Randomized, controlled, multicenter phase III trial of standard-dose fluorouracil-epirubicin-cyclophosphamide (FEC), compared with time-intensive FEC (FEC-G) and mitoxantrone-methotrexate-mitomycin C (MMM-G) in metastatic breast carcinoma

A. M. Capotorto, L. Pavesi, P. Pedrazzoli, G. A. Da Prada, C. Zamagni, B. Massidda, A. Farris, A. Martoni, G. Lelli, G. Robustelli Della Cuna

Research output: Contribution to journalArticle

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Abstract

The purpose of this multicenter phase III trial was to assess the impact of a time-intensification of FEC (fluorouracil, epirubicin, cyclophosphamide) and MMM (mitoxantrone, methotrexate, mitomycin C) regimens, supported by lenograstim (G-CSF) on the objective response rate, time to progression and survival of patients with chemotherapy-naive metastatic breast cancer (mbc). Women with mbc were randomized to receive as first-line chemotherapy either standard-dose FEC (all doses in mg/m2): arm A (500, 75, 500 every 21 days), or time-intensified FEC-G: arm B (500, 75, 500 every 14 days), or time-intensified MMM-G: arm C (mitoxantrone 10, methotrexate 35 every 14 days and mitomycin C 10 every 28 days), both with support of lenograstim (G-CSF 150 μg/m2/day sc for 10 days). All study treatments were administered for six cycles. Eligible female patients were in the 31-70 year range with histologically proven mbc, and measurable or evaluable disease. An intent-to-treat analysis was performed. The overall response rate (CR + PR, intent-to-treat analysis) was significantly improved in the time-intensified FEC-G regimen (69%) in comparison with standard-dose FEC (41%), p=0.002. Time-intensified MMM-G (51%) did not lead to a significant improvement in the response rate. The percentage of complete responses was significantly higher in the FEC-G arm as compared to standard-dose FEC (17% vs. 4.7%; p=0.002). The median duration was longer in the intensified-dose arms without, however, achieving a statistically significant improvement. The median time to progression (TTP), and the median survival time did not differ between the three treatment arms. Grade 3-4 leukopenia was significantly higher (p

Original languageEnglish
Pages (from-to)184-191
Number of pages8
JournalJournal of Chemotherapy
Volume15
Issue number2
Publication statusPublished - Apr 2003

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Mitoxantrone
Epirubicin
Mitomycin
Methotrexate
Fluorouracil
Cyclophosphamide
Breast Neoplasms
Granulocyte Colony-Stimulating Factor
Drug Therapy
Survival
mitomycin G
Leukopenia
Therapeutics

Keywords

  • Breast cancer
  • Dose-intensity
  • FEC regimen
  • Metastatic breast cancer
  • MMM regimen
  • Time-intensification

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Microbiology (medical)

Cite this

Randomized, controlled, multicenter phase III trial of standard-dose fluorouracil-epirubicin-cyclophosphamide (FEC), compared with time-intensive FEC (FEC-G) and mitoxantrone-methotrexate-mitomycin C (MMM-G) in metastatic breast carcinoma. / Capotorto, A. M.; Pavesi, L.; Pedrazzoli, P.; Da Prada, G. A.; Zamagni, C.; Massidda, B.; Farris, A.; Martoni, A.; Lelli, G.; Robustelli Della Cuna, G.

In: Journal of Chemotherapy, Vol. 15, No. 2, 04.2003, p. 184-191.

Research output: Contribution to journalArticle

Capotorto, A. M. ; Pavesi, L. ; Pedrazzoli, P. ; Da Prada, G. A. ; Zamagni, C. ; Massidda, B. ; Farris, A. ; Martoni, A. ; Lelli, G. ; Robustelli Della Cuna, G. / Randomized, controlled, multicenter phase III trial of standard-dose fluorouracil-epirubicin-cyclophosphamide (FEC), compared with time-intensive FEC (FEC-G) and mitoxantrone-methotrexate-mitomycin C (MMM-G) in metastatic breast carcinoma. In: Journal of Chemotherapy. 2003 ; Vol. 15, No. 2. pp. 184-191.
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abstract = "The purpose of this multicenter phase III trial was to assess the impact of a time-intensification of FEC (fluorouracil, epirubicin, cyclophosphamide) and MMM (mitoxantrone, methotrexate, mitomycin C) regimens, supported by lenograstim (G-CSF) on the objective response rate, time to progression and survival of patients with chemotherapy-naive metastatic breast cancer (mbc). Women with mbc were randomized to receive as first-line chemotherapy either standard-dose FEC (all doses in mg/m2): arm A (500, 75, 500 every 21 days), or time-intensified FEC-G: arm B (500, 75, 500 every 14 days), or time-intensified MMM-G: arm C (mitoxantrone 10, methotrexate 35 every 14 days and mitomycin C 10 every 28 days), both with support of lenograstim (G-CSF 150 μg/m2/day sc for 10 days). All study treatments were administered for six cycles. Eligible female patients were in the 31-70 year range with histologically proven mbc, and measurable or evaluable disease. An intent-to-treat analysis was performed. The overall response rate (CR + PR, intent-to-treat analysis) was significantly improved in the time-intensified FEC-G regimen (69{\%}) in comparison with standard-dose FEC (41{\%}), p=0.002. Time-intensified MMM-G (51{\%}) did not lead to a significant improvement in the response rate. The percentage of complete responses was significantly higher in the FEC-G arm as compared to standard-dose FEC (17{\%} vs. 4.7{\%}; p=0.002). The median duration was longer in the intensified-dose arms without, however, achieving a statistically significant improvement. The median time to progression (TTP), and the median survival time did not differ between the three treatment arms. Grade 3-4 leukopenia was significantly higher (p",
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