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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
Author(s) -
Thieblemont Catherine,
Howlett Susannah,
Casasnovas RenéOlivier,
Mounier Nicolas,
Perrot Aurore,
Morschhauser Franck,
Fruchart Christophe,
Daguindau Nicolas,
Eygen Koen,
Obéric Lucie,
Bouabdallah Reda,
Pica Gian Matteo,
NicolasVirezelier Emmanuelle,
Abraham Julie,
Fitoussi Olivier,
Snauwaert Sylvia,
Eisenmann JeanClaude,
LionneHuyghe Pauline,
Bron Dominique,
Tricot Sabine,
Deeren Dries,
Gonzalez Hugo,
Costello Régis,
Le Du Katell,
Silva Maria Gomes,
Grosicki Sebastian,
Trotman Judith,
Catalano John,
Caballero Dolores,
Greil Richard,
Cohen Amos M.,
Gaulard Philippe,
Roulin Louise,
Takeshita Kenichi,
Casadebaig MarieLaure,
Tilly Hervé,
Coiffier Bertrand
Publication year - 2020
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.16300
Subject(s) - lenalidomide , medicine , adverse effect , placebo , quality of life (healthcare) , dosing , oncology , multiple myeloma , alternative medicine , nursing , pathology
Summary 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.