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荷兰黑色素瘤治疗登记处:荷兰转移性黑色素瘤患者护理的质量保证。

Dutch Melanoma Treatment Registry: Quality assurance in the care of patients with metastatic melanoma in the Netherlands.

作者信息

Jochems Anouk, Schouwenburg Maartje G, Leeneman Brenda, Franken Margreet G, van den Eertwegh Alfons J M, Haanen John B A G, Gelderblom Hans, Uyl-de Groot Carin A, Aarts Maureen J B, van den Berkmortel Franchette W P J, Blokx Willeke A M, Cardous-Ubbink Mathilde C, Groenewegen Gerard, de Groot Jan Willem B, Hospers Geke A P, Kapiteijn Ellen, Koornstra Rutger H, Kruit Wim H, Louwman Marieke W, Piersma Djura, van Rijn Rozemarijn S, Ten Tije Albert J, Vreugdenhil Gerard, Wouters Michel W J M, van der Hoeven Jacobus J M

机构信息

Department of Medical Oncology, Leiden University Medical Centre, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.

Institute for Medical Technology Assessment, Erasmus University, Burgemeester Oudlaan 50, 3062 PA, Rotterdam, The Netherlands.

出版信息

Eur J Cancer. 2017 Feb;72:156-165. doi: 10.1016/j.ejca.2016.11.021. Epub 2016 Dec 25.

Abstract

BACKGROUND

In recent years, the treatment of metastatic melanoma has changed dramatically due to the development of immune checkpoint and mitogen-activated protein (MAP) kinase inhibitors. A population-based registry, the Dutch Melanoma Treatment Registry (DMTR), was set up in July 2013 to assure the safety and quality of melanoma care in the Netherlands. This article describes the design and objectives of the DMTR and presents some results of the first 2 years of registration.

METHODS

The DMTR documents detailed information on all Dutch patients with unresectable stage IIIc or IV melanoma. This includes tumour and patient characteristics, treatment patterns, clinical outcomes, quality of life, healthcare utilisation, informal care and productivity losses. These data are used for clinical auditing, increasing the transparency of melanoma care, providing insights into real-world cost-effectiveness and creating a platform for research.

RESULTS

Within 1 year, all melanoma centres were participating in the DMTR. The quality performance indicators demonstrated that the BRAF inhibitors and ipilimumab have been safely introduced in the Netherlands with toxicity rates that were consistent with the phase III trials conducted. The median overall survival of patients treated with systemic therapy was 10.1 months (95% confidence interval [CI] 9.1-11.1) in the first registration year and 12.7 months (95% CI 11.6-13.7) in the second year.

CONCLUSION

The DMTR is the first comprehensive multipurpose nationwide registry and its collaboration with all stakeholders involved in melanoma care reflects an integrative view of cancer management. In future, the DMTR will provide insights into challenging questions regarding the definition of possible subsets of patients who benefit most from the new drugs.

摘要

背景

近年来,由于免疫检查点抑制剂和丝裂原活化蛋白(MAP)激酶抑制剂的发展,转移性黑色素瘤的治疗发生了巨大变化。2013年7月设立了一个基于人群的登记处——荷兰黑色素瘤治疗登记处(DMTR),以确保荷兰黑色素瘤治疗的安全性和质量。本文描述了DMTR的设计和目标,并展示了前两年登记的一些结果。

方法

DMTR记录了所有荷兰不可切除的IIIc期或IV期黑色素瘤患者的详细信息。这包括肿瘤和患者特征、治疗模式、临床结果、生活质量、医疗保健利用、非正式护理和生产力损失。这些数据用于临床审计、提高黑色素瘤治疗的透明度、深入了解实际成本效益并创建一个研究平台。

结果

在1年内,所有黑色素瘤中心都参与了DMTR。质量绩效指标表明,BRAF抑制剂和伊匹单抗已在荷兰安全引入,毒性率与进行的III期试验一致。在第一个登记年份,接受全身治疗的患者的中位总生存期为10.1个月(95%置信区间[CI]9.1-11.1),在第二年为12.7个月(95%CI 11.6-13.7)。

结论

DMTR是首个全面的多用途全国性登记处,其与参与黑色素瘤治疗的所有利益相关者的合作反映了癌症管理的综合观点。未来,DMTR将深入探讨关于可能从新药中获益最多的患者亚组定义的具有挑战性的问题。

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