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
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 maintenan...
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| Veröffentlicht in: | British journal of haematology 2020-04, Vol.189 (1), p.84-96 |
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| creator | Thieblemont, Catherine Howlett, Susannah Casasnovas, René‐Olivier Mounier, Nicolas Perrot, Aurore Morschhauser, Franck Fruchart, Christophe Daguindau, Nicolas 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 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 |
| description | 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. |
| doi_str_mv | 10.1111/bjh.16300 |
| format | Article |
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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.</description><identifier>ISSN: 0007-1048</identifier><identifier>EISSN: 1365-2141</identifier><identifier>DOI: 10.1111/bjh.16300</identifier><identifier>PMID: 31702836</identifier><language>eng</language><publisher>England: Blackwell Publishing Ltd</publisher><subject>B-cell lymphoma ; Chemotherapy ; Dosage ; Fatigue ; Geriatrics ; Haematological Malignancy ‐ Clinical ; Hematology ; Immunotherapy ; Life Sciences ; Lymphoma ; non‐Hodgkin lymphoma ; Quality of life ; Research Paper ; Targeted cancer therapy ; therapy</subject><ispartof>British journal of haematology, 2020-04, Vol.189 (1), p.84-96</ispartof><rights>2019 The Authors. published by British Society for Haematology and John Wiley & Sons Ltd</rights><rights>2019 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.</rights><rights>2019. This article is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). 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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.</description><subject>B-cell lymphoma</subject><subject>Chemotherapy</subject><subject>Dosage</subject><subject>Fatigue</subject><subject>Geriatrics</subject><subject>Haematological Malignancy ‐ Clinical</subject><subject>Hematology</subject><subject>Immunotherapy</subject><subject>Life Sciences</subject><subject>Lymphoma</subject><subject>non‐Hodgkin lymphoma</subject><subject>Quality of life</subject><subject>Research Paper</subject><subject>Targeted cancer 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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.</abstract><cop>England</cop><pub>Blackwell Publishing Ltd</pub><pmid>31702836</pmid><doi>10.1111/bjh.16300</doi><tpages>13</tpages><orcidid>https://orcid.org/0000-0002-9941-2448</orcidid><orcidid>https://orcid.org/0000-0002-1634-1104</orcidid><orcidid>https://orcid.org/0000-0002-4243-905X</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | British journal of haematology, 2020-04, Vol.189 (1), p.84-96 |
| issn | 0007-1048 1365-2141 |
| language | eng |
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| source | Wiley Online Library Journals Frontfile Complete; Wiley Online Library Free Content |
| subjects | B-cell lymphoma Chemotherapy Dosage Fatigue Geriatrics Haematological Malignancy ‐ Clinical Hematology Immunotherapy Life Sciences Lymphoma non‐Hodgkin lymphoma Quality of life Research Paper Targeted cancer therapy therapy |
| 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 |
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