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. 2024 Dec 5;16(23):4072.
doi: 10.3390/cancers16234072.

Retrospective-Prospective Observational Study of Italian Patients Treated in Melanoma Adjuvant Cohort MAP-MADAM (Maximing ADjuvAnt MAP): Interim Analysis

Francesca Consoli  1 , Marco Tucci  2 , Jacopo Pigozzo  3 , Ester Simeone  4 , Francesco Spagnolo  5   6 , Teresa Troiani  7 , Francesca Morgese  8 , Michele Del Vecchio  9 , Barbara Melotti  10 , Maria Chiara Tronconi  11 , Maria Francesca Morelli  12 , Federica Grosso  13 , Barbara Merelli  14 , Ilaria Marcon  15 , Diletta Valsecchi  15 , Pietro Quaglino  16
Affiliations

Retrospective-Prospective Observational Study of Italian Patients Treated in Melanoma Adjuvant Cohort MAP-MADAM (Maximing ADjuvAnt MAP): Interim Analysis

Francesca Consoli et al. Cancers (Basel). .

Abstract

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.

Keywords: adjuvant; dabrafenib plus trametinib; melanoma; relapse-free survival; stage III.

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Conflict of interest statement

I.M. and D.V. are employed by Novartis Farma S.p.A; M.D.V. has been advisor and/or consultant for B.M.S., M.S.D., Novartis, Pierre Fabre, Immunocore; F.G. reports personal fees for advisory role, speaker engagements and travel and accommodation expenses from Merck Sharp & Dohme, Novocure, Bristol Myers Squibb, Boehringer Ingelheim, Pharmamar, Novartis and Pierre Fabre; F.M. has been advisor for Novartis, B.M.S., Sunpharma, Sanofi, Pierre-Fabre, Ipsen and M.S.D.; F.S. declares to have received fees from B.M.S., M.S.D., Novartis, Pierre Fabre, Merck, Sanofi, Sun Pharma and has been advisor for M.S.D., Novartis, Pierre Fabre, Philogen; P.Q. received speaker fees and has been advisor for Novartis, B.M.S., M.S.D., Pierre Fabre; T.T. has been advisor for Amgen, Novartis, B.M.S., Roche, Servier, Pierre Fabre, M.S.D. No other COIs have been disclosed.

Figures

Figure 1
Figure 1
Relapse-free survival estimates of the entire cohort (A), according to the completion of 12-month treatment (B), and according to reason for discontinuation (C). In all graphs, dots represent censors; log-rank test was used instead of Wilcoxon test as specified in the SAP to give equal weight to all time points.
Figure 2
Figure 2
Overall survival estimates of the entire cohort (A), according to the completion of 12-month treatment (B), and according to reason for discontinuation (C). In all graphs, dots represent censors; log-rank test was used instead of Wilcoxon test as specified in the SAP to give equal weight to all time points.
Figure 3
Figure 3
Relapse-free survival estimates according to AJCC v.8. Dots represent censors; log-rank test was used instead of Wilcoxon test as specified in the SAP to give equal weight to all time points.
Figure 4
Figure 4
Overall survival estimates according to AJCC v.8. Dots represent censors; log-rank test was used instead of Wilcoxon test as specified in the SAP to give equal weight to all time points.
See this image and copyright information in PMC

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