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Dose-dense paclitaxel once a week in combination with carboplatin every 3 weeks for advanced ovarian cancer: a phase 3, open-label, randomised controlled trial
The Lancet - Early Online Publication, 09/24/09

Katsumata N et al. – Dose-dense weekly paclitaxel plus carboplatin improved survival compared with the conventional regimen and represents a new treatment option in women with advanced epithelial ovarian cancer.

Methods

Phase 3, open-label, randomised controlled trial
Patients with stage II to IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer eligible for enrolment
Randomly assigned by computer-generated randomisation sequence to receive six cycles of either paclitaxel (180 mg/m2; 3-h intravenous infusion) plus carboplatin (area under the curve [AUC] 6 mg/mL per min), given on day 1 of a 21-day cycle (conventional regimen; n=320)
Or dose-dense paclitaxel (80 mg/m2; 1-h intravenous infusion) given on days 1, 8, and 15 plus carboplatin given on day 1 of a 21-day cycle (dose-dense regimen; n=317)
Primary endpoint progression-free survival
Analysis was by intention to treat (ITT)

Results

631 of the 637 enrolled patients were eligible for treatment and were included in the ITT population
Median progression-free survival was longer in the dose-dense treatment group than in the conventional treatment group
Overall survival at 3 years was higher in the dose-dense regimen group (72·1%) than in the conventional treatment
165 patients assigned to the dose-dense regimen and 117 assigned to the conventional regimen discontinued treatment early
Reasons for participant dropout balanced between the groups, apart from withdrawal because of toxicity, which was higher in the dose-dense regimen group than in the conventional regimen group

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