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

Ipilimumab in the real world: the UK expanded access programme experience in previously treated advanced melanoma patients
Ipilimumab in the real world: the UK expanded access programme experience in previously treated advanced melanoma patients
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.
0960-8931
432-442
Ahmad, Saif S.
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Qian, Wendi
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Ellis, Sarah
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Mason, Elaine
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Khattak, Muhammad A.
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Gupta, Avinash
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Shaw, Heather
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Quinton, Amy
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Kovarikova, Jarmila
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Thillai, Kiruthikah
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Rao, Ankit
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Board, Ruth
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Nobes, Jenny
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Dalgleish, Angus
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Grumett, Simon
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Maraveyas, Anthony
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Danson, Sarah
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Talbot, Toby
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Harries, Mark
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Marples, Maria
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Plummer, Ruth
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Kumar, Satish
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Nathan, Paul
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Middleton, Mark R.
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Larkin, James
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Lorigan, Paul
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Wheater, Matthew
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Ottensmeier, Christian H.
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Corrie, Pippa G.
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Ahmad, Saif S.
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Qian, Wendi
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Ellis, Sarah
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Mason, Elaine
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Khattak, Muhammad A.
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Gupta, Avinash
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Shaw, Heather
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Quinton, Amy
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Kovarikova, Jarmila
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Thillai, Kiruthikah
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Rao, Ankit
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Board, Ruth
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Nobes, Jenny
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Dalgleish, Angus
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Grumett, Simon
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Maraveyas, Anthony
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Danson, Sarah
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Talbot, Toby
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Harries, Mark
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Marples, Maria
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Plummer, Ruth
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Kumar, Satish
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Nathan, Paul
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Middleton, Mark R.
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Larkin, James
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Lorigan, Paul
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Wheater, Matthew
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Ottensmeier, Christian H.
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Corrie, Pippa G.
3db0646e-eb17-4b5e-b13f-d02dd449cddb

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. and Corrie, Pippa G. (2015) Ipilimumab in the real world: the UK expanded access programme experience in previously treated advanced melanoma patients. Melanoma Research, 25 (5), 432-442. (PMID:26225580)

Record type: Article

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.

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Published date: October 2015
Organisations: Cancer Sciences

Identifiers

Local EPrints ID: 396337
URI: https://eprints.soton.ac.uk/id/eprint/396337
ISSN: 0960-8931
PURE UUID: 1ffbb4d6-0b56-4f76-b901-b9e521c901d2

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Date deposited: 08 Jun 2016 10:56
Last modified: 08 Nov 2017 21:14

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Contributors

Author: Saif S. Ahmad
Author: Wendi Qian
Author: Sarah Ellis
Author: Elaine Mason
Author: Muhammad A. Khattak
Author: Avinash Gupta
Author: Heather Shaw
Author: Amy Quinton
Author: Jarmila Kovarikova
Author: Kiruthikah Thillai
Author: Ankit Rao
Author: Ruth Board
Author: Jenny Nobes
Author: Angus Dalgleish
Author: Simon Grumett
Author: Anthony Maraveyas
Author: Sarah Danson
Author: Toby Talbot
Author: Mark Harries
Author: Maria Marples
Author: Ruth Plummer
Author: Satish Kumar
Author: Paul Nathan
Author: Mark R. Middleton
Author: James Larkin
Author: Paul Lorigan
Author: Matthew Wheater
Author: Pippa G. Corrie

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