title: Randomized study to evaluate the use of high-dose therapy as part of primary treatment for "aggressive" lymphoma.
abstract: OBJECTIVE
  This trial of the German High-Grade Non-Hodgkin's Lymphoma Study Group compares the use of high-dose therapy (HDT) as part of primary treatment with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) plus etoposide followed by involved-field (IF) radiotherapy in a randomized, multicenter, phase III study.
  
  
  METHODS
  Three hundred twelve patients with "aggressive" non-Hodgkin's lymphoma aged <or= 60 years with elevated serum lactate dehydrogenase levels were included from 1990 to 1997. Patients with at least a minor response after two cycles of CHOEP (CHOP + etoposide 3 x 100 mg/m(2)) were to receive three further cycles of CHOEP followed by IF radiotherapy (arm A) or one further cycle of CHOEP followed by autologous stem-cell transplantation and IF radiotherapy (arm B).
  
  
  RESULTS
  Among 158 patients randomized to arm B, 103 (65%) received HDT. The complete remission rate at the end of treatment was 62.9% in arm A and 69.9% in arm B. With a median observation time of 45.5 months, overall survival for all 312 patients was 63% after 3 years (63% for arm A, 62% for arm B; P =.68). Event-free survival was 49% for arm A versus 59% for arm B (P =.22). Relapse in arm B was associated with a significantly worse survival rate than relapse in arm A (P <.05). Relapse after HDT occurred early (median interval, 3 months). Six patients developed secondary neoplasia, three in arm A and three in arm B.
  
  
  CONCLUSIONS
  Results of the randomized trial comparing CHOP-like chemotherapy with early HDT do not support the use of HDT with carmustine, etoposide, cytarabine, and melphalan following shortened standard chemotherapy.
authors.affiliation: Department of Hematology, Universitätsklinikum Marburg, Germany. pd.dr.u.kaiser@bernward-khs.de
authors.forename: Ulrich
authors.initials: U
authors.lastname: Kaiser
authors.forename: Irmgard
authors.initials: I
authors.lastname: Uebelacker
authors.forename: Ulrich
authors.initials: U
authors.lastname: Abel
authors.forename: Josef
authors.initials: J
authors.lastname: Birkmann
authors.forename: Lorenz
authors.initials: L
authors.lastname: Trümper
authors.forename: Harald
authors.initials: H
authors.lastname: Schmalenberg
authors.forename: Tunca
authors.initials: T
authors.lastname: Karakas
authors.forename: Bernd
authors.initials: B
authors.lastname: Metzner
authors.forename: Dieter K
authors.initials: DK
authors.lastname: Hossfeld
authors.forename: Helge G
authors.initials: HG
authors.lastname: Bischoff
authors.forename: Astrid
authors.initials: A
authors.lastname: Franke
authors.forename: Marcel
authors.initials: M
authors.lastname: Reiser
authors.forename: Peter
authors.initials: P
authors.lastname: Müller
authors.forename: Luisa
authors.initials: L
authors.lastname: Mantovani
authors.forename: Marc
authors.initials: M
authors.lastname: Grundeis
authors.forename: Frank
authors.initials: F
authors.lastname: Rothmann
authors.forename: Cay-Uwe
authors.initials: CU
authors.lastname: von Seydewitz
authors.forename: Rolf M
authors.initials: RM
authors.lastname: Mesters
authors.forename: Ernst U
authors.initials: EU
authors.lastname: Steinhauer
authors.forename: Dorothea
authors.initials: D
authors.lastname: Krahl
authors.forename: Kurt
authors.initials: K
authors.lastname: Schumacher
authors.forename: Michael
authors.initials: M
authors.lastname: Kneba
authors.forename: Michael
authors.initials: M
authors.lastname: Baudis
authors.forename: Norbert
authors.initials: N
authors.lastname: Schmitz
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Pfab
authors.forename: Hubert
authors.initials: H
authors.lastname: Köppler
authors.forename: Reza
authors.initials: R
authors.lastname: Parwaresch
authors.forename: Michael
authors.initials: M
authors.lastname: Pfreundschuh
authors.forename: Klaus
authors.initials: K
authors.lastname: Havemann
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D002330:Carmustine / Q000008:administration & dosage; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage; D003561:Cytarabine / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D005858:Germany; D006801:Humans; D007770:L-Lactate Dehydrogenase / Q000097:blood*; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy / Q000201:enzymology* / Q000532:radiotherapy / Q000628:therapy*; D008297:Male; D008558:Melphalan / Q000008:administration & dosage; D008875:Middle Aged; D011239:Prednisolone / Q000008:administration & dosage; D011379:Prognosis; D011446:Prospective Studies; D018714:Radiotherapy, Adjuvant; D012306:Risk; D033581:Stem Cell Transplantation; D016019:Survival Analysis; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D003561:Cytarabine; D014750:Vincristine; D005047:Etoposide; D004317:Doxorubicin; D003520:Cyclophosphamide; D011239:Prednisolone; D007770:L-Lactate Dehydrogenase; D008558:Melphalan; D002330:Carmustine