Event-free survival at 24 months is a robust end point for disease-related outcome in diffuse large B-cell lymphoma treated with immunochemotherapy.

Details

Serval ID
serval:BIB_40DE3FED5CBA
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Event-free survival at 24 months is a robust end point for disease-related outcome in diffuse large B-cell lymphoma treated with immunochemotherapy.
Journal
Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Author(s)
Maurer M.J., Ghesquières H., Jais J.P., Witzig T.E., Haioun C., Thompson C.A., Delarue R., Micallef I.N., Peyrade F., Macon W.R., Jo Molina T., Ketterer N., Syrbu S.I., Fitoussi O., Kurtin P.J., Allmer C., Nicolas-Virelizier E., Slager S.L., Habermann T.M., Link B.K., Salles G., Tilly H., Cerhan J.R.
ISSN
1527-7755 (Electronic)
ISSN-L
0732-183X
Publication state
Published
Issued date
2014
Peer-reviewed
Oui
Volume
32
Number
10
Pages
1066-1073
Language
english
Notes
Publication types: Clinical Trial ; Journal Article ; Research Support, N.I.H., Extramural Publication Status: ppublish PDF: Original Report
Abstract
PURPOSE: Studies of diffuse large B-cell lymphoma (DLBCL) are typically evaluated by using a time-to-event approach with relapse, re-treatment, and death commonly used as the events. We evaluated the timing and type of events in newly diagnosed DLBCL and compared patient outcome with reference population data.
PATIENTS AND METHODS: Patients with newly diagnosed DLBCL treated with immunochemotherapy were prospectively enrolled onto the University of Iowa/Mayo Clinic Specialized Program of Research Excellence Molecular Epidemiology Resource (MER) and the North Central Cancer Treatment Group NCCTG-N0489 clinical trial from 2002 to 2009. Patient outcomes were evaluated at diagnosis and in the subsets of patients achieving event-free status at 12 months (EFS12) and 24 months (EFS24) from diagnosis. Overall survival was compared with age- and sex-matched population data. Results were replicated in an external validation cohort from the Groupe d'Etude des Lymphomes de l'Adulte (GELA) Lymphome Non Hodgkinien 2003 (LNH2003) program and a registry based in Lyon, France.
RESULTS: In all, 767 patients with newly diagnosed DLBCL who had a median age of 63 years were enrolled onto the MER and NCCTG studies. At a median follow-up of 60 months (range, 8 to 116 months), 299 patients had an event and 210 patients had died. Patients achieving EFS24 had an overall survival equivalent to that of the age- and sex-matched general population (standardized mortality ratio [SMR], 1.18; P = .25). This result was confirmed in 820 patients from the GELA study and registry in Lyon (SMR, 1.09; P = .71). Simulation studies showed that EFS24 has comparable power to continuous EFS when evaluating clinical trials in DLBCL.
CONCLUSION: Patients with DLBCL who achieve EFS24 have a subsequent overall survival equivalent to that of the age- and sex-matched general population. EFS24 will be useful in patient counseling and should be considered as an end point for future studies of newly diagnosed DLBCL.
Keywords
Adolescent, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Murine-Derived/administration & dosage, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Case-Control Studies, Clinical Trials as Topic, Disease-Free Survival, Female, Humans, Kaplan-Meier Estimate, Lymphoma, Large B-Cell, Diffuse/drug therapy, Lymphoma, Large B-Cell, Diffuse/mortality, Male, Middle Aged, Recurrence, Time Factors, Young Adult
Pubmed
Web of science
Create date
06/08/2014 19:10
Last modification date
20/08/2019 13:39
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