The primary efficacy end points were 2-year progression-free survival and overall survival.
ResultsOf 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 this website 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.
ConclusionsEarly
autologous Selleck Emricasan 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 OSI-027 purchase by the National Cancer Institute, Department of Health and Human Services, and others; SWOG-9704
ClinicalTrials.gov number, NCT00004031.)
This randomized study showed that including autologous transplantation as part of primary treatment improved progression-free survival but not overall survival among high-intermediate-risk and high-risk patients with aggressive lymphoma. Autologous stem-cell transplantation has long been known to improve both progression-free survival and overall survival among patients with diffuse, aggressive non-Hodgkin’s lymphoma in second remission.(1) When it became possible to identify patients at diagnosis who have less than a 50% chance of sustained remission, as defined by the International Prognostic Index(2) (IPI) (see Table S1 in the Supplementary Appendix, available with the full text of this article at NEJM.org), trials of up-front transplantation in this group were conducted. In the first trial, LNH-87, patients received full-course induction chemotherapy, regardless of their IPI risk category; those with a complete response were randomly …”
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