Extra-nodal sites were observed in 121 patients (40%). Main tumor sites were cervical (n=159), Waldeyer’s ring and sinus (n=36), inguinal (n=29), axillary (n=25), mediastinum (n=21). Most patients had normal LDH (82%), PS=0 (80%), and no B symptoms (96% of cases). There were 181 males and 120 females: 106 patients (35%) were older than 60 yr. The primary objective was EFS at one year after the last randomization, and secondary objectives were the impact of interim FDG-PET on EFS and the toxicity of RT.įrom May 2005 to December 2013, 313 patients were randomized and 301 patients are currently evaluable. For patients in partial response (defined by a tumor regression >50% but a persistent positive FDG-PET) after C4, 2 additional cycles of R-CHOP followed by RT (even if not initially allocated) were recommended. All patients were evaluated by an FDG-PET at baseline, after 4 cycles of R-CHOP and at the end of treatment. Patients with IPI=0 (no risk factor) and those with IPI≥1 (≥1risk factor) received 4 or 6 consecutive cycles of R-CHOP 14 respectively, followed or not by IFRT at 40 GY delivered 4 weeks after the last cycle of R-CHOP.
UNFOLDER DLBCL TRIAL TRIAL
In 2005, we conducted a randomized trial in patients with non-bulky (defined by a tumor size 60 yrs), stage (I vs II). More recently, the German Unfolder study prematurely closed the R-CHOP without RT arm in bulky limited-stage DLBCL due to an excess of relapse. Before the Rituximab era, 4 randomized trials have been reported with conflicting results (ECOG 1484 and SWOG 8736, GELA 93-1 and 93-4 studies). The benefit of radiotherapy (RT) following chemotherapy in limited-stage DLBCL remains controversial.
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