Autologous transplantation for aggressive non-Hodgkin's lymphoma: results of a randomized trial evaluating graft source and minimal residual disease.
OBJECTIVE
To determine whether the source of autologous hematopoietic stem cells altered the clinical outcomes of patients undergoing high-dose chemotherapy and hematopoietic stem-cell transplantation (HSCT) for aggressive non-Hodgkin's lymphoma (NHL).


METHODS
Of 105 high-risk, persistent, or relapsed NHL patients slated for an autologous HSCT entered onto this trial, 93 eligible patients were randomized to receive cytokine-naive autologous bone marrow transplantation (ABMT) (n = 46) or mobilized peripheral-blood stem-cell transplantation (PBSCT) (n = 47). All patients received carmustine, etoposide, cytarabine, and cyclophosphamide as the conditioning regimen. PBSCT patients also received identical mobilization with granulocyte colony-stimulating factor (G-CSF) 10 microg/kg/d, and both groups received G-CSF 5 microg/kg/d after the infusion of the stem-cell product until neutrophil engraftment.


RESULTS
PBSCT patients had significantly faster engraftment of all cell lineages: median time to absolute neutrophil count > or = 500/microL, 10 days versus 13 days on the ABMT arm; median time to platelet count greater than 20,000/microL untransfused, 11 days versus 15 days on the ABMT arm; and median time to RBC transfusion independence, 8 days versus 16 days on the ABMT arm. The complete response rate was 72% for PBSCT and 54% for ABMT. The death rate before posttransplant day 100 was 2% on the ABMT arm and 6% on PBSCT arm. Event-free survival was 37% for PBSCT and 37% for ABMT. However, overall survival for PBSCT was 61% compared with 43% for ABMT.


CONCLUSIONS
Patients with aggressive NHL receiving HSCT randomized to PBSCT demonstrated improved neutrophil engraftment and platelet and RBC transfusion independence. The complete response rate and EFS were not statistically different by randomization arm. Patients whose harvests were positive for minimal residual disease by molecular analysis had poorer EFS.
Vose
Julie M
JM
Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE 69198, USA. jmvose@unmc.edu
Sharp
Graham
G
Chan
Wing C
WC
Nichols
Craig
C
Loh
Kevin
K
Inwards
David
D
Rifkin
Robert
R
Bierman
Philip J
PJ
Lynch
James C
JC
Weisenburger
Dennis D
DD
Kessinger
Anne
A
Armitage
James O
JO
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002330:Carmustine / Q000008:administration & dosage; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D003561:Cytarabine / Q000008:administration & dosage; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006085:Graft Survival; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D018365:Neoplasm, Residual; D016016:Proportional Hazards Models; D019172:Transplantation Conditioning / Q000379:methods; D014182:Transplantation, Autologous; D016896:Treatment Outcome
D003561:Cytarabine; D005047:Etoposide; D003520:Cyclophosphamide; D002330:Carmustine