title: Autologous transplantation as consolidation for aggressive non-Hodgkin's lymphoma.
abstract: BACKGROUND
  The efficacy of autologous stem-cell transplantation during the first remission in patients with diffuse, aggressive non-Hodgkin's lymphoma classified as high-intermediate risk or high risk on the International Prognostic Index remains controversial and is untested in the rituximab era.
  
  
  METHODS
  We treated 397 patients who had disease with an age-adjusted classification of high risk or high-intermediate risk with five cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or CHOP plus rituximab. Patients with a response were randomly assigned to receive three additional cycles of induction chemotherapy (control group) or one additional cycle of induction chemotherapy followed by autologous stem-cell transplantation (transplantation group). The primary efficacy end points were 2-year progression-free survival and overall survival.
  
  
  RESULTS
  Of 370 induction-eligible patients, 253 were randomly assigned to the transplantation group (125) or the control group (128). Forty-six patients in the transplantation group and 68 in the control group had disease progression or died, with 2-year progression-free survival rates of 69 and 55%, respectively (hazard ratio in the control group vs. the transplantation group, 1.72; 95% confidence interval [CI], 1.18 to 2.51; P=0.005). Thirty-seven patients in the transplantation group and 47 in the control group died, with 2-year overall survival rates of 74 and 71%, respectively (hazard ratio, 1.26; 95% CI, 0.82 to 1.94; P=0.30). Exploratory analyses showed a differential treatment effect according to risk level for both progression-free survival (P=0.04 for interaction) and overall survival (P=0.01 for interaction). Among high-risk patients, the 2-year overall survival rate was 82% in the transplantation group and 64% in the control group.
  
  
  CONCLUSIONS
  Early autologous stem-cell transplantation improved progression-free survival among patients with high-intermediate-risk or high-risk disease who had a response to induction therapy. Overall survival after transplantation was not improved, probably because of the effectiveness of salvage transplantation. (Funded by the National Cancer Institute, Department of Health and Human Services, and others; SWOG-9704 ClinicalTrials.gov number, NCT00004031.).
authors.affiliation: From Loyola University Medical Center, Maywood, IL (P.J.S., K.P.B.); Southwest Oncology Group Statistical Center, Fred Hutchinson Cancer Research Center, Seattle (J.M.U., M.L.); Cleveland Clinic, Cleveland (J.R.C., R.R.T.); University of Rochester, Rochester, NY (L.S.C., J.W.F., R.I.F.); Queen Elizabeth II Health Sciences Centre and Dalhousie University, Halifax, NS (S.C.), University of Calgary-Tom Baker Cancer Centre, Calgary, AB (D.A.S.), and Margaret and Charles Juravinski Cancer Centre, Hamilton, ON (D.M.) - all in Canada; University of North Carolina at Chapel Hill, Chapel Hill (T.C.S.); Ohio State University Medical Center, Columbus (P.P.); Northwestern University, Chicago (J.N.W.); University of Wisconsin, Madison (B.S.K.); University of Arizona, Tucson (T.P.M., L.M.R.); Louisiana State University Health Sciences Center, Shreveport (G.M.M.); City of Hope Medical Center, Duarte, CA (S.J.F.); and Fox Chase Cancer Center-Temple Health, Temple University School of Medicine, Philadelphia (R.I.F.).
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Stiff
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Unger
authors.forename: James R
authors.initials: JR
authors.lastname: Cook
authors.forename: Louis S
authors.initials: LS
authors.lastname: Constine
authors.forename: Stephen
authors.initials: S
authors.lastname: Couban
authors.forename: Douglas A
authors.initials: DA
authors.lastname: Stewart
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Shea
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Porcu
authors.forename: Jane N
authors.initials: JN
authors.lastname: Winter
authors.forename: Brad S
authors.initials: BS
authors.lastname: Kahl
authors.forename: Thomas P
authors.initials: TP
authors.lastname: Miller
authors.forename: Raymond R
authors.initials: RR
authors.lastname: Tubbs
authors.forename: Deborah
authors.initials: D
authors.lastname: Marcellus
authors.forename: Jonathan W
authors.initials: JW
authors.lastname: Friedberg
authors.forename: Kevin P
authors.initials: KP
authors.lastname: Barton
authors.forename: Glenn M
authors.initials: GM
authors.lastname: Mills
authors.forename: Michael
authors.initials: M
authors.lastname: LeBlanc
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Rimsza
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Forman
authors.forename: Richard I
authors.initials: RI
authors.lastname: Fisher
mesh_terms: D000328:Adult; D000368:Aged; D058846:Antibodies, Monoclonal, Murine-Derived / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000627:therapeutic use; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000627:therapeutic use; D000069283:Rituximab; D033581:Stem Cell Transplantation; D015996:Survival Rate; D014182:Transplantation, Autologous; D014750:Vincristine / Q000627:therapeutic use
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone