Effectiveness of vemurafenib in metastatic melanoma

• Autores: María Paz Quesada Sanz, Dulce Guerra Estévez, Eloísa Márquez Fernández, José Manuel Rodríguez García, Pablo Villanueva Jiménez, Juan Manuel Mateo Quintero
• Localización: European journal of clinical pharmacy: atención farmacéutica, ISSN 2385-409X, Vol. 18, Nº. 5, 2016, págs. 5-5
• Idioma: inglés
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• Resumen

  • Background: Vemurafenib is a drug which specifically inhibits the BRAF serinethreonine kinase that is present in about half of all cases of melanoma. Our objective is to study the efficacy of vemurafenib in patients diagnosed with unresectable BRAF positive melanoma.

    Method: Retrospective observational study of patients with metastatic melanoma and positive BRAF V600 mutation who began oral monotherapy with vemurafenib since January 2012 to April 2016. The data were obtained from outpatient dispensing program Dipex® and by reviewing medical records. All patients received an initial dose of 960 mg vemurafenib twice daily. Overall Survival (OS) and Progression-Free Survival (PFS) were considered as efficacy criteria, obtained by Kaplan-Meier method and defined as the time from initiation of the treatment to death from any cause or disease progression, respectively, censoring those patients who had not died or progressed at the end of the study.

    Results: Five women with an average age of 51.8 ±12 years, initiating treatment with vemurafenib during the study period, three in first line, one after adjuvant immunotherapy with interferon alpha-2 beta, and another in second line after the use of interferon alpha2-beta and ipilimumab, which finally was suspended due to cerebral progression. Eastern Cooperative Oncology Group Performance Status (ECOG PS) in all cases was between 0 and 1. Regarding the stage of the disease, one patient presented metastases with lymph node involvement (stage M1a), two lung metastases (stage M1b) and other two had metastases in central nervous system and gastric mucosa (stage M1c), respectively. Of the five patients, only the patient with stage M1a presented a partial response to vemurafenib at the end of the study and four died during the follow up period. The median OS was nine months (95% CI: 0.4-17.5) and median PFS was six months (95% CI: 3.8-8.1).

    Conclusions: OS data obtained are lower than those published in the pivotal BRIM3 study (nine months vs. 13.6 months); while no significant differences in PFS (six months vs. 6.87 months) were observed. Contrary to previous reports, in our case we cannot affirm that patients with worse prognosis present better results