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Capecitabine plus docetaxel every 3 weeks in first- and second-line metastatic oesophageal cancer: final results of a phase II trial

Capecitabine and docetaxel have single-agent activity in upper gastrointestinal tumours, and have together demonstrated preclinical synergy and a survival benefit in breast cancer, and high response rates in first-line metastatic gastric cancer. This trial assessed the efficacy, safety and feasibili...

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Autores principales: Lorenzen, S, Duyster, J, Lersch, C, von Delius, S, Hennig, M, Bredenkamp, R, Peschel, C, Lordick, F
Formato: Texto
Lenguaje:English
Publicado: Nature Publishing Group 2005
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2361804/
https://www.ncbi.nlm.nih.gov/pubmed/15942631
http://dx.doi.org/10.1038/sj.bjc.6602645
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author Lorenzen, S
Duyster, J
Lersch, C
von Delius, S
Hennig, M
Bredenkamp, R
Peschel, C
Lordick, F
author_facet Lorenzen, S
Duyster, J
Lersch, C
von Delius, S
Hennig, M
Bredenkamp, R
Peschel, C
Lordick, F
author_sort Lorenzen, S
collection PubMed
description Capecitabine and docetaxel have single-agent activity in upper gastrointestinal tumours, and have together demonstrated preclinical synergy and a survival benefit in breast cancer, and high response rates in first-line metastatic gastric cancer. This trial assessed the efficacy, safety and feasibility of capecitabine in combination with docetaxel in patients with metastatic oesophageal cancer. In all, 24 patients with advanced disease (17 squamous cell carcinoma and seven adenocarcinoma) received oral capecitabine (1000 mg m(−2) twice daily on days 1–14) plus intravenous docetaxel (75 mg m(−2) on day 1) every 3 weeks as first- (n=16) or second-line (n=8) therapy. Patients received a median of four cycles of treatment (range, 0–6). The median follow-up is 16.5 months (range, 7.9–21.4 months). Intent-to-treat efficacy analysis showed an overall response rate of 46%. Of the 11 responders (one complete and 10 partial), nine of 16 (56%) received first-line and two of eight (25%) received second-line therapy. The median time to progression was 6.1 months (95% confidence interval (CI), 4.5–7.7 months). The meian survival was 15.8 months (95% CI, 7.8–23.9 months). Severe adverse events (grade 3/4) reported were: neutropenia (42%, including febrile neutropenia 8%), hand-foot syndrome (29%), diarrhoea (13%), sensory neuropathy (13%), anaemia (8%) and fatigue (8%). Capecitabine plus docetaxel has a manageable adverse event profile and very promising activity in metastatic oesophageal cancer, at least comparable to other doublet regimens. Therefore, the combination merits further investigation in this setting.
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spelling pubmed-23618042009-09-10 Capecitabine plus docetaxel every 3 weeks in first- and second-line metastatic oesophageal cancer: final results of a phase II trial Lorenzen, S Duyster, J Lersch, C von Delius, S Hennig, M Bredenkamp, R Peschel, C Lordick, F Br J Cancer Clinical Study Capecitabine and docetaxel have single-agent activity in upper gastrointestinal tumours, and have together demonstrated preclinical synergy and a survival benefit in breast cancer, and high response rates in first-line metastatic gastric cancer. This trial assessed the efficacy, safety and feasibility of capecitabine in combination with docetaxel in patients with metastatic oesophageal cancer. In all, 24 patients with advanced disease (17 squamous cell carcinoma and seven adenocarcinoma) received oral capecitabine (1000 mg m(−2) twice daily on days 1–14) plus intravenous docetaxel (75 mg m(−2) on day 1) every 3 weeks as first- (n=16) or second-line (n=8) therapy. Patients received a median of four cycles of treatment (range, 0–6). The median follow-up is 16.5 months (range, 7.9–21.4 months). Intent-to-treat efficacy analysis showed an overall response rate of 46%. Of the 11 responders (one complete and 10 partial), nine of 16 (56%) received first-line and two of eight (25%) received second-line therapy. The median time to progression was 6.1 months (95% confidence interval (CI), 4.5–7.7 months). The meian survival was 15.8 months (95% CI, 7.8–23.9 months). Severe adverse events (grade 3/4) reported were: neutropenia (42%, including febrile neutropenia 8%), hand-foot syndrome (29%), diarrhoea (13%), sensory neuropathy (13%), anaemia (8%) and fatigue (8%). Capecitabine plus docetaxel has a manageable adverse event profile and very promising activity in metastatic oesophageal cancer, at least comparable to other doublet regimens. Therefore, the combination merits further investigation in this setting. Nature Publishing Group 2005-06-20 2005-06-07 /pmc/articles/PMC2361804/ /pubmed/15942631 http://dx.doi.org/10.1038/sj.bjc.6602645 Text en Copyright © 2005 Cancer Research UK https://creativecommons.org/licenses/by/4.0/This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material.If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit https://creativecommons.org/licenses/by/4.0/.
spellingShingle Clinical Study
Lorenzen, S
Duyster, J
Lersch, C
von Delius, S
Hennig, M
Bredenkamp, R
Peschel, C
Lordick, F
Capecitabine plus docetaxel every 3 weeks in first- and second-line metastatic oesophageal cancer: final results of a phase II trial
title Capecitabine plus docetaxel every 3 weeks in first- and second-line metastatic oesophageal cancer: final results of a phase II trial
title_full Capecitabine plus docetaxel every 3 weeks in first- and second-line metastatic oesophageal cancer: final results of a phase II trial
title_fullStr Capecitabine plus docetaxel every 3 weeks in first- and second-line metastatic oesophageal cancer: final results of a phase II trial
title_full_unstemmed Capecitabine plus docetaxel every 3 weeks in first- and second-line metastatic oesophageal cancer: final results of a phase II trial
title_short Capecitabine plus docetaxel every 3 weeks in first- and second-line metastatic oesophageal cancer: final results of a phase II trial
title_sort capecitabine plus docetaxel every 3 weeks in first- and second-line metastatic oesophageal cancer: final results of a phase ii trial
topic Clinical Study
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2361804/
https://www.ncbi.nlm.nih.gov/pubmed/15942631
http://dx.doi.org/10.1038/sj.bjc.6602645
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