1. Anti-PD1 checkpoint inhibitor therapy in acral melanoma: a multicenter study of 193 Japanese patients
- Author
-
Y. Nakamura, K. Namikawa, K. Yoshino, S. Yoshikawa, H. Uchi, K. Goto, S. Fukushima, Y. Kiniwa, T. Takenouchi, H. Uhara, T. Kawai, N. Hatta, T. Funakoshi, Y. Teramoto, A. Otsuka, H. Doi, D. Ogata, S. Matsushita, T. Isei, T. Hayashi, Y. Shibayama, and N. Yamazaki
- Subjects
0301 basic medicine ,Oncology ,medicine.medical_specialty ,Skin Neoplasms ,medicine.medical_treatment ,Programmed Cell Death 1 Receptor ,Pembrolizumab ,03 medical and health sciences ,0302 clinical medicine ,Japan ,Internal medicine ,medicine ,Humans ,Stage (cooking) ,Melanoma ,Retrospective Studies ,business.industry ,Common Terminology Criteria for Adverse Events ,Hematology ,Immunotherapy ,medicine.disease ,Clinical trial ,030104 developmental biology ,030220 oncology & carcinogenesis ,Toxicity ,Nivolumab ,business - Abstract
Acral melanoma (AM) is an epidemiologically and molecularly distinct entity that is underrepresented in clinical trials on immunotherapy in melanoma. We aimed to analyze the efficacy of anti-programmed cell death 1 (anti-PD-1) antibodies in advanced AM.We retrospectively evaluated unresectable stage III or stage IV AM patients treated with an anti-PD-1 antibody in any line at 21 Japanese institutions between 2014 and 2018. The clinicobiologic characteristics, objective response rate (ORR, RECIST), survival estimated using Kaplan-Meier analysis, and toxicity (Common Terminology Criteria for Adverse Events 4.0.) were analyzed to estimate the efficacy of the anti-PD-1 antibodies.In total, 193 patients (nail apparatus, 70; palm and sole, 123) were included in the study. Anti-PD-1 antibody was used as first-line therapy in 143 patients (74.1%). Baseline lactate dehydrogenase (LDH) was within the normal concentration in 102 patients (52.8%). The ORR of all patients was 16.6% (complete response, 3.1%; partial response, 13.5%), and the median overall survival (OS) was 18.1 months. Normal LDH concentrations showed a significantly stronger association with better OS than abnormal concentrations (median OS 24.9 versus 10.7 months; P0.001). Although baseline characteristics were similar between the nail apparatus and the palm and sole groups, ORR was significantly lower in the nail apparatus group [6/70 patients (8.6%) versus 26/123 patients (21.1%); P = 0.026]. Moreover, the median OS in this group was significantly poorer (12.8 versus 22.3 months; P = 0.03).Anti-PD-1 antibodies have limited efficacy in AM patients. Notably, patients with nail apparatus melanoma had poorer response and survival, making nail apparatus melanoma a strong candidate for further research on the efficacy of novel combination therapies with immune checkpoint inhibitors.
- Published
- 2020