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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
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 t...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7154674/ https://www.ncbi.nlm.nih.gov/pubmed/31702836 http://dx.doi.org/10.1111/bjh.16300 |
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author | Thieblemont, Catherine Howlett, Susannah Casasnovas, René‐Olivier Mounier, Nicolas Perrot, Aurore Morschhauser, Franck Fruchart, Christophe Daguindau, Nicolas van Eygen, Koen Obéric, Lucie Bouabdallah, Reda Pica, Gian Matteo Nicolas‐Virezelier, Emmanuelle Abraham, Julie Fitoussi, Olivier Snauwaert, Sylvia Eisenmann, Jean‐Claude Lionne‐Huyghe, Pauline Bron, Dominique Tricot, Sabine Deeren, Dries Gonzalez, Hugo Costello, Régis Le Du, Katell da Silva, Maria Gomes Grosicki, Sebastian Trotman, Judith Catalano, John Caballero, Dolores Greil, Richard Cohen, Amos M. Gaulard, Philippe Roulin, Louise Takeshita, Kenichi Casadebaig, Marie‐Laure Tilly, Hervé Coiffier, Bertrand |
author_facet | Thieblemont, Catherine Howlett, Susannah Casasnovas, René‐Olivier Mounier, Nicolas Perrot, Aurore Morschhauser, Franck Fruchart, Christophe Daguindau, Nicolas van Eygen, Koen Obéric, Lucie Bouabdallah, Reda Pica, Gian Matteo Nicolas‐Virezelier, Emmanuelle Abraham, Julie Fitoussi, Olivier Snauwaert, Sylvia Eisenmann, Jean‐Claude Lionne‐Huyghe, Pauline Bron, Dominique Tricot, Sabine Deeren, Dries Gonzalez, Hugo Costello, Régis Le Du, Katell da Silva, Maria Gomes Grosicki, Sebastian Trotman, Judith Catalano, John Caballero, Dolores Greil, Richard Cohen, Amos M. Gaulard, Philippe Roulin, Louise Takeshita, Kenichi Casadebaig, Marie‐Laure Tilly, Hervé Coiffier, Bertrand |
author_sort | Thieblemont, Catherine |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-7154674 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-71546742020-04-14 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 Thieblemont, Catherine Howlett, Susannah Casasnovas, René‐Olivier Mounier, Nicolas Perrot, Aurore Morschhauser, Franck Fruchart, Christophe Daguindau, Nicolas van Eygen, Koen Obéric, Lucie Bouabdallah, Reda Pica, Gian Matteo Nicolas‐Virezelier, Emmanuelle Abraham, Julie Fitoussi, Olivier Snauwaert, Sylvia Eisenmann, Jean‐Claude Lionne‐Huyghe, Pauline Bron, Dominique Tricot, Sabine Deeren, Dries Gonzalez, Hugo Costello, Régis Le Du, Katell da Silva, Maria Gomes Grosicki, Sebastian Trotman, Judith Catalano, John Caballero, Dolores Greil, Richard Cohen, Amos M. Gaulard, Philippe Roulin, Louise Takeshita, Kenichi Casadebaig, Marie‐Laure Tilly, Hervé Coiffier, Bertrand Br J Haematol Haematological Malignancy ‐ Clinical 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. John Wiley and Sons Inc. 2019-11-08 2020-04 /pmc/articles/PMC7154674/ /pubmed/31702836 http://dx.doi.org/10.1111/bjh.16300 Text en © 2019 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Haematological Malignancy ‐ Clinical Thieblemont, Catherine Howlett, Susannah Casasnovas, René‐Olivier Mounier, Nicolas Perrot, Aurore Morschhauser, Franck Fruchart, Christophe Daguindau, Nicolas van Eygen, Koen Obéric, Lucie Bouabdallah, Reda Pica, Gian Matteo Nicolas‐Virezelier, Emmanuelle Abraham, Julie Fitoussi, Olivier Snauwaert, Sylvia Eisenmann, Jean‐Claude Lionne‐Huyghe, Pauline Bron, Dominique Tricot, Sabine Deeren, Dries Gonzalez, Hugo Costello, Régis Le Du, Katell da Silva, Maria Gomes Grosicki, Sebastian Trotman, Judith Catalano, John Caballero, Dolores Greil, Richard Cohen, Amos M. Gaulard, Philippe Roulin, Louise Takeshita, Kenichi Casadebaig, Marie‐Laure Tilly, Hervé Coiffier, Bertrand 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Haematological Malignancy ‐ Clinical |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7154674/ https://www.ncbi.nlm.nih.gov/pubmed/31702836 http://dx.doi.org/10.1111/bjh.16300 |
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