Combined anti-microtubule therapy: a phase II study of weekly docetaxel plus estramustine in patients with metastatic breast cancer.
BACKGROUND
Docetaxel and estramustine exert anti-tumor effects by inhibiting microtubule function. In vitro data suggest synergism with this combination. This phase II study evaluated the response rate and toxicity of docetaxel and estramustine in patients with metastatic breast cancer (MBC).


METHODS
Patients were treated with docetaxel 35 mg/m(2) on day 2 and estramustine phosphate 280 mg p.o. tds days 1-3 weekly for 3 of 4 weeks, for a maximum of six treatment cycles.


RESULTS
Thirty-nine patients were enrolled between August 1999 and March 2001; 36 were eligible. Of 31 evaluable patients, responses were observed in 15 patients (47%); two patients (6%) obtained a complete response. Median time to treatment failure was 6 months; median survival was 1 year. Thromboembolic toxicity occurred in 11% of patients: three experienced deep venous thromboses and one had a fatal pulmonary embolism. Myelosuppression was minimal with this regimen.


CONCLUSIONS
Despite modest activity in metastatic breast cancer, the toxicity observed with the combination of estramustine and docetaxel precludes the routine use of this combination in the treatment of breast cancer. Further studies using this compound in metastatic breast cancer are not warranted.
Soule
S E
SE
Hoosier Oncology Group, Walther Cancer Institute and Division of Hematology/Oncology, Indiana University, Indianapolis, IN, USA. shsoule@iupui.edu
Miller
K D
KD
Porcu
P
P
Ansari
R
R
Fata
F
F
McClean
J W
JW
Zon
R
R
Sledge
G W
GW
Einhorn
L H
LH
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000077143:Docetaxel; D004334:Drug Administration Schedule; D004961:Estramustine / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008870:Microtubules / Q000502:physiology; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013534:Survival; D043823:Taxoids; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000139:chemically induced
D043823:Taxoids; D000077143:Docetaxel; D004961:Estramustine; D017239:Paclitaxel