Characteristics of Real-World Patients with High-Risk BRAF V600E/K -Mutated Melanoma Receiving Adjuvant Treatment with Dabrafenib Plus Trametinib After Surgical Resection, Through the Italian Managed Access Program.

Autor:	Quaglino P; Department of Medical Sciences, Dermatologic Clinic, University of Turin, Turin, Italy., Ascierto PA; Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy., Consoli F; Department of Oncology, ASST Spedali Civili, Brescia, Italy., Queirolo P; Oncology Division, Policlinico San Martino IRCCS, Genova, Italy, and Division of Medical Oncology for Melanoma, Sarcoma, and Rare Tumors, IEO, European Institute of Oncology IRCCS, Milan, Italy., Spagnolo F; Skin Cancer Unit, IRCCS Ospedale Policlinico San Martino, Genova, Italy., Morelli MF; Department of Oncology and Dermatological Oncology, Istituto Dermopatico dell'Immacola, Rome, Italy., Berardi R; Università Politecnica delle Marche - Azienda Ospedaliero-Universitaria delle Marche, Ancona, Italy., Chiarion-Sileni V; Melanoma Oncology Unit, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy., Tucci M; Medical Oncology Unit, Department of Interdisciplinary Medicine, University of Bari 'Aldo Moro', Bari, Italy., Troiani T; Faculty of Medicine, Second University of Naples, Naples, Italy., Melotti B; Medical Oncology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy., Rossi E; Medical Oncology, Fondazione Policlinico Universitario A.Gemelli IRCCS, Rome, Italy., Mandala M; Division of Oncology, Papa Giovanni XXIII Hospital, Bergamo, Italy, and University of Perugia, Perugia, Italy., Rinaldi G; UOC Oncologia Medica Aoup Paolo Giaccone, Palermo, Italy., Marcon IG; Novartis Farma S.p.A, Milan, Italy., Pizzuti M; Novartis Farma S.p.A, Milan, Italy., Del Vecchio M; Unit of Melanoma Medical Oncology, Department of Medical Oncology and Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Jazyk:	angličtina
Zdroj:	Cancer management and research [Cancer Manag Res] 2023 Nov 11; Vol. 15, pp. 1271-1281. Date of Electronic Publication: 2023 Nov 11 (Print Publication: 2023).
DOI:	10.2147/CMAR.S423970
Abstrakt:	Purpose: Real-world data from patients with BRAF V600 -mutated, resected, stage III melanoma treated with dabrafenib plus trametinib as adjuvant targeted therapy are limited, and it is important to gain an understanding of the characteristics of this patient population, as well as of the patient journey. Here we aimed to describe the characteristics, dosage reductions and discontinuations in patients with BRAF V600E/K -mutated melanoma receiving adjuvant dabrafenib plus trametinib after surgical resection through an Italian managed access program (MAP). Patients and Methods: Eligible patients had completely resected cutaneous melanoma with confirmed BRAF V600E or V600K mutation, or initially resectable lymph node recurrence after a diagnosis of stage I or II melanoma. The starting dose of dabrafenib and trametinib was 150 mg twice daily and 2 mg once daily, respectively. Results: A total of 557 patients received dabrafenib plus trametinib through the MAP (stage III resected disease at inclusion, 554). Median age was 54.0 years, and 40.2% of patients were female. The proportion of all treated patients who required a dose reduction was low (10.8%) as was the proportion of patients who discontinued treatment (13.5%). The main reason for treatment discontinuation was adverse events (36.0%). Conclusion: New treatments, including BRAF-targeted therapies and immunotherapy, have transformed the natural history of melanoma. This is the largest study to date describing patients treated with dabrafenib plus trametinib in routine clinical practice in Italy between 2018 and 2019. Results highlight the characteristics of the patients treated and their journey, as well as the tolerable safety profile of dabrafenib plus trametinib in a real-world patient population. Competing Interests: PQuaglino has received honoraria from Bristol Myers Squibb, MSD, Novartis, Pierre Fabre and Roche; has received travel support from Bristol Myers Squibb, MSD, Novartis, Pierre Fabre and Roche; has participated in advisory boards for Bristol Myers Squibb, MSD, Novartis, Pierre Fabre, and Roche. PAA has received institutional grants from Bio-AI Health, Bristol Myers Squibb, Pfizer/Array, Roche-Genentech, and Sanofi; has received consulting fees from 4SC, Bayer, Erasca, Bio-Al Health, Bristol Myers Squibb, Idera, Italfarmaco, Lunaphore, Medicenna, Merck Serono, MSD, Nektar Therapeutics, Novartis, Pfizer/Array, Pierre Fabre, Replimmune, Roche-Genentech, Sandoz, Sanofi, Sun Pharma, and ValoTx; has received travel support from Pfizer; has participated in advisory boards for AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Eisai, Immunocore, iTeos, MSD, Nouscom, Novartis, Oncosec, Regeneron, Roche-Genentech, and Seagen. FC has received honoraria from Bristol Myers Squibb, MSD, Novartis, and Pierre Fabre; has participated in advisory board meetings for Bristol Myers Squibb, MSD and Novartis. PQueirolo has received consulting fees from Bristol Myers Squibb, Merck, Novartis, Pierre Fabre, Roche, and Sanofi; has received honoraria from Bristol Myers Squibb, Merck, Novartis, Pierre Fabre, Roche and Sanofi; has received travel support from Bristol Myers Squibb, Merck, Novartis, Pierre Fabre, Roche and Sanofi; has participated in advisory board meetings for Bristol Myers Squibb, Merck, Novartis, Pierre Fabre, Roche and Sanofi. FS has received honoraria from Bristol Myers Squibb, Merck, MSD, Novartis, Pierre Fabre, Sanofi, and Sun Pharma; has participated in advisory board meetings for MSD, Novartis, Pierre Fabre, Philogen, and Sun Pharma. RB has participated in advisory board meetings for Amgen, AstraZeneca, Boehringer Ingelheim, Eisai, Glaxo Smith Kline, Gilead, Lilly, MSD, Novartis, Otsuka, and Roche. VC-S has received honoraria from Bristol Myers Squibb, MSD, Novartis, and Pierre Fabre; has received travel support from Novartis and Pierre Fabre; has participated in advisory board meetings for MSD. MT has received honoraria from Bristol Myers Squibb and Novartis; has participated in advisory board meetings for Sanofi. TT has received honoraria from Amgen, Bayer, Bristol Myers Squibb, Novartis, and Servier. BM has received honoraria from AstraZeneca, Bristol Myers Squibb, MSD, Novartis, Roche, Sanofi, and Sun Pharma; has received travel support from AstraZeneca, Bristol Myers Squibb, MSD, Novartis, Roche, Sanofi, and Sun Pharma; has participated in advisory board meetings for AstraZeneca, Bristol Myers Squibb, MSD, Novartis, Roche, Sanofi, and Sun Pharma. ER has received honoraria from Bristol Myers Squibb, MSD, Novartis, and Pierre Fabre; has received support for attending meetings/travel from Ipsen, Janssen, MSD, and Novartis; has participated in advisory board meetings for Immunocore, MSD, Novartis, and Pfizer. IGM is an employee of Novartis. MP was an employee of Novartis during the conduct of the study. MDV has received consulting fees from Bristol Myers Squibb, MSD, Novartis, and Pierre Fabre; has received honoraria from Bristol Myers Squibb, MSD, Novartis, and Pierre Fabre. The other authors have no conflicts of interest to disclose for this work. (© 2023 Quaglino et al.)
Databáze:	MEDLINE
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