Abstract
BackgroundThe association between immune-related adverse events (irAEs) and survival outcomes in patients with advanced melanoma receiving therapy with immune checkpoint inhibitors (ICIs) has not been well established, particularly in Asian melanoma.MethodsWe retrospectively reviewed 49 melanoma patients undergoing therapy with ICIs (anti-PD-1 monotherapy), and analyzed the correlation between irAEs and clinical outcomes including progression-free survival (PFS) and overall survival (OS). Results: Overall, the patients who experienced grade 1–2 irAEs had longer PFS (median PFS, 4.6 vs. 2.5 months; HR, 0.52; 95% CI: 0.27–0.98; p = 0.042) and OS (median OS, 15.2 vs. 5.7 months; HR, 0.50; 95% CI: 0.24–1.02; p = 0.058) than the patients who did not experience irAEs. Regarding the type of irAE, the patients with either skin/vitiligo or endocrine irAEs showed better PFS (median PFS, 6.1 vs. 2.7 months; HR, 0.40, 95% CI: 0.21–0.74; p = 0.003) and OS (median OS, 18.7 vs. 4.5 months; HR, 0.34, 95% CI: 0.17–0.69, p = 0.003) than patients without any of these irAEs.ConclusionsMelanoma patients undergoing anti-PD-1 monotherapy and experiencing mild-to-moderate irAEs (grade 1–2), particularly skin (vitiligo)/endocrine irAEs had favorable survival outcomes. Therefore, the association between irAEs and the clinical outcomes in melanoma patients undergoing anti-PD-1 ICIs may be severity and type dependent.
Highlights
The association between immune-related adverse events and survival outcomes in patients with advanced melanoma receiving therapy with immune checkpoint inhibitors (ICIs) has not been well established, in Asian melanoma
The combination of ipilimumab and nivolumab demonstrated greater effectiveness than monotherapy with either of these [4,5,6,7]; combination therapy had the greater toxicity than monotherapy and insufficient power for overall survival (OS) over nivolumab limit the application of combination treatment in advanced melanoma
Patient characteristics In the current study, a total of 49 advanced melanoma patients undergoing anti-PD-1 monotherapy (33 with nivolumab and 16 with pembrolizumab) as their firstline ICI treatment were included for retrospective analysis
Summary
The association between immune-related adverse events (irAEs) and survival outcomes in patients with advanced melanoma receiving therapy with immune checkpoint inhibitors (ICIs) has not been well established, in Asian melanoma. ICIs induce favorable response in some patients, so biomarkers are needed to determine the clinical course of ICIs in advanced melanoma. One potentially effective clinical biomarker of ICI response in cancer patients is immune-related adverse event (irAE) [8]. Patients who experience irAEs during therapy with anti-PD-1 and anti-PD-L1 antibodies have been found to show favorable outcomes – overall response rate (ORR), progression-free survival (PFS), and OS – in cases of melanoma, lung cancer, and urothelial carcinoma [9,10,11,12,13,14,15]. Given most of the previous publications are studied on cutaneous melanoma, it raises the question that whether those results could be applied in Asian in which acral and mucosal melanoma are predominant
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