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Clinical Trial
. 2020 Apr;189(1):84-96.
doi: 10.1111/bjh.16300. Epub 2019 Nov 8.

Lenalidomide maintenance for diffuse large B-cell lymphoma patients responding to R-CHOP: quality of life, dosing, and safety results from the randomised controlled REMARC study

Catherine Thieblemont  1 , Susannah Howlett  2 , René-Olivier Casasnovas  3 , Nicolas Mounier  4 , Aurore Perrot  5 , Franck Morschhauser  6 , Christophe Fruchart  7 , Nicolas Daguindau  8 , Koen van Eygen  9 , Lucie Obéric  10 , Reda Bouabdallah  11 , Gian Matteo Pica  12 , Emmanuelle Nicolas-Virezelier  13 , Julie Abraham  14 , Olivier Fitoussi  15 , Sylvia Snauwaert  16 , Jean-Claude Eisenmann  17 , Pauline Lionne-Huyghe  18 , Dominique Bron  19 , Sabine Tricot  20 , Dries Deeren  21 , Hugo Gonzalez  22 , Régis Costello  23 , Katell Le Du  24 , Maria Gomes da Silva  25 , Sebastian Grosicki  26 , Judith Trotman  27 , John Catalano  28 , Dolores Caballero  29 , Richard Greil  30 , Amos M Cohen  31 , Philippe Gaulard  32 , Louise Roulin  33 , Kenichi Takeshita  2 , Marie-Laure Casadebaig  34 , Hervé Tilly  35 , Bertrand Coiffier  36
Affiliations
Clinical Trial

Lenalidomide maintenance for diffuse large B-cell lymphoma patients responding to R-CHOP: quality of life, dosing, and safety results from the randomised controlled REMARC study

Catherine Thieblemont et al. Br J Haematol. 2020 Apr.

Abstract

Lenalidomide maintenance therapy prolonged progression-free survival (PFS) versus placebo in elderly patients with diffuse large B-cell lymphoma (DLBCL) responding to induction chemotherapy in the phase 3 REMARC study. This subpopulation analysis assessed the impact of lenalidomide maintenance and treatment-emergent adverse events (TEAEs) on health-related quality of life (HRQOL). Global health status (GHS), and physical functioning and fatigue subscales were evaluated in patients who completed the European Organisation for Research and Treatment of Cancer quality-of-life questionnaire-C30 v3.0. The impact of TEAEs classified post hoc as subjective (patients can feel) or observable (only measurable by physicians) on dose reductions and discontinuations was assessed. Among 457 patients (lenalidomide, n = 229; placebo, n = 228), mean (standard deviation) GHS was similar between treatment arms [68·2 (20·7) Versus 72·0 (17·8)] at randomisation and remained similar during maintenance. Patients receiving lenalidomide experienced no meaningful changes in GHS, physical functioning, or fatigue. Observable TEAEs were more common (81·1% Versus 66·3%) and more likely to lead to dose reductions, than subjective TEAEs in both arms. PFS was superior in the lenalidomide arm regardless of dose reduction. Lenalidomide maintenance prolonged PFS and did not negatively impact HRQOL in patients with DLBCL despite TEAEs being more common, when compared with placebo.

Keywords: non-Hodgkin lymphoma; quality of life; therapy.

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Conflict of interest statement

CT has been on an advisory board for Celgene Corporation, Gilead, Kyte, Novartis, and Roche. SH is an employee of Celgene Corporation. R‐OC has received grants, personal fees, and non‐financial support from Roche, Takeda, and Gilead; and personal fees from Bristol‐Myers Squibb, Merck, and Janssen. NM has no conflict of interest to disclose. AP has no conflict of interest to disclose. FM has been on an advisory board and provided scientific lectures to Celgene Corporation and Roche; has been on an advisory board for Gilead and Bristol‐Myers Squibb; provided scientific lectures for Janssen; and provided consultancy to Epizyme. CF has no conflict of interest to disclose. ND has no conflict of interest to disclose. KVE has no conflict of interest to disclose. LO has no conflict of interest to disclose. RB has no conflict of interest to disclose. GMP has no conflict of interest to disclose. EN‐V has no conflict of interest to disclose. JA has no conflict of interest to disclose. OF has no conflict of interest to disclose. SS has no conflict of interest to disclose. J‐CE has no conflict of interest to disclose. PL‐H has no conflict of interest to disclose. DB has received research funding. ST has no conflict of interest to disclose. DD has no conflict of interest to disclose. HG has no conflict of interest to disclose. RC has no conflict of interest to disclose. KLD has no conflict of interest to disclose. MGdS has received a research grant from, and provided consultancy to, Gilead Sciences; been on an advisory board for AbbVie; received institutional payments and travel reimbursement from Roche; provided consultancy to, and received travel reimbursement from, Janssen Cilag; and received travel reimbursement from Celgene Corporation. SG has no conflict of interest to disclose. JT has received non‐financial support from Celgene Corporation; and received clinical trials funding from BeiGene, Celgene, Janssen, PCYC, and Roche. JC has received travel reimbursement from Amgen and Celgene Corporation. DC has no conflict of interest to disclose. RG has received honoraria, research funding, travel and accommodation expenses, and provided consultancy or been on an advisory board for, Celgene Corporation, Roche, Merck, Takeda, AstraZeneca, Novartis, Amgen, Bristol‐Myers Squibb, MSD, Sandoz, AbbVie, and Janssen. AMC has no conflict of interest to disclose. PG has received a grant and personal fees from Takeda. LR has no conflict of interest to disclose. KT is a former employee of, and has stock ownership in, Celgene Corporation. MLC is an employee of Celgene Corporation. HT has received personal fees and non‐financial support from Roche; and received personal fees from AstraZeneca, Bristol‐Myers Squibb, and Karyopharm.

Figures

Figure 1
Figure 1
(A) Overall GHS. (B) GHS in patients with grade 3–4 TEAEs. (C) GHS in patients without grade 3–4 TEAEs. (D) GHS in patients with grade 3–4 treatment‐emergent neutropaenia. (E) GHS in patients without grade 3–4 treatment‐emergent neutropaenia. (F) GHS in patients undergoing dose reductions. Patients were enrolled in the HRQOL‐evaluable population. Median and interquartile ranges are shown. A change in MID of ±10 points was considered clinically meaningful. EOM, end of maintenance; GHS, global health status; HRQOL, health‐related quality of life; ITT, intention‐to‐treat; LEN, lenalidomide; MID, minimal important difference; PBO, placebo; TEAE, treatment‐emergent adverse event.
Figure 2
Figure 2
PFS (central review) in patients with and without dose reductions receiving lenalidomide or placebo. Patients in the overall REMARC study population. KM, Kaplan–Meier; LEN, lenalidomide; NR, not reached; PBO, placebo; PFS, progression‐free survival.
See this image and copyright information in PMC

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