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- Title
Phase III Randomized Trial of Docetaxel—Carboplatin Versus Paclitaxel—Carboplatin as First-line Chemotherapy for Ovarian Carcinoma.
- Authors
Vasey, Paul A.; Jayson, Gordon C.; Gordon, Alan; Gabra, Hani; Coleman, Rob; Atkinson, Ronnie; Parkin, David; Paul, James; Hay, Andrea; Kaye, Stan B.
- Abstract
Background: Chemotherapy with a platinum agent and a taxane (paclitaxel) is considered the standard of care for treatment of ovarian carcinoma. We compared the combination of docetaxel-carboplatin with the combination of paclitaxel-carboplatin as first-line chemotherapy for stage Ic-IV epithelial ovarian or primary peritoneal cancer. Methods: We randomly assigned 1077 patients to receive docetaxel at 75 mg/m² of body surface area (1-hour intravenous infusion) or paclitaxel at 175 mg/m² (3-hour intravenous infusion). Both treatments then were followed by carboplatin to an area under the plasma concentration-time curve of 5. The treatments were repeated every 3 weeks for six cycles; in responding patients, an additional three cycles of single-agent carboplatin was perrnitted. Survival curves were calculated by the Kaplan-Meier method, and hazard ratios were estimated with the Cox proportional hazards model. All statistical tests were two-sided. Results: After a median follow-up of 23 months, both groups had similar progression-free survival (medians of 15.0 months for docetaxel- carboplatin and 14.8 months for paclitaxel-carboplatin; hazard ratio [HR] docetaxel-paclitaxel = 0.97, 95% confidence interval [CI] = 0.83 to 1.13; P = .707), overall survival rates at 2 years (64.2% and 68.9%, respectively; HR = 1.13, 95% CI = 0.92 to 1.39; P = .238), and objective tumor (58.7% and 59.5%, respectively; difference between docetaxel and paclitaxel = -0.8%, 95% CI = -8.6% to 7.1%; P = .868) and CA-125 (75.8% and 76.8%, respectively; difference docetaxel-paclitaxel = -1.0%, 95% CI = -7.2% to 5.1%; P = .794) response rates. However, docetaxel- carboplatin was associated with substantially less overall and grade 2 or higher neurotoxicity than paclitaxel- carboplatin (grade ≥2 neurosensory toxicity in 11% versus 30%, difference = 19%, 95% CI = 15% to 24%; P < .001; grade ≥2 neuromotor toxicity in 3% versus 7%, difference = 4%, 95% CI = 1% to 7%; P < .001). Treatment with docetaxel-carboplatin was associated with statistically significantly more grade 3-4 neutropenia (94% versus 84%, difference = 11%, 95% CI = 7% to 14%; P < .001) and neutropenic complications than treatment with paclitaxel-carboplatin, although myelosuppression did not influence dose delivery or patient safety. Global quality of life was similar in both arms, but substantive differences in many symptom scores favored docetaxel. Conclusions: Docetaxel-carboplatin appears to be similar to paclitaxel-carboplatin in terms of progression-free survival and response, although longer follow-up is required for a definitive statement on survival. Thus, docetaxel- carboplatin represents an alternative first-line chemotherapy regimen for patients with newly diagnosed ovarian cancer.
- Subjects
OVARIAN cancer; CANCER chemotherapy; ANTINEOPLASTIC agents; DOCETAXEL; PACLITAXEL; CANCER treatment
- Publication
JNCI: Journal of the National Cancer Institute, 2004, Vol 96, Issue 22, p1682
- ISSN
0027-8874
- Publication type
Article