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Blood, 15 November 2006, Vol. 108, No. 10, pp. 3295-3301.
Prepublished online as a Blood First Edition Paper on July 27, 2006; DOI 10.1182/blood-2006-05-021113.
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CLINICAL TRIALS AND OBSERVATIONS
Rituximab maintenance improves clinical outcome of relapsed/resistant follicular non-Hodgkin lymphoma in patients both with and without rituximab during induction: results of a prospective randomized phase 3 intergroup trial
Marinus H. J. van Oers,
Richard Klasa,
Robert E. Marcus,
Max Wolf,
Eva Kimby,
Randy D. Gascoyne,
Andrew Jack,
Mars van't Veer,
Andrej Vranovsky,
Harald Holte,
Martine van Glabbeke,
Ivana Teodorovic,
Cynthia Rozewicz, and
Anton Hagenbeek
From the European Organisation for Research and Treatment of Cancer (EORTC) Lymphoma Group, Hemato-Oncologie voor Volwassenen Nederland (HOVON), National Cancer Institute of Canada (NCIC) Clinical Trials Group (CTG) (Canada), British National Lymphoma Investigation (BNLI), Australasian Leukaemia and Lymphoma Group (ALLG), Nordic Lymphoma Group (NLG), and EORTC Data Center.
We evaluated the role of rituximab (R) both in remission induction and maintenance treatment of relapsed/resistant follicular lymphoma (FL). A total of 465 patients were randomized to induction with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (every 3 weeks) or R-CHOP (R: 375 mg/m2 intravenously, day 1). Those in complete remission (CR) or partial remission (PR) were randomized to maintenance with R (375 mg/m2 intravenously once every 3 months for a maximum of 2 years) or observation. R-CHOP induction yielded an increased overall response rate (CHOP, 72.3%; R-CHOP, 85.1%; P < .001) and CR rate (CHOP, 15.6%; R-CHOP, 29.5%; P < .001). Median progression-free survival (PFS) from first randomization was 20.2 months after CHOP versus 33.1 months after R-CHOP (hazard ratio [HR], 0.65; P < .001). Rituximab maintenance yielded a median PFS from second randomization of 51.5 months versus 14.9 months with observation (HR, 0.40; P < .001). Improved PFS was found both after induction with CHOP (HR, 0.30; P < .001) and R-CHOP (HR, 0.54; P = .004). R maintenance also improved overall survival from second randomization: 85% at 3 years versus 77% with observation (HR, 0.52; P = .011). This is the first trial showing that in relapsed/resistant FL rituximab maintenance considerably improves PFS not only after CHOP but also after R-CHOP induction.
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