Characteristics of Real-World Patients with High-Risk

BRAF mutation dabrafenib managed access program melanoma real-world trametinib

Journal

Cancer management and research
ISSN: 1179-1322
Titre abrégé: Cancer Manag Res
Pays: New Zealand
ID NLM: 101512700

Informations de publication

Date de publication:
2023
Historique:
received: 12 07 2023
accepted: 25 10 2023
medline: 29 11 2023
pubmed: 29 11 2023
entrez: 29 11 2023
Statut: epublish

Résumé

Real-world data from patients with Eligible patients had completely resected cutaneous melanoma with confirmed 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%). 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.

Identifiants

pubmed: 38027240
doi: 10.2147/CMAR.S423970
pii: 423970
pmc: PMC10649847
doi:

Types de publication

Journal Article

Langues

eng

Pagination

1271-1281

Informations de copyright

© 2023 Quaglino et al.

Déclaration de conflit d'intérêts

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.

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Auteurs

Pietro Quaglino (P)

Department of Medical Sciences, Dermatologic Clinic, University of Turin, Turin, Italy.

Paolo A Ascierto (PA)

Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy.

Francesca Consoli (F)

Department of Oncology, ASST Spedali Civili, Brescia, Italy.

Paola 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.

Francesco Spagnolo (F)

Skin Cancer Unit, IRCCS Ospedale Policlinico San Martino, Genova, Italy.

Maria Francesca Morelli (MF)

Department of Oncology and Dermatological Oncology, Istituto Dermopatico dell'Immacola, Rome, Italy.

Rossana Berardi (R)

Università Politecnica delle Marche - Azienda Ospedaliero-Universitaria delle Marche, Ancona, Italy.

Vanna Chiarion-Sileni (V)

Melanoma Oncology Unit, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy.

Marco Tucci (M)

Medical Oncology Unit, Department of Interdisciplinary Medicine, University of Bari 'Aldo Moro', Bari, Italy.

Teresa Troiani (T)

Faculty of Medicine, Second University of Naples, Naples, Italy.

Barbara Melotti (B)

Medical Oncology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.

Ernesto Rossi (E)

Medical Oncology, Fondazione Policlinico Universitario A.Gemelli IRCCS, Rome, Italy.

Mario Mandala (M)

Division of Oncology, Papa Giovanni XXIII Hospital, Bergamo, Italy, and University of Perugia, Perugia, Italy.

Gaetana Rinaldi (G)

UOC Oncologia Medica Aoup Paolo Giaccone, Palermo, Italy.

Ilaria Gioia Marcon (IG)

Novartis Farma S.p.A, Milan, Italy.

Matteo Pizzuti (M)

Novartis Farma S.p.A, Milan, Italy.

Michele Del Vecchio (M)

Unit of Melanoma Medical Oncology, Department of Medical Oncology and Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.

Classifications MeSH