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A randomised phase II study of second-line XELIRI regimen versus irinotecan monotherapy in advanced biliary tract cancer patients progressed on gemcitabine and cisplatin
BACKGROUND: The majority of advanced biliary tract cancer (ABTC) patients will progress after gemcitabine and cisplatin (GP) doublet therapy, while the standard second-line regimen has not been established. We conducted this study to assess the efficacy and safety of second-line irinotecan and capec...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group UK
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6068158/ https://www.ncbi.nlm.nih.gov/pubmed/29955136 http://dx.doi.org/10.1038/s41416-018-0138-2 |
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author | Zheng, Yi Tu, Xiaoxuan Zhao, Peng Jiang, Weiqin Liu, Lulu Tong, Zhou Zhang, Hangyu Yan, Cong Fang, Weijia Wang, Weilin |
author_facet | Zheng, Yi Tu, Xiaoxuan Zhao, Peng Jiang, Weiqin Liu, Lulu Tong, Zhou Zhang, Hangyu Yan, Cong Fang, Weijia Wang, Weilin |
author_sort | Zheng, Yi |
collection | PubMed |
description | BACKGROUND: The majority of advanced biliary tract cancer (ABTC) patients will progress after gemcitabine and cisplatin (GP) doublet therapy, while the standard second-line regimen has not been established. We conducted this study to assess the efficacy and safety of second-line irinotecan and capecitabine (XELIRI) regimen vs. irinotecan monotherapy in ABTC patients progressed on GP. METHODS: Sixty-four GP refractory ABTC patients were randomised to either irinotecan 180 mg/m(2) on day 1 plus capecitabine 1000 mg/m(2) twice daily on days 1–10 of a 14-day cycle (XELIRI-arm) or single-agent irinotecan 180 mg/m(2) on day 1 of a 14-day cycle (IRI-arm). Treatments were repeated until disease progression or unacceptable toxicity occurred. RESULTS: A total of 60 patients were included in the analysis. For XELIRI and IRI-arms, respectively, the median PFS was 3.7 vs. 2.4 months, 9-month survival rate 60.9% vs. 32.0%, median OS 10.1 vs. 7.3 months, and disease control rate 63.3% vs. 50.0%. The most common grade 3 or 4 toxicities were leucopaenia and neutropaenia. CONCLUSIONS: This randomised, phase II study of irinotecan-containing regimens in good PS second-line ABTC patients showed a clear benefit of XELIRI regimen over irinotecan monotherapy in prolonging PFS, with acceptable toxicity. |
format | Online Article Text |
id | pubmed-6068158 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Nature Publishing Group UK |
record_format | MEDLINE/PubMed |
spelling | pubmed-60681582019-08-01 A randomised phase II study of second-line XELIRI regimen versus irinotecan monotherapy in advanced biliary tract cancer patients progressed on gemcitabine and cisplatin Zheng, Yi Tu, Xiaoxuan Zhao, Peng Jiang, Weiqin Liu, Lulu Tong, Zhou Zhang, Hangyu Yan, Cong Fang, Weijia Wang, Weilin Br J Cancer Article BACKGROUND: The majority of advanced biliary tract cancer (ABTC) patients will progress after gemcitabine and cisplatin (GP) doublet therapy, while the standard second-line regimen has not been established. We conducted this study to assess the efficacy and safety of second-line irinotecan and capecitabine (XELIRI) regimen vs. irinotecan monotherapy in ABTC patients progressed on GP. METHODS: Sixty-four GP refractory ABTC patients were randomised to either irinotecan 180 mg/m(2) on day 1 plus capecitabine 1000 mg/m(2) twice daily on days 1–10 of a 14-day cycle (XELIRI-arm) or single-agent irinotecan 180 mg/m(2) on day 1 of a 14-day cycle (IRI-arm). Treatments were repeated until disease progression or unacceptable toxicity occurred. RESULTS: A total of 60 patients were included in the analysis. For XELIRI and IRI-arms, respectively, the median PFS was 3.7 vs. 2.4 months, 9-month survival rate 60.9% vs. 32.0%, median OS 10.1 vs. 7.3 months, and disease control rate 63.3% vs. 50.0%. The most common grade 3 or 4 toxicities were leucopaenia and neutropaenia. CONCLUSIONS: This randomised, phase II study of irinotecan-containing regimens in good PS second-line ABTC patients showed a clear benefit of XELIRI regimen over irinotecan monotherapy in prolonging PFS, with acceptable toxicity. Nature Publishing Group UK 2018-06-29 2018-08-01 /pmc/articles/PMC6068158/ /pubmed/29955136 http://dx.doi.org/10.1038/s41416-018-0138-2 Text en © Cancer Research UK 2018 https://creativecommons.org/licenses/by/4.0/This work is published under the standard license to publish agreement. After 12 months the work will become freely available and the license terms will switch to a Creative Commons Attribution 4.0 International (CC BY 4.0). |
spellingShingle | Article Zheng, Yi Tu, Xiaoxuan Zhao, Peng Jiang, Weiqin Liu, Lulu Tong, Zhou Zhang, Hangyu Yan, Cong Fang, Weijia Wang, Weilin A randomised phase II study of second-line XELIRI regimen versus irinotecan monotherapy in advanced biliary tract cancer patients progressed on gemcitabine and cisplatin |
title | A randomised phase II study of second-line XELIRI regimen versus irinotecan monotherapy in advanced biliary tract cancer patients progressed on gemcitabine and cisplatin |
title_full | A randomised phase II study of second-line XELIRI regimen versus irinotecan monotherapy in advanced biliary tract cancer patients progressed on gemcitabine and cisplatin |
title_fullStr | A randomised phase II study of second-line XELIRI regimen versus irinotecan monotherapy in advanced biliary tract cancer patients progressed on gemcitabine and cisplatin |
title_full_unstemmed | A randomised phase II study of second-line XELIRI regimen versus irinotecan monotherapy in advanced biliary tract cancer patients progressed on gemcitabine and cisplatin |
title_short | A randomised phase II study of second-line XELIRI regimen versus irinotecan monotherapy in advanced biliary tract cancer patients progressed on gemcitabine and cisplatin |
title_sort | randomised phase ii study of second-line xeliri regimen versus irinotecan monotherapy in advanced biliary tract cancer patients progressed on gemcitabine and cisplatin |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6068158/ https://www.ncbi.nlm.nih.gov/pubmed/29955136 http://dx.doi.org/10.1038/s41416-018-0138-2 |
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