Multicenter phase II trial of first-line docetaxel/gemcitabine in advanced breast cancer pretreated with adjuvant anthracyclines.
The aim of this study was to evaluate activity and tolerability of docetaxel-gemcitabine combination as first-line treatment in patients with metastatic breast cancer previously treated with adjuvant anthracyclines.


METHODS
Sixty-eight women received gemcitabine 1,000 mg/m(2) as 30-minute infusion on days 1 and 8, and docetaxel 80 mg/m(2) as 1-hour infusion on day 8, with cycles repeated every 3 weeks.


RESULTS
Objective responses were observed in 32 out of 68 evaluable patients (45%; 95% confidence interval, 35.2-58.8%). Responses were 44%, 42%, 49% in soft tissue, bone and visceral lesions, respectively, 50% /52% in HER2-positive/-negative tumors, and 50% in both ER- positive/-negative tumors. Median time to progression and overall survival were 6 and 16 months, respectively. Treatment was usually well tolerated, with grade 3-4 neutropenia in 32% - 7% of the patients, and neutropenic fever, grade 3 vomiting, mucositis and peripheral neurotoxicity in 3% of the patients.


CONCLUSIONS
Gemcitabine-docetaxel combination is effective and well tolerated as first-line treatment in advanced breast cancer previously treated with adjuvant anthracyclines.
Vici
Patrizia
P
Division of Medical Oncology B, Regina Elena Institute for Cancer Research, Via E. Chianesi, 53, 00144 Rome, Italy. pvici@ifo.it
Giotta
Francesco
F
DI Lauro
Luigi
L
Brandi
Mario
M
Gebbia
Vittorio
V
Foggi
Paolo
P
Lorusso
Vito
V
Vitucci
Carlo
C
Sergi
Domenico
D
Fattoruso
Silvia Ileana
SI
Giannarelli
Diana
D
Viola
Giuditta
G
Corsetti
Serena
S
Colucci
Giuseppe
G
Lopez
Massimo
M
D018943:Anthracyclines / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D005260:Female; D006801:Humans; D043823:Taxoids / Q000008:administration & dosage; D000093542:Gemcitabine
D018943:Anthracyclines; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000093542:Gemcitabine