TY - JOUR
T1 - Lenalidomide maintenance for diffuse large B-cell lymphoma patients responding to R-CHOP
T2 - quality of life, dosing, and safety results from the randomised controlled REMARC study
AU - Thieblemont, Catherine
AU - Howlett, Susannah
AU - Casasnovas, René Olivier
AU - Mounier, Nicolas
AU - Perrot, Aurore
AU - Morschhauser, Franck
AU - Fruchart, Christophe
AU - Daguindau, Nicolas
AU - van Eygen, Koen
AU - Obéric, Lucie
AU - Bouabdallah, Reda
AU - Pica, Gian Matteo
AU - Nicolas-Virezelier, Emmanuelle
AU - Abraham, Julie
AU - Fitoussi, Olivier
AU - Snauwaert, Sylvia
AU - Eisenmann, Jean Claude
AU - Lionne-Huyghe, Pauline
AU - Bron, Dominique
AU - Tricot, Sabine
AU - Deeren, Dries
AU - Gonzalez, Hugo
AU - Costello, Régis
AU - Le Du, Katell
AU - da Silva, Maria Gomes
AU - Grosicki, Sebastian
AU - Trotman, Judith
AU - Catalano, John
AU - Caballero, Dolores
AU - Greil, Richard
AU - Cohen, Amos M.
AU - Gaulard, Philippe
AU - Roulin, Louise
AU - Takeshita, Kenichi
AU - Casadebaig, Marie Laure
AU - Tilly, Hervé
AU - Coiffier, Bertrand
N1 - Publisher Copyright:
© 2019 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd
PY - 2020/4/1
Y1 - 2020/4/1
N2 - 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.
AB - 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.
KW - non-Hodgkin lymphoma
KW - quality of life
KW - therapy
UR - http://www.scopus.com/inward/record.url?scp=85074817306&partnerID=8YFLogxK
U2 - 10.1111/bjh.16300
DO - 10.1111/bjh.16300
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C2 - 31702836
AN - SCOPUS:85074817306
VL - 189
SP - 84
EP - 96
JO - British Journal of Haematology
JF - British Journal of Haematology
SN - 0007-1048
IS - 1
ER -