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Thursday 27 July 2006

Rituximab maintenance improves clinical outcome of relapsed/resistant follicular non-Hodgkin's lymphoma, both in patients with and without rituximab during induction: results of a prospective randomized phase III intergroup trial.

By: van Oers MH, Klasa R, Marcus RE, Wolf M, Kimby E, Gascoyne RD, Jack A

We evaluated the role of rituximab (R) both in remission induction and maintenance treatment of relapsed /resistant follicular lymphoma (FL).

465 patients were randomized to induction with 6 cycles of CHOP (3-weekly) or R-CHOP (R: 375 mg/m(2) i.v. day 1). Those in complete (CR) or partial remission (PR) were randomized to maintenance with R (375 mg/m(2) i.v. once every 3 months for a maximum of two years) or observation. R-CHOP induction yielded an increased overall response rate (CHOP 72.3%; R-CHOP 85.1%; p<0.0001) and CR rate (CHOP 15.6%; R-CHOP 29.5%; p<0.0001). Median progression free survival (PFS) from first randomization was 20.2 months after CHOP versus 33.1 months after R-CHOP (HR 0.65; p=0.0003). Rituximab maintenance yielded a median PFS from second randomization of 51.5 months versus 14.9 months with observation (HR 0.40; p<0.0001).

Improved PFS was found both after induction with CHOP (HR 0.30; p< 0.0001) and R-CHOP (HR 0.54; p=0.0043). R maintenance also improved overall survival from second randomization: 85% at 3 years versus 77% with observation (HR 0.52; p= 0.0111). 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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