New Docetaxel Ovarian Cancer Trial

May 1, 1995

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.

LISBON, Portugal--Encouraging news for women with platinum-resistantadvanced ovarian cancer has emerged from a large phase II trialof docetaxel (Taxotere) conducted by the European Organizationfor Research and Treatment of Cancer (EORTC) Early Clinical TrialsGroup.

The EORTC Group recruited 90 women with measurable bidimensionallesions, 42 of whom had progressive or relapsing disease within4 months of platinum-containing therapy and 48 of whom had progressedor relapsed 4 to 12 months after treatment. Participants receiveddocetaxel, 100 mg/m² as a 1-hour IV infusion, every 3 weeks.

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

Docetaxel appeared to be more effective in women who had previouslyexperienced late relapse or progression (23% response rate) thanin 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 ofpatients experienced hair loss and fatigue, and half also developedmild neurosensory symptoms.

Emphasizing that docetaxel was given without steroid premedicationin this study, Dr. Piccart cited a 44% incidence of peripheraledema, a 12% incidence of pleural effusion, and a 19% incidenceof weight gain between 2 kg and 20 kg. Toxicity had a variableimpact on drug delivery. Although only one quarter of patientsrequired dose reduction, 20% stopped treatment because of sideeffects.