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Annals of Oncology Advance Access published online on October 17, 2006
Annals of Oncology, doi:10.1093/annonc/mdl355
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© 2006 European Society for Medical Oncology
Received August 28, 2006
Accepted August 29, 2006

original article

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. Piedbois 1 *, D. Serin 2, F. Priou 3, P. Laplaige 4, S. Greget 5, E. Angellier 6, E. Teissier 7, J.-F. Berdah 8, M. Fabbro 9, B. Valenza 10, P. Herait 11, V. Jehl 12, and M. Buyse 12

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

* To whom correspondence should be addressed.
P. Piedbois, E-mail: pascal.piedbois{at}hmn.aphp.fr


  Abstract

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.

Keywords: cyclophosphamide; docetaxel; dose-dense chemotherapy; epirubicin; node-positive breast cancer; randomized phase II study.
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