REMARC STUDY: CORRELATION OF LYMPHOMA PD AND DEATH AND HEALTH‐RELATED QOL WITH MAINTENANCE LENALIDOMIDE VS PLACEBO IN ELDERLY DLBCL PATIENT RESPONDERS TO R‐CHOP

Abstract

Introduction: Outcomes are poor in DLBCL patients experiencing relapse; innovative strategies to improve outcomes by minimizing risk of relapse and progressive disease (PD) without impacting healthrelated quality of life (HRQoL) are needed. REMARC is a multicenter, randomized phase III trial (NCT01122472) of maintenance lenalidomide (LEN) vs placebo (PBO) in 650 patients responding to RCHOP, resulting in significantly improved PFS in patients treated with 2 years of LEN maintenance (P = .01). Method(s): Relative risks (RR [95% CI]) were calculated on ITT patients to identify treatment effect and pre-treatment variables that have an impact on patient's respective PD/relapse, death with relapse, or death without relapse. Mean change in HRQoL was assessed per the EORTC QLQ-C30 v3.0 questionnaire at randomization ( = 70 (RR = 5.17). HRQoL evaluable patients (n = 136 LEN, n = 127 PBO) had similar questionnaire completion rates at baseline: 59% LEN vs 56% PBO. Subscale scores at baseline were generally similar for LEN vs PBO, respectively: 68 vs 72 for GHS, 80 vs 85 for physical functioning and 32 vs 26 for fatigue. There was no change in MID +/- 10 from baseline during maintenance in either group (Figure 1). No significant difference was shown in GHS (improvement, stable, worsening) between LEN and PBO. There was no change in MID +/- 10 from baseline at any post-randomization maintenance visit for secondary endpoints of physical functioning or fatigue subscales, nor in a subset of patients experiencing grade 3/4 treatment-emergent neutropenia. Conclusion(s): Competing risk analysis confirmed that lenalidomide in maintenance prevents lymphoma progression without increasing toxic death risks. This analysis suggests that patient-reported HRQoL in elderly patients with DLBCL receiving 2 years of maintenance LEN following R-CHOP is not different from patients receiving PBO. HRQoL was maintained despite the higher incidence of grade 3/4 AEs, such as cytopenia, reported in the LEN arm. (Figure Presented).