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Randomized Parallel Study of Doxorubicin Plus Paclitaxel and Doxorubicin Plus Cyclophosphamide As Neoadjuvant Treatment of Patients With Breast Cancer

From the Institut Curie; Hôtel Dieu, Paris; Centre René Gauducheau, Nantes; Centre Val d’Aurelle, Montpellier; Centre René Huguenin, Saint Cloud; Centre Antoine Lacassagne, Nice; Institut Bergonié, Bordeaux; Centre Léon Bérard, Lyon; Centre Eugène Marquis, Rennes; Centre Paul Papin, Angers; Centre Jean Perrin, Clermont-Ferrand, France; and the International Drug Development Institute, Brussels, Belgium.

Address reprint requests to V. Diéras, Institut Curie, Department of Medical Oncology, 26 rue d’Ulm, 75005 Paris, France; e-mail: veronique.dieras{at}curie.net

PURPOSE: This randomized, noncomparative, parallel-group study was designed to evaluate the pathologic complete response (pCR) rate of combined doxorubicin plus paclitaxel (AP) and doxorubicin plus cyclophosphamide (AC) as neoadjuvant chemotherapy in patients with previously untreated breast cancer who were unsuitable for conservative surgery.

PATIENTS AND METHODS: A total of 200 patients with T2-3, N0-1, M0 disease were randomly assigned in a 2:1 ratio to receive preoperative chemotherapy with either doxorubicin 60 mg/m² plus paclitaxel 200 mg/m² as a 3-hour infusion (AP) or doxorubicin 60 mg/m² plus cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 courses followed by surgery.

RESULTS: A pCR (eradication of invasive carcinoma in tumor and in axillary lymph nodes) was found in 16% and 10% of patients in the AP and AC arms, respectively, by study center pathologists, and in 8% and 6% of patients, respectively, by independent pathologists. Patients with pCRs tended to have unifocal disease, tumors with negative hormonal receptor status, and less differentiation (Scarff, Bloom, and Richardson scale grade 3). Breast-conserving surgery was performed in 58% and 45% of patients in the AP and AC arms, respectively. An objective clinical response was achieved in 89% of patients in the AP arm and 70% in the AC arm. At a median follow-up of 31 months, disease-free survival (DFS) was higher in patients who reached pCR versus those without pCR (91% v 70%).

CONCLUSION: The encouraging pathologic and clinical responses of patients with breast cancer after neoadjuvant chemotherapy with doxorubicin plus paclitaxel warrant additional investigation of paclitaxel in the neoadjuvant setting of breast cancer management.

Supported by a grant from Bristol-Myers Squibb, France.

Presented in part at the Breast Cancer Symposium, San Antonio, TX, December 12-15, 1998, and the 35th Annual Meeting of the American Society of Clinical Oncology, Atlanta, GA, May 15-18, 1999.

Authors’ disclosures of potential conflicts of interest are found at the end of this article.

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