GLASGOW--Docetaxel (Taxotere) used in combination with 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
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 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 (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.