Phase II study of epirubicin and vinorelbine with granulocyte colony- stimulating factor: A high-activity, dose-dense weekly regimen for advanced breast cancer

C. Nisticò, C. Garufi, S. Barni, L. Frontini, D. A P Gallà, D. Giannarelli, A. Vaccaro, A. M. D'Ottavio, E. Terzoli

Research output: Contribution to journalArticle

Abstract

Background: This study was designed to explore the effectiveness and tolerability of a weekly regimen of epirubicin and vinorelbine plus granulocyte colony-stimulating factor (G-CSF). Patients and methods: Fifty- two patients with previously untreated advanced breast cancer were treated with epirubicin (25 mg/m2/week) and vinorelbine (25 mg/m2/week) with G-CSF support, for 24 consecutive weeks. Results: The median number of courses per patient was 22 (range 10-24). The administered dose intensity was 23 mg/m2 for both epirubicin and vinorelbine. Ten complete responses (19%) and 30 partial responses (58%) were obtained, for an overall response rate of 77%. None of the patients progressed during treatment. The median response duration and time to progression were both 10 months. A total of 1065 courses were assessed for toxicity. Grade 3 neutropenia was the most common toxic manifestation, (39% of patients), without febrile neutropenia or neutropenic sepsis. Two patients had grade 3 cardiac toxicity, which regressed without sequelae. Median survival was 31 months, with a median follow-up of 24 months (range 9-40). Conclusions: Owing to its effectiveness and tolerability, the weekly regimen of epirubicin and vinorelbine plus G-CSF may represent an acceptable alternative for patients with untreated metastatic breast cancer. It could be tested in the adjuvant and neoadjuvant setting.

Original languageEnglish
Pages (from-to)937-942
Number of pages6
JournalAnnals of Oncology
Volume10
Issue number8
DOIs
Publication statusPublished - 1999

Fingerprint

Epirubicin
Granulocyte Colony-Stimulating Factor
Breast Neoplasms
Febrile Neutropenia
Poisons
vinorelbine
Neutropenia
Sepsis
Survival

Keywords

  • Breast cancer
  • Dose-intensity
  • Epirubicin
  • G-CSF
  • Vinorelbine
  • Weekly schedule

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Phase II study of epirubicin and vinorelbine with granulocyte colony- stimulating factor : A high-activity, dose-dense weekly regimen for advanced breast cancer. / Nisticò, C.; Garufi, C.; Barni, S.; Frontini, L.; Gallà, D. A P; Giannarelli, D.; Vaccaro, A.; D'Ottavio, A. M.; Terzoli, E.

In: Annals of Oncology, Vol. 10, No. 8, 1999, p. 937-942.

Research output: Contribution to journalArticle

Nisticò, C. ; Garufi, C. ; Barni, S. ; Frontini, L. ; Gallà, D. A P ; Giannarelli, D. ; Vaccaro, A. ; D'Ottavio, A. M. ; Terzoli, E. / Phase II study of epirubicin and vinorelbine with granulocyte colony- stimulating factor : A high-activity, dose-dense weekly regimen for advanced breast cancer. In: Annals of Oncology. 1999 ; Vol. 10, No. 8. pp. 937-942.
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AU - Barni, S.

AU - Frontini, L.

AU - Gallà, D. A P

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