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    Ipilimumab in the real world: the UK expanded access programme experience in previously treated advanced melanoma patients.

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    Authors
    Ahmad, S
    Qian, W
    Ellis, S
    Mason, Elaine
    Khattak, M
    Gupta, A
    Shaw, H
    Quinton, A
    Kovarikova, J
    Thillai, K
    Rao, A
    Board, R
    Nobes, J
    Dalgleish, A
    Grumett, S
    Maraveyas, A
    Danson, S
    Talbot, T
    Harries, M
    Marples, M
    Plummer, R
    Kumar, S
    Nathan, P
    Middleton, M
    Larkin, J
    Lorigan, Paul C
    Wheater, M
    Ottensmeier, C
    Corrie, P
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    Affiliation
    Department of Oncology Cambridge Cancer Trials Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge
    Issue Date
    2015-10
    
    Metadata
    Show full item record
    Abstract
    Before licensing, ipilimumab was first made available to previously treated advanced melanoma patients through an expanded access programme (EAP) across Europe. We interrogated data from UK EAP patients to inform future clinical practice. Clinicians registered in the UK EAP provided anonymized patient data using a prespecified variable fields datasheet. Data collected were baseline patient characteristics, treatment delivered, toxicity, response, progression-free survival and overall survival (OS). Data were received for 193 previously treated metastatic melanoma patients, whose primary sites were cutaneous (82%), uveal (8%), mucosal (2%), acral (3%) or unknown (5%). At baseline, 88% of patients had a performance status (PS) of 0-1 and 20% had brain metastases. Of the patients, 53% received all four planned cycles of ipilimumab; the most common reason for stopping early was disease progression, including death from melanoma. Toxicity was recorded for 171 patients, 30% of whom experienced an adverse event of grade 3 or higher, the most common being diarrhoea (13%) and fatigue (9%). At a median follow-up of 23 months, the median progression-free survival and OS were 2.8 and 6.1 months, respectively; the 1-year and 2-year OS rates were 31 and 14.8%, respectively. The 2-year OS was significantly lower for patients with poorer PS (P<0.0001), low albumin concentrations (P<0.0001), the presence of brain metastases (P=0.007) and lactate dehydrogenase levels more than two times the upper limit of normal (P<0.0001) at baseline. These baseline characteristics are negative predictors of benefit from ipilimumab and should be taken into consideration before prescription.
    Citation
    Ipilimumab in the real world: the UK expanded access programme experience in previously treated advanced melanoma patients. 2015, 25 (5):432-42 Melanoma Res
    Journal
    Melanoma Research
    URI
    http://hdl.handle.net/10541/577425
    DOI
    10.1097/CMR.0000000000000185
    PubMed ID
    26225580
    Type
    Article
    Language
    en
    ISSN
    1473-5636
    ae974a485f413a2113503eed53cd6c53
    10.1097/CMR.0000000000000185
    Scopus Count
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    All Christie Publications

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