Epirubicin plus docetaxel in metastatic breast cancer: Escalating dose does not improve efficacy. A phase II study

Alessandra Fabi, Paola Papaldo, Maria Simona Pino, Gianluigi Ferretti, Paolo Carlini, Umberto Pacetti, Serena Di Cosimo, Chiara Nardoni, Diana Giannarelli, Italo Sacchi, Francesco Cognetti

Research output: Contribution to journalArticle

Abstract

Background: The combination of anthracyclines and docetaxel have demonstrated a significant activity in metastatic breast cancer (MBC) as first-line chemotherapy. In a previous multicenter phase I study, we recommended two schedules of epirubicin-docetaxel combination for MBC: 1) epirubicin 75 mg/m2, docetaxel 80 mg/m2 every 3 weeks without G-CSF; 2) epirubicin 90 mg/m2 plus docetaxel 90 mg/m2 every 3 weeks, with G-CSF support. Patients and Methods: Twenty-five advanced breast cancer patients were treated with epirubicin 90 mg/m2 plus docetaxel 90 mg/m2 every 3 weeks, with prophylactic G-CSF. Results: The main toxicity was grade 3-4 neutropenia (41% of cycles) despite the use of G-CSF; febrile neutropenia was observed in 14% of cycles necessitating a dose reduction of both drugs in 30% of patients. Response was observed in 79% of patients: 21% complete responses and 58% partial responses. The median response duration was 10 months (range: 3-16). The median time to progression was 11 months. The overall 3-year survival was 49.7%. Conclusion: The antitumor activity observed in this series was comparable with that seen in other studies of taxane/anthracycline combinations. The degree of myelosuppression was severe, even though G-CSF was administered as a prophylactic. We recommend a lower dose of both drugs as reported by other authors.

Original languageEnglish
Pages (from-to)1963-1967
Number of pages5
JournalAnticancer Research
Volume24
Issue number3 B
Publication statusPublished - May 2004

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docetaxel
Epirubicin
Granulocyte Colony-Stimulating Factor
Breast Neoplasms
Anthracyclines
Febrile Neutropenia
Granulocyte-Macrophage Colony-Stimulating Factor
Neutropenia
Pharmaceutical Preparations
Appointments and Schedules
Drug Therapy
Survival

Keywords

  • Docetaxel
  • Epirubicin
  • Epirubicin dose
  • Metastatic breast cancer

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Epirubicin plus docetaxel in metastatic breast cancer : Escalating dose does not improve efficacy. A phase II study. / Fabi, Alessandra; Papaldo, Paola; Pino, Maria Simona; Ferretti, Gianluigi; Carlini, Paolo; Pacetti, Umberto; Di Cosimo, Serena; Nardoni, Chiara; Giannarelli, Diana; Sacchi, Italo; Cognetti, Francesco.

In: Anticancer Research, Vol. 24, No. 3 B, 05.2004, p. 1963-1967.

Research output: Contribution to journalArticle

Fabi, A, Papaldo, P, Pino, MS, Ferretti, G, Carlini, P, Pacetti, U, Di Cosimo, S, Nardoni, C, Giannarelli, D, Sacchi, I & Cognetti, F 2004, 'Epirubicin plus docetaxel in metastatic breast cancer: Escalating dose does not improve efficacy. A phase II study', Anticancer Research, vol. 24, no. 3 B, pp. 1963-1967.
Fabi, Alessandra ; Papaldo, Paola ; Pino, Maria Simona ; Ferretti, Gianluigi ; Carlini, Paolo ; Pacetti, Umberto ; Di Cosimo, Serena ; Nardoni, Chiara ; Giannarelli, Diana ; Sacchi, Italo ; Cognetti, Francesco. / Epirubicin plus docetaxel in metastatic breast cancer : Escalating dose does not improve efficacy. A phase II study. In: Anticancer Research. 2004 ; Vol. 24, No. 3 B. pp. 1963-1967.
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T2 - Escalating dose does not improve efficacy. A phase II study

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AU - Pino, Maria Simona

AU - Ferretti, Gianluigi

AU - Carlini, Paolo

AU - Pacetti, Umberto

AU - Di Cosimo, Serena

AU - Nardoni, Chiara

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AU - Sacchi, Italo

AU - Cognetti, Francesco

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AB - Background: The combination of anthracyclines and docetaxel have demonstrated a significant activity in metastatic breast cancer (MBC) as first-line chemotherapy. In a previous multicenter phase I study, we recommended two schedules of epirubicin-docetaxel combination for MBC: 1) epirubicin 75 mg/m2, docetaxel 80 mg/m2 every 3 weeks without G-CSF; 2) epirubicin 90 mg/m2 plus docetaxel 90 mg/m2 every 3 weeks, with G-CSF support. Patients and Methods: Twenty-five advanced breast cancer patients were treated with epirubicin 90 mg/m2 plus docetaxel 90 mg/m2 every 3 weeks, with prophylactic G-CSF. Results: The main toxicity was grade 3-4 neutropenia (41% of cycles) despite the use of G-CSF; febrile neutropenia was observed in 14% of cycles necessitating a dose reduction of both drugs in 30% of patients. Response was observed in 79% of patients: 21% complete responses and 58% partial responses. The median response duration was 10 months (range: 3-16). The median time to progression was 11 months. The overall 3-year survival was 49.7%. Conclusion: The antitumor activity observed in this series was comparable with that seen in other studies of taxane/anthracycline combinations. The degree of myelosuppression was severe, even though G-CSF was administered as a prophylactic. We recommend a lower dose of both drugs as reported by other authors.

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