Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer.

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.

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.

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.

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.

• Authors: S E Jones, J Erban, B Overmoyer, G T Budd, L Hutchins, E Lower, L Laufman, S Sundaram, W J Urba, K I Pritchard, R Mennel, D Richards, S Olsen, M L Meyers, P M Ravdin
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 23 Issue 24 Pg. 5542-51 (Aug 20 2005) ISSN: 0732-183X [Print] United States
• PMID: 16110015 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents, Phytogenic
• Taxoids
• Docetaxel
• Paclitaxel

Topics

• Adenocarcinoma (drug therapy, pathology)
• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents, Phytogenic (therapeutic use)
• Breast Neoplasms (drug therapy, pathology)
• Chi-Square Distribution
• Disease Progression
• Docetaxel
• Female
• Humans
• Infusions, Intravenous
• Logistic Models
• Middle Aged
• Paclitaxel (therapeutic use)
• Proportional Hazards Models
• Quality of Life
• Taxoids (therapeutic use)
• Treatment Outcome