Abstract
Introduction: Immunotherapy has become standard for the treatment of melanoma, showing benefit over chemotherapy. The use of pembrolizumab drug for metastatic melanoma is becoming widespread, showing beneficial results in clinical trials.
Objectives: Analyze the efficacy and safety results of pembrolizumab in metastatic melanoma patients at Barrualde-Galdakao ESI and compare them to the KEYNOTE-006 clinical trial.
Methods: This is an observational, descriptive and retrospective review of the medical records of patients with metastatic melanoma treated with pembrolizumab in the OSI Barrualde-Galdakao Day Hospital between April 2017 and April 2023. Patients have been monitored until death or the study has been closed and various variables have been collected through statistical analysis. The variables are then compared to the KEYNOTE-006 clinical trial.
Results: 32 patients were evaluated. Survival without progression was 68.8% for study and 46.4% for clinical trial KEYNOTE-006 and survival rates at 12 months, 71.9% and 68.4%, respectively. In the study, 15.6% of patients had a full response and 28.1% had a partial response after 14 months of follow-up. In the case of clinical trials, 6% had a full response and 27% had a partial response after 7.9 months of follow-up. The rates and effectiveness of severe undesirable effects associated with treatment were similar in both groups, although the study showed more undesirable effects of any degree. The differences are largely due to the small size of the sample.
Conclusions: The data confirm that pembrolizumab can be an effective and appropriate therapeutic option in metastatic melanoma patients. The drug has shown beneficial results, causing it to completely replace chemotherapy and become standard.

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Copyright (c) 2025 Andrea González Aldazabal, Francisco Javier Goikolea Ugarte Goikolea Ugarte, Edurne Alonso