Ipilimumab Real-World Efficacy and Safety in Korean Melanoma Patients from the Korean Named-Patient Program Cohort

Abstract

PurposeIpilimumab improves survival in advanced melanoma patients. However, the efficacy and safety of ipilimumab has not been evaluated in Asian melanoma patients with a high frequency of mucosal and acral melanoma subtypes.Materials and MethodsAdvanced melanoma patients treated with 3 mg/kg ipilimumab in a Korean multicenter named-patient program (NPP) were evaluated between September 2014 and July 2015. Baseline characteristics and blood parameters including neutrophil to lymphocyte ratio (NLR) were assessed, and outcome and adverse events were evaluated according to subtypes.ResultsA total of 104 advanced melanoma patients were treated. The primary sites were acral (31.7%), mucosal (26%), cutaneous (26%), uveal (9.6%), and unknown (6.7%). Sixty-eight patients (65.4%) experienced adverse events, and the most common toxicity was skin rash (22.1%), 10 patients (9.6%) experienced adverse events of grade 3 or higher. The median progression-free survival (PFS) was 2.73 months (95% confidence interval, 2.67 to 2.85), and there was no difference in PFS according to subtypes. Poor performance status, liver metastasis, and NLR (≥ 5) were independent poor prognostic factors by multivariate analysis.ConclusionIn the Korean NPP cohort, ipilimumab showed similar efficacy and tolerability compared to Western patients, regardless of subtypes. All subtypes should benefit from ipilimumab with consideration of performance status, liver metastasis, and NLR.

The Role of Immune Checkpoint Blockade in Uveal Melanoma

“…Five additional prospective studies with 185 patients in total investigated ipilimumab at a dose of 3 mg/kg body weight [105][106][107][108][109]. In the study published by Jung et al [109], 10 UM patients (total n = 106 melanoma patients) were treated. The median PFS was 2.8 months (graphically determined based on the published time-to-event analyses), and it was unclear whether the median OS had been reached at the time of publication.…”

“…The median PFS was 2.8 months (graphically determined based on the published time-to-event analyses), and it was unclear whether the median OS had been reached at the time of publication. Secondary outcomes were not reported; furthermore, the UM subgroup was poorly described [109]. In the other prospective studies that investigated this dosage scheme (3 mg/kg), overall response rates (ORR) ranged from 0% [108] to a sobering 4.8% [107].…”

Pretreatment hematological markers predict clinical outcome in cancer patients receiving immune checkpoint inhibitors: A meta‐analysis

“…The following information was extracted from each study: first author's name, publication year, country of origin, number of patients, therapeutic regimen, cancer type, and clinical factors. HRs and 95% CIs were used to combine these data, they were obtained directly from 13 articles when described in text or tables, [14][15][16][17][18][19][20][21][22][23][24][25][26][27] or calculated from available numerical data using methods reported by Tierney et al, [28][29][30] or by emailing the authors. 31 Multivariate data were preferable to univariate data if both were provided; however, univariate data were acceptable if multivariate results were not presented.…”

“…Jung et al 28 Jeyakumar et al 22 Suh et al 31 Bagley et al 14 Shiroyama et al 15 Diem et al 16 Cassidy et al 18 Ferrucci et al 19 tr Jung et al 28 Khoja et al 20 Jeyakumar et al 22 Bilen et al 26 Park et al 27 Overall (I-squared = 85.1%, P = 0.000) Fukui et al 23 Bagley et al 14 Diem et al 16…”

“…Jung et al 28 Khoja et al 20 Zaragoza et al 21 Jeyakumar et al 22 Fukui et al 23 Rosner et al 25 Fujisawa et al 30 Bilen et al 26 Park et al 27 Overall (I-squared = 86.4%, P = 0.000) 0.01 1 100 NOTE: Weights are from random effects analysis 15 20 25 Ferrucci et al 19 tr Ferrucci et al 19…”