Phase III randomized trial of docetaxel-carboplatin versus paclitaxel-carboplatin as first-line chemotherapy for ovarian carcinoma.
dc.contributor.author | Vasey, Paul | |
dc.contributor.author | Jayson, Gordon C | |
dc.contributor.author | Gordon, Alan | |
dc.contributor.author | Gabra, Hani | |
dc.contributor.author | Coleman, Robert E | |
dc.contributor.author | Atkinson, Ronnie | |
dc.contributor.author | Parkin, David | |
dc.contributor.author | Paul, James | |
dc.contributor.author | Hay, Andrea | |
dc.contributor.author | Kaye, Stan B | |
dc.date.accessioned | 2009-08-20T10:16:30Z | en |
dc.date.available | 2009-08-20T10:16:30Z | en |
dc.date.issued | 2004-11-17 | en |
dc.identifier.citation | Phase III randomized trial of docetaxel-carboplatin versus paclitaxel-carboplatin as first-line chemotherapy for ovarian carcinoma. 2004, 96 (22):1682-91 J. Natl. Cancer Inst. | en |
dc.identifier.issn | 1460-2105 | en |
dc.identifier.pmid | 15547181 | en |
dc.identifier.doi | 10.1093/jnci/djh323 | en |
dc.identifier.uri | http://hdl.handle.net/10541/77979 | en |
dc.description.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 permitted. 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 > or =2 neurosensory toxicity in 11% versus 30%, difference = 19%, 95% CI = 15% to 24%; P<.001; grade > or =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. | |
dc.language.iso | en | en |
dc.subject | Ovarian Cancer | en |
dc.subject | Peritoneal Cancer | en |
dc.subject.mesh | Adult | en |
dc.subject.mesh | Aged | en |
dc.subject.mesh | Antineoplastic Combined Chemotherapy Protocols | en |
dc.subject.mesh | Carboplatin | en |
dc.subject.mesh | Carcinoma | en |
dc.subject.mesh | Confidence Intervals | en |
dc.subject.mesh | Disease-Free Survival | en |
dc.subject.mesh | Drug Administration Schedule | en |
dc.subject.mesh | Female | en |
dc.subject.mesh | Humans | en |
dc.subject.mesh | Middle Aged | en |
dc.subject.mesh | Neutropenia | en |
dc.subject.mesh | Odds Ratio | en |
dc.subject.mesh | Ovarian Neoplasms | en |
dc.subject.mesh | Paclitaxel | en |
dc.subject.mesh | Peripheral Nervous System Diseases | en |
dc.subject.mesh | Peritoneal Neoplasms | en |
dc.subject.mesh | Proportional Hazards Models | en |
dc.subject.mesh | Quality of Life | en |
dc.subject.mesh | Survival Analysis | en |
dc.subject.mesh | Taxoids | en |
dc.subject.mesh | Treatment Outcome | en |
dc.title | Phase III randomized trial of docetaxel-carboplatin versus paclitaxel-carboplatin as first-line chemotherapy for ovarian carcinoma. | en |
dc.type | Article | en |
dc.contributor.department | Cancer Research U.K. Department of Medical Oncology, Glasgow, UK. paul_vasey@health.qld.gov.au | en |
dc.identifier.journal | Journal of the National Cancer Institute | en |
html.description.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 permitted. 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 > or =2 neurosensory toxicity in 11% versus 30%, difference = 19%, 95% CI = 15% to 24%; P<.001; grade > or =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. |