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Docetaxel plus epirubicin is a highly active, well-tolerated, first-line chemotherapy for metastatic breast cancer: results of a large, multicentre phase II study

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Abstract

Purpose

In this multicentre phase II study, the efficacy and safety profile of the combination of docetaxel and epirubicin as first-line chemotherapy for metastatic breast cancer (MBC) were evaluated.

Methods

Epirubicin (75 mg/m2) and docetaxel (75 mg/m2) were given intravenously once every 3 weeks for six cycles to 133 patients with MBC.

Results

The overall clinical response rate was 67% (complete and partial responses were 23% and 44%, respectively). The median time to progression was 10.8 months (95% CI 9.7–12.6) and the median overall survival was 19.5 months. Granulocyte colony-stimulating factor support was administered to 32% of patients and in 22% of cycles. Grade 3/4 neutropenia occurred in 35% of patients and febrile neutropenia in 19%. The most frequent grade 3/4 non-haematological toxicities (as percent of patients) were asthenia (6%), vomiting (5%) and nausea (5%). No patients developed congestive heart failure.

Conclusions

The combination of docetaxel and epirubicin was highly active as first-line treatment for MBC and showed a manageable toxicity profile.

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Acknowledgements

The authors acknowledge the help in data monitoring and statistical analysis provided by Cibest and the general coordination of Aventis Pharma, Spain.

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Authors and Affiliations

  1. Medical Oncology Service, Hospital Arnau de Vilanova, Avda. Alcalde Rovira Roure, 80, 25198, Lleida, Spain

    Serafín Morales

  2. Hospital Puerto Real, Cádiz, Spain

    Antonio Lorenzo

  3. Centro Oncológico de Galicia, A Coruña, Spain

    Manuel Ramos

  4. Hospital La Inmaculada, Almería, Spain

    Pedro Ballesteros

  5. Hospital de Móstoles, Madrid, Spain

    Miguel Méndez

  6. Clínica Povisa, Vigo, Spain

    Concepción Almanza

  7. Complejo Hospitalario Xeral Cíes, Vigo, Spain

    Javier Castellanos

  8. Hospital Virgen del Rocío, Sevilla, Spain

    José Andrés Moreno-Nogueira

  9. Hospital Do Meixoeiro, Vigo, Spain

    Joaquín Casal

  10. Hospital San Juan de Alicante, Alicante, Spain

    José Lizón

  11. Hospital Virgen de los Lirios, Alicante, Spain

    Amparo Oltra

  12. Hospital Provincial de Castellón, Castellón de la Plana, Spain

    Adolfo Frau

  13. Hospital Sagrado Corazón-La Alianza, Barcelona, Spain

    Ignacio Machengs

  14. Hospital de Sagunto, Valencia, Spain

    Antonio Galán

  15. Hospital Virgen de las Nieves, Granada, Spain

    Joaquín Belón

  16. Hospital General de Elda, Alicante, Spain

    Cristina Llorca

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  1. Serafín Morales
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  2. Antonio Lorenzo
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Correspondence to Serafín Morales.

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Morales, S., Lorenzo, A., Ramos, M. et al. Docetaxel plus epirubicin is a highly active, well-tolerated, first-line chemotherapy for metastatic breast cancer: results of a large, multicentre phase II study. Cancer Chemother Pharmacol 53, 75–81 (2004). https://doi.org/10.1007/s00280-003-0690-0

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  • DOI: https://doi.org/10.1007/s00280-003-0690-0

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