Phase II trial of S‐1 treatment as palliative‐intent chemotherapy for previously treated advanced thymic carcinoma
Abstract Thymic carcinoma (TC) is a rare cancer with minimal evidence of survival following palliative‐intent chemotherapy. Sunitinib, everolimus, and pembrolizumab have been proposed as active agents based on previous phase II trials. In this phase II study, TC patients previously treated with plat...
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Language: | English |
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Wiley
2020-10-01
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Series: | Cancer Medicine |
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Online Access: | https://doi.org/10.1002/cam4.3385 |
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doaj-76f9d6f96b7745e6b7c709b7da86e565 |
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record_format |
Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Yusuke Okuma Yasushi Goto Fumiyoshi Ohyanagi Kuniko Sunami Yoshiro Nakahara Satoru Kitazono Keita Kudo Yuichi Tambo Shintaro Kanda Noriko Yanagitani Atsushi Horiike Hidehito Horinouchi Yutaka Fujiwara Hiroshi Nokihara Noboru Yamamoto Makoto Nishio Yuichiro Ohe Yukio Hosomi |
spellingShingle |
Yusuke Okuma Yasushi Goto Fumiyoshi Ohyanagi Kuniko Sunami Yoshiro Nakahara Satoru Kitazono Keita Kudo Yuichi Tambo Shintaro Kanda Noriko Yanagitani Atsushi Horiike Hidehito Horinouchi Yutaka Fujiwara Hiroshi Nokihara Noboru Yamamoto Makoto Nishio Yuichiro Ohe Yukio Hosomi Phase II trial of S‐1 treatment as palliative‐intent chemotherapy for previously treated advanced thymic carcinoma Cancer Medicine chemotherapy phase II rare cancer S‐1 thymic carcinoma |
author_facet |
Yusuke Okuma Yasushi Goto Fumiyoshi Ohyanagi Kuniko Sunami Yoshiro Nakahara Satoru Kitazono Keita Kudo Yuichi Tambo Shintaro Kanda Noriko Yanagitani Atsushi Horiike Hidehito Horinouchi Yutaka Fujiwara Hiroshi Nokihara Noboru Yamamoto Makoto Nishio Yuichiro Ohe Yukio Hosomi |
author_sort |
Yusuke Okuma |
title |
Phase II trial of S‐1 treatment as palliative‐intent chemotherapy for previously treated advanced thymic carcinoma |
title_short |
Phase II trial of S‐1 treatment as palliative‐intent chemotherapy for previously treated advanced thymic carcinoma |
title_full |
Phase II trial of S‐1 treatment as palliative‐intent chemotherapy for previously treated advanced thymic carcinoma |
title_fullStr |
Phase II trial of S‐1 treatment as palliative‐intent chemotherapy for previously treated advanced thymic carcinoma |
title_full_unstemmed |
Phase II trial of S‐1 treatment as palliative‐intent chemotherapy for previously treated advanced thymic carcinoma |
title_sort |
phase ii trial of s‐1 treatment as palliative‐intent chemotherapy for previously treated advanced thymic carcinoma |
publisher |
Wiley |
series |
Cancer Medicine |
issn |
2045-7634 |
publishDate |
2020-10-01 |
description |
Abstract Thymic carcinoma (TC) is a rare cancer with minimal evidence of survival following palliative‐intent chemotherapy. Sunitinib, everolimus, and pembrolizumab have been proposed as active agents based on previous phase II trials. In this phase II study, TC patients previously treated with platinum‐based chemotherapy were enrolled. The patients received S‐1 orally twice daily at a dose of 40‐60 mg/m2 for 4 weeks, followed by 2 weeks off until the progression of the disease or the presence of unacceptable toxicities. The primary endpoint was the objective response rate (ORR), and secondary endpoints were progression‐free survival (PFS), overall survival (OS), and safety. The sample size of 26 patients was planned to reject the ORR of 10% under the expectation of 30% with a power of 0.80 and a type I error of 0.05 (one‐sided). Twenty‐six patients were recruited between 2013 and 2016; 23 patients had squamous cell carcinoma and 10 had an ECOG performance status of 0. One patient showed complete response and seven patients showed partial responses, resulting in a 30.8% response rate (90% confidence interval [CI], 18.3‐46.9) and an 80.8% disease control rate (90% CI, 65.4‐90.3). The median PFS was 4.3 months (95% CI, 2.3‐10.3 months) and median OS was 27.4 months (95% CI, 16.6‐34.3). Adverse events of grade ≥ 3 included neutropenia (12%), skin rash (8%), elevated alanine aminotransferase, and fatigue (4%). No treatment‐related death was observed. S‐1 confirmed clinical activity with tolerability in patients with previously treated TC. (UMIN000010736). |
topic |
chemotherapy phase II rare cancer S‐1 thymic carcinoma |
url |
https://doi.org/10.1002/cam4.3385 |
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doaj-76f9d6f96b7745e6b7c709b7da86e5652020-11-25T03:57:46ZengWileyCancer Medicine2045-76342020-10-019207418742710.1002/cam4.3385Phase II trial of S‐1 treatment as palliative‐intent chemotherapy for previously treated advanced thymic carcinomaYusuke Okuma0Yasushi Goto1Fumiyoshi Ohyanagi2Kuniko Sunami3Yoshiro Nakahara4Satoru Kitazono5Keita Kudo6Yuichi Tambo7Shintaro Kanda8Noriko Yanagitani9Atsushi Horiike10Hidehito Horinouchi11Yutaka Fujiwara12Hiroshi Nokihara13Noboru Yamamoto14Makoto Nishio15Yuichiro Ohe16Yukio Hosomi17Department of Thoracic Oncology and Respiratory Medicine Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Tokyo JapanDepartment of Thoracic Oncology National Cancer Center Hospital Tokyo JapanDepartment of Thoracic Medical Oncology The Cancer Institute Hospital of Japanese Foundation for Cancer Research Tokyo JapanDepartment of Pathology and Clinical Laboratories National Cancer Center Hospital Tokyo JapanDepartment of Thoracic Oncology and Respiratory Medicine Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Tokyo JapanDepartment of Thoracic Medical Oncology The Cancer Institute Hospital of Japanese Foundation for Cancer Research Tokyo JapanDepartment of Thoracic Medical Oncology The Cancer Institute Hospital of Japanese Foundation for Cancer Research Tokyo JapanDepartment of Thoracic Medical Oncology The Cancer Institute Hospital of Japanese Foundation for Cancer Research Tokyo JapanDepartment of Thoracic Oncology National Cancer Center Hospital Tokyo JapanDepartment of Thoracic Medical Oncology The Cancer Institute Hospital of Japanese Foundation for Cancer Research Tokyo JapanDepartment of Thoracic Medical Oncology The Cancer Institute Hospital of Japanese Foundation for Cancer Research Tokyo JapanDepartment of Thoracic Oncology National Cancer Center Hospital Tokyo JapanDepartment of Thoracic Oncology National Cancer Center Hospital Tokyo JapanDepartment of Thoracic Oncology National Cancer Center Hospital Tokyo JapanDepartment of Thoracic Oncology National Cancer Center Hospital Tokyo JapanDepartment of Thoracic Medical Oncology The Cancer Institute Hospital of Japanese Foundation for Cancer Research Tokyo JapanDepartment of Thoracic Oncology National Cancer Center Hospital Tokyo JapanDepartment of Thoracic Oncology and Respiratory Medicine Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Tokyo JapanAbstract Thymic carcinoma (TC) is a rare cancer with minimal evidence of survival following palliative‐intent chemotherapy. Sunitinib, everolimus, and pembrolizumab have been proposed as active agents based on previous phase II trials. In this phase II study, TC patients previously treated with platinum‐based chemotherapy were enrolled. The patients received S‐1 orally twice daily at a dose of 40‐60 mg/m2 for 4 weeks, followed by 2 weeks off until the progression of the disease or the presence of unacceptable toxicities. The primary endpoint was the objective response rate (ORR), and secondary endpoints were progression‐free survival (PFS), overall survival (OS), and safety. The sample size of 26 patients was planned to reject the ORR of 10% under the expectation of 30% with a power of 0.80 and a type I error of 0.05 (one‐sided). Twenty‐six patients were recruited between 2013 and 2016; 23 patients had squamous cell carcinoma and 10 had an ECOG performance status of 0. One patient showed complete response and seven patients showed partial responses, resulting in a 30.8% response rate (90% confidence interval [CI], 18.3‐46.9) and an 80.8% disease control rate (90% CI, 65.4‐90.3). The median PFS was 4.3 months (95% CI, 2.3‐10.3 months) and median OS was 27.4 months (95% CI, 16.6‐34.3). Adverse events of grade ≥ 3 included neutropenia (12%), skin rash (8%), elevated alanine aminotransferase, and fatigue (4%). No treatment‐related death was observed. S‐1 confirmed clinical activity with tolerability in patients with previously treated TC. (UMIN000010736).https://doi.org/10.1002/cam4.3385chemotherapyphase IIrare cancerS‐1thymic carcinoma |