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Sequential or alternating administration of docetaxel (Taxotere®) combined with FEC in metastatic breast cancer: a randomised phase II trial
The aim of this study, using a Fleming single-stage design, was to explore the efficacy and safety of Taxotere® 100 mg m(−2) docetaxel and FEC 75 cyclophosphamide 500 mg m(−2), fluorouracil 500 mg m(−2) and epirubicin 75 mg m(−2), in alternating and sequential schedules for the first-line treatment...
Autores principales: | , , , , , , , |
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Formato: | Texto |
Lenguaje: | English |
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Nature Publishing Group
2002
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2375306/ https://www.ncbi.nlm.nih.gov/pubmed/11875727 http://dx.doi.org/10.1038/sj.bjc.6600165 |
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author | Spielmann, M Tubiana-Hulin, M Namer, M Mansouri, H Bougnoux, P h Tubiana-Mathieu, N Lotz, V Eymard, J C |
author_facet | Spielmann, M Tubiana-Hulin, M Namer, M Mansouri, H Bougnoux, P h Tubiana-Mathieu, N Lotz, V Eymard, J C |
author_sort | Spielmann, M |
collection | PubMed |
description | The aim of this study, using a Fleming single-stage design, was to explore the efficacy and safety of Taxotere® 100 mg m(−2) docetaxel and FEC 75 cyclophosphamide 500 mg m(−2), fluorouracil 500 mg m(−2) and epirubicin 75 mg m(−2), in alternating and sequential schedules for the first-line treatment of metastatic breast cancer. One hundred and thirty-six women were randomly allocated, to one of three treatment regimens: DTX 100 plus FEC 75, alternated for eight courses (ALT); four courses of DTX 100 followed by four courses of FEC 75 (SEQ T); or four courses of FEC 75 followed by four courses of DTX 100 (SEQ F). One hundred and thirty-one women were evaluable for tumour response. Although the treatment outcome was equivalent in the two sequential arms and the alternating regimen (P=0.110, not significant), the response rate was less encouraging in the SEQ F arm (52.3%) than in the other two arms (71.1% for ALT and 70.5% for SEQ T), in which docetaxel was administered first. Time to progression was similar in the ALT, SEQ T and SEQ F arms (9.5, 9.3 and 10.4 months respectively). Grade 3–4 neutropenia was observed in nearly all patients; febrile neutropenia occurred in 9% (ALT), 16% (SEQ T) and 2% (SEQ F) of patients. Few patients (⩽9%) developed grade 3–4 non-haematological toxicities. Relative dose intensity was 97–99% for all regimens. All treatment regimens were active and well tolerated. British Journal of Cancer (2002) 86, 692–697. DOI: 10.1038/sj/bjc/6600165 www.bjcancer.com © 2002 Cancer Research UK |
format | Text |
id | pubmed-2375306 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2002 |
publisher | Nature Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-23753062009-09-10 Sequential or alternating administration of docetaxel (Taxotere®) combined with FEC in metastatic breast cancer: a randomised phase II trial Spielmann, M Tubiana-Hulin, M Namer, M Mansouri, H Bougnoux, P h Tubiana-Mathieu, N Lotz, V Eymard, J C Br J Cancer Clinical The aim of this study, using a Fleming single-stage design, was to explore the efficacy and safety of Taxotere® 100 mg m(−2) docetaxel and FEC 75 cyclophosphamide 500 mg m(−2), fluorouracil 500 mg m(−2) and epirubicin 75 mg m(−2), in alternating and sequential schedules for the first-line treatment of metastatic breast cancer. One hundred and thirty-six women were randomly allocated, to one of three treatment regimens: DTX 100 plus FEC 75, alternated for eight courses (ALT); four courses of DTX 100 followed by four courses of FEC 75 (SEQ T); or four courses of FEC 75 followed by four courses of DTX 100 (SEQ F). One hundred and thirty-one women were evaluable for tumour response. Although the treatment outcome was equivalent in the two sequential arms and the alternating regimen (P=0.110, not significant), the response rate was less encouraging in the SEQ F arm (52.3%) than in the other two arms (71.1% for ALT and 70.5% for SEQ T), in which docetaxel was administered first. Time to progression was similar in the ALT, SEQ T and SEQ F arms (9.5, 9.3 and 10.4 months respectively). Grade 3–4 neutropenia was observed in nearly all patients; febrile neutropenia occurred in 9% (ALT), 16% (SEQ T) and 2% (SEQ F) of patients. Few patients (⩽9%) developed grade 3–4 non-haematological toxicities. Relative dose intensity was 97–99% for all regimens. All treatment regimens were active and well tolerated. British Journal of Cancer (2002) 86, 692–697. DOI: 10.1038/sj/bjc/6600165 www.bjcancer.com © 2002 Cancer Research UK Nature Publishing Group 2002-03-04 /pmc/articles/PMC2375306/ /pubmed/11875727 http://dx.doi.org/10.1038/sj.bjc.6600165 Text en Copyright © 2002 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 Spielmann, M Tubiana-Hulin, M Namer, M Mansouri, H Bougnoux, P h Tubiana-Mathieu, N Lotz, V Eymard, J C Sequential or alternating administration of docetaxel (Taxotere®) combined with FEC in metastatic breast cancer: a randomised phase II trial |
title | Sequential or alternating administration of docetaxel (Taxotere®) combined with FEC in metastatic breast cancer: a randomised phase II trial |
title_full | Sequential or alternating administration of docetaxel (Taxotere®) combined with FEC in metastatic breast cancer: a randomised phase II trial |
title_fullStr | Sequential or alternating administration of docetaxel (Taxotere®) combined with FEC in metastatic breast cancer: a randomised phase II trial |
title_full_unstemmed | Sequential or alternating administration of docetaxel (Taxotere®) combined with FEC in metastatic breast cancer: a randomised phase II trial |
title_short | Sequential or alternating administration of docetaxel (Taxotere®) combined with FEC in metastatic breast cancer: a randomised phase II trial |
title_sort | sequential or alternating administration of docetaxel (taxotere®) combined with fec in metastatic breast cancer: a randomised phase ii trial |
topic | Clinical |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2375306/ https://www.ncbi.nlm.nih.gov/pubmed/11875727 http://dx.doi.org/10.1038/sj.bjc.6600165 |
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