Cancer Res Treat.  2017 Jan;49(1):44-53. 10.4143/crt.2016.024.

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

Affiliations
  • 1Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea. SSJ338@yuhs.ac
  • 2Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
  • 3Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
  • 4Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
  • 5Division of Hematology-Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
  • 6Department of Internal Medicine, Dong-A University Hospital, Dong-A University College of Medicine, Busan, Korea.
  • 7Division of Hematology-Oncology, Department of Internal Medicine, Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, Korea.

Abstract

PURPOSE
Ipilimumab 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 METHODS
Advanced 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.
RESULTS
A 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.
CONCLUSION
In 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.

Keyword

Melanoma; Immunotherapy; Ipilimumab; Biomarkers

MeSH Terms

Asian Continental Ancestry Group
Biomarkers
Cohort Studies*
Disease-Free Survival
Exanthema
Humans
Immunotherapy
Liver
Lymphocytes
Melanoma*
Multivariate Analysis
Neoplasm Metastasis
Neutrophils
Biomarkers

Figure

  • Fig. 1. Kaplan-Meier curves. (A) Progression-free survival (PFS) and overall survival (OS) in all patients. (B) PFS according to response. (C) OS according to response. (D) PFS according to primary site. (E) OS according to primary site. (F) PFS according to according to neutrophil to lymphocyte ratio (NLR). (G) OS according to according to NLR. (H) PFS according to risk factors (Eastern Cooperative Oncology Group performance status [ECOG PS] [0-1 vs. 2], liver metastasis [no vs. yes], and NLR [< 5 or ≥ 5]). (I) OS according to risk factors (ECOG PS [0-1 vs. 2] and liver metastasis [no vs. yes]). DC, disease control (complete response+partial response+stable disease); PD, progression of disease.


Reference

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