Rituximab extended schedule or retreatment trial for low tumour burden non‐follicular indolent B‐cell non‐Hodgkin lymphomas: Eastern Cooperative Oncology Group Protocol E4402. (11th March 2016)

• Record Type: Journal Article
• Authors: Williams, Michael E.; Hong, Fangxin; 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.; Kahl, Brad S.
• Is Part Of: British journal of haematology. Volume 173:Number 6(2016)
• Page Start: 867
• Page End: 875
• Publication Date: 2016-03-11
• Subjects: B‐cell lymphoma -- indolent lymphoma -- rituximab -- maintenance; Hematology -- Periodicals; Blood -- Diseases -- Periodicals; 616.15
• DOI: 10.1111/bjh.14007
• Languages: English
• ISSNs: 0007-1048

Abstract

Summary: 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.