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Published on 6/5/2006 in the Prospect News Biotech Daily.

Sanofi meta-analysis shows benefits of Taxotere

By Elaine Rigoli

Tampa, Fla., June 5 - Sanofi-aventis announced that a meta-analysis performed on seven clinical trials in patients with advanced non-small cell lung cancer showed that patients receiving Taxotere (docetaxel) injection concentrate had demonstrated overall survival and less febrile neutropenia than those treated with vinca-alkaloid (vinorelbine or vindesine) regimens.

The trials used Taxotere and vinca-alkaloids alone or in combination as first-line therapy for advanced non-small cell lung cancer. Six of the trials compared Taxotere to vinorelbine regimens and one to a vindesine regimen.

The pooled results of the seven trials conducted on a total of 2,867 patients show that Taxotere regimens significantly improved overall survival compared to vinca-alkaloid regimens in this patient population, according to a news release.

The comparison was done on a total of 1,638 patients who received Taxotere regimens and 1,229 who received vinca-alkaloid regimens.

The meta-analysis also demonstrated that the benefit derived from Taxotere therapy persisted after exclusion of the vindesine study and also when monotherapy regimens were excluded from the analysis.

While neutropenia was a common adverse event in the trials, it was significantly less frequent with Taxotere than with vinca-alkoloid regimens, as was febrile neutropenia, a condition marked by fever and decrease in the number of a type of white blood cells that helps fight infection, the release said.

The findings of the meta-analysis are in line with the results of the pivotal TAX 326 study, which provided the basis for the Taxotere approval in the first-line treatment of non-small cell lung cancer.

Sanofi-aventis is a global pharmaceutical company located in Paris.


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