Background In recent years, new drugs have been approved for metastatic melanoma. The BRAF gene is the most common mutation in cutaneous melanomas and is present in 50% of melanomas. Vemurafenib and dabrafenib are used for the treatment of adult patients with unresectable or metastatic melanoma who are BRAF V600 mutation positive.
Purpose To analyse the use of the targeted anti-BRAF therapies, vemurafenib or dabrafenib, alone or combined with the MEK inhibitor trametinib or cobimetinib in a tertiary hospital in patients diagnosed with metastatic melanoma.
Material and methods A retrospective observational study was conducted in all patients treated with vemurafenib or dabrafenib, alone or with trametinib or cobimetinib, from May 2014 to April 2016. SAP software was used for medical history, nursing and dispensation records.
Results 6 patients, 50% men, were evaluated, with an average age of 63 years (84–46). 1 received vemurafenib alone, 3 patients received vemurafenib associated with cobimetinib and the other 2 received trametinib with dabrafenib. 1 of the patients who received dabrafenib and trametinib (2 cycles, ECOG 2) and the patient who received vemurafenib alone (3 cycles, not reflected ECOG) died. The remaining patients continued on treatment: 17 cycles for the patient who received dabrafenib-trametinib, 5 cycles for 2 patients who received vemurafenib-cobimetinib and 4 cycles for the other, with ECOG 0. 1 patient had lung, lymph nodes and liver metastases, 1 lung metastases, 1 mediastinal metastases, 1 skin and peritoneal metastases and 2 patients had lymph node progression when they started anti-BRAF therapy. LDH levels were increased in 50% of patients.
Adverse reactions included fever in the patient who received dabrafenib-trametinib and acne, mild abdominal pain and asthenia in 1 patient who received dabrafenib-trametinib. In the case of vemurafenib, eritrodermia required discontinuation of treatment. In the cases of vemurafenib-cobimetinib, skin toxicity (sores) associated with vemurafenib reached grade III, forcing halving of the dose to both drugs, and the likely drug induced fever caused hospitalisation of this patient.
Conclusion It seems that the number and location of metastases, LDH values, ECOG 0 and combination of anti-BRAF drugs with the MEK inhibitor determines survival and tolerance to the drug, but further follow-up is needed to determine the evolution of patients.
References and/or acknowledgements https://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/IPT-zelboraf-melanoma.pdf https://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/IPT-dabrafenib-tafinlar.pdf
No conflict of interest
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