Efficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: A multicenter single-arm phase II study Journal Article
| Authors: | O'Day, S. J.; Maio, M.; Chiarion-Sileni, V.; Gajewski, T. F.; Pehamberger, H.; Bondarenko, I. N.; Queirolo, P.; Lundgren, L.; Mikhailov, S.; Roman, L.; Verschraegen, C.; Humphrey, R.; Ibrahim, R.; de Pril, V.; Hoos, A.; Wolchok, J. D. |
| Article Title: | Efficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: A multicenter single-arm phase II study |
| 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. © The Author 2010. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. |
| Keywords: | adult; cancer chemotherapy; cancer survival; aged; acute granulocytic leukemia; major clinical study; overall survival; clinical trial; advanced cancer; cancer growth; drug efficacy; drug safety; drug withdrawal; monotherapy; side effect; cancer staging; ipilimumab; melanoma; multiple cycle treatment; phase 2 clinical trial; maintenance therapy; pneumonia; immunotherapy; arthritis; pancreatitis; drug response; liver disease; skin disease; cancer control; corticosteroid; cytotoxic t lymphocyte antigen 4; autoimmune disease; gastrointestinal disease; endocrine disease; immunopathology; multiple organ failure; phase ii clinical trial; metastatic melanoma; cytotoxic t-lymphocyte antigen-4; acute glomerulonephritis; hypovolemic shock; temporal arteritis |
| Journal Title: | Annals of Oncology |
| Volume: | 21 |
| Issue: | 8 |
| ISSN: | 0923-7534 |
| Publisher: | Oxford University Press |
| Date Published: | 2010-08-01 |
| Start Page: | 1712 |
| End Page: | 1717 |
| Language: | English |
| DOI: | 10.1093/annonc/mdq013 |
| PROVIDER: | scopus |
| PUBMED: | 20147741 |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 20" - "Export Date: 20 April 2011" - "CODEN: ANONE" - "Source: Scopus" |
