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

Paul A. Vasey, Gordon C. Jayson, Alan Gordon, Hani Gabra, Rob Coleman, Ronnie Atkinson, David Parkin, James Paul, Andrea Hay, Stan B. Kaye

    Research output: Contribution to journalArticlepeer-review

    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 ≥2 neurosensory toxicity in 11% versus 30%, difference = 19%, 95% CI = 15% to 24%; P
    Original languageEnglish
    Pages (from-to)1682-1691
    Number of pages9
    JournalJournal of the National Cancer Institute
    Volume96
    Issue number22
    DOIs
    Publication statusPublished - 17 Nov 2004

    Keywords

    • Adult
    • Aged
    • adverse effects: Antineoplastic Combined Chemotherapy Protocols
    • administration & dosage: Carboplatin
    • drug therapy: Carcinoma
    • Confidence Intervals
    • Disease-Free Survival
    • Drug Administration Schedule
    • Female
    • Humans
    • Middle Aged
    • chemically induced: Neutropenia
    • Odds Ratio
    • drug therapy: Ovarian Neoplasms
    • administration & dosage: Paclitaxel
    • chemically induced: Peripheral Nervous System Diseases
    • drug therapy: Peritoneal Neoplasms
    • Proportional Hazards Models
    • Quality of Life
    • Research Support, Non-U.S. Gov't
    • Survival Analysis
    • administration & dosage: Taxoids
    • Treatment Outcome

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