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New Docetaxel Ovarian Cancer Trial

New Docetaxel Ovarian Cancer Trial

LISBON, Portugal--Encouraging news for women with platinum-resistant advanced ovarian cancer has emerged from a large phase II trial of docetaxel (Taxotere) conducted by the European Organization for Research and Treatment of Cancer (EORTC) Early Clinical Trials Group.

The EORTC Group recruited 90 women with measurable bidimensional lesions, 42 of whom had progressive or relapsing disease within 4 months of platinum-containing therapy and 48 of whom had progressed or relapsed 4 to 12 months after treatment. Participants received docetaxel, 100 mg/m² as a 1-hour IV infusion, every 3 weeks.

According to an intention-to-treat analysis, the response rate for the study population as a whole was 20% (95% confidence interval, 11% to 29%), reported Dr. Martine J. Piccart, of Institute Jules Bordet, Brussels, at the European Society of Medical Oncology congress. The median duration of response was 6.7 months, median progression-free survival was 3.9 months, and median overall survival was 8.4 months.

Docetaxel appeared to be more effective in women who had previously experienced late relapse or progression (23% response rate) than in those who had relapsed within 4 months of their previous chemotherapy (16.7%). "Docetaxel is at least as active as paclitaxel [Taxol] in patients with platinum-refractory ovarian cancer," Dr. Piccart said.

Neutropenia occurred during half the treatment courses, she said. Gastrointestinal toxicity, including nausea, vomiting, and diarrhea, was largely grade 1 and 2 and easily managed. The majority of patients experienced hair loss and fatigue, and half also developed mild neurosensory symptoms.

Emphasizing that docetaxel was given without steroid premedication in this study, Dr. Piccart cited a 44% incidence of peripheral edema, a 12% incidence of pleural effusion, and a 19% incidence of weight gain between 2 kg and 20 kg. Toxicity had a variable impact on drug delivery. Although only one quarter of patients required dose reduction, 20% stopped treatment because of side effects.

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