Rituximab extended schedule or re-treatment trial for low-tumor burden follicular lymphoma

Eastern cooperative oncology group protocol E4402

Brad S. Kahl, Fangxin Hong, Michael E. Williams, Randy D. Gascoyne, Lynne I. Wagner, John C. Krauss, Thomas M. Habermann, Lode J. Swinnen, Stephen J. Schuster, Christopher G. Peterson, Mark D. Sborov, S. Eric Martin, Matthias Weiss, W. Christopher Ehmann, Sandra J. Horning

Research output: Contribution to journalArticle

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Abstract

Purpose In low-tumor burden follicular lymphoma (FL), maintenance rituximab (MR) has been shown to improve progression-free survival when compared with observation. It is not known whether MR provides superior long-term disease control compared with re-treatment rituximab (RR) administered on an as-needed basis. E4402 (RESORT) was a randomized clinical trial designed to compare MR against RR.

Patients and Methods Eligible patients with previously untreated low-tumor burden FL received four doses of rituximab, and responding patients were randomly assigned to either RR or MR. Patients receiving RR were eligible for re-treatment at each disease progression until treatment failure. Patients assigned to MR received a single dose of rituximab every 3 months until treatment failure. The primary end point was time to treatment failure. Secondary end points included time to first cytotoxic therapy, toxicity, and health-related quality of life (HRQOL).

Results A total of 289 patients were randomly assigned to RR or MR. With a median follow-up of 4.5 years, the estimated median time to treatment failure was 3.9 years for patients receiving RR and 4.3 years for those receiving MR (P = .54). Three-year freedom from cytotoxic therapy was 84% for those receiving RR and 95% for those receiving MR (P = .03). The median number of rituximab doses was four patients receiving RR and 18 for those receiving MR. There was no difference in HRQOL. Grade 3 to 4 toxicities were infrequent in both arms.

Conclusion In low-tumor burden FL, a re-treatment strategy uses less rituximab while providing disease control comparable to that achieved with a maintenance strategy.

Original languageEnglish (US)
Pages (from-to)3096-3102
Number of pages7
JournalJournal of Clinical Oncology
Volume32
Issue number28
DOIs
StatePublished - Oct 1 2014

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Follicular Lymphoma
Tumor Burden
Appointments and Schedules
Maintenance
Therapeutics
Treatment Failure
Rituximab
Quality of Life

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Kahl, Brad S. ; Hong, Fangxin ; Williams, Michael E. ; Gascoyne, Randy D. ; Wagner, Lynne I. ; Krauss, John C. ; Habermann, Thomas M. ; Swinnen, Lode J. ; Schuster, Stephen J. ; Peterson, Christopher G. ; Sborov, Mark D. ; Martin, S. Eric ; Weiss, Matthias ; Ehmann, W. Christopher ; Horning, Sandra J. / Rituximab extended schedule or re-treatment trial for low-tumor burden follicular lymphoma : Eastern cooperative oncology group protocol E4402. In: Journal of Clinical Oncology. 2014 ; Vol. 32, No. 28. pp. 3096-3102.
@article{c9fc5fd8e08b4f65a65c8cc77f1822e1,
title = "Rituximab extended schedule or re-treatment trial for low-tumor burden follicular lymphoma: Eastern cooperative oncology group protocol E4402",
abstract = "Purpose In low-tumor burden follicular lymphoma (FL), maintenance rituximab (MR) has been shown to improve progression-free survival when compared with observation. It is not known whether MR provides superior long-term disease control compared with re-treatment rituximab (RR) administered on an as-needed basis. E4402 (RESORT) was a randomized clinical trial designed to compare MR against RR.Patients and Methods Eligible patients with previously untreated low-tumor burden FL received four doses of rituximab, and responding patients were randomly assigned to either RR or MR. Patients receiving RR were eligible for re-treatment at each disease progression until treatment failure. Patients assigned to MR received a single dose of rituximab every 3 months until treatment failure. The primary end point was time to treatment failure. Secondary end points included time to first cytotoxic therapy, toxicity, and health-related quality of life (HRQOL).Results A total of 289 patients were randomly assigned to RR or MR. With a median follow-up of 4.5 years, the estimated median time to treatment failure was 3.9 years for patients receiving RR and 4.3 years for those receiving MR (P = .54). Three-year freedom from cytotoxic therapy was 84{\%} for those receiving RR and 95{\%} for those receiving MR (P = .03). The median number of rituximab doses was four patients receiving RR and 18 for those receiving MR. There was no difference in HRQOL. Grade 3 to 4 toxicities were infrequent in both arms.Conclusion In low-tumor burden FL, a re-treatment strategy uses less rituximab while providing disease control comparable to that achieved with a maintenance strategy.",
author = "Kahl, {Brad S.} and Fangxin Hong and Williams, {Michael E.} and Gascoyne, {Randy D.} and Wagner, {Lynne I.} and Krauss, {John C.} and Habermann, {Thomas M.} and Swinnen, {Lode J.} and Schuster, {Stephen J.} and Peterson, {Christopher G.} and Sborov, {Mark D.} and Martin, {S. Eric} and Matthias Weiss and Ehmann, {W. Christopher} and Horning, {Sandra J.}",
year = "2014",
month = "10",
day = "1",
doi = "10.1200/JCO.2014.56.5853",
language = "English (US)",
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pages = "3096--3102",
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Kahl, BS, Hong, F, Williams, ME, Gascoyne, RD, Wagner, LI, Krauss, JC, Habermann, TM, Swinnen, LJ, Schuster, SJ, Peterson, CG, Sborov, MD, Martin, SE, Weiss, M, Ehmann, WC & Horning, SJ 2014, 'Rituximab extended schedule or re-treatment trial for low-tumor burden follicular lymphoma: Eastern cooperative oncology group protocol E4402', Journal of Clinical Oncology, vol. 32, no. 28, pp. 3096-3102. https://doi.org/10.1200/JCO.2014.56.5853

Rituximab extended schedule or re-treatment trial for low-tumor burden follicular lymphoma : Eastern cooperative oncology group protocol E4402. / Kahl, Brad S.; Hong, Fangxin; Williams, Michael E.; Gascoyne, Randy D.; Wagner, Lynne I.; Krauss, John C.; Habermann, Thomas M.; Swinnen, Lode J.; Schuster, Stephen J.; Peterson, Christopher G.; Sborov, Mark D.; Martin, S. Eric; Weiss, Matthias; Ehmann, W. Christopher; Horning, Sandra J.

In: Journal of Clinical Oncology, Vol. 32, No. 28, 01.10.2014, p. 3096-3102.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Rituximab extended schedule or re-treatment trial for low-tumor burden follicular lymphoma

T2 - Eastern cooperative oncology group protocol E4402

AU - Kahl, Brad S.

AU - Hong, Fangxin

AU - Williams, Michael E.

AU - Gascoyne, Randy D.

AU - Wagner, Lynne I.

AU - Krauss, John C.

AU - Habermann, Thomas M.

AU - Swinnen, Lode J.

AU - Schuster, Stephen J.

AU - Peterson, Christopher G.

AU - Sborov, Mark D.

AU - Martin, S. Eric

AU - Weiss, Matthias

AU - Ehmann, W. Christopher

AU - Horning, Sandra J.

PY - 2014/10/1

Y1 - 2014/10/1

N2 - Purpose In low-tumor burden follicular lymphoma (FL), maintenance rituximab (MR) has been shown to improve progression-free survival when compared with observation. It is not known whether MR provides superior long-term disease control compared with re-treatment rituximab (RR) administered on an as-needed basis. E4402 (RESORT) was a randomized clinical trial designed to compare MR against RR.Patients and Methods Eligible patients with previously untreated low-tumor burden FL received four doses of rituximab, and responding patients were randomly assigned to either RR or MR. Patients receiving RR were eligible for re-treatment at each disease progression until treatment failure. Patients assigned to MR received a single dose of rituximab every 3 months until treatment failure. The primary end point was time to treatment failure. Secondary end points included time to first cytotoxic therapy, toxicity, and health-related quality of life (HRQOL).Results A total of 289 patients were randomly assigned to RR or MR. With a median follow-up of 4.5 years, the estimated median time to treatment failure was 3.9 years for patients receiving RR and 4.3 years for those receiving MR (P = .54). Three-year freedom from cytotoxic therapy was 84% for those receiving RR and 95% for those receiving MR (P = .03). The median number of rituximab doses was four patients receiving RR and 18 for those receiving MR. There was no difference in HRQOL. Grade 3 to 4 toxicities were infrequent in both arms.Conclusion In low-tumor burden FL, a re-treatment strategy uses less rituximab while providing disease control comparable to that achieved with a maintenance strategy.

AB - Purpose In low-tumor burden follicular lymphoma (FL), maintenance rituximab (MR) has been shown to improve progression-free survival when compared with observation. It is not known whether MR provides superior long-term disease control compared with re-treatment rituximab (RR) administered on an as-needed basis. E4402 (RESORT) was a randomized clinical trial designed to compare MR against RR.Patients and Methods Eligible patients with previously untreated low-tumor burden FL received four doses of rituximab, and responding patients were randomly assigned to either RR or MR. Patients receiving RR were eligible for re-treatment at each disease progression until treatment failure. Patients assigned to MR received a single dose of rituximab every 3 months until treatment failure. The primary end point was time to treatment failure. Secondary end points included time to first cytotoxic therapy, toxicity, and health-related quality of life (HRQOL).Results A total of 289 patients were randomly assigned to RR or MR. With a median follow-up of 4.5 years, the estimated median time to treatment failure was 3.9 years for patients receiving RR and 4.3 years for those receiving MR (P = .54). Three-year freedom from cytotoxic therapy was 84% for those receiving RR and 95% for those receiving MR (P = .03). The median number of rituximab doses was four patients receiving RR and 18 for those receiving MR. There was no difference in HRQOL. Grade 3 to 4 toxicities were infrequent in both arms.Conclusion In low-tumor burden FL, a re-treatment strategy uses less rituximab while providing disease control comparable to that achieved with a maintenance strategy.

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U2 - 10.1200/JCO.2014.56.5853

DO - 10.1200/JCO.2014.56.5853

M3 - Article

VL - 32

SP - 3096

EP - 3102

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 28

ER -