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

Matthew J. Maurer, Hervé Ghesquières, Jean Philippe Jais, Thomas Elmer Witzig, Corinne Haioun, Carrie A Thompson, Richard Delarue, Ivana Micallef, Fréd́eric Peyrade, William R. Macon, Thierry Jo Molina, Nicolas Ketterer, Sergei I. Syrbu, Olivier Fitoussi, Paul J. Kurtin, Cristine Allmer, Emmanuelle Nicolas-Virelizier, Susan L Slager, Thomas Matthew Habermann, Brian K. Link & 3 others Gilles Salles, Hervé Tilly, James R Cerhan

Research output: Contribution to journalArticle

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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.

Original languageEnglish (US)
Pages (from-to)1066-1073
Number of pages8
JournalJournal of Clinical Oncology
Volume32
Issue number10
DOIs
StatePublished - Apr 1 2014

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Lymphoma, Large B-Cell, Diffuse
Disease-Free Survival
Molecular Epidemiology
Population
Survival
Registries
Clinical Trials
Mortality
France
Counseling

ASJC Scopus subject areas

  • Oncology
  • Cancer Research
  • Medicine(all)

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Event-free survival at 24 months is a robust end point for disease-related outcome in diffuse large B-cell lymphoma treated with immunochemotherapy. / Maurer, Matthew J.; Ghesquières, Hervé; Jais, Jean Philippe; Witzig, Thomas Elmer; Haioun, Corinne; Thompson, Carrie A; Delarue, Richard; Micallef, Ivana; Peyrade, Fréd́eric; Macon, William R.; Molina, Thierry Jo; Ketterer, Nicolas; Syrbu, Sergei I.; Fitoussi, Olivier; Kurtin, Paul J.; Allmer, Cristine; Nicolas-Virelizier, Emmanuelle; Slager, Susan L; Habermann, Thomas Matthew; Link, Brian K.; Salles, Gilles; Tilly, Hervé; Cerhan, James R.

In: Journal of Clinical Oncology, Vol. 32, No. 10, 01.04.2014, p. 1066-1073.

Research output: Contribution to journalArticle

Maurer, MJ, Ghesquières, H, Jais, JP, Witzig, TE, Haioun, C, Thompson, CA, Delarue, R, Micallef, I, Peyrade, F, Macon, WR, Molina, TJ, Ketterer, N, Syrbu, SI, Fitoussi, O, Kurtin, PJ, Allmer, C, Nicolas-Virelizier, E, Slager, SL, Habermann, TM, Link, BK, Salles, G, Tilly, H & Cerhan, JR 2014, '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 of Clinical Oncology, vol. 32, no. 10, pp. 1066-1073. https://doi.org/10.1200/JCO.2013.51.5866
Maurer, Matthew J. ; Ghesquières, Hervé ; Jais, Jean Philippe ; Witzig, Thomas Elmer ; Haioun, Corinne ; Thompson, Carrie A ; Delarue, Richard ; Micallef, Ivana ; Peyrade, Fréd́eric ; Macon, William R. ; Molina, Thierry Jo ; Ketterer, Nicolas ; Syrbu, Sergei I. ; Fitoussi, Olivier ; Kurtin, Paul J. ; Allmer, Cristine ; Nicolas-Virelizier, Emmanuelle ; Slager, Susan L ; Habermann, Thomas Matthew ; Link, Brian K. ; Salles, Gilles ; Tilly, Hervé ; Cerhan, James R. / Event-free survival at 24 months is a robust end point for disease-related outcome in diffuse large B-cell lymphoma treated with immunochemotherapy. In: Journal of Clinical Oncology. 2014 ; Vol. 32, No. 10. pp. 1066-1073.
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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.",
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T1 - Event-free survival at 24 months is a robust end point for disease-related outcome in diffuse large B-cell lymphoma treated with immunochemotherapy

AU - Maurer, Matthew J.

AU - Ghesquières, Hervé

AU - Jais, Jean Philippe

AU - Witzig, Thomas Elmer

AU - Haioun, Corinne

AU - Thompson, Carrie A

AU - Delarue, Richard

AU - Micallef, Ivana

AU - Peyrade, Fréd́eric

AU - Macon, William R.

AU - Molina, Thierry Jo

AU - Ketterer, Nicolas

AU - Syrbu, Sergei I.

AU - Fitoussi, Olivier

AU - Kurtin, Paul J.

AU - Allmer, Cristine

AU - Nicolas-Virelizier, Emmanuelle

AU - Slager, Susan L

AU - Habermann, Thomas Matthew

AU - Link, Brian K.

AU - Salles, Gilles

AU - Tilly, Hervé

AU - Cerhan, James R

PY - 2014/4/1

Y1 - 2014/4/1

N2 - 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.

AB - 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.

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