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
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.
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