A phase II study of sunitinib as a second-line treatment in advanced biliary tract carcinoma: A multicentre, multinational study
Background: Biliary tract carcinoma (BTC) is rare in the West, but not uncommon in Asia and is a highly fatal malignancy. VEGF expression is related with poor outcome in patients with BTC. Therefore, we conducted a phase II study to evaluate the efficacy and safety of sunitinib as second-line treatm...
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th-cmuir.6653943832-514352018-09-04T06:12:43Z A phase II study of sunitinib as a second-line treatment in advanced biliary tract carcinoma: A multicentre, multinational study Jun Ho Yi Sumitra Thongprasert Jeeyun Lee D. C. Doval Se Hoon Park Joon Oh Park Young Suk Park Won Ki Kang Ho Yeong Lim Biochemistry, Genetics and Molecular Biology Medicine Background: Biliary tract carcinoma (BTC) is rare in the West, but not uncommon in Asia and is a highly fatal malignancy. VEGF expression is related with poor outcome in patients with BTC. Therefore, we conducted a phase II study to evaluate the efficacy and safety of sunitinib as second-line treatment. Methods: This was a prospective, single-arm, multicentre, multinational study. Patients with unresectable, metastatic BTC who progressed after first-line chemotherapy were eligible. Sunitinib was administered at 37.5mg once daily continuously with 4-week cycle. The primary end point was the time to progression (TTP). Results: Between May 2009 and October 2010, a total of 56 patients were enrolled from three countries. The median age was 55 years (range 38-75) and male to female ratio was 37:19. Median TTP was 1.7 months (95% confidence interval (CI) 1.0-2.4). The objective response rate was 8.9% (5 partial response) and disease control rate was 50.0%. (23 stable disease) Grade 3-4 toxicities were observed in 46.4% of the patients with neutropenia and thrombocytopenia being the most frequent (21.4%). Conclusions: This phase II study suggests that sunitinib monotherapy demonstrated marginal efficacy in metastatic BTC patients although toxicity should be concerned in Asian population. © 2011 Elsevier Ltd. All rights reserved. 2018-09-04T06:01:53Z 2018-09-04T06:01:53Z 2012-01-01 Journal 18790852 09598049 2-s2.0-84655161964 10.1016/j.ejca.2011.11.017 https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84655161964&origin=inward http://cmuir.cmu.ac.th/jspui/handle/6653943832/51435 |
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Biochemistry, Genetics and Molecular Biology Medicine Jun Ho Yi Sumitra Thongprasert Jeeyun Lee D. C. Doval Se Hoon Park Joon Oh Park Young Suk Park Won Ki Kang Ho Yeong Lim A phase II study of sunitinib as a second-line treatment in advanced biliary tract carcinoma: A multicentre, multinational study |
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Background: Biliary tract carcinoma (BTC) is rare in the West, but not uncommon in Asia and is a highly fatal malignancy. VEGF expression is related with poor outcome in patients with BTC. Therefore, we conducted a phase II study to evaluate the efficacy and safety of sunitinib as second-line treatment. Methods: This was a prospective, single-arm, multicentre, multinational study. Patients with unresectable, metastatic BTC who progressed after first-line chemotherapy were eligible. Sunitinib was administered at 37.5mg once daily continuously with 4-week cycle. The primary end point was the time to progression (TTP). Results: Between May 2009 and October 2010, a total of 56 patients were enrolled from three countries. The median age was 55 years (range 38-75) and male to female ratio was 37:19. Median TTP was 1.7 months (95% confidence interval (CI) 1.0-2.4). The objective response rate was 8.9% (5 partial response) and disease control rate was 50.0%. (23 stable disease) Grade 3-4 toxicities were observed in 46.4% of the patients with neutropenia and thrombocytopenia being the most frequent (21.4%). Conclusions: This phase II study suggests that sunitinib monotherapy demonstrated marginal efficacy in metastatic BTC patients although toxicity should be concerned in Asian population. © 2011 Elsevier Ltd. All rights reserved. |
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Jun Ho Yi Sumitra Thongprasert Jeeyun Lee D. C. Doval Se Hoon Park Joon Oh Park Young Suk Park Won Ki Kang Ho Yeong Lim |
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Jun Ho Yi Sumitra Thongprasert Jeeyun Lee D. C. Doval Se Hoon Park Joon Oh Park Young Suk Park Won Ki Kang Ho Yeong Lim |
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Jun Ho Yi |
title |
A phase II study of sunitinib as a second-line treatment in advanced biliary tract carcinoma: A multicentre, multinational study |
title_short |
A phase II study of sunitinib as a second-line treatment in advanced biliary tract carcinoma: A multicentre, multinational study |
title_full |
A phase II study of sunitinib as a second-line treatment in advanced biliary tract carcinoma: A multicentre, multinational study |
title_fullStr |
A phase II study of sunitinib as a second-line treatment in advanced biliary tract carcinoma: A multicentre, multinational study |
title_full_unstemmed |
A phase II study of sunitinib as a second-line treatment in advanced biliary tract carcinoma: A multicentre, multinational study |
title_sort |
phase ii study of sunitinib as a second-line treatment in advanced biliary tract carcinoma: a multicentre, multinational study |
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2018 |
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https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84655161964&origin=inward http://cmuir.cmu.ac.th/jspui/handle/6653943832/51435 |
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