PHASE-II TRIAL OF DOCETAXEL - A NEW, HIGHLY EFFECTIVE ANTINEOPLASTIC AGENT IN THE MANAGEMENT OF PATIENTS WITH ANTHRACYCLINE-RESISTANT METASTATIC BREAST-CANCER
V. Valero et al., PHASE-II TRIAL OF DOCETAXEL - A NEW, HIGHLY EFFECTIVE ANTINEOPLASTIC AGENT IN THE MANAGEMENT OF PATIENTS WITH ANTHRACYCLINE-RESISTANT METASTATIC BREAST-CANCER, Journal of clinical oncology, 13(12), 1995, pp. 2886-2894
Purpose: To determine the efficacy (objective response rate and durati
on of response and survival) and toxicity of docetaxel in patients wit
h strictly defined anthracycline-resistont metastatic breast cancer (M
BC). Patients and Methods: Thirty-five patients with bidimensionally m
easurable MBC who had progressive disease while receiving anthracyclin
e-containing chemotherapy were registered onto the phase II trial, Doc
etaxel wets administered at a dose of 100 mg/m(2) over 1 hour every 21
days. Results: Thirty-four patients were assessable for disease respo
nse; 18 (53%; 95% confidence interval [CI], 35% to 70%) achieved a par
tial response, The median times to disease progression and survival du
ration were 7.5 and 13.5 months, respectively, for responding patients
. The median overall survival duration was 9 months, Two hundred eight
cycles (median, five) of docetaxel were administered. Neutropenia wit
h less than 500 cells/mu L developed in 31 of 35 patients; it was comp
licated by fever in 30 (14%) of 208 cycles and in 18 (51%) of 35 patie
nts, including one treatment-related death, Fluid retention was seen i
n 15 (43%) of 35 patients, including pleural effusions in 11 patients
(31%). Moderate skin toxicity, asthenia, and myalgia were observed in
16%, 58%, and 37% of cycles, respectively. Conclusion: Docetaxel has t
he highest reported anti-tumor activity in anthracycline-resistant MBC
. High objective response rates were seen in patients with visceral-do
minant involvement, multiple metastatic sites, or extensive previous t
herapy, Docetaxel is associated with severe bur reversible neutropenia
, asthenia, and cumulative dose-related fluid retention. Dexamethasone
decreased the frequency and severity of skin toxicity and appeared to
ameliorate fluid retention. (C) 1995 by American Society of Clinical
Oncology.