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Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2005 Aug 20; Vol. 23 (24), pp. 5542-51. - Publication Year :
- 2005
-
Abstract
- Purpose: 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.<br />Patients and 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.<br />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.<br />Conclusion: 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.
- Subjects :
- Adenocarcinoma pathology
Adult
Aged
Aged, 80 and over
Breast Neoplasms pathology
Chi-Square Distribution
Disease Progression
Docetaxel
Female
Humans
Infusions, Intravenous
Logistic Models
Middle Aged
Proportional Hazards Models
Quality of Life
Treatment Outcome
Adenocarcinoma drug therapy
Antineoplastic Agents, Phytogenic therapeutic use
Breast Neoplasms drug therapy
Paclitaxel therapeutic use
Taxoids therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 0732-183X
- Volume :
- 23
- Issue :
- 24
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 16110015
- Full Text :
- https://doi.org/10.1200/JCO.2005.02.027