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Efficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: a multicenter single-arm phase II study

O'Day, S. J.; Maio, M.; Chiarion-Sileni, V.; Gajewski, T. F.; Pehamberger, H.; Bondarenko, I. N.; Queirolo, P.; Lundgren, Lotta LU ; Mikhailov, S. and Roman, L., et al. (2010) In Annals of Oncology 21(8). p.1712-1717
Abstract
Background: This phase II study evaluated the safety and activity of ipilimumab, a fully human mAb that blocks cytotoxic T-lymphocyte antigen-4, in patients with advanced melanoma. Patients and methods: Patients with previously treated, unresectable stage III/stage IV melanoma received 10 mg/kg ipilimumab every 3 weeks for four cycles (induction) followed by maintenance therapy every 3 months. The primary end point was best overall response rate (BORR) using modified World Health Organization (WHO) criteria. We also carried out an exploratory analysis of proposed immune-related response criteria (irRC). Results: BORR was 5.8% with a disease control rate (DCR) of 27% (N = 155). One-and 2-year survival rates (95% confidence interval) were... (More)
Background: This phase II study evaluated the safety and activity of ipilimumab, a fully human mAb that blocks cytotoxic T-lymphocyte antigen-4, in patients with advanced melanoma. Patients and methods: Patients with previously treated, unresectable stage III/stage IV melanoma received 10 mg/kg ipilimumab every 3 weeks for four cycles (induction) followed by maintenance therapy every 3 months. The primary end point was best overall response rate (BORR) using modified World Health Organization (WHO) criteria. We also carried out an exploratory analysis of proposed immune-related response criteria (irRC). Results: BORR was 5.8% with a disease control rate (DCR) of 27% (N = 155). One-and 2-year survival rates (95% confidence interval) were 47.2% (39.5% to 55.1%) and 32.8% (25.4% to 40.5%), respectively, with a median overall survival of 10.2 months (7.6-16.3). Of 43 patients with disease progression by modified WHO criteria, 12 had disease control by irRC (8% of all treated patients), resulting in a total DCR of 35%. Adverse events (AEs) were largely immune related, occurring mainly in the skin and gastrointestinal tract, with 19% grade 3 and 3.2% grade 4. Immune-related AEs were manageable and generally reversible with corticosteroids. Conclusion: Ipilimumab demonstrated clinical activity with encouraging long-term survival in a previously treated advanced melanoma population. (Less)
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publication status
published
subject
keywords
phase II clinical trial, metastatic, melanoma, ipilimumab, cytotoxic T-lymphocyte antigen-4, immunotherapy
in
Annals of Oncology
volume
21
issue
8
pages
1712 - 1717
publisher
Oxford University Press
external identifiers
  • wos:000280532000025
  • scopus:77955256254
ISSN
1569-8041
DOI
10.1093/annonc/mdq013
language
English
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yes
id
c688fe8d-01ee-49bb-89b8-ef29865ecfff (old id 1678524)
date added to LUP
2010-09-21 08:51:24
date last changed
2018-07-01 03:46:23
@article{c688fe8d-01ee-49bb-89b8-ef29865ecfff,
  abstract     = {Background: This phase II study evaluated the safety and activity of ipilimumab, a fully human mAb that blocks cytotoxic T-lymphocyte antigen-4, in patients with advanced melanoma. Patients and methods: Patients with previously treated, unresectable stage III/stage IV melanoma received 10 mg/kg ipilimumab every 3 weeks for four cycles (induction) followed by maintenance therapy every 3 months. The primary end point was best overall response rate (BORR) using modified World Health Organization (WHO) criteria. We also carried out an exploratory analysis of proposed immune-related response criteria (irRC). Results: BORR was 5.8% with a disease control rate (DCR) of 27% (N = 155). One-and 2-year survival rates (95% confidence interval) were 47.2% (39.5% to 55.1%) and 32.8% (25.4% to 40.5%), respectively, with a median overall survival of 10.2 months (7.6-16.3). Of 43 patients with disease progression by modified WHO criteria, 12 had disease control by irRC (8% of all treated patients), resulting in a total DCR of 35%. Adverse events (AEs) were largely immune related, occurring mainly in the skin and gastrointestinal tract, with 19% grade 3 and 3.2% grade 4. Immune-related AEs were manageable and generally reversible with corticosteroids. Conclusion: Ipilimumab demonstrated clinical activity with encouraging long-term survival in a previously treated advanced melanoma population.},
  author       = {O'Day, S. J. and Maio, M. and Chiarion-Sileni, V. and Gajewski, T. F. and Pehamberger, H. and Bondarenko, I. N. and Queirolo, P. and Lundgren, Lotta and Mikhailov, S. and Roman, L. and Verschraegen, C. and Humphrey, R. and Ibrahim, R. and de Pril, V. and Hoos, A. and Wolchok, J. D.},
  issn         = {1569-8041},
  keyword      = {phase II clinical trial,metastatic,melanoma,ipilimumab,cytotoxic T-lymphocyte antigen-4,immunotherapy},
  language     = {eng},
  number       = {8},
  pages        = {1712--1717},
  publisher    = {Oxford University Press},
  series       = {Annals of Oncology},
  title        = {Efficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: a multicenter single-arm phase II study},
  url          = {http://dx.doi.org/10.1093/annonc/mdq013},
  volume       = {21},
  year         = {2010},
}