Cancer Management and Research (Nov 2023)

Characteristics of Real-World Patients with High-Risk BRAFV600E/K-Mutated Melanoma Receiving Adjuvant Treatment with Dabrafenib Plus Trametinib After Surgical Resection, Through the Italian Managed Access Program

  • Quaglino P,
  • Ascierto PA,
  • Consoli F,
  • Queirolo P,
  • Spagnolo F,
  • Morelli MF,
  • Berardi R,
  • Chiarion-Sileni V,
  • Tucci M,
  • Troiani T,
  • Melotti B,
  • Rossi E,
  • Mandala M,
  • Rinaldi G,
  • Marcon IG,
  • Pizzuti M,
  • Del Vecchio M

Journal volume & issue
Vol. Volume 15
pp. 1271 – 1281

Abstract

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Pietro Quaglino,1 Paolo A Ascierto,2 Francesca Consoli,3 Paola Queirolo,4 Francesco Spagnolo,5 Maria Francesca Morelli,6 Rossana Berardi,7 Vanna Chiarion-Sileni,8 Marco Tucci,9 Teresa Troiani,10 Barbara Melotti,11 Ernesto Rossi,12 Mario Mandala,13 Gaetana Rinaldi,14 Ilaria Gioia Marcon,15 Matteo Pizzuti,15 Michele Del Vecchio16 1Department of Medical Sciences, Dermatologic Clinic, University of Turin, Turin, Italy; 2Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy; 3Department of Oncology, ASST Spedali Civili, Brescia, Italy; 4Oncology 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; 5Skin Cancer Unit, IRCCS Ospedale Policlinico San Martino, Genova, Italy; 6Department of Oncology and Dermatological Oncology, Istituto Dermopatico dell’Immacola, Rome, Italy; 7Università Politecnica delle Marche – Azienda Ospedaliero-Universitaria delle Marche, Ancona, Italy; 8Melanoma Oncology Unit, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy; 9Medical Oncology Unit, Department of Interdisciplinary Medicine, University of Bari ‘Aldo Moro’, Bari, Italy; 10Faculty of Medicine, Second University of Naples, Naples, Italy; 11Medical Oncology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; 12Medical Oncology, Fondazione Policlinico Universitario A.Gemelli IRCCS, Rome, Italy; 13Division of Oncology, Papa Giovanni XXIII Hospital, Bergamo, Italy, and University of Perugia, Perugia, Italy; 14UOC Oncologia Medica Aoup Paolo Giaccone, Palermo, Italy; 15Novartis Farma S.p.A, Milan, Italy; 16Unit of Melanoma Medical Oncology, Department of Medical Oncology and Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, ItalyCorrespondence: Michele Del Vecchio, Unit of Melanoma Medical Oncology, Department of Medical Oncology and Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Giacomo Venezian, 1 20133, Milano, Italy, Tel +39 2.23902557, Email [email protected]: Real-world data from patients with BRAFV600-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 BRAFV600E/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.Keywords: BRAF mutation, dabrafenib, melanoma, real-world, trametinib, managed access program

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