title: Rituximab extended schedule or retreatment trial for low tumour burden non-follicular indolent B-cell non-Hodgkin lymphomas: Eastern Cooperative Oncology Group Protocol E4402.
abstract: The rituximab extended schedule or retreatment trial (RESORT; E4402) was a phase 3 randomized prospective trial comparing maintenance rituximab (MR) versus a retreatment (RR) dosing strategy in asymptomatic, low tumour burden indolent lymphoma. A planned exploratory sub-study compared the two strategies for small lymphocytic (SLL) and marginal zone lymphomas (MZL). Patients responding to rituximab weekly × 4 were randomized to MR (single dose rituximab every 3 months until treatment failure) or RR (rituximab weekly × 4) at the time of each progression until treatment failure. The primary endpoint was time to treatment failure (TTTF). Patients with SLL (n = 57), MZL (n = 71) and unclassifiable small B-cell lymphoma (n = 3) received induction rituximab. The overall response rate (ORR) was 40% [95% confidence interval (CI) 31-49%; SLL ORR 22·8%; MZL ORR 52·1%]; all 52 responders were randomized. At a median of 4·3 years from randomization, treatment failure occurred in 18/23 RR and 15/29 MR. The median TTTF was 1·4 years for RR and 4·8 years for MR (P = 0·012); median time to first cytotoxic therapy was 6·3 years for RR and not reached for MR (P = 0·0002). Survival did not differ (P = 0·72). In low tumour burden SLL and MZL patients responding to rituximab induction, MR significantly improved TTTF as compared with RR.
authors.affiliation: University of Virginia Cancer Center, Charlottesville, VA, USA.
authors.forename: Michael E
authors.initials: ME
authors.lastname: Williams
authors.affiliation: Dana Farber Cancer Institute, Boston, MA, USA.
authors.forename: Fangxin
authors.initials: F
authors.lastname: Hong
authors.affiliation: British Columbia Cancer Agency, Center for Lymphoid Cancer, Vancouver, BC, Canada.
authors.forename: Randy D
authors.initials: RD
authors.lastname: Gascoyne
authors.affiliation: Northwestern University, Chicago, IL, USA.
authors.forename: Lynne I
authors.initials: LI
authors.lastname: Wagner
authors.affiliation: University of Michigan, Ann Arbor, MI, USA.
authors.forename: John C
authors.initials: JC
authors.lastname: Krauss
authors.affiliation: Mayo Clinic, Rochester, MN, USA.
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Habermann
authors.affiliation: Johns Hopkins University, Baltimore, MD, USA.
authors.forename: Lode J
authors.initials: LJ
authors.lastname: Swinnen
authors.affiliation: University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Schuster
authors.affiliation: Aspirus Regional Cancer Center, Wausau, WI, USA.
authors.forename: Christopher G
authors.initials: CG
authors.lastname: Peterson
authors.affiliation: Fairview-Southdale Hospital, St. Louis Park, MN, USA.
authors.forename: Mark D
authors.initials: MD
authors.lastname: Sborov
authors.affiliation: Christiana Care CCOP and the Helen F. Graham Cancer Network, Newark, DE, USA.
authors.forename: S Eric
authors.initials: SE
authors.lastname: Martin
authors.affiliation: Marshfield Clinic, Marshfield, WI, USA.
authors.forename: Matthias
authors.initials: M
authors.lastname: Weiss
authors.affiliation: Penn State Cancer Institute, Hershey, PA, USA.
authors.forename: W Christopher
authors.initials: WC
authors.lastname: Ehmann
authors.affiliation: Genentech, Inc., South San Francisco, CA, USA.
authors.forename: Sandra J
authors.initials: SJ
authors.lastname: Horning
authors.affiliation: Washington University School of Medicine, St. Louis, MO, USA.
authors.forename: Brad S
authors.initials: BS
authors.lastname: Kahl
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy; D016393:Lymphoma, B-Cell / Q000188:drug therapy*; D018442:Lymphoma, B-Cell, Marginal Zone / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D012074:Remission Induction / Q000379:methods; D019233:Retreatment; D000069283:Rituximab / Q000008:administration & dosage*; D017211:Treatment Failure; D047368:Tumor Burden
chemical_list: D000970:Antineoplastic Agents; D000069283:Rituximab
keywords: B-cell lymphoma; indolent lymphoma; maintenance; rituximab