors.lastname: Fagerli
authors.forename: Ole V
authors.initials: OV
authors.lastname: Gadeberg
authors.forename: Christer
authors.initials: C
authors.lastname: Sundström
authors.forename: Jan
authors.initials: J
authors.lastname: Delabie
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Ralfkiaer
authors.forename: Martine
authors.initials: M
authors.lastname: Vornanen
authors.forename: Helle E
authors.initials: HE
authors.lastname: Toldbod
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage; D018450:Disease Progression; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D005047:Etoposide / Q000008:administration & dosage; D005060:Europe; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D016411:Lymphoma, T-Cell, Peripheral / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D020360:Neoadjuvant Therapy; D011241:Prednisone / Q000008:administration & dosage; D016016:Proportional Hazards Models; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D033581:Stem Cell Transplantation / Q000009:adverse effects / Q000401:mortality; D013997:Time Factors; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D014750:Vincristine; D005047:Etoposide; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone