Background Ipilimumab is a high-cost drug that requires authorisation from the Medical Board for its use in our hospital.
Purpose To describe the experience with ipilimumab in the treatment of advanced melanoma (unresectable or metastatic) after at least one prior unsuccessful chemotherapy treatment in a third-level hospital.
Material and methods Retrospective review of medical records of all patients treated and collection of the following data: diagnosis, pre-treatments, cycles received, response to treatment, tolerance and safety.
Results Since January 2012 ipilimumab has been requested for 6 patients (four men and two women) with a mean age of 53 years (45–60). The initial diagnosis was Clark level II (n = 3), level III (n = 1), level IV (n = 1) melanoma; only one of them presented choroid melanoma in the left eye. After first-line treatment, patients developed metastases in lung and bone (n = 2), lung and liver (n = 1), lung and central nervous system (n = 1), bone and liver (n = 1) and brain metastases (n = 4). The first-line treatments received were: high-dose interferon (n = 2), fotemustine (n = 2), vemurafenib (n = 2) due to BRAF gene mutation. As second-line treatments, patients received ipilimumab (3 mg/kg every 21 days × 4 cycles). Only two patients completed all four doses, and only one of them has remained stable for the last two years. Regarding tolerance, two cases documented severe headache, and the other one presented grade II gastrointestinal toxicity.
Conclusion In our experience, the patient who received four complete cycles and had no brain metastases or choroidal melanoma was the only one who responded to the treatment. The remaining patients did not meet the inclusion criteria of the pivotal trial (MDX010–20) for the approval of ipilimumab.
References and/or Acknowledgements
Assessment Report for Yervoy (ipilimumab). Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002213/WC500109302.pdf (Access November 2014)
References and/or AcknowledgementsNo conflict of interest.
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