Ahmad, S. S., Qian, W. D., Ellis, S., Mason, E., Khattak, M. A., 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. R., Larkin, J., Lorigan, P., Wheater, M., Ottensmeier, C. H., Corrie, P. G. (2015) Ipilimumab in the real world: the UK expanded access programme experience in previously treated advanced melanoma patients. MELANOMA RESEARCH, 25 (5). pp. 432-442. ISSN 0960-8931

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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.

Item Type:	Article
Authors (ICR Faculty only):	Larkin, James
All Authors:	Ahmad, S. S., Qian, W. D., Ellis, S., Mason, E., Khattak, M. A., 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. R., Larkin, J., Lorigan, P., Wheater, M., Ottensmeier, C. H., Corrie, P. G.
Additional Information:	ISI Document Delivery No.: CR2YC Times Cited: 0 Cited Reference Count: 23 Ahmad, Saif S. Qian, Wendi Ellis, Sarah Mason, Elaine Khattak, Muhammad A. Gupta, Avinash Shaw, Heather Quinton, Amy Kovarikova, Jarmila Thillai, Kiruthikah Rao, Ankit Board, Ruth Nobes, Jenny Dalgleish, Angus Grumett, Simon Maraveyas, Anthony Danson, Sarah Talbot, Toby Harries, Mark Marples, Maria Plummer, Ruth Kumar, Satish Nathan, Paul Middleton, Mark R. Larkin, James Lorigan, Paul Wheater, Matthew Ottensmeier, Christian H. Corrie, Pippa G. BMS P.G.C. has received payment for attending BMS advisory boards. C.H.O. has received payment for attending BMS advisory boards, and his institution has received money for travel to a BMS meeting. R.P. has received payment from BMS for consultancy and travel expenses. For the remaining authors there are no conflicts of interest. 0 LIPPINCOTT WILLIAMS & WILKINS PHILADELPHIA MELANOMA RES
Uncontrolled Keywords:	expanded access programme ipilimumab metastatic melanoma treatment outcomes PRETREATED ADVANCED MELANOMA LONG-TERM SURVIVAL METASTATIC MELANOMA OPEN-LABEL CLINICAL-EXPERIENCE BRAIN METASTASES PHASE-2 TRIAL SINGLE-CENTER 10 MG/KG SAFETY
Research teams:	ICR divisions > Clinical Studies > Melanoma and Kidney Cancer Clinical Units > Renal & Melanoma Unit
Depositing User:	Barry Jenkins
Date Deposited:	14 Oct 2015 15:57
Last Modified:	14 Oct 2015 15:57
URI:	http://publications.icr.ac.uk/id/eprint/14443

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