Sequential docetaxel followed by epirubicin-vinorelbine as first-line chemotherapy in advanced breast cancer.
BACKGROUND
This phase II study evaluated the efficacy and the tolerability of a sequential regimen of docetaxel followed by epirubicin-vinorelbine combination as first-line chemotherapy in advanced breast cancer.


METHODS
Twenty-seven patients received docetaxel 100 mg/m2 (4 cycles) followed by 4 cycles of epirubicin 90 mg/m2 (day 1) combined with vinorelbine 25 mg/m2 (days 1 and 5), with cycles repeated every 3 weeks. G-CSF was administered during epirubicin-vinorelbine treatment.


RESULTS
There were 1 (3.7%) CR and 14 (51.9%) PR, for an overall response rate of 55.6% (95% CI, 36.9%-74.3%). Median time to response, time to progression and overall survival were 2, 9 and 25 months, respectively. The dose-limiting toxicity was neutropenia (grade 3 to 4 in 85% of the patients). There was one toxic death due to neutropenic fever. Gastrointestinal side-effects were generally mild According to the Simon two-stage design the response rate was considered unsatisfactory and patient accrual was terminated.


CONCLUSIONS
This sequential regimen appears to be moderately effective; possibly, a modulation of the treatment based on objective responses instead of a fixed number of cycles may be more appropriate in order to obtain better results.
Vici
Patrizia
P
Regina Elena Institute for Cancer Research, Via Elio Chianesi 53, 00144 Rome, Italy.
Foggi
Paolo
P
Colucci
Giuseppe
G
Capomolla
Elisabetta
E
Brandi
Mario
M
Giotta
Francesco
F
Gebbia
Nicola
N
Di Lauro
Luigi
L
Valerio
Maria Rosaria
MR
Paoletti
Giancarlo
G
Belli
Franca
F
Pizza
Carmine
C
Giannarelli
Diana
D
Lopez
Massimo
M
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009503:Neutropenia / Q000139:chemically induced; D043823:Taxoids / Q000008:administration & dosage*; D014747:Vinblastine / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D000077235:Vinorelbine
D043823:Taxoids; D000077143:Docetaxel; D015251:Epirubicin; D014747:Vinblastine; D000077235:Vinorelbine