Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer.
OBJECTIVE
This randomized, controlled, multicenter, open-label, phase III study compared docetaxel versus paclitaxel in patients with advanced breast cancer that had progressed after an anthracycline-containing chemotherapy regimen.


METHODS
Patients (n = 449) were randomly assigned to receive either docetaxel 100 mg/m2 (n = 225) or paclitaxel 175 mg/m2 (n = 224) on day 1, every 21 days until tumor progression, unacceptable toxicity, or withdrawal of consent.


RESULTS
In the intent-to-treat population, both the median overall survival (OS, 15.4 v 12.7 months; hazard ratio [HR], 1.41; 95% CI, 1.15 to 1.73; P = .03) and the median time to progression (TTP, 5.7 months v 3.6 months; HR, 1.64; 95% CI, 1.33 to 2.02; P < .0001) for docetaxel were significantly longer than for paclitaxel, and the overall response rate (ORR, 32% v 25%; P = .10) was higher for docetaxel. These results were confirmed by multivariate analyses. The incidence of treatment-related hematologic and nonhematologic toxicities was greater for docetaxel than for paclitaxel; however, quality-of-life scores were not statistically different between treatment groups over time.


CONCLUSIONS
Docetaxel was superior to paclitaxel in terms of OS and TTP. ORR was higher for docetaxel. Hematologic and nonhematologic toxicities occurred more frequently in the docetaxel group. The global quality-of-life scores were similar for both agents over time.
Jones
S E
SE
Texas Oncology, 3535 Worth St, Suite 600, Dallas, TX 75246, USA. steve.jones@usoncology.com
Erban
J
J
Overmoyer
B
B
Budd
G T
GT
Hutchins
L
L
Lower
E
E
Laufman
L
L
Sundaram
S
S
Urba
W J
WJ
Pritchard
K I
KI
Mennel
R
R
Richards
D
D
Olsen
S
S
Meyers
M L
ML
Ravdin
P M
PM
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016009:Chi-Square Distribution; D018450:Disease Progression; D000077143:Docetaxel; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D016015:Logistic Models; D008875:Middle Aged; D017239:Paclitaxel / Q000627:therapeutic use*; D016016:Proportional Hazards Models; D011788:Quality of Life; D043823:Taxoids / Q000627:therapeutic use*; D016896:Treatment Outcome
D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel; D017239:Paclitaxel