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Journal of Clinical Oncology, Vol 23, No 12 (April 20), 2005: pp. 2676-2685
© 2005 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2005.05.078
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Doxorubicin With Cyclophosphamide Followed by Docetaxel Every 21 Days Compared With Doxorubicin and Docetaxel Every 14 Days As Preoperative Treatment in Operable Breast Cancer: The GEPARDUO Study of the German Breast Group

Gunter von Minckwitz, Günter Raab, Angelika Caputo, Martin Schütte, Jörn Hilfrich, Jens U. Blohmer, Bernd Gerber, Serban D. Costa, Elisabeth Merkle, Holger Eidtmann, Dieter Lampe, Christian Jackisch, Andreas du Bois, Manfred Kaufmann

From the German Breast Group, Neu-Isenburg/Frankfurt; Frauenklinik vom Roten Kreuz; Universitäts Frauenklinik, Munich; Institut für Medizinische Biometrie und Medizinische Informatik, Freiburg; Bethesda Krankenhaus, Essen; Henrietten Stift, Hannover; Universtitäsklinikum der Charité, Berlin; Universitäts Frauenklinik Magdeburg; Gynäkologische Praxis, Bad Reichenhall; Universitäts-Frauenklink, Kiel; Kreiskrankenhaus, Weißenfels; Universitäts-Frauenklinik, Marburg; Dr. Horst-Schmidt-Kliniken, Wiesbaden; and Universitäts-Frauenklinik, Frankfurt, Germany

Address reprint requests to Gunter von Minckwitz, MD, Universitäts-Frauenklinik Frankfurt/German Breast Group, Schleussner Str 42, 63263 Neu-Isenburg/Frankfurt, Germany; e-mail: Minckwitz{at}germanbreastgroup.de

PURPOSE: Dose-dense and sequential administration of cytotoxic drugs are current approaches to improve outcomes in patients with early-stage breast cancer.

METHODS: This phase III study investigated 913 women with untreated operable breast cancer (T2-3, N0-2, M0) randomly assigned to receive either doxorubicin 50 mg/m2 plus docetaxel 75 mg/m2 every 14 days for four cycles with filgrastim support (ADOC), or doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 every 21 days followed by docetaxel 100 mg/m2 every 21 days for four cycles each (AC-DOC). The primary end point was the incidence of pathologic complete (invasive and noninvasive) response (pCR) in the breast and axillary nodes. Secondary end points were predictors for pCR, clinical response, rate of breast conservation, and safety.

RESULTS: A pCR was achieved in 94 patients (10.6%), but the likelihood was significantly greater with AC-DOC (14.3%; n = 63) than with ADOC (7.0%; n = 31) (odds ratio, 2.22; 90% CI, 1.52 to 3.24; P < .001). Independent predictors of attaining a pCR included the use of sequential therapy, high tumor grade, and negative hormone receptor status. The response rates detected by palpation and by imaging were significantly higher with AC-DOC (85.0% and 78.6%, respectively) than with ADOC (75.2% and 68.6%, respectively; both P values < .001). The rate of breast-conserving surgery was 63.4% for AC-DOC and 58.1% for ADOC (P = .05). Predominant grade 3/4 toxicities were leucopenia (AC-DOC, 74.2%; ADOC, 53.7%) and neutropenia (AC-DOC, 66.4%; ADOC, 44.7%) but were infrequently associated with fever (AC-DOC, 4.6%; ADOC, 3.1%).

CONCLUSION: Sequential AC-DOC is more effective at inducing pCR than dose-dense ADOC as preoperative treatment for patients with operable breast cancer.

Supported in part by Aventis Pharmaceuticals, Germany; Amgen Germany; and Chugai, Germany.

Presented at the 38th Annual Meeting of the American Society of Clinical Oncology, May 18-21, 2002, Orlando, FL.

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


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