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Annals of Oncology 14:1623-1628, 2003
© 2003 European Society for Medical Oncology

Original Paper

Phase II trial combining docetaxel and doxorubicin as neoadjuvant chemotherapy in patients with operable breast cancer

G. Ganem1,+, M. Tubiana-Hulin2, P. Fumoleau3, M. Combe4, J.-L. Misset5, J.-M. Vannetzel6, T. Bachelot7, L. R. De Ybarlucea4, V. Lotz8, B. Bendahmane8 and V. Dieras9

1 Centre Jean Bernard, Le Mans; 2 Centre R. Huguenin, St Cloud; 3 Centre R. Gauducheau, IRCNA, Nantes, St Herblain; 4 C. H., Le Mans; 5 Hôpital Paul Brousse, Villejuif; 6 Clinique Hartmann, Neuillys/Seine; 7 Centre L. Bérard-Lyon; 8 Laboratoire Aventis, Paris; 9 Institut Curie, Paris, France

Received 20 February 2003 ; revised 22 May 2003; accepted 28 July 2003

Background:

This study was conducted to assess the antitumour activity of docetaxel in combination with doxorubicin for neoadjuvant therapy of patients with breast cancer.

Patients and methods:

Forty-eight women were treated with intravenous doxorubicin 50 mg/m2 over 15 min followed by a 1-h infusion of docetaxel 75 mg/m2 every 3 weeks for six cycles. Dexamethasone or prednisolone premedication was allowed. Granulocyte colony-stimulating factor was not allowed as primary prophylaxis. The primary end point was the pathologically documented complete response rate (pathological response).

Results:

The mean relative dose intensity calculated for four or more cycles was 0.99 for doxorubicin and 0.99 for docetaxel. Overall, the pathological response rate was 13%. There were 11 complete and 29 partial clinical responses for an overall response rate of 85% [95% confidence interval (CI) 75% to 95%] in the evaluable population (n = 47). Disease-free and overall survival rates were 85% (95% CI 71% to 94%) and 96% (95% CI 85% to 99%), respectively, after a median follow-up of 36.6 months. Grade 3/4 neutropenia was observed in 65% of patients and 17% reported grade 4 febrile neutropenia.

Conclusions:

Docetaxel and doxorubicin is an effective and well-tolerated combination in the neoadjuvant therapy of breast cancer. Future controlled trials are warranted to investigate the best schedules and to correlate response with biological factors.

Key words: breast cancer, docetaxel, doxorubicin, neoadjuvant chemotherapy


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