Vemurafenib in BRAF-mutant metastatic melanoma patients in real-world clinical practice: prognostic factors associated with clinical outcomes

被引：9

作者：

Schouwenburg, Maartje G. ^{[1
,2
]}

Jochems, Anouk ^{[1
,2
]}

Leeneman, Brenda ^{[3
]}

Franken, Margreet G. ^{[4
]}

van den Eertwegh, Alfons J. M. ^{[6
]}

Haanen, John B. A. G. ^{[7
]}

van Zeijl, Michiel C. T. ^{[1
,2
]}

Aarts, Maureen J. ^{[9
]}

van Akkooi, Alexander C. J. ^{[8
]}

van den Berkmortel, Franchette W. P. J. ^{[10
]}

Blokx, Willeke A. M. ^{[11
]}

de Groot, Jan Willem B. ^{[13
]}

Hospers, Geke A. P. ^{[14
]}

Kapiteijn, Ellen ^{[1
]}

Koornstra, Rutger H. ^{[12
]}

Kruit, Wim H. ^{[5
]}

Louwman, Marieke W. J. ^{[15
]}

Piersma, Djura ^{[17
]}

van Rijn, Rozemarijn S. ^{[18
]}

Suijkerbuijk, Karijn P. M. ^{[16
]}

ten Tije, Albert J. ^{[7
,19
]}

Vreugdenhil, Gerard ^{[20
]}

Wouters, Michel W. J. M. ^{[2
,8
]}

van der Hoeven, Jacobus J. M. ^{[1
]}

机构：

[1] Leiden Univ, Dept Med Oncol, Med Ctr, Albinusdreef 2,POB 9600, NL-2300 RC Leiden, Netherlands

[2] Dutch Inst Clin Auditing, Leiden, Netherlands

[3] Erasmus Sch Hlth Policy & Management, Dept Hlth Technol Assessment, Rotterdam, Netherlands

[4] Erasmus Univ, Inst Med Technol Assessment, Rotterdam, Netherlands

[5] Erasmus MC Canc Inst, Dept Med Oncol, Rotterdam, Netherlands

[6] Vrije Univ Amsterdam Med Ctr, Dept Med Oncol, Amsterdam, Netherlands

[7] Antoni van Leeuwenhoek Hosp, Netherlands Canc Inst, Dept Med Oncol, Amsterdam, Netherlands

[8] Antoni van Leeuwenhoek Hosp, Netherlands Canc Inst, Dept Surg Oncol, Amsterdam, Netherlands

[9] Maastricht Univ, Dept Med Oncol, Med Ctr, Maastricht, Netherlands

[10] Zuyderland Med Ctr Geleen Heerlen, Dept Internal Med, Sittard Geleen, Netherlands

[11] Radboud Univ Nijmegen, Med Ctr, Dept Pathol, Nijmegen, Netherlands

[12] Radboud Univ Nijmegen, Med Ctr, Dept Med Oncol, Nijmegen, Netherlands

[13] Isala, Dept Med Oncol, Zwolle, Netherlands

[14] Univ Groningen, Univ Med Ctr Groningen, Dept Med Oncol, Groningen, Netherlands

[15] Netherlands Comprehens Canc Org, Utrecht, Netherlands

[16] Univ Med Ctr Utrecht, Dept Med Oncol, Ctr Canc, Utrecht, Netherlands

[17] Med Spectrum Twente, Dept Internal Med, Enschede, Netherlands

[18] Med Ctr Leeuwarden, Dept Internal Med, Leeuwarden, Netherlands

[19] Amphia Hosp, Dept Internal Med, Breda, Netherlands

[20] Maxima Med Ctr, Dept Internal Med, Veldhoven, Netherlands

来源：

MELANOMA RESEARCH | 2018年 / 28卷 / 04期

关键词：

clinical practice; metastatic melanoma; prognostic factors; risk score; vemurafenib; MUTATION-POSITIVE MELANOMA; OPEN-LABEL; FOLLOW-UP; MULTICENTER; DABRAFENIB; IPILIMUMAB; SAFETY; SURVIVAL; REGISTRY; PHASE-3;

D O I：

10.1097/CMR.0000000000000453

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

The aim of this population-based study was to identify the factors associated with clinical outcomes in vemurafenib-treated patients and to evaluate outcomes across subgroups of patients with different risk profiles. Data were retrieved from the Dutch Melanoma Treatment Registry. Time to next treatment (TTNT) and overall survival (OS) of all metastatic melanoma patients who received vemurafenib between 2012 and 2015 were assessed using Kaplan-Meier estimates. A risk score was developed on the basis of all prognostic factors associated with TTNT and OS derived from multivariable Cox regression analyses. Patients were stratified according to the presence of prognostic risk factors by counting the number of factors, ranging from 0 to 6. A total of 626 patients received vemurafenib with a median follow-up of 35.8 months. The median TTNT and OS were 4.7 months [95% confidence intervals (CI): 4.4-5.1] and 7.3 months (95% CI: 6.6-8.0). The strongest prognostic factors were serum lactate dehydrogenase (LDH) level, Eastern Cooperative Oncology Group performance score, number of organ sites involved and brain metastases. Patients with a favourable risk profile (no risk factors) had a median TTNT and OS of 7.1 (95% CI: 5.8-8.5) and 15.4 months (95% CI: 10.0-20.9). The median OS more than halved for patients with greater than or equal to 2 risk factors compared with patients with no risk factors. The clinical outcomes of vemurafenib in metastatic melanoma patients with a favourable risk profile are comparable with the results of the trials. Combining prognostic factors into a risk score could be valuable to stratify patients into favourable and poor-prognosis groups. Copyright (c) 2018 Wolters Kluwer Health, Inc. All rights reserved.

引用

页码：326 / 332

页数：7

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