Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2002 Nov 18;87(11):1210-5.
doi: 10.1038/sj.bjc.6600645.

Docetaxel vs 5-fluorouracil plus vinorelbine in metastatic breast cancer after anthracycline therapy failure

J Bonneterre  1 , H Roché, A Monnier, J P Guastalla, M Namer, P Fargeot, S Assadourian
Affiliations
Clinical Trial

Docetaxel vs 5-fluorouracil plus vinorelbine in metastatic breast cancer after anthracycline therapy failure

J Bonneterre et al. Br J Cancer. .

Abstract

This multicentre, randomised phase III study compared docetaxel with 5-fluorouracil+vinorelbine in patients with metastatic breast cancer after failure of neo/adjuvant or one line of palliative anthracycline-based chemotherapy. One hundred and seventy-six metastatic breast cancer patients were randomised to receive docetaxel (100 mg m(-2)) every 3 weeks or 5-fluorouracil+vinorelbine: 5-fluorouracil (750 mg m(-2) per day continuous infusion) D1-5 plus vinorelbine (25 mg m(-2)) D1 and D5 of each 3-week cycle. Eighty-six patients received 516 cycles of docetaxel; 90 patients received 476 cycles of 5-fluorouracil+vinorelbine. Median time to progression (6.5 vs 5.1 months) and overall survival (16.0 vs 15.0 months) did not differ significantly between the docetaxel and 5-fluorouracil+vinorelbine arms, respectively. Six (7%) complete responses and 31 (36%) partial responses occurred with docetaxel (overall response rate 43%, 95% confidence interval: 32-53%), while 4 (4.4%) complete responses and 31 (34.4%) partial responses occurred with 5-fluorouracil+vinorelbine (overall response rate 38.8%, 95% confidence interval: 29-49%). Main grade 3-4 toxicities were (docetaxel vs 5-fluorouracil+vinorelbine): neutropenia 82% vs 67%; stomatitis 5% vs 40%; febrile neutropenia 13% vs 22%; and infection 2% vs 7%. There was one possible treatment-related death in the docetaxel arm and five with 5-fluorouracil+vinorelbine. In anthracycline-pretreated metastatic breast cancer patients, docetaxel showed comparable efficacy to 5-fluorouracil+vinorelbine, but was less toxic.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Time to tumour progression in the all-treated population.
Figure 2
Figure 2
Time to tumour progression in the anthracycline-resistant/ refractory population.
Figure 3
Figure 3
Overall survival in the all-treated population.
Figure 4
Figure 4
Overall survival in the anthracycline-resistant/refractory population.
See this image and copyright information in PMC

References

    1. AlexopoulosCGRigatosGEfremidisAPPapacharalambousAAlexopoulosAVassilomanolakisMPatilaE1999A phase II study of the effectiveness of docetaxel (Taxotere) in women with advanced breast cancer previously treated with polychemotherapy. Hellenic Cooperative Interhospital Group in Oncology Cancer Chemother Pharmacol 44253258 - PubMed
    1. BrodowiczTKoestlerWJTomekSVaclavikIHerscoviciVWiltschkeCStegerGGZielinskiCC2000Monotherapy with docetaxel in second- or third-line treatment of anthracycline-resistant metastatic breast cancer Anticancer Drugs 11149153 - PubMed
    1. BrufmanGColajoriEGhilezanNLassusMMartoniAPerevodchikovaNToselloCViaroDZielinskiC1997Doubling epirubicin dose intensity (100 mg/m2 versus 50 mg/m2) in the FEC regimen significantly increases response rates. An international randomised phase III study in metastatic breast cancerThe Epirubicin High Dose (HEPI 010) Study GroupAnn Oncol 8155162 - PubMed
    1. CaballeroGAAismanRKQuebbemanEJ1985Long-term, ambulatory continuous IV infusion of 5-FU for the treatment of advanced adenocarcinomas Cancer Treat Rep 691315 - PubMed
    1. CanyLToulouseCRavaudADurandMMauriacL1996Vinorelbine/5-FU combination in metastatic breast cancer chemotherapy. A retrospective study of 63 cases Eur J Cancer 32A370371 - PubMed

Publication types

MeSH terms