Brad S Kahl1, Fangxin Hong2, Michael E Williams2, Randy D Gascoyne2, Lynne I Wagner2, John C Krauss2, Thomas M Habermann2, Lode J Swinnen2, Stephen J Schuster2, Christopher G Peterson2, Mark D Sborov2, S Eric Martin2, Matthias Weiss2, W Christopher Ehmann2, Sandra J Horning2. 1. Brad S. Kahl, University of Wisconsin, Madison; Christopher G. Peterson, Aspirus Regional Cancer Center, Wausau; Matthias Weiss, Marshfield Clinic, Marshfield, WI; Fangxin Hong, Dana-Farber Cancer Institute, Boston, MA; Michael E. Williams, University of Virginia, Charlottesville, VA; Randy D. Gascoyne, British Columbia Cancer Agency, Vancouver, British Columbia, Canada; Lynne I. Wagner, Northwestern University, Chicago, IL; John C. Krauss, University of Michigan, Ann Arbor, MI; Thomas M. Habermann, Mayo Clinic, Rochester; Mark D. Sborov, Fairview-Southdale Hospital, St Louis Park, MN; Lode J. Swinnen, Johns Hopkins University, Baltimore, MD; Stephen J. Schuster, University of Pennsylvania, Philadelphia; W. Christopher Ehmann, Penn State Cancer Institute, Hershey, PA; S. Eric Martin, Christiana Care Community Clinical Oncology Program and Helen F. Graham Cancer Network, Newark, DE; and Sandra J. Horning, Genentech, South San Francisco, CA. bsk@medicine.wisc.edu. 2. Brad S. Kahl, University of Wisconsin, Madison; Christopher G. Peterson, Aspirus Regional Cancer Center, Wausau; Matthias Weiss, Marshfield Clinic, Marshfield, WI; Fangxin Hong, Dana-Farber Cancer Institute, Boston, MA; Michael E. Williams, University of Virginia, Charlottesville, VA; Randy D. Gascoyne, British Columbia Cancer Agency, Vancouver, British Columbia, Canada; Lynne I. Wagner, Northwestern University, Chicago, IL; John C. Krauss, University of Michigan, Ann Arbor, MI; Thomas M. Habermann, Mayo Clinic, Rochester; Mark D. Sborov, Fairview-Southdale Hospital, St Louis Park, MN; Lode J. Swinnen, Johns Hopkins University, Baltimore, MD; Stephen J. Schuster, University of Pennsylvania, Philadelphia; W. Christopher Ehmann, Penn State Cancer Institute, Hershey, PA; S. Eric Martin, Christiana Care Community Clinical Oncology Program and Helen F. Graham Cancer Network, Newark, DE; and Sandra J. Horning, Genentech, South San Francisco, CA.
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.
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.
Authors: B D Cheson; S J Horning; B Coiffier; M A Shipp; R I Fisher; J M Connors; T A Lister; J Vose; A Grillo-López; A Hagenbeek; F Cabanillas; D Klippensten; W Hiddemann; R Castellino; N L Harris; J O Armitage; W Carter; R Hoppe; G P Canellos Journal: J Clin Oncol Date: 1999-04 Impact factor: 44.544
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Authors: P Colombat; G Salles; N Brousse; P Eftekhari; P Soubeyran; V Delwail; E Deconinck; C Haïoun; C Foussard; C Sebban; A Stamatoullas; N Milpied; F Boué; B Taillan; P Lederlin; A Najman; C Thièblemont; F Montestruc; A Mathieu-Boué; A Benzohra; P Solal-Céligny Journal: Blood Date: 2001-01-01 Impact factor: 22.113
Authors: P Brice; Y Bastion; E Lepage; N Brousse; C Haïoun; P Moreau; N Straetmans; H Tilly; I Tabah; P Solal-Céligny Journal: J Clin Oncol Date: 1997-03 Impact factor: 44.544
Authors: T A Davis; A J Grillo-López; C A White; P McLaughlin; M S Czuczman; B K Link; D G Maloney; R L Weaver; J Rosenberg; R Levy Journal: J Clin Oncol Date: 2000-09 Impact factor: 44.544
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Authors: N L Berinstein; A J Grillo-López; C A White; I Bence-Bruckler; D Maloney; M Czuczman; D Green; J Rosenberg; P McLaughlin; D Shen Journal: Ann Oncol Date: 1998-09 Impact factor: 32.976
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