Outcomes of elderly diffuse large B-cell lymphoma patients treated with R-CHOP: 10-year follow-up of the LNH03-6B trial.

The LNH03-6B trial was a phase 3 randomized trial evaluating the efficacy of first-Line R-CHOP delivered every 2 weeks (R-CHOP14) or 3 weeks (R-CHOP21) in diffuse large B-cell lymphoma patients aged 60-80 years with an age-adjusted IPI score greater than or equal to 1 (registered as NCT00144755). We implemented a prospective long-term follow-up (LTFU) program at the end of this trial. The primary endpoints were progression-free survival (PFS) and Overall survival (OS). Relapse patterns and PFS/OS after the first progression (PFS2/OS2) were secondary endpoints. LNH03-6B was registered with ClinicalTrial.gov number NCT00144755. In the LNH03-6B trial, 304 and 296 patients were assigned to receive 8 cycles of R-CHOP14 or R-CHOP21, respectively. LTFU data were investigated for 256/384 (67%) patients who were still alive at the primary analysis. With a median follow-up of 10.1 years, 213 patients progressed, and 140 patients died without progression. The ten-year PFS was 40.4% (95% CI: 35.9-44.9). Ten-year OS was based on 302 deaths and estimated at 50% (43-56). One hundred and five of the 213 patients (49%) progressed after second-line therapy, and 77 patients died without a second progression (36%). The 1-year PFS2 and 1-year OS2 were estimated at 37.9% [31.4-44.5] and 55.8% [48.8-62.2], respectively. Ten years after randomization, the outcomes of patients treated for DLBCL were similar according to PFS and OS between the RCHOP-14 and R-CHOP21 groups. Progression/relapse led to poor prognosis after second-line chemotherapy in the pre-CAR-T era. Novel approaches in first-line and alternative treatments in second-line treatments are warranted in this population.