FINAL RESULTS OF A PROSPECTIVE MULTICENTER OBSERVATIONAL PROGRAM BENEFIT «EVALUATION OF BR COMBINED THERAPY ROUTINE USE FOLLOWED BY MAINTENANCE THERAPY WITH RITUXIMAB IN PA TIENTS WITH RELAPSED/REFRACTORY INHL»
Authors: I.V. Poddubnaya, L.G. Babicheva, V.Y. Melnichenko, I.L. Davydkin, R.V. Orlova, D.B. Olkin, E.M. Volodicheva, T.S. Kaporskaya, O.I. Kovalev, E.N. Babich, K.D. Kaplanov, E.E. Kuznetsova, I.B. Lysenko, N.E. Mochkin
Aim. Objectives of this study were to evaluate the effectiveness, safety, and tolerability of bendamustine/rituximab combination followed by rituximab maintenance therapy for relapsed or refractory (R/R) iNHL patients in the Russian Federation.
Methods. Adult subjects (≥18 yr), diagnosed with R/R iNHL according to local diagnostic standards, were enrolled in this prospective observational study. Overall response rate (ORR) was assessed after 3 (Evaluation 1) and 6–8 (Evaluation 2) 28-day cycles.
These are the results of 102 subjects enrolled between June 2012 and October 2015. Most study subjects were heavily pretreated with a median number of 2 prior lines of therapy before entering the study (range: 1–6). At Evaluation 2, ORR was high (n=58; 69,9%) with 35 (42,2%) subjects achieving CR (confirmed, n=20 [24,1%]; unconfirmed, n=15 [18,1%]) and 23 (27,7%) achieving PR. At follow up (17 mo), neither median OS or PFS had been reached; 2-year OS was 88,9% (95% CI: 79,7–99,0%) and 2-year PFS was 72,5% (95% CI: 61,6–85,3%). 31 of 96 subjects (32,3%) reported≥1 AE. Decreased neutrophil count, decreased white blood cell count, and infections were the most commonly reported AEs.