Background Ipilimumab is a cytotoxic T lymphocyte antigen 4 (CTLA-4) blocking monoclonal antibody indicated for the treatment of unresectable or metastatic melanoma. In phase III studies, ipilimumab has been shown to increase overall survival by 3.6 months, progression free survival (PFS) by 2.7 months with a response rate of 9.5% with the induction dosing regimen: intravenous administration 3 mg/kg every 3 weeks, for a total of 4 applications.
Purpose To describe the demographic characteristics, efficiency in terms of response, PFS and toxicity of Ipilimumab in a third level hospital.
Material and methods Retrospective review of 100% of medical charts of patients diagnosed with metastatic melanoma and treated with ipilimumab from January to September 2015.
Results 8 medical charts were reviewed. 75% of patients were women and the average age was 62 years (range 49–75 years). 100% of patients had an ECOG performance status 0–1. 100% of patients had received prior systemic therapy with fotemustine. 1 patient did not complete the four course of ipilimumab due to progression of disease after the third dose. Efficacy data: 1 partial responder (response rate 12.5%), 2 stable disease and 5 cases of disease progression. In the 5 patients with disease progression, median PFS was 2.9 months (range 68–96 days). All patients had toxicity to ipilimumab but in no case was it necessary to delay/discontinue the treatment. Registered adverse effects were grade I or II: diarrhoea (3 patients), headache (2 patients), impaired vision (2 patients), pruritus (1 patient), oedema (1 patient), pain costal (1 patient) and epigastritis (1 patient).
Conclusion PFS and the response rate in patients receiving ipilimumab in our hospital were significantly higher than those obtained in the pivotal trial. Ipilimumab is a well tolerated drug. It is essential to measure the results and health of novel and expensive drugs to rationalise their use and optimise efficiency in the oncology area.
References and/or Acknowledgements
US Food and Drug Administration. Medication Guides. Yervoy. Silver Spring, MD. 2011. http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202429s000lbl.pdf)
European Medicines Agency. Yervoy EPAR Product Information. EMA/H/C/002213/2011. http://www.ema.europa.eu/docs/es_ES/document_library/EPAR__Product_Information/human/002213/WC500109299.pdf
Hodi FS, O’Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363:711-23. (Clinicaltrials.gov Identifier: NCT00094653)
References and/or AcknowledgementsNo conflict of interest.
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