Original ResearchDutch Melanoma Treatment Registry: Quality assurance in the care of patients with metastatic melanoma in the Netherlands
Introduction
Malignant melanoma is one of the most aggressive types of skin cancer. The incidence of melanoma has increased in Europe over the past few decades [1], [2]. In the Netherlands, the number of new cases of invasive melanoma (all stages) more than doubled between 2000 and 2014 and it accounts for approximately 90% of skin-cancer-related mortality in 2014 [3]. The increased incidence accompanied by the high mortality rates made it one of the worst-performing tumours in the Netherlands over recent years, especially for males [4].
The treatment of unresectable and metastatic melanoma has changed dramatically in recent years due to the development of immune checkpoint inhibitors (e.g. ipilimumab, nivolumab and pembrolizumab) and inhibitors of the mitogen-activated protein (MAP) kinase pathway (e.g. the BRAF inhibitors vemurafenib and dabrafenib and the MAP kinase kinase (MEK) inhibitors trametinib and cobimetinib) [5], [6], [7], [8]. These drugs create new opportunities to prolong progression-free and overall survival (OS) for patients with metastatic melanoma. However, the introduction of the new drugs poses several challenges. First, adequate selection of subsets of patients who may benefit from immune checkpoint inhibitors or MAP kinase inhibitors and sequencing these new drugs present a challenge. Second, experience in recognising and treating the potentially life-threatening side-effects of immune checkpoint inhibitors is essential. Finally, the high costs of these new drugs raise questions about their cost-effectiveness in daily clinical practice.
The introduction of the new drugs to treat metastatic melanoma was approved by the Dutch Minister of Health subject to two firm conditions: I) the concentration of metastatic melanoma treatment in a limited number of designated centres and II) the recording of all patients with unresectable or metastatic melanoma (stage IIIc or stage IV melanoma) in a nationwide registry.
To achieve centralisation, the Dutch Society of Medical Oncologists (NVMO) selected 14 hospitals as melanoma centres in 2012. These centres were chosen on the basis of their expertise in the systemic treatment of melanoma, their infrastructure and their geographic distribution. At the same time, a set of multidisciplinary quality standards was established by the professional organisations involved in melanoma treatment, including a minimum volume standard of 20 new patients annually receiving systemic treatment for metastatic melanoma [9]. This number of patients is based on safety reports in clinical trials [5], [6]. In addition, it was assumed that this would allow the centres to have sufficient experience in treating patients with severe toxicity.
The Dutch Melanoma Treatment Registry (DMTR) was set up in July 2013. A unique consortium of organisations, including medical specialists, policymakers, healthcare researchers, patient advocates and pharmaceutical companies, was involved in establishing the registry.
This article describes the design and the objectives of the DMTR and presents some results of the first 2 years of registration.
Section snippets
Objectives of the DMTR
The DMTR was designed to serve multiple objectives: I) clinical auditing, II) improving transparency concerning the quality of melanoma care, III) providing an insight into real-world outcomes on effects and costs and IV) to create a platform for research.
Patient characteristics
From 1st July 2012 to 1st July 2014, 1472 patients with metastatic melanoma were registered in the DMTR. A total of 60 patients were not referred to a melanoma centre and therefore received only a concise entry mainly due to poor performance status or limited prognosis. Of all the patients referred to a melanoma centre (n = 1412), 23 patients (1.6%) were excluded because of missing data on date of birth, date of first visit to a melanoma centre, date of diagnosis of disseminated disease and the
Discussion
This article reports on the start-up and key elements of the DMTR. The DMTR is unique in its collaboration between all stakeholders involved in treating metastatic melanoma, and its multipurpose design. The active participation of the 14 dedicated melanoma centres led to the nationwide coverage of all patients with metastatic melanoma in the registry within the first year.
The results of the DMTR demonstrate that treatment with BRAF inhibitors and ipilimumab has been implemented as standard of
Funding
This work was supported by the Netherlands Organisation for Health Research and Development (ZonMW) [grant no. 836002002]. The Dutch Melanoma Treatment Registry (DMTR) was sponsored by Roche Nederland B.V, Bristol-Myers Squibb (BMS), GlaxoSmithKline (GSK)/Novartis and Merck Sharp & Dohme (MSD).
Role of the funding source: representatives of the pharmaceutical companies that sponsor the DMTR and ZonMW have a seat on the advisory board. This body advises the Board of Directors and the Medical
Conflict of interest statement
None declared.
Acknowledgments
The authors thank all physicians and data managers who registered the data in the Dutch Melanoma Treatment Registry. They would also like to thank ZonMW and the pharmaceutical companies for their financial support.
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Both authors contributed equally.