Key result
Combination chemotherapy with FEC was as effective as FAC for advanced breast cancer (response rate 50.4% vs 52%), but induced significantly less neutropenia, nausea, vomiting, and alopecia.
Why the study?
Does the FEC regimen reduce toxicity while maintaining efficacy compared to the FAC regimen in patients with advanced breast cancer?
RCT (n=263)
randomized
Yes
Does the FEC regimen reduce toxicity while maintaining efficacy compared to the FAC regimen in patients with advanced breast cancer?
Absolute Event Rate: 50.4% vs 52%
p-value: p=not significant
In patients with advanced breast cancer, the FEC regimen is as effective as FAC but significantly better tolerated, with lower rates of neutropenia, nausea, alopecia, and cardiotoxicity.
May support comparable efficacy between FEC and FAC; leaves open optimal anthracycline choice pending larger randomized data.
Two hundred sixty-three patients with advanced breast cancer were randomized to two treatment regimens consisting of fluorouracil, 500 mg/m2; cyclophosphamide, 500 mg/m2; and either epirubicin (Farmorubicin, Farmitalia Carlo Erba SpA, Italy), 50 mg/m2 (FEC); or doxorubicin (Adriamycin, Adria Laboratories, Columbus, OH), 50 mg/m2 (FAC), administered intravenously (IV) every 3 weeks. Two hundred thirty patients (FAC, 113; FEC, 117) were evaluable for response, and 244 patients for toxicity (FAC, 120; FEC, 124). The two groups were comparable with respect to age, menopausal status, disease-free interval to first recurrence, time from initial diagnosis to protocol activation, indicator lesions, performance status, and prior adjuvant therapy. Of 117 evaluable patients treated with FEC, 59 (50.4%) had a partial response (PR) or complete response (CR), 40 showed no change (NC), and 18 had progressive disease. Of 113 evaluable patients treated with FAC, 54 (52%) showed a remission, 30 NC, and 18 progression. There was no statistical difference between the two regimens in overall response rate, response rate according to tumor site, time to response, or duration of response. Median survival was 15 months for FEC and 18.2 months for FAC (not significant). In the 120 patients evaluable for toxicity treated with FAC, three episodes of congestive heart failure (CHF) were observed after 225, 350, and 550 mg/m2 of doxorubicin, respectively. Of the 124 evaluable patients treated with FEC, 25 received greater than 600 mg/m2 of epirubicin and no CHF was recorded. FEC induced significantly less neutropenia (P = .01), less nausea and vomiting (P less than .01), and less complete alopecia (P less than 10(-3) than did FAC. The results of this study demonstrate that FEC is as effective a regimen as FAC for the therapy of advanced breast cancer. Moreover, FEC was better tolerated than FAC in this patient population.
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A 1988 study conducted an RCT in advanced breast cancer (n=263). FEC (fluorouracil, cyclophosphamide, epirubicin) vs. FAC (fluorouracil 500 mg/m2; cyclophosphamide 500 mg/m2; doxorubicin 50 mg/m2 IV every 3 weeks) was evaluated on overall response rate (partial or complete response) (p=not significant). Combination chemotherapy with FEC was as effective as FAC for advanced breast cancer (response rate 50.4% vs 52%), but induced significantly less neutropenia, nausea, vomiting, and alopecia.
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