@article{oai:soar-ir.repo.nii.ac.jp:00020229, author = {Yamazaki, N. and Kiyohara, Y. and Uhara, H. and Fukushima, S. and Uchi, H. and Shibagaki, N. and Tsutsumida, A. and Yoshikawa, S. and Okuyama, R. and Ito, Y. and Tokudome, T.}, issue = {5}, journal = {CANCER CHEMOTHERAPY AND PHARMACOLOGY}, month = {Sep}, note = {Purpose
Ipilimumab is designed to block cytotoxic T-lymphocyte antigen-4 to augment antitumor T cell responses. In studies of predominantly Caucasian patients with advanced melanoma, ipilimumab was associated with durable response, long-term survival benefit, and a manageable safety profile. This phase II study assessed the safety of ipilimumab in Japanese patients with unresectable stage III or IV melanoma.
Methods
Patients received ipilimumab 3 mg/kg every 3 weeks for four doses. The database lock for the original analysis was in August 2014. Overall survival, progression-free survival, and data on deaths were based on an updated, follow-up analysis (database lock April 2015).
Results
Data are reported from 20 patients. Fifteen patients (75 %) received all four doses of ipilimumab during induction. Twelve patients (60 %) had at least one drug-related adverse event (AE), and no patients discontinued due to a drug-related AE. There were no deaths related to study drug. The most common drug-related AEs were rash (n = 7), pyrexia (n = 3), increased aspartate aminotransferase (AST; n = 3), and increased alanine aminotransferase (ALT; n = 3). Twelve patients (60 %) reported immune-related AEs (irAEs); most frequent were skin (n = 9) and liver (n = 3) disorders. Grade 3 irAEs were ALT and AST elevation (n = 2) and diabetes mellitus (n = 1). Two patients had a partial response and two had stable disease, yielding a 20 % disease control rate. Median overall survival and progression-free survival were 8.71 and 2.74 months, respectively.
Conclusion
Ipilimumab 3 mg/kg had a manageable AE profile in this Japanese patient population with clinical outcomes similar to that in Caucasian patients., Article, CANCER CHEMOTHERAPY AND PHARMACOLOGY.76(5):997-1004(2015)}, pages = {997--1004}, title = {Phase II study of ipilimumab monotherapy in Japanese patients with advanced melanoma}, volume = {76}, year = {2015} }