Dw. Van Toorn et al., Randomized phase II study of FEC day 1+8 and FEC day 1 in patients with advanced breast cancer, BREAST CANC, 60(1), 2000, pp. 57-62
Background: Dose-intensive chemotherapy regimens without stem cell support
have not resulted in an improved survival compared to standard dose regimen
s in patients with metastatic breast cancer. Combinations of an anthracycli
ne, cyclophosphamide and 5 fluorouracil are still standard in such patients
. The aim of this study was to investigate the two different schedules of e
pirubicin in a standard dose FEC regimen with respect to response and toxic
ity.
Materials and methods: Patients were randomly assigned to receive a day 1 8 schedule (5FU and CTX 500 mg/m(2) day 1, epirubicin 40 mg/m(2) day 1 and
8) or a day 1 schedule (5FU, CTX 500 mg/m(2) and epirubicin 80 mg/m(2) day
1), q day 21, both given without hematopoietic growth factors. A total of
104 eligible patients were analyzed, 52 in each arm.
Results and conclusions: A significantly higher relative dose-intensity was
found for the day 1 schedule compared to the day 1 + 8 schedule. Although
the trial was not set up to reliably detect a difference in response rate,
this difference in relative dose-intensity in favour of the day 1 schedule
does not suggest any improvement in response rate or duration of response f
or the day 1 schedule. Myelosuppression was severe in the day 1 + 8 schedul
e. We conclude that a day 1 + 8 FEC schedule has no advantage over a day 1
FEC schedule without hematopoietic growth factors in patients with metastat
ic breast cancer.