Phase I dose escalation study of sorafenib plus S-1 for advanced solid tumors

Abstract S-1, an oral pyrimidine fluoride-derived agent, is effective against various cancers. Sorafenib, an oral multikinase inhibitor, was found to prolong the survival of various cancers and enhance the cytotoxicity of chemotherapeutic agents. We conducted a phase I dose escalation study to deter...

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Autores principales:	Hui-Jen Tsai, Her-Shyong Shiah, Jang-Yang Chang, Wu-Chou Su, Nai-Jung Chiang, Li-Tzong Chen
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/4f7d321634ba464c96a8af513e32056b
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spelling	oai:doaj.org-article:4f7d321634ba464c96a8af513e32056b2021-12-02T15:54:09ZPhase I dose escalation study of sorafenib plus S-1 for advanced solid tumors10.1038/s41598-021-84279-62045-2322https://doaj.org/article/4f7d321634ba464c96a8af513e32056b2021-03-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-84279-6https://doaj.org/toc/2045-2322Abstract S-1, an oral pyrimidine fluoride-derived agent, is effective against various cancers. Sorafenib, an oral multikinase inhibitor, was found to prolong the survival of various cancers and enhance the cytotoxicity of chemotherapeutic agents. We conducted a phase I dose escalation study to determine dose-limiting toxicity (DLT) and maximal tolerated dose (MTD) of S-1 when combined with sorafenib for refractory solid tumors. Eligible patients received escalating doses (30, 35, and 40 mg/m2 bid) of S-1 Day 1 (D1)–D14 and continuous sorafenib 400 mg bid from cycle 1 D8 every 21 days in a standard 3 + 3 study design. Primary endpoint was MTD. Thirteen patients were enrolled between May 2010 and Feb 2012. DLT developed in two (one grade 3 erythema and one prolonged grade 2 hand-foot-skin reaction) of the 6 patients at 35 mg/m2 dose level. One pancreatic neuroendocrine tumor (pNET) patient achieved a durable partial response (27.9 months). Four colon cancer patients had stable disease and 3 of them had progression-free survival greater than 6 months. This study determined the recommended (MTD) S-1 dose of 30 mg/m2 bid for this regimen. This result warrants further phase II studies for advanced pNET and colon cancer to evaluate the efficacy of this combination.Hui-Jen TsaiHer-Shyong ShiahJang-Yang ChangWu-Chou SuNai-Jung ChiangLi-Tzong ChenNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-10 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Hui-Jen Tsai Her-Shyong Shiah Jang-Yang Chang Wu-Chou Su Nai-Jung Chiang Li-Tzong Chen Phase I dose escalation study of sorafenib plus S-1 for advanced solid tumors
description	Abstract S-1, an oral pyrimidine fluoride-derived agent, is effective against various cancers. Sorafenib, an oral multikinase inhibitor, was found to prolong the survival of various cancers and enhance the cytotoxicity of chemotherapeutic agents. We conducted a phase I dose escalation study to determine dose-limiting toxicity (DLT) and maximal tolerated dose (MTD) of S-1 when combined with sorafenib for refractory solid tumors. Eligible patients received escalating doses (30, 35, and 40 mg/m2 bid) of S-1 Day 1 (D1)–D14 and continuous sorafenib 400 mg bid from cycle 1 D8 every 21 days in a standard 3 + 3 study design. Primary endpoint was MTD. Thirteen patients were enrolled between May 2010 and Feb 2012. DLT developed in two (one grade 3 erythema and one prolonged grade 2 hand-foot-skin reaction) of the 6 patients at 35 mg/m2 dose level. One pancreatic neuroendocrine tumor (pNET) patient achieved a durable partial response (27.9 months). Four colon cancer patients had stable disease and 3 of them had progression-free survival greater than 6 months. This study determined the recommended (MTD) S-1 dose of 30 mg/m2 bid for this regimen. This result warrants further phase II studies for advanced pNET and colon cancer to evaluate the efficacy of this combination.
format	article
author	Hui-Jen Tsai Her-Shyong Shiah Jang-Yang Chang Wu-Chou Su Nai-Jung Chiang Li-Tzong Chen
author_facet	Hui-Jen Tsai Her-Shyong Shiah Jang-Yang Chang Wu-Chou Su Nai-Jung Chiang Li-Tzong Chen
author_sort	Hui-Jen Tsai
title	Phase I dose escalation study of sorafenib plus S-1 for advanced solid tumors
title_short	Phase I dose escalation study of sorafenib plus S-1 for advanced solid tumors
title_full	Phase I dose escalation study of sorafenib plus S-1 for advanced solid tumors
title_fullStr	Phase I dose escalation study of sorafenib plus S-1 for advanced solid tumors
title_full_unstemmed	Phase I dose escalation study of sorafenib plus S-1 for advanced solid tumors
title_sort	phase i dose escalation study of sorafenib plus s-1 for advanced solid tumors
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/4f7d321634ba464c96a8af513e32056b
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Phase I dose escalation study of sorafenib plus S-1 for advanced solid tumors

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