Health-related quality of life impact of cobimetinib in combination with vemurafenib in patients with advanced or metastatic BRAFV600 mutation-positive melanoma

被引：16

作者：

Dreno, Brigitte ^{[1
]}

Ascierto, Paolo A. ^{[2
]}

Atkinson, Victoria ^{[3
]}

Liszkay, Gabriella ^{[4
]}

Maio, Michele ^{[5
]}

Mandala, Mario ^{[6
]}

Demidov, Lev ^{[7
]}

Stroyakovskiy, Daniil ^{[8
]}

Thomas, Luc ^{[9
]}

de la Cruz-Merino, Luis ^{[10
]}

Dutriaux, Caroline ^{[11
]}

Garbe, Claus ^{[12
]}

Bartley, Karen ^{[13
]}

Karagiannis, Thomas ^{[13
]}

Chang, Ilsung ^{[13
]}

Rooney, Isabelle ^{[13
]}

Koralek, Daniel O. ^{[13
]}

Larkin, James ^{[14
]}

McArthur, Grant A. ^{[15
,16
,17
]}

Ribas, Antoni

机构：

[1] Nantes Univ, Dept Dermato Cancerol, F-44093 Nantes, France

[2] Fdn G Pascale, Ist Nazl Tumori, I-80131 Naples, Italy

[3] Princess Alexandra Hosp, Woolloongabba, Qld 4102, Australia

[4] Natl Inst Oncol, H-1122 Budapest, Hungary

[5] Azienda Osped Univ Senese, I-53100 Siena, Italy

[6] Papa Giovanni XXIII Hosp, Dept Oncol & Haematol, I-24127 Bergamo, Italy

[7] NN Blokhin Russian Canc Res Ctr, Moscow 115478, Russia

[8] Moscow City Oncol Hosp 62, Krasnogorsk 14301, Russia

[9] Ctr Hosp Lyon Sud, Serv Dermatol, F-69495 Pierre Benite, France

[10] Hosp Univ Virgen Macarena, Seville 41009, Spain

[11] Hop St Andre, F-33075 Bordeaux, France

[12] Univ Tubingen, Dept Dermatol, D-72074 Tubingen, Germany

[13] Genentech Inc, San Francisco, CA 94080 USA

[14] Royal Marsden NHS Fdn Trust, London SW3 6JJ, England

[15] Peter MacCallum Canc Ctr, East Melbourne, Vic 3002, Australia

[16] Univ Melbourne, Parkville, Vic 3052, Australia

[17] Univ Calif Los Angeles, Jonsson Comprehens Canc Ctr, Los Angeles, CA 90095 USA

来源：

BRITISH JOURNAL OF CANCER | 2018年 / 118卷 / 06期

关键词：

vemurafenib; cobimetinib; MEK inhibitor; BRAF inhibitor; HRQOL; EORTC QLQ-C30; metastatic melanoma; DABRAFENIB; TRAMETINIB; MONOTHERAPY; PHASE-3;

D O I：

10.1038/bjc.2017.488

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: In the coBRIM study, cobimetinib plus vemurafenib (C+V) significantly improved survival outcomes vs placebo and vemurafenib (P+V) in patients with advanced/metastatic BRAF(V600)-mutated melanoma. An analysis of health-related quality of life (HRQOL) from coBRIM is reported. Methods: Patients completing the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline and >= 1 time point thereafter constituted the analysis population. Change from baseline >= 10 points was considered clinically meaningful. Results: Mean baseline scores for all QLQ-C30 domains were similar between arms. Most on-treatment scores for QLQ-C30 domains were also comparable between arms. A transient deterioration in role function in cycle 1 day 15 (C1D15; -14.7 points) in the P+V arm and improvement in insomnia in the C+V arm at C2D15 (-12.4 points) was observed. Among patients who experienced a >= 10-point change from baseline (responders), between-group differences were greatest for insomnia (16%), social functioning (10%), fatigue (9%) and pain (7%), all favouring C+V. Diarrhoea, photosensitivity reaction, pyrexia, and rash did not meaningfully affect global health status (GHS). Serous retinopathy was associated with a transient decrease in GHS at C1D15 assessment. Conclusions: In patients with advanced/metastatic BRAFV600-mutated melanoma, treatment with C+V maintained HRQOL compared with P+V, with superior efficacy.

引用

页码：777 / 784

页数：8

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