Phase III randomized trial of docetaxel-carboplatin versus paclitaxel-carboplatin as first-line chemotherapy for ovarian carcinoma.

2.50
Hdl Handle:
http://hdl.handle.net/10541/77979
Title:
Phase III randomized trial of docetaxel-carboplatin versus paclitaxel-carboplatin as first-line chemotherapy for ovarian carcinoma.
Authors:
Vasey, Paul; Jayson, Gordon C ( 0000-0002-8515-8944 ) ; Gordon, Alan; Gabra, Hani; Coleman, Robert E; 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 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.
Affiliation:
Cancer Research U.K. Department of Medical Oncology, Glasgow, UK. paul_vasey@health.qld.gov.au
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.
Journal:
Journal of the National Cancer Institute
Issue Date:
17-Nov-2004
URI:
http://hdl.handle.net/10541/77979
DOI:
10.1093/jnci/djh323
PubMed ID:
15547181
Type:
Article
Language:
en
ISSN:
1460-2105
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorVasey, Paulen
dc.contributor.authorJayson, Gordon Cen
dc.contributor.authorGordon, Alanen
dc.contributor.authorGabra, Hanien
dc.contributor.authorColeman, Robert Een
dc.contributor.authorAtkinson, Ronnieen
dc.contributor.authorParkin, Daviden
dc.contributor.authorPaul, Jamesen
dc.contributor.authorHay, Andreaen
dc.contributor.authorKaye, Stan Ben
dc.date.accessioned2009-08-20T10:16:30Zen
dc.date.available2009-08-20T10:16:30Zen
dc.date.issued2004-11-17en
dc.identifier.citationPhase 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.issn1460-2105en
dc.identifier.pmid15547181en
dc.identifier.doi10.1093/jnci/djh323en
dc.identifier.urihttp://hdl.handle.net/10541/77979en
dc.description.abstractBACKGROUND: 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.en
dc.language.isoenen
dc.subjectOvarian Canceren
dc.subjectPeritoneal Canceren
dc.subject.meshAdulten
dc.subject.meshAgeden
dc.subject.meshAntineoplastic Combined Chemotherapy Protocolsen
dc.subject.meshCarboplatinen
dc.subject.meshCarcinomaen
dc.subject.meshConfidence Intervalsen
dc.subject.meshDisease-Free Survivalen
dc.subject.meshDrug Administration Scheduleen
dc.subject.meshFemaleen
dc.subject.meshHumansen
dc.subject.meshMiddle Ageden
dc.subject.meshNeutropeniaen
dc.subject.meshOdds Ratioen
dc.subject.meshOvarian Neoplasmsen
dc.subject.meshPaclitaxelen
dc.subject.meshPeripheral Nervous System Diseasesen
dc.subject.meshPeritoneal Neoplasmsen
dc.subject.meshProportional Hazards Modelsen
dc.subject.meshQuality of Lifeen
dc.subject.meshSurvival Analysisen
dc.subject.meshTaxoidsen
dc.subject.meshTreatment Outcomeen
dc.titlePhase III randomized trial of docetaxel-carboplatin versus paclitaxel-carboplatin as first-line chemotherapy for ovarian carcinoma.en
dc.typeArticleen
dc.contributor.departmentCancer Research U.K. Department of Medical Oncology, Glasgow, UK. paul_vasey@health.qld.gov.auen
dc.identifier.journalJournal of the National Cancer Instituteen

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