{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,18]],"date-time":"2026-02-18T12:16:07Z","timestamp":1771416967709,"version":"3.50.1"},"reference-count":36,"publisher":"MDPI AG","issue":"4","license":[{"start":{"date-parts":[[2026,2,18]],"date-time":"2026-02-18T00:00:00Z","timestamp":1771372800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Novartis Pharma AG, Basel, Switzerland"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>Background\/Objectives: Malignant melanoma is a highly aggressive cancer associated with significant mortality, underscoring the need for continued research efforts. COMBI-EU (NCT03944356) is a prospective, non-interventional study that aims to assess adjuvant dabrafenib and trametinib usage in clinical practice, the impact of AE management, and the usage of app-based documentation on treatment adherence. Methods: Adults with complete surgical resection of stage III BRAF V600-mutant cutaneous melanoma were included. The primary endpoint was median time on treatment (TOT). Adverse event (AE) management was classified as either a high or low level of management. The rating of AE management based on a self-developed algorithm and rules from COMBI-APlus was used to analyze the impact of AE management on TOT. App-based documentation of medication intake and patient-reported outcomes (CANKADO PRO-React; version 6.0, 06.03.2019) was offered. Results: For 225 patients, the median TOT was 11.8 months (95% confidence interval [CI]: 11.7, 12.0). Treatment was completed by 138 patients (61.3%); 37 (16.4%) discontinued due to treatment-related AEs (TRAEs). TRAEs (\u22651) were experienced by 181 patients (80.4%); the most common was pyrexia (38.2%). High-level AE management showed a trend toward improved treatment adherence (high versus low level: hazard ratio [HR]: 0.74; 95% CI: 0.49, 1.14); this improvement was significant with pyrexia management (HR: 0.52; 95% CI: 0.29, 0.93). Seventy-nine (35%) and 33 patients (15%) intended to use and eventually used the app, respectively. A similar proportion of patients remained on treatment for 12 months irrespective of app usage (use, 39.4% vs. non-use, 36.5%). Conclusions: High-level TRAE management showed a trend toward improved treatment adherence, which was statistically significant for pyrexia. Optional use of an app did not influence treatment adherence.<\/jats:p>","DOI":"10.3390\/cancers18040667","type":"journal-article","created":{"date-parts":[[2026,2,18]],"date-time":"2026-02-18T11:45:58Z","timestamp":1771415158000},"page":"667","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["COMBI-EU: Real-World Evidence on Adverse Event Management and Time on Therapy with Adjuvant Dabrafenib Plus Trametinib in Patients with BRAF V600-Mutant Melanoma"],"prefix":"10.3390","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9060-4961","authenticated-orcid":false,"given":"Michael","family":"Weichenthal","sequence":"first","affiliation":[{"name":"Skin Cancer Center Kiel, University Hospital Schleswig-Holstein, 24105 Kiel, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dirk","family":"Debus","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Paracelsus Medical University, Nuremberg General Hospital, 90419 Nuremberg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lisa","family":"Zimmer","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Venereology and Allergology, University Hospital Essen, 45147 Essen, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Imke von","family":"Wasielewski","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Allergy, Skin Cancer Center Hannover, 30625 Hannover, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Friedegund","family":"Meier","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Faculty of Medicine, University Hospital Carl Gustav Carus, Technische Universit\u00e4t Dresden, 01307 Dresden, Germany"},{"name":"Skin Cancer Center, National Center for Tumor Diseases and University Cancer Centre Dresden, 01307 Dresden, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"T\u00fcting","sequence":"additional","affiliation":[{"name":"Department of Dermatology, University Medical Center, 39120 Magdeburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4603-1825","authenticated-orcid":false,"given":"Markus V.","family":"Heppt","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Uniklinikum Erlangen, Friedrich-Alexander University Erlangen-N\u00fcrnberg (FAU), 91054 Erlangen, Germany"},{"name":"Comprehensive Cancer Center, Erlangen-European Metropolitan Area of Nuremberg (CC ER-EMN), 91054 Erlangen, Germany"},{"name":"Bavarian Cancer Research Center (BZKF), 91052 Erlangen, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7575-6230","authenticated-orcid":false,"given":"Jessica C.","family":"Hassel","sequence":"additional","affiliation":[{"name":"Department of Dermatology and National Center for Tumor Diseases (NCT), Medical Faculty Heidelberg, Heidelberg University, NCT Heidelberg, a Partnership Between DKFZ and University Hospital Heidelberg, 69120 Heidelberg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2519-1312","authenticated-orcid":false,"given":"Fabian","family":"Ziller","sequence":"additional","affiliation":[{"name":"Department of Dermatology, DRK Hospital Chemnitz-Rabenstein, 09117 Chemnitz, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Mohr","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Elbekliniken Buxtehude, 21614 Buxtehude, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pia","family":"D\u00fccker","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Skin Cancer Center, Hospital Dortmund, 44137 Dortmund, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anca","family":"Sindrilaru","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Allergology, Skin Cancer Center, University Hospital Ulm, 89070 Ulm, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edgar","family":"Dippel","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Ludwigshafen Medical Center, 67063 Ludwigshafen, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lucie","family":"Heinzerling","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Uniklinikum Erlangen, Friedrich-Alexander University Erlangen-N\u00fcrnberg (FAU), 91054 Erlangen, Germany"},{"name":"Department of Dermatology and Allergy, University Hospital, Ludwig-Maximilians-University (LMU), 80337 Munich, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marc","family":"Bender","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Elbekliniken Buxtehude, 21614 Buxtehude, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manar","family":"Aoun","sequence":"additional","affiliation":[{"name":"Novartis Campus Basel, 4056 Basel, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Magdalena","family":"Walecki","sequence":"additional","affiliation":[{"name":"EUMelaReg Consortium, 14057 Berlin, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rudolf","family":"Herbst","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Helios Klinikum Erfurt, 99088 Erfurt, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6643-7286","authenticated-orcid":false,"given":"Yenny","family":"Angela","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Johannes Wesling Medical Center, Ruhr University Bochum, Campus Minden, 32429 Minden, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2683-6028","authenticated-orcid":false,"given":"Rudolf","family":"Stadler","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Johannes Wesling Medical Center, Ruhr University Bochum, Campus Minden, 32429 Minden, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3894-8345","authenticated-orcid":false,"given":"Sebastian","family":"Haferkampf","sequence":"additional","affiliation":[{"name":"Department of Dermatology, University Hospital Regensburg, 93053 Regensburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claus-Detlev","family":"Klemke","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Skin Cancer Center, General Hospital Karlsruhe, Academic Teaching Hospital of the University of Freiburg, 76187 Karlsruhe, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kjell Matthias","family":"Kaune","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Dermatosurgery and Allergology, Klinikum Bremen-Ost, 28195 Bremen, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Johannes","family":"Wohlrab","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Venereology, Martin Luther University Halle-Wittenberg, 06120 Halle, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8019-1577","authenticated-orcid":false,"given":"Ulrike","family":"Leiter","sequence":"additional","affiliation":[{"name":"Department of Dermatology, University Hospital Tuebingen, 72076 Tuebingen, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6853-0743","authenticated-orcid":false,"given":"Nessr Abu","family":"Rached","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Venereology and Allergology, Skin Cancer Center, Ruhr-University Bochum, 44791 Bochum, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5316-0241","authenticated-orcid":false,"given":"Jochen","family":"Utikal","sequence":"additional","affiliation":[{"name":"Skin Cancer Unit, German Cancer Research Center (DKFZ), 69120 Heidelberg, Germany"},{"name":"Department of Dermatology, Venereology and Allergology, University Medical Center Mannheim, Ruprecht-Karl University of Heidelberg, 68167 Mannheim, Germany"},{"name":"DKFZ Hector Cancer Institute, University Medical Center Mannheim, 68167 Mannheim, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gaston","family":"Schley","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Venereology, Helios Klinikum Schwerin, 19055 Schwerin, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jens","family":"Ulrich","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Allergy, Harzklinikum Dorothea Christiane Erxleben GmbH, 06484 Quedlinburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erwin","family":"Schultz","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Paracelsus Medical University, Nuremberg General Hospital, 90419 Nuremberg, 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