Safety Profile of Immunotherapy Combined With Antiangiogenic Therapy in Patients With Melanoma: Analysis of Three Clinical Studies

Objective: To describe the frequency and spectrum of treatment-related adverse events (TRAEs) of immunotherapy combined with antiangiogenic therapy in patients with melanoma.Methods: This retrospective cohort study included three clinical trials on patients with stage III/IV melanoma treated with an...

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Autores principales:	Hui Tian, Xuan Wang, Bin Lian, Xieqiao Yan, Lu Si, Zhihong Chi, Xinan Sheng, Yan Kong, Lili Mao, Xue Bai, Bixia Tang, Siming Li, Li Zhou, Chuanliang Cui, Jun Guo
Formato:	article
Lenguaje:	EN
Publicado:	Frontiers Media S.A. 2021
Materias:	combination therapy safety profile immunetherapy antiangiogenic therapy melanoma Therapeutics. Pharmacology RM1-950
Acceso en línea:	https://doaj.org/article/263504d5f99249bc929eaada676564f3
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spelling	oai:doaj.org-article:263504d5f99249bc929eaada676564f32021-11-09T06:02:05ZSafety Profile of Immunotherapy Combined With Antiangiogenic Therapy in Patients With Melanoma: Analysis of Three Clinical Studies1663-981210.3389/fphar.2021.747416https://doaj.org/article/263504d5f99249bc929eaada676564f32021-11-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fphar.2021.747416/fullhttps://doaj.org/toc/1663-9812Objective: To describe the frequency and spectrum of treatment-related adverse events (TRAEs) of immunotherapy combined with antiangiogenic therapy in patients with melanoma.Methods: This retrospective cohort study included three clinical trials on patients with stage III/IV melanoma treated with anti–PD 1 and antiangiogenic therapy.Results: We analyzed data from 72 patients with a median follow-up time of 25.9 months (95% CI, 9.1–42.7 m). The median treatment duration was 7.5 months (range, 0.7–42.8 m), and the median of treatment cycles was 11.0 (range, 1–90). Most patients (70 of 72 or 97.2%) experienced TRAEs (mostly grades 1 or 2). No drug-related deaths were reported. Most TRAEs were hepatic (75%), endocrine (72.2%), skin (65.3%), and gastrointestinal tract (59.7%) manifestations, followed by myelosuppression (55.6%), renal dysfunction (55.6%), and dyslipidaemia (54.2%). The adverse event (AE) spectra were similar between regimens. Using multivariate Cox proportional risk models showed that hypertension was associated with a long PFS. According to our multivariable logistic regression models, TRAEs were not associated with ORR.Conclusion: We found that the prevalence of AEs was higher than that of anti–PD-1 monotherapy. Most of the AEs were mild. The AE spectra were similar to those seen after anti–PD-1 or antiangiogenic therapy monotherapy, without unexpected AEs. Immunotherapy combined with antiangiogenic therapy was well tolerated.Clinical Trial Registration: ClinicalTrials.gov, identifier NCT03955354.Hui TianXuan WangBin LianXieqiao YanLu SiZhihong ChiXinan ShengYan KongLili MaoXue BaiBixia TangSiming LiLi ZhouChuanliang CuiJun GuoFrontiers Media S.A.articlecombination therapysafety profileimmunetherapyantiangiogenic therapymelanomaTherapeutics. PharmacologyRM1-950ENFrontiers in Pharmacology, Vol 12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	combination therapy safety profile immunetherapy antiangiogenic therapy melanoma Therapeutics. Pharmacology RM1-950
spellingShingle	combination therapy safety profile immunetherapy antiangiogenic therapy melanoma Therapeutics. Pharmacology RM1-950 Hui Tian Xuan Wang Bin Lian Xieqiao Yan Lu Si Zhihong Chi Xinan Sheng Yan Kong Lili Mao Xue Bai Bixia Tang Siming Li Li Zhou Chuanliang Cui Jun Guo Safety Profile of Immunotherapy Combined With Antiangiogenic Therapy in Patients With Melanoma: Analysis of Three Clinical Studies
description	Objective: To describe the frequency and spectrum of treatment-related adverse events (TRAEs) of immunotherapy combined with antiangiogenic therapy in patients with melanoma.Methods: This retrospective cohort study included three clinical trials on patients with stage III/IV melanoma treated with anti–PD 1 and antiangiogenic therapy.Results: We analyzed data from 72 patients with a median follow-up time of 25.9 months (95% CI, 9.1–42.7 m). The median treatment duration was 7.5 months (range, 0.7–42.8 m), and the median of treatment cycles was 11.0 (range, 1–90). Most patients (70 of 72 or 97.2%) experienced TRAEs (mostly grades 1 or 2). No drug-related deaths were reported. Most TRAEs were hepatic (75%), endocrine (72.2%), skin (65.3%), and gastrointestinal tract (59.7%) manifestations, followed by myelosuppression (55.6%), renal dysfunction (55.6%), and dyslipidaemia (54.2%). The adverse event (AE) spectra were similar between regimens. Using multivariate Cox proportional risk models showed that hypertension was associated with a long PFS. According to our multivariable logistic regression models, TRAEs were not associated with ORR.Conclusion: We found that the prevalence of AEs was higher than that of anti–PD-1 monotherapy. Most of the AEs were mild. The AE spectra were similar to those seen after anti–PD-1 or antiangiogenic therapy monotherapy, without unexpected AEs. Immunotherapy combined with antiangiogenic therapy was well tolerated.Clinical Trial Registration: ClinicalTrials.gov, identifier NCT03955354.
format	article
author	Hui Tian Xuan Wang Bin Lian Xieqiao Yan Lu Si Zhihong Chi Xinan Sheng Yan Kong Lili Mao Xue Bai Bixia Tang Siming Li Li Zhou Chuanliang Cui Jun Guo
author_facet	Hui Tian Xuan Wang Bin Lian Xieqiao Yan Lu Si Zhihong Chi Xinan Sheng Yan Kong Lili Mao Xue Bai Bixia Tang Siming Li Li Zhou Chuanliang Cui Jun Guo
author_sort	Hui Tian
title	Safety Profile of Immunotherapy Combined With Antiangiogenic Therapy in Patients With Melanoma: Analysis of Three Clinical Studies
title_short	Safety Profile of Immunotherapy Combined With Antiangiogenic Therapy in Patients With Melanoma: Analysis of Three Clinical Studies
title_full	Safety Profile of Immunotherapy Combined With Antiangiogenic Therapy in Patients With Melanoma: Analysis of Three Clinical Studies
title_fullStr	Safety Profile of Immunotherapy Combined With Antiangiogenic Therapy in Patients With Melanoma: Analysis of Three Clinical Studies
title_full_unstemmed	Safety Profile of Immunotherapy Combined With Antiangiogenic Therapy in Patients With Melanoma: Analysis of Three Clinical Studies
title_sort	safety profile of immunotherapy combined with antiangiogenic therapy in patients with melanoma: analysis of three clinical studies
publisher	Frontiers Media S.A.
publishDate	2021
url	https://doaj.org/article/263504d5f99249bc929eaada676564f3
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Safety Profile of Immunotherapy Combined With Antiangiogenic Therapy in Patients With Melanoma: Analysis of Three Clinical Studies

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