{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T01:38:56Z","timestamp":1760146736294,"version":"build-2065373602"},"reference-count":31,"publisher":"MDPI AG","issue":"23","license":[{"start":{"date-parts":[[2024,12,5]],"date-time":"2024-12-05T00:00:00Z","timestamp":1733356800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Novartis Farma Italy"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>Background\/Objective: Dabrafenib and trametinib (D + T) have been approved for the treatment of stage III melanoma with BRAF V600E V600K mutations in an adjuvant setting, based on the results from the COMBI-AD trial. To provide early access to this combination therapy prior to its commercial availability in Italy, a Managed Access Program (MAP) was run in Italy from June 2018 to December 2019. Methods: The MADAM (Maximing ADjuvAnt MAP) study is an Italian retrospective\u2013prospective observational study that included patients who received at least one dose of D + T through the MAP. The primary endpoints were relapse-free survival (RFS) and overall survival (OS). Results: This interim analysis presents findings after the first 24 months of follow-up. A total of 310 patients were included in the study; 240 completed the 12-month treatment with D + T, while 70 discontinued the combination. RFS rates were 93.2% at 12 months and 80.2% at 24 months. The median RFS was not reached for the overall population or any subgroups. Similarly, the median OS was not reached, with OS rates of 96.4% at 12 months and 92.5% at 24 months. Conclusions: D + T achieved an RFS benefit, with effects sustained beyond the treatment period, indicating positive outcomes in this patient population.<\/jats:p>","DOI":"10.3390\/cancers16234072","type":"journal-article","created":{"date-parts":[[2024,12,5]],"date-time":"2024-12-05T06:24:44Z","timestamp":1733379884000},"page":"4072","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Retrospective-Prospective Observational Study of Italian Patients Treated in Melanoma Adjuvant Cohort MAP\u2013MADAM (Maximing ADjuvAnt MAP): Interim Analysis"],"prefix":"10.3390","volume":"16","author":[{"given":"Francesca","family":"Consoli","sequence":"first","affiliation":[{"name":"Medical Oncology, ASST Spedali Civili, 25123 Brescia, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4008-4897","authenticated-orcid":false,"given":"Marco","family":"Tucci","sequence":"additional","affiliation":[{"name":"Medical Oncology Unit, University of Bari Aldo Moro, Policlinico Hospital of Bari, 70124 Bari, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2427-8915","authenticated-orcid":false,"given":"Jacopo","family":"Pigozzo","sequence":"additional","affiliation":[{"name":"Veneto Institute of Oncology IOV-IRCCS, 35128 Padova, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ester","family":"Simeone","sequence":"additional","affiliation":[{"name":"Unit of Melanoma, Cancer Immunotherapy and Innovative Therapy, National Cancer Institute G. Pascale, 80131 Naples, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesco","family":"Spagnolo","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy"},{"name":"Department of Surgical Sciences and Integrated Diagnostics (DISC), Plastic Surgery, University of Genova, 16132 Genoa, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0646-4901","authenticated-orcid":false,"given":"Teresa","family":"Troiani","sequence":"additional","affiliation":[{"name":"Medical Oncology Unit, Department of Precision Medicine, University of Campania \u201cLuigi Vanvitelli\u201d, 80123 Naples, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesca","family":"Morgese","sequence":"additional","affiliation":[{"name":"Oncology Clinic, Polytechnic University of Marche, United Hospitals of Ancona, 60126 Ancona, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michele","family":"Del Vecchio","sequence":"additional","affiliation":[{"name":"S.S. Oncologia Medica Melanomi, S.C. Oncologia Medica 1, Dipartimento di Oncologia Medica ed Ematologia, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1041-391X","authenticated-orcid":false,"given":"Barbara","family":"Melotti","sequence":"additional","affiliation":[{"name":"Divisione di Oncologia Medica, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4911-2823","authenticated-orcid":false,"given":"Maria Chiara","family":"Tronconi","sequence":"additional","affiliation":[{"name":"IRCCS Humanitas Research Hospital, Rozzano, 20089 Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria Francesca","family":"Morelli","sequence":"additional","affiliation":[{"name":"Oncologia e Oncologia Dermatologica, Istituto Dermopatico dell\u2019Immacolata IDI-IRCCS, 00167 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6843-3369","authenticated-orcid":false,"given":"Federica","family":"Grosso","sequence":"additional","affiliation":[{"name":"Mesothelioma and Rare Cancers Unit, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo, 15121 Alessandria, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-8535-119X","authenticated-orcid":false,"given":"Barbara","family":"Merelli","sequence":"additional","affiliation":[{"name":"Unit of Medical Oncology, ASST Papa Giovanni XXIII, 24127 Bergamo, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ilaria","family":"Marcon","sequence":"additional","affiliation":[{"name":"Novartis Farma S.p.A, 20154 Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Diletta","family":"Valsecchi","sequence":"additional","affiliation":[{"name":"Novartis Farma S.p.A, 20154 Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pietro","family":"Quaglino","sequence":"additional","affiliation":[{"name":"Dermatology Clinic, Department of Medical Sciences, University of Turin, 10126 Turin, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2024,12,5]]},"reference":[{"key":"ref_1","unstructured":"(2024, September 30). 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