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Annals of Oncology Advance Access originally published online on October 17, 2006
Annals of Oncology 2007 18(1):52-57; doi:10.1093/annonc/mdl355
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© 2006 European Society for Medical Oncology

breast cancer

Dose-dense adjuvant chemotherapy in node-positive breast cancer: docetaxel followed by epirubicin/cyclophosphamide (T/EC), or the reverse sequence (EC/T), every 2 weeks, versus docetaxel, epirubicin and cyclophosphamide (TEC) every 3 weeks. AERO B03 randomized phase II study

P Piedbois1,*, D Serin2, F Priou3, P Laplaige4, S Greget5, E Angellier6, E Teissier7, J-F Berdah8, M Fabbro9, B Valenza10, P Herait11, V Jehl12 and M Buyse12

1 Hôpital Henri-Mondor, Créteil
2 Institut Sainte-Catherine, Avignon
3 Hôpital départemental, La Roche-sur-Yon
4 Clinique Saint-Come et Saint-Damien, Blois
5 Clinique Sainte-Clotilde, Saint-Louis de la Réunion
6 Hôpital Fontenoy, Chartres
7 Clinique Plein Ciel, Mougins
8 Clinique de l'Espérance, Hyères
9 CRLCC Val d'Aurelle, Montpellier
10 Centre Hospitalier, Draguignan, France, for the European Association for Research in Oncology
11 Soisy-sous-Montmorency
12 International Drug Development Institute, Brussels, Belgium

* Correspondence to: Dr P. Piedbois, Department of Medical Oncology, Hôpital Henri-Mondor, Assistance Publique Hôpitaux de Paris, 94000 Créteil, France. Tel: +33 1 49 81 25 82; Fax: +33 149 81 25 79; E-mail: pascal.piedbois{at}hmn.aphp.fr

Background: Adding a taxane to anthracycline-based adjuvant chemotherapy prolongs survival in node-positive patients but optimal dose and schedule remain undetermined. This study aimed to select a dose-dense regimen for further assessment in phase III studies.

Patients and methods: Ninety-nine patients with node-positive invasive breast adenocarcinoma were randomly assigned to docetaxel (Taxotere) (T) 75 mg/m2, epirubicin (E) 75 mg/m2 and cyclophosphamide (C) 500 mg/m2 (TEC) x 6, every 3 weeks; E 100 mg/m2, C 600 mg/m2 x 4, then T 100 mg/m2 x 4 (EC->T) or the reverse sequence (T->EC), every 2 weeks, with pegfilgrastim support. The primary end point was the incidence of grade 4 toxicity.

Results: Dose intensity was almost doubled with dose-dense regimens, compared with TEC. Twenty-seven patients experienced grade 4 toxicity: 26%, 40% and 18% with TEC, EC->T and T->EC, respectively, mainly neutropenia, but febrile neutropenia occurred only in 11%, 10% and 3%. Grade 3–4 nail disorders, hand–foot syndrome and peripheral neuropathy occurred in 46%, 73% and 68% of patients with TEC, EC->T and T->EC, respectively.

Conclusions: Dose-dense regimens yield more frequent and severe nonhematological toxic effects than standard dose TEC regimen. Though grade 4 toxicity rates appear acceptable with the T->EC regimen, the incidence of grade 3–4 events makes it difficult to recommend either dose-dense regimen for further investigation.

Key words: cyclophosphamide, docetaxel, dose-dense chemotherapy, epirubicin, node-positive breast cancer, randomized phase II study


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