Rhone-Poulenc Rorer said data from recent clinical trials of Taxotereshowed the anti-cancer drug prompted a 75 percent response rate inpatients whose advanced breast cancer metastasized to the liver.
"This is relatively new data," said Rhone-Poulenc spokesman GuyEsnouf. "We were looking at whether the [Taxotere] activity iseffective in metastasis and the liver is one of the real problem areas."
The trial results were presented Friday at the 17th annual SanAntonio Breast Cancer Symposium. The studies involved 35 patientswith advanced breast cancer and in 16 of them the cancer spread totheir livers. Of those 16 patients, 12 experienced at least a partialresponse in reduction of tumor size in the liver. Investigators saidtumors in four patients were eliminated.
In a second study, Collegeville, Pa.-based Rhone-Poulenc Rorer, asubsidiary of France-based Rhone-Poulenc Group, said 68 percent of32 advanced breast cancer patients who received Taxotere as a first-line treatment experienced a reduction in tumor size.
A third clinical trial tested the drug on 35 patients whose breastcancer was resistant to the chemotherapeutic treatments, doxorubicinand mitoxantrone. In that study, tumor size was reduced in 57percent of the participants.
Side effects in the studies included a decrease in white blood cells,hypersensitivity, nausea, fluid retention and skin rash.
The data are part of a series of clinical trials conducted by Rhone-Poulenc to support regulatory approvals. Mexico granted its approvallate last month. The FDA's Oncologic Drugs Advisory Committee isexpected to announce its recommendation Tuesday.
Rhone-Poulenc is targeting Taxotere for advanced breast cancer andadvanced non-small cell lung cancer and is using data from about 35clinical studies worldwide to support its various regulatoryapplications. In all studies, a response was defined as at least a 50percent reduction in tumor size.
In data submitted to the FDA, Taxotere prompted a 48.6 percentresponse rate as a second-line treatment in patients with advancedbreast cancer and 3.6 percent of the patients experienced a completeresponse. When administered as a first-line treatment 56.4 percent ofpatients showed a response to Taxotere.
For advanced non-small cell lung cancer, which is the most commonform of lung cancer, Taxotere was tested as a treatment for patientswho failed to respond to the most common chemotherapy currentlyused. Data submitted to the FDA revealed that 17 percent of thosepatients experienced a response to the Taxotere treatments.
Taxotere, derived from the needles of the European yew tree, is asemi-synthetic compound related to taxol.
-- Charles Craig
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