A. Riccardi et al., A phase II study of sequential 5-fluorouracil, epirubicin and cyclophosphamide (FEC) and paclitaxel in advanced breast cancer (Protocol PVBC 97/01), BR J CANC, 85(2), 2001, pp. 141-146
Sequential administration of the association of 5-fluorouracil, epirubicin
and cyclophosphamide (FEC) and paclitaxel could be better tolerated than th
e association of an anthracycline and paclitaxel while having a similar ant
itumour effect. 69 patients with advanced breast cancer previously untreate
d with anthracyclines or paclitaxel entered a phase II multicentre study in
which FEC was followed by paclitaxel. Both regimens were administered 4 ti
mes every 21 days. The median follow-up is 20 months and 38/69 patients hav
e died. Grade III-IV toxicity was acceptable. Leukopenia occurred in 26% of
patients, thrombocytopenia in 2% and anaemia in 4%. One patient had revers
ible heart failure during FEC therapy. Peripheral neuropathy and arthralgia
-myalgia occurred in 9% and 4% of patients, respectively and one patient ha
d respiratory hypersensitivity during paclitaxel treatment. 9 patients did
not complete therapy because of: treatment refusal (n = 1), cardiac toxicit
y (n = 1), early death during FEC chemotherapy (n = 1), major protocol viol
ations (n = 4), hypersensitivity reaction (n = 1) and early death during pa
clitaxel chemotherapy (n = 1). The overall response rate was 65% (95% Cl =
53-76), and 7% of patients had stable disease. Therapy was defined as havin
g failed in 28% of patients because they were not evaluable (13%) or had pr
ogressive disease (15%). The median time to progression and survival are 13
.2 and 23.5 months, respectively. Sequential FEC-paclitaxel is a suitable s
trategy for patients with metastatic breast cancer who have not been previo
usly treated with anthracyclines and/or taxanes. In fact, it avoids major h
aematologic toxicity and has a good antitumour effect. (C) 2001 Cancer Rese
arch Campaign http://www.bjcancer,com.