A MULTICENTER, RANDOMIZED PHASE III STUDY OF RITUXIMAB AS MAINTENANCE TREATMENT VERSUS OBSERVATION ALONE IN PATIENTS WITH AGGRESSIVE B-CELL LYMPHOMA: THE AGMT NHL13 TRIAL

Konference: 2013 18th Congress of the European Hematology Association - účast ČR

Kategorie: Maligní lymfomy a leukémie

Téma: Non-Hodgkin lymphoma - Clinical

Číslo abstraktu: P309

Autoři: M.D. Ulrich Jäger; Prof. MUDr. Marek Trněný, CSc.; Helen Melzer; Michael Praxmarer; Prim. Univ. Doz. Dr. Michael Fridrik; MD Weersak Nawarawong; Biljana Mihaljevic, Ph.D.; Dr. Osman Ilhan; MUDr. Veronika Ballová; MD Michael Hedenus, Ph.D.; MD Liang-Tsai Hsiao; Dr. Josef Thaler, Ph.D.; Dr. Gerhard Weidinger; M.D. Felix Keil; Prim. Univ. Prof. Dr. Christian Dittrich; Cathrin Skrabs; Dr. Anton Klingler; MD Richard Greil, Ph.D.

Background: The clinical impact of maintenance treatment after intensive induction immunochemotherapy in diffuse large B-cell lymphoma (DLBCL) is still unclear. Rituximab (R) maintenance was not superior to observation in the ECOG 4494 study (Habermann TM et al. J Clin Oncol. 2006;24:3121-7), which was unfortunately not fully powered for this analysis.

Aims: The Austrian Study Group (AGMT) initiated a clinical trial (NHL13, Eudract Nr. 2005-005187-90, http://www.clinicaltrials.gov/ct2/results?term=NCT00400478&Search=Search) to investigate the value of R maintenance in patients with DLBCL and follicular lymphoma grade 3B (FL G3B) in complete or unconfirmed complete remission (CR, CRu) after induction with RCHOP- like chemotherapy (Figure 1).

Methods: In the NHL13 multicenter, prospective trial 683 previously untreated adult patients with DLBCL (N=662) or FL G3B (N=21) recruited in 27 countries (163 sites) between June 2004 and September 2008 were randomized. Inclusion criteria were DLBCL at all stages in CR or CRu after treatment with 4 to 8 cycles of R-CHOP like therapy. Patients were randomized between R maintenance (375 mg/m2 every 2 months for 2 years) (N=338) and observation only (N=345). The last patient received R in September 2010. The study was closed after 148 events had been reached in March 2012. The primary endpoint of this study was event-free survival. Secondary endpoints included progression-free survival and overall survival. Data will be analysed using a Cox regression model.

Results: Both arms were well balanced regarding clinical presentation, sex or prognostic indices at study entry. No major safety signals were seen in 2 planned interim analyses. In the interim analysis in 2010 a significantly higher rate of infections (mainly NCI CTC V 2.0 grade 1 or 2) was noted in female patients in the R arm (P=0.004). Final analysis will be performed in March 2013 and the data will be presented at the meeting.

Summary / Conclusion: The AGMT NHL13 trial should provide a definitive answer to the question whether Rituximab maintenance therapy is beneficial for patients with DLBCL and FL G3B in general or in particular subgroups.