Clinical

British Journal of Cancer (2002) 87, 1210–1215. doi:10.1038/sj.bjc.6600645 www.bjcancer.com
Published online 12 November 2002

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

J Bonneterre1, H Roché2, A Monnier3, J P Guastalla4, M Namer5, P Fargeot6 and S Assadourian7

  1. 1Centre Oscar Lambret, 3 rue F. Combemale, 59020 Lille, France
  2. 2Centre Claudius Regaud, Service Oncologie, 20–24 rue du Pont-Saint-Pierre, 31052 Toulouse, France
  3. 3CHG André Boulloche, Service Oncologie, 2 rue du Dr Flamand, 25209 Montbelliard, France
  4. 4Centre Léon Berard, 28 rue Laënnec, 69373 Lyon, France
  5. 5Centre Antoine Lacassagne, 3 av de Valombrose, 06189 Nice, France
  6. 6Centre Georges-François Leclerc, 1 rue du Pr. Marion, 21034 Dijon, France
  7. 7Aventis Pharma, 20 Av Raymond Aron, Croix-de-Berny, 92165 Antony, France

Correspondence: J Bonneterre, E-mail: j-bonneterre@o-lambret.fr

Received 8 March 2002; Revised 8 August 2002; Accepted 8 September 2002.

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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.

Keywords:

metastatic breast cancer, anthracycline, docetaxel, 5-fluorouracil, second-line chemotherapy, vinorelbine