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Stiff PJ , Unger JM , Cook JR , Constine LS , Couban S , Stewart DA , Shea TC , Porcu P , Winter JN , Kahl BS , Miller TP , Tubbs RR , Marcellus D , Friedberg JW , Barton KP , Mills GM , LeBlanc M , Rimsza LM , Forman SJ , Fisher RI
Autologous transplantation as consolidation for aggressive non-Hodgkin's lymphoma
N Engl J Med. 2013 Oct 31;369(18) :1681-90
PMID: 24171516   
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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.).
Notes
Stiff, Patrick J Unger, Joseph M Cook, James R Constine, Louis S Couban, Stephen Stewart, Douglas A Shea, Thomas C Porcu, Pierluigi Winter, Jane N Kahl, Brad S Miller, Thomas P Tubbs, Raymond R Marcellus, Deborah Friedberg, Jonathan W Barton, Kevin P Mills, Glenn M LeBlanc, Michael Rimsza, Lisa M Forman, Stephen J Fisher, Richard I CA047559/CA/NCI NIH HHS/United States CA04919/CA/NCI NIH HHS/United States CA077202/CA/NCI NIH HHS/United States CA077658/CA/NCI NIH HHS/United States CA11083/CA/NCI NIH HHS/United States CA12644/CA/NCI NIH HHS/United States CA13612/CA/NCI NIH HHS/United States CA14028/CA/NCI NIH HHS/United States CA17145/CA/NCI NIH HHS/United States CA20319/CA/NCI NIH HHS/United States CA21076/CA/NCI NIH HHS/United States CA21115/CA/NCI NIH HHS/United States CA22433/CA/NCI NIH HHS/United States CA27057/CA/NCI NIH HHS/United States CA32102/CA/NCI NIH HHS/United States CA35090/CA/NCI NIH HHS/United States CA35178/CA/NCI NIH HHS/United States CA35192/CA/NCI NIH HHS/United States CA35261/CA/NCI NIH HHS/United States CA35281/CA/NCI NIH HHS/United States CA35431/CA/NCI NIH HHS/United States CA37981/CA/NCI NIH HHS/United States CA38926/CA/NCI NIH HHS/United States CA45377/CA/NCI NIH HHS/United States CA45560/CA/NCI NIH HHS/United States CA46113/CA/NCI NIH HHS/United States CA46282/CA/NCI NIH HHS/United States CA46368/CA/NCI NIH HHS/United States CA46441/CA/NCI NIH HHS/United States CA52654/CA/NCI NIH HHS/United States CA58416/CA/NCI NIH HHS/United States CA58658/CA/NCI NIH HHS/United States CA58686/CA/NCI NIH HHS/United States CA58861/CA/NCI NIH HHS/United States CA63844/CA/NCI NIH HHS/United States CA63845/CA/NCI NIH HHS/United States CA67575/CA/NCI NIH HHS/United States CA76132/CA/NCI NIH HHS/United States CA76447/CA/NCI NIH HHS/United States CA76448/CA/NCI NIH HHS/United States Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't United States The New England journal of medicine N Engl J Med. 2013 Oct 31;369(18):1681-90. doi: 10.1056/NEJMoa1301077.