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January 1, 1991Cancer Investigation

Combination Chemotherapy with Cyclophosphamide, Fluorouracil, and Either Epirubicin or Mitoxantrone: a Comparative Randomized Multicenter Study in Metastatic Breast Carcinoma

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Why the study?

Does FEC compared to FNC improve response rates in patients with advanced breast cancer?

Population

60 patients with advanced breast cancer and no prior chemotherapy for advanced disease

Comparison

Fluorouracil 500 mg/m2, epirubicin 50 mg/m2, and… vs Fluorouracil 500 mg/m2, mitoxantrone 10 mg/m2…

Design

RCT, Randomized

Authors

PPP PeritiNational Academies of Sciences, Engineering, and MedicineFPF PannutiANT Foundation Italy OnlusGCG. Robustelli della CunaUniversity of Parma

Discussion

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Implication

FEC does not improve response rates over FNC in advanced breast cancer; confirms comparable efficacy between regimens in this RCT.

Key Points

  • To compare the efficacy and toxicity of two chemotherapy regimens in patients with metastatic breast carcinoma.
  • Randomized multicenter trial involving 60 patients with advanced breast cancer
  • Patients received either fluorouracil, epirubicin, cyclophosphamide (FEC) or fluorouracil, mitoxantrone, cyclophosphamide (FNC) every 3 weeks
  • Evaluated response rates, duration, and toxicity measures
  • Response rates were 48.2% for FEC (CR 10.3%, PR 37.9%) and 40.7% for FNC (CR 3.7%, PR 37%), not significantly different (NS)
  • Median time to progression was 244 days for FEC and 86 days for FNC (NS)
  • Alopecia occurred in 80.6% of FEC patients compared to 44.8% of FNC patients (p<0.05)

Structured PICO

Does FEC compared to FNC improve response rates in patients with advanced breast cancer?

P
Population
60 patients with advanced breast cancer and no prior chemotherapy for advanced disease
I
Intervention
Fluorouracil 500 mg/m2, epirubicin 50 mg/m2, and cyclophosphamide 500 mg/m2 (FEC) i.v. Day 1 every 3 weeks
C
Comparator
Fluorouracil 500 mg/m2, mitoxantrone 10 mg/m2, and cyclophosphamide 500 mg/m2 (FNC) i.v. Day 1 every 3 weeks
O
Outcome
Response rate (complete response and partial response)surrogate

FEC and FNC regimens demonstrate similar efficacy in advanced breast cancer, but FNC is associated with significantly less alopecia.

Cite This Study

Periti et al. (1991) studied this question.

synapsesocial.com/papers/6a1bcd3c6f692abb725ee579https://doi.org/10.3109/07357909109021321
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Also Consider

Synapse has enriched 3 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1A prospective randomized phase III trial comparing combination chemotherapy with cyclophosphamide, fluorouracil, and either doxorubicin or epirubicin. French Epirubicin Study Group.1988 · 181 citations
  2. 2A randomized multicenter trial comparing mitoxantrone, cyclophosphamide, and fluorouracil with doxorubicin, cyclophosphamide, and fluorouracil in the therapy of metastatic breast carcinoma.1988 · 110 citations
  3. 3A comparison of mitoxantrone and doxorubicin in breast cancer.1986 · 119 citations