Aggressive conventional chemotherapy compared with high-dose chemotherapy with autologous haemopoietic stem-cell transplantation for relapsed chemosensitive Hodgkin's disease: a randomised trial.
BACKGROUND
High-dose chemotherapy followed by transplantation of autologous haemopoietic stem cells (BEAM-HSCT) is frequently used to treat patients with relapsed Hodgkin's disease. We aimed to compare this treatment with conventional aggressive chemotherapy without stem-cell transplantation (Dexa-BEAM).


METHODS
161 patients between 16 and 60 years of age with relapsed Hodgkin's disease were randomly assigned two cycles of Dexa-BEAM (dexamethasone and carmustine, etoposide, cytarabine, and melphalan) and either two further courses of Dexa-BEAM or high-dose BEAM and transplantation of haemopoietic stem cells. Only patients with chemosensitive disease (complete or partial remission after two courses of Dexa-BEAM) proceeded to further treatment. The primary endpoint was freedom from treatment failure for patients with chemosensitive disease. Analysis was per protocol.


RESULTS
17 patients were excluded from the study after randomisation (ten given Dexa-BEAM and seven given BEAM-HSCT). Median follow-up was 39 months (IQR 3-78). Freedom from treatment failure at 3 years was significantly better for patients given BEAM-HSCT (55%) than for those on Dexa-BEAM (34%; difference -21%, 95% CI -39.87 to -2.13; p=0.019). Overall survival of patients given either treatment did not differ significantly.


CONCLUSIONS
High-dose BEAM and transplantation of haemopoietic stem cells improves freedom from treatment failure in patients with chemosensitive first relapse of Hodgkin's disease irrespective of length of initial remission.
Schmitz
Norbert
N
Department of Internal Medicine II, University of Kiel, Kiel, Germany
Pfistner
Beate
B
Sextro
Michael
M
Sieber
Markus
M
Carella
Angelo M
AM
Haenel
Matthias
M
Boissevain
Friederike
F
Zschaber
Reinhart
R
Müller
Peter
P
Kirchner
Hartmut
H
Lohri
Andreas
A
Decker
Susanne
S
Koch
Bettina
B
Hasenclever
Dirk
D
Goldstone
Anthony H
AH
Diehl
Volker
V
D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002330:Carmustine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002423:Cause of Death; D003561:Cytarabine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D003907:Dexamethasone / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D005047:Etoposide / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006689:Hodgkin Disease / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D006801:Humans; D008297:Male; D008558:Melphalan / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D012008:Recurrence; D016879:Salvage Therapy / Q000379:methods*
D003561:Cytarabine; D005047:Etoposide; D003907:Dexamethasone; D008558:Melphalan; D002330:Carmustine