A retrospective chart review study describing metastatic melanoma patients profile and treatment patterns in Spain
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To describe patient characteristics by disease stage, resectability status and current treatment management after first diagnosis of IIIB to IV1c advanced (AM)/metastatic melanoma (MM).
Multicentre, retrospective study based on data from medical charts of patients > 18 years at MM first diagnosis, visited by oncologists at 4 reference centres in Spain: Hospital Universitario Gregorio Marañón (Madrid), Hospital General de Valencia (Valencia), Clínica Universidad de Navarra (Pamplona), and Hospital Clínic (Barcelona).
Metastatic non-visceral melanoma (IIIB, IIIC, IV M1a) was reported in 139 (48.6%) patients and 40.9% (n = 117) were diagnosed with IV-M1c disease. 160 (55.9%) metastases were resectable. Available therapies under clinical practice were used in 210 patients; 74 were treated under clinical trials (CT). Intention-to-cure surgery (47.6%) was the most common treatment at time of MM diagnosis. Systemic (45.1% overall) therapy included chemo-, targeted- and immunotherapy (19.6%, 14.3%, 8.4%, respectively). At time of data collection, 26 patients were still alive and 120 had progressed to IV-M1c. Median overall survival (OS) was significantly larger in IIIB patients, 28.9 m (25.2–32.7); the shortest for IV-M1c patients, 11.0 m (8.7–13.3).
Novel treatments are undoubtedly a major step forward in AM/MM, however these are often only available in the CT setting because early stages of development or country-specific regulations. Further prospective studies and multifactorial analysis should be performed to clearly identify possible clinical associations for outcome in Spanish patients with AM/MM.
KeywordsAdvanced melanoma Metastatic melanoma Spanish melanoma Chart review
This study was funded by Amgen SA. Medical writing support was provided Cindy L. Larios M.D. from MFAR Clinical Research S.L. (Spain).
Medical writing support for this manuscript was funded by Amgen SA.
Compliance with ethical standards
Conflict of interest
Iván Márquez Rodas has participated in consulting and advisory boards of BMS, MSD, Novartis, Roche, Pierre-Fabre, Amgen, AstraZeneca, Merck-Serono, Incyte, Bioncotech, and Sanofi. Ana Arance has participated in consulting, advisory boards and Speaker’s bureau of BMS, Roche, MSD and Novartis. Alfonso Berrocal has received honoraria for consulting and advisory boards of MSD, BMS, Roche and Novartis. Cindy L. Larios and Jordi Curto are employed by MFAR Clinical Research, a CRO for Amgen for this study, analysis and manuscript. Ignasi X. Campos Tapias and Ana Belén Blanca are full-time employees at Amgen S.A. and own Amgen stocks. Salvador Martín Algarra reports receiving advisory board fees from Amgen, BMS, Incyte, Merck-Serono, MSD, Pierre-Fabre, Tesaro and Roche; speaker activities fees from BMS, MSD and Pierre-Fabre; consulting fees from Novartis and travel support from Roche.
The study was approved by an independent Ethical Committee and conducted in accordance with the good clinical practice (GCP), the principles of the Declaration of Helsinki and current local applicable regulations.
All patients participating in the study signed informed consent.
- 10.Mohr PM, Ascierto P, Arance A, McArthur G, Hernaez A, Kaskel P, et al. Real-world treatment patterns and outcomes among metastatic cutaneous melanoma patients treated with ipilimumab. J Eur Acad Dermatol Venereol. 2017;71(5).Google Scholar
- 13.Dummer R, Hauschild A, Lindenblatt N, Pentheroudakis G, Keilholz U on behalf of the ESMO Guidelines Committee. Cutaneous melanoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015; 5:v126–132.Google Scholar
- 14.European Medicines Agency. EPAR summary for the public. 2012. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Summary_for_the_public/human/002409/WC500124320.pdf.
- 15.Agencia Española de Medicamentos y Productos Sanitarios. Informe de Posicionamiento terapeutico. PT/V1/15112013,2. Informe de Posicionamiento Terapéutico de Vemurafenib (Zelboraf®). https://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/IPT-zelboraf-melanoma.pdf.
- 19.Chesney J, Puzanov I, Collichio F, Singh P, Milhem MM, Glaspy J. Randomized, open-label phase II study evaluating the efficacy and safety of talimogene laherparepvec in combination with ipilimumab versus ipilimumab alone in patients with advanced, unresectable melanoma. JCO. 2018;36:1658–67.CrossRefGoogle Scholar
- 21.A. Percentage of patients treated under available therapies or within a clinical trial (RCT) according to stage first-treatment line treatment for advanced melanoma (real clinical practice or as part of a RCT) from 2007 to 2015.Google Scholar