During the past ten years several fundamental breakthroughs have radically changed the treatment options in metastatic melanoma. Both targeted therapies (TT) and immunotherapies (IT) randomized clinical trials have shown significant benefit in relapse free and overall survival. Since the underlying clinical trials represent selected patient populations who had to meet several inclusion and exclusion criteria, the EuMelaReg consortium sought to evaluate "real world" melanoma cases presenting for initial treatment decision with stage IV or unresectable stage III disease.
Data sources from Denmark (Danish metastatic melanoma database), Germany (ADOReg Registry) or The Netherlands (Dutch Melanoma Treatment Registry) were merged in a stepwise procedure into a standardized data representation format. The harmonized database for the current analysis included subgroups of patients presenting in 2014 for treatment of non-resectable stage III or metastatic stage IV disease on a regular basis. Criteria used to validate the process of data harmonization contained primary demographic data as well as data concerning the advanced disease status (ECOG status, serum LDH, and baseline tumor burden including the presence of brain metastasis), and the different treatment strategies and regimens.
It could be shown that more than 30 percent of the cases included would not have qualified for common inclusion and/or exclusion criteria of clinical phase III trials in advanced melanoma. Moreover, the distribution of prognostic and predicive factors varied substancially between the real-world populations and published study populations.
Final endpoints of the ongoing data collection and analysis will contain among other parameters progression free survival, overall survival, and tolerability of treatment. Collaboration is sought to a range of other European registries and countries.
Clinical trial identification
Legal entity responsible for the study
The EUMelaReg Consortium (European Melanoma Registries Network).
BMS, MSD, Roche, Novartis.
M. Weichenthal: Grants, honoraria, fees: BMS, MSD, Roche, Novartis, Millennium, Medac, Takeda, Amgen, Pierre-Fabre. A.C.J. van Akkooi, P. Mohr, E. Ellebaek, I-M. Svane, S. Ugurel-Becker, U. Leiter, L. Hoejberg, J.B.A.G. Haanen, H. Schmidt, T.H. Oellegaard, M.W.J.M. Wouters, D. Schadendorf, L. Bastholt: BMS, MSD, Roche, Novartis.