Lenvatinib Plus PD-1 Inhibitors as First-Line Treatment in Patients With Unresectable Biliary Tract Cancer: A Single-Arm, Open-Label, Phase II Study

ObjectiveWe investigated lenvatinib plus programmed cell death-1 (PD-1) inhibitors as a first-line treatment for initially unresectable biliary tract cancer (BTC).MethodsIn this Phase II study, adults with initially unresectable BTC received lenvatinib (body weight ≥60 kg, 12 mg; <60 kg, 8 mg...

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Autores principales:	Qiyi Zhang, Xingyu Liu, Shumei Wei, Lufei Zhang, Yang Tian, Zhenzhen Gao, Ming Jin, Sheng Yan
Formato:	article
Lenguaje:	EN
Publicado:	Frontiers Media S.A. 2021
Materias:	biliary tract cancer lenvatinib PD-1 inhibitors first-line treatment conversion surgery Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/cfb2044694e440f68486f97f20618b47
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spelling	oai:doaj.org-article:cfb2044694e440f68486f97f20618b472021-11-30T15:47:07ZLenvatinib Plus PD-1 Inhibitors as First-Line Treatment in Patients With Unresectable Biliary Tract Cancer: A Single-Arm, Open-Label, Phase II Study2234-943X10.3389/fonc.2021.751391https://doaj.org/article/cfb2044694e440f68486f97f20618b472021-11-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fonc.2021.751391/fullhttps://doaj.org/toc/2234-943XObjectiveWe investigated lenvatinib plus programmed cell death-1 (PD-1) inhibitors as a first-line treatment for initially unresectable biliary tract cancer (BTC).MethodsIn this Phase II study, adults with initially unresectable BTC received lenvatinib (body weight ≥60 kg, 12 mg; <60 kg, 8 mg) daily and PD-1 inhibitors (pembrolizumab/tislelizumab/sintilimab/camrelizumab 200 mg or toripalimab 240 mg) every 3 weeks. Primary endpoints were objective response rate (ORR) and safety. Secondary endpoints included surgical conversion rate, disease control rate (DCR), event-free survival (EFS), overall survival (OS) and tumor biomarkers.ResultsAmong 38 enrolled patients, the ORR was 42.1% and the DCR was 76.3%. Thirteen (34.2%) patients achieved downstaging and underwent surgery, six of whom (46.2%) achieved a major pathologic response (n=2) or partial pathologic response (n=4) in the primary tumor. In total, 84.2% of patients experienced ≥1 treatment-related adverse event (TRAE), 34.2% experienced a Grade ≥3 TRAE and no treatment-related deaths occurred. After a median follow-up of 13.7 months the median EFS was 8.0 months (95% CI: 4.6–11.4) and the median OS was 17.7 months (95% CI: not estimable).ConclusionsLenvatinib plus PD-1 inhibitors showed promising anti-tumor efficacy in patients with initially unresectable BTC and was generally well tolerated.Clinical Trial Registrationwww.chictr.org.cn, ChiCTR2100044476.Qiyi ZhangQiyi ZhangXingyu LiuXingyu LiuShumei WeiLufei ZhangLufei ZhangYang TianYang TianZhenzhen GaoZhenzhen GaoMing JinMing JinSheng YanSheng YanFrontiers Media S.A.articlebiliary tract cancerlenvatinibPD-1 inhibitorsfirst-line treatmentconversion surgeryNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENFrontiers in Oncology, Vol 11 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	biliary tract cancer lenvatinib PD-1 inhibitors first-line treatment conversion surgery Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	biliary tract cancer lenvatinib PD-1 inhibitors first-line treatment conversion surgery Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Qiyi Zhang Qiyi Zhang Xingyu Liu Xingyu Liu Shumei Wei Lufei Zhang Lufei Zhang Yang Tian Yang Tian Zhenzhen Gao Zhenzhen Gao Ming Jin Ming Jin Sheng Yan Sheng Yan Lenvatinib Plus PD-1 Inhibitors as First-Line Treatment in Patients With Unresectable Biliary Tract Cancer: A Single-Arm, Open-Label, Phase II Study
description	ObjectiveWe investigated lenvatinib plus programmed cell death-1 (PD-1) inhibitors as a first-line treatment for initially unresectable biliary tract cancer (BTC).MethodsIn this Phase II study, adults with initially unresectable BTC received lenvatinib (body weight ≥60 kg, 12 mg; <60 kg, 8 mg) daily and PD-1 inhibitors (pembrolizumab/tislelizumab/sintilimab/camrelizumab 200 mg or toripalimab 240 mg) every 3 weeks. Primary endpoints were objective response rate (ORR) and safety. Secondary endpoints included surgical conversion rate, disease control rate (DCR), event-free survival (EFS), overall survival (OS) and tumor biomarkers.ResultsAmong 38 enrolled patients, the ORR was 42.1% and the DCR was 76.3%. Thirteen (34.2%) patients achieved downstaging and underwent surgery, six of whom (46.2%) achieved a major pathologic response (n=2) or partial pathologic response (n=4) in the primary tumor. In total, 84.2% of patients experienced ≥1 treatment-related adverse event (TRAE), 34.2% experienced a Grade ≥3 TRAE and no treatment-related deaths occurred. After a median follow-up of 13.7 months the median EFS was 8.0 months (95% CI: 4.6–11.4) and the median OS was 17.7 months (95% CI: not estimable).ConclusionsLenvatinib plus PD-1 inhibitors showed promising anti-tumor efficacy in patients with initially unresectable BTC and was generally well tolerated.Clinical Trial Registrationwww.chictr.org.cn, ChiCTR2100044476.
format	article
author	Qiyi Zhang Qiyi Zhang Xingyu Liu Xingyu Liu Shumei Wei Lufei Zhang Lufei Zhang Yang Tian Yang Tian Zhenzhen Gao Zhenzhen Gao Ming Jin Ming Jin Sheng Yan Sheng Yan
author_facet	Qiyi Zhang Qiyi Zhang Xingyu Liu Xingyu Liu Shumei Wei Lufei Zhang Lufei Zhang Yang Tian Yang Tian Zhenzhen Gao Zhenzhen Gao Ming Jin Ming Jin Sheng Yan Sheng Yan
author_sort	Qiyi Zhang
title	Lenvatinib Plus PD-1 Inhibitors as First-Line Treatment in Patients With Unresectable Biliary Tract Cancer: A Single-Arm, Open-Label, Phase II Study
title_short	Lenvatinib Plus PD-1 Inhibitors as First-Line Treatment in Patients With Unresectable Biliary Tract Cancer: A Single-Arm, Open-Label, Phase II Study
title_full	Lenvatinib Plus PD-1 Inhibitors as First-Line Treatment in Patients With Unresectable Biliary Tract Cancer: A Single-Arm, Open-Label, Phase II Study
title_fullStr	Lenvatinib Plus PD-1 Inhibitors as First-Line Treatment in Patients With Unresectable Biliary Tract Cancer: A Single-Arm, Open-Label, Phase II Study
title_full_unstemmed	Lenvatinib Plus PD-1 Inhibitors as First-Line Treatment in Patients With Unresectable Biliary Tract Cancer: A Single-Arm, Open-Label, Phase II Study
title_sort	lenvatinib plus pd-1 inhibitors as first-line treatment in patients with unresectable biliary tract cancer: a single-arm, open-label, phase ii study
publisher	Frontiers Media S.A.
publishDate	2021
url	https://doaj.org/article/cfb2044694e440f68486f97f20618b47
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Lenvatinib Plus PD-1 Inhibitors as First-Line Treatment in Patients With Unresectable Biliary Tract Cancer: A Single-Arm, Open-Label, Phase II Study

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