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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.
British Journal of Haematology ( IF 6.5 ) Pub Date : 2019-11-08 , DOI: 10.1111/bjh.16300
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
Affiliation  

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.

中文翻译:

来那度胺维持治疗对R-CHOP有反应的弥漫性大B细胞淋巴瘤患者:生活质量,剂量和安全性来自随机对照REMARC研究。

在REMARC研究的3期研究中,来那度胺维持疗法与安慰剂相比,对诱导化疗的老年弥漫性大B细胞淋巴瘤(DLBCL)患者延长了无进展生存期(PFS)。该亚人群分析评估来那度胺维持和紧急治疗不良事件(TEAE)对与健康相关的生活质量(HRQOL)的影响。在完成了欧洲癌症研究和治疗组织生活质量问卷-C30 v3.0的患者中,评估了其总体健康状况(GHS)以及身体机能和疲劳分量表。评估了事后归类为主观(患者可以感觉到)或可观察到(仅可由医生测量)的TEAE对减少剂量和停药的影响。在457名患者中(来那度胺,n = 229;安慰剂,n = 228),治疗组之间的平均(标准差)GHS相似[68·2(20·7)对72·0(17·8)],在维持期间保持相似。来那度胺的患者在GHS,身体机能或疲劳方面没有任何有意义的变化。与两组中的主观TEAE相比,可观察到的TEAE更常见(81·1%对66·3%),并且更可能导致剂量减少。不论剂量减少,来那度胺组的PFS均较优。与TEA相比,来那度胺维持可使PFS延长,并且对DLBCL患者的HRQOL没有负面影响,尽管TEAE较安慰剂更为常见。或疲劳。与两组中的主观TEAE相比,可观察到的TEAE更常见(81·1%对66·3%),并且更可能导致剂量减少。不论剂量减少,来那度胺组的PFS均较优。与TEA相比,来那度胺维持可使PFS延长,并且对DLBCL患者的HRQOL没有负面影响,尽管TEAE较安慰剂更为常见。或疲劳。与两组中的主观TEAE相比,可观察到的TEAE更常见(81·1%对66·3%),并且更可能导致剂量减少。不论剂量减少,来那度胺组的PFS均较优。与TEA相比,来那度胺维持可使PFS延长,并且对DLBCL患者的HRQOL没有负面影响,尽管TEAE较安慰剂更为常见。
更新日期:2019-11-08
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