A first prospective population-based analysis investigating the actual practice of melanoma diagnosis, treatment and follow-up
Introduction
Melanoma incidence is on a steady increase with some even calling it an epidemic. According to the World Health Organisation (WHO), the incidence of melanoma is increasing faster than any other cancer in the world. With an incidence rate of 68,130 for 2010, melanoma is currently the 5th most common cancer in men and the 7th most common cancer in women in the United States (US)1 and thus poses a significant health issue and economic burden.
In the best interest of the patient as well as at a time of tight health budgets, the extent of diagnostic and therapeutic procedures undertaken in melanoma patients should be adapted to consensus-based guidelines which exist in many countries.2, 3, 4, 5, 6, 7, 8 However, there are no universally accepted guidelines nor recommendations with regard to follow up frequency and duration and staging procedures differ considerably.
Investigations assessing the implementation of these guideline recommendations in the daily actual practice are limited. Especially in Europe, clinical practice assessments for melanoma are sparse, generally of retrospective nature and often only consider one aspect such as safety margin excision or sentinel lymph node biopsy (SLNB).9, 10 Only one extensive population-based study was conducted retrospectively in France; Grange et al. assessed and compared the clinical management of stages I–III melanoma patients in five French regions to the existing French guidelines in 2004.11 The authors found that disparities in the management of melanoma depended to a great extent on medical and geographical neighbourhood rather than on the characteristics of either patients or tumours. Staging procedures often exceeded French recommendations.
The German melanoma guideline recommends comparatively extensive diagnostic procedures5 with questionable benefit especially in low-risk melanoma. The detection rate of metastases in asymptomatic, low-risk patients is known to be quite low whereas the frequency of false-positive findings is high. Studies analysing the costs of initial and follow-up staging procedures in Germany have already demonstrated the expenses and low efficacy of these elaborate staging procedures.12, 13, 14 These studies were, however, only restrospective monocentre evaluations.
The aim of this study was, therefore, to assess (i) the current practice of melanoma diagnosis, treatment and follow-up in Germany, (ii) the adherence of the actual melanoma management with the German melanoma guideline, (iii) if there are disparities of the actual management with regard to geographical area, centre size, insurance status, treating physician or patient and tumour characteristics and (iv) the costs generated by staging procedures at the time of initial diagnosis in stages I–III melanoma patients. As retrospective studies always yield a great risk of a recall bias, our investigation was designed as a prospective study, being the first prospective population-based analysis investigating the actual practice of melanoma diagnosis, treatment and follow-up in Germany. Patients were registered at the time of initial melanoma diagnosis and will be followed up for 4 years. For this investigation, data of patients with melanoma in situ and cutaneous melanoma stages I–III at registration were analysed.
Section snippets
Study design
The study was initiated in Germany in April 2008 as a nation-wide project (population = 82 million inhabitants [source: German Federal Statistical office, 2008], divided into 16 federal states). The study was a joint project of the Arbeitsgemeinschaft Dermatoonkologie (Dermatologic Cooperative Oncology Group, DeCOG), the Deutsche Dermatologische Gesellschaft (German Society of Dermatologists, DDG) and the Berufsverband der Deutschen Dermatologen (Professional Organization of German Dermatologists
Results
Patients (1360) were registered in the database, informed consent was obtained in 1271 cases. After correction for duplicate cases, a total of 1264 cases remained leading to an exhaustiveness rate of 0.26. Additionally, patients with unknown primary, primary other than cutaneous, unknown tumour thickness, distant metastases and unclassifiable tumour stage were excluded, leaving 1081 cases from 106 different centres for complete analysis. 20% of all patients were registered by 73 small centres,
Discussion
Our prospective data analysis of 1081 patients diagnosed with stages I–III melanoma from April to June 2008 in Germany investigated the actual clinical practice of melanoma management and whether variations of melanoma management were dependent on geographic, demographic or tumour specific characteristics.
Overall, demographic data were consistent with those of the largest German melanoma register in Tübingen, Germany (Table 1, Table 2). There was no sex preponderance, but men were significantly
Financial disclosures
None of the authors have any relevant financial interest in this study.
Role of the sponsors
The sponsors had no role in the design and conduct of the study; in the collection, analysis, and interpretation of data; in the preparation of the manuscript; or in the review or approval of the manuscript.
Additional contributions
We thank all centres participating in this study for providing patient data. We thank Alcedis GmbH for data documentation and analysis.
Funding/support
This study was supported by grants from Essex Pharma, Medac Onkologie, Bayer Health Care, Bristol-Myer Squibb, Swedish Orphan International.
Conflict of interest statement
None declared.
Acknowledgements
We thank all investigators who registered patients for this study: Ms. Petersen, Dep. of Dermatology, University Hospital Tübingen; Dr. K. Havliza, Prof. Dr. Rompel, Dep. of Dermatology, Kassel Hospital; Dr. Trefzer, Dep. of Dermatology, Charité University Hospital Berlin; Prof. Nashan, Dep. of Dermatology, University Hospital Freiburg; Dr. S. Rotterdam, Dep. of Dermatology, University Hospital Bochum; Prof. Dr. S. Ugurel, Dep. of Dermatology, University Hospital Würzburg; Dr. Gauwerky, Dep. of
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