Francesca Consoli, Marco Tucci, Jacopo Pigozzo, Ester Simeone, Francesco Spagnolo, Teresa Troiani, Francesca Morgese, Michele Del Vecchio, Barbara Melotti, Maria Chiara Tronconi, Maria Francesca Morelli, Federica Grosso, Barbara Merelli, Ilaria Marcon, Diletta Valsecchi, Pietro Quaglino
{"title":"对接受黑色素瘤辅助治疗队列 MAP-MADAM(Maximing ADjuvAnt MAP)治疗的意大利患者进行的回顾性-前瞻性观察研究:中期分析。","authors":"Francesca Consoli, Marco Tucci, Jacopo Pigozzo, Ester Simeone, Francesco Spagnolo, Teresa Troiani, Francesca Morgese, Michele Del Vecchio, Barbara Melotti, Maria Chiara Tronconi, Maria Francesca Morelli, Federica Grosso, Barbara Merelli, Ilaria Marcon, Diletta Valsecchi, Pietro Quaglino","doi":"10.3390/cancers16234072","DOIUrl":null,"url":null,"abstract":"<p><p><b>Background/Objective</b>: 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. <b>Methods</b>: The MADAM (Maximing ADjuvAnt MAP) study is an Italian retrospective-prospective 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). <b>Results</b>: 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. <b>Conclusions</b>: D + T achieved an RFS benefit, with effects sustained beyond the treatment period, indicating positive outcomes in this patient population.</p>","PeriodicalId":9681,"journal":{"name":"Cancers","volume":"16 23","pages":""},"PeriodicalIF":4.5000,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Retrospective-Prospective Observational Study of Italian Patients Treated in Melanoma Adjuvant Cohort MAP-MADAM (Maximing ADjuvAnt MAP): Interim Analysis.\",\"authors\":\"Francesca Consoli, Marco Tucci, Jacopo Pigozzo, Ester Simeone, Francesco Spagnolo, Teresa Troiani, Francesca Morgese, Michele Del Vecchio, Barbara Melotti, Maria Chiara Tronconi, Maria Francesca Morelli, Federica Grosso, Barbara Merelli, Ilaria Marcon, Diletta Valsecchi, Pietro Quaglino\",\"doi\":\"10.3390/cancers16234072\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b>Background/Objective</b>: 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. <b>Methods</b>: The MADAM (Maximing ADjuvAnt MAP) study is an Italian retrospective-prospective 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). <b>Results</b>: 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. <b>Conclusions</b>: D + T achieved an RFS benefit, with effects sustained beyond the treatment period, indicating positive outcomes in this patient population.</p>\",\"PeriodicalId\":9681,\"journal\":{\"name\":\"Cancers\",\"volume\":\"16 23\",\"pages\":\"\"},\"PeriodicalIF\":4.5000,\"publicationDate\":\"2024-12-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Cancers\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.3390/cancers16234072\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cancers","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3390/cancers16234072","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
Retrospective-Prospective Observational Study of Italian Patients Treated in Melanoma Adjuvant Cohort MAP-MADAM (Maximing ADjuvAnt MAP): Interim Analysis.
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-prospective 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.
期刊介绍:
Cancers (ISSN 2072-6694) is an international, peer-reviewed open access journal on oncology. It publishes reviews, regular research papers and short communications. Our aim is to encourage scientists to publish their experimental and theoretical results in as much detail as possible. There is no restriction on the length of the papers. The full experimental details must be provided so that the results can be reproduced.