GLASGOW--Docetaxel (Taxotere) used in combination with carboplatin(Drug information on carboplatin) (Paraplatin) appears to be an active and well-tolerated first-line treatment for advanced ovarian cancer, producing minimal neurotoxicity. Only 5% of patients experienced neuropathy, said lead investigator Paul Vasey, MD.
Dr. Vasey, a medical oncologist at the Cancer Research Campaigns Beatson Medical Centre, Glasgow, Scotland, reported the results of this phase II dose-finding study at a poster session of the annual ASCO meeting.
Among 30 patients who have completed 6 cycles of treatment and were considered clinically evaluable, the overall response rate was 67% and the CA 125 response rate was 70%, he said. Of these patients, 40% had a complete response, 27% a partial response, and 20% had stable disease.
"While our results are preliminary, they strongly suggest that a Taxotere-carboplatin combination may be an effective front-line regimen with an impressive safety profile for patients with advanced ovarian cancer," Dr. Vasey said.
The study enrolled 111 women with previously untreated advanced ovarian cancer (stage IC to stage IV) from nine UK centers. All had undergone cytoreductive surgery. Patients received 60 to 85 mg/m² of docetaxel(Drug information on docetaxel) as a 1-hour infusion, and carboplatin to an AUC of 5 to 7. Both drugs were given once every 3 weeks for a total of 6 cycles.
As expected, the most common adverse effect was myelosuppression, with 86% of patients experiencing neutropenia. However, Dr. Vasey said, less than 5% of patients experienced febrile neutropenia, and there was no clinically significant cumulative myelosuppression.
Of the four dose levels tested, he said, the combination of docetaxel at a dose of 75 mg/m², and carboplatin to an AUC of 5 represented the optimal balance between safety and efficacy.
Phase III Trial Planned
Dr. Vasey said that a randomized, prospective phase III trial comparing docetaxel/carboplatin with paclitaxel(Drug information on paclitaxel) (Taxol)/carboplatin as first-line treatment following initial surgery for advanced ovarian cancer is scheduled to start this year.
The primary endpoint for this multinational study, which includes sites in the United States, is progression-free survival, Dr.Vasey said. Early results are expected within 1 to 2 years.