Healthcare Industry News:  NSCLC 

Biopharmaceuticals Oncology

 News Release - June 3, 2006

Results of a Meta-Analysis Show Benefits of Taxotere(R) (Docetaxel) Regimens in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)

Findings show demonstrated overall survival with less febrile neutropenia for Taxotere(R) versus vinca-alkaloid regimens

PARIS, June 3 (HSMN NewsFeed) -- Sanofi-aventis announced today that a meta-analysis performed on seven clinical trials in patients with advanced non-small cell lung cancer showed that patients receiving TaxotereŽ (docetaxel) Injection Concentrate had demonstrated overall survival and less febrile neutropenia than those treated with vinca-alkaloid (vinorelbine or vindesine) regimens. The trials used TaxotereŽ and vinca-alkaloids alone or in combination as first-line therapy for advanced non-small cell lung cancer. Six of the trials compared TaxotereŽ to vinorelbine regimens and one to a vindesine regimen. The results of the meta-analysis will be presented at the 42nd Annual Meeting of the American Society of Clinical Oncology (ASCO), in Atlanta, Georgia.

The pooled results of the seven trials conducted on a total of 2867 patients show that TaxotereŽ regimens significantly improved Overall Survival (OS) (Hazard Ratio (HR) = 0.89, 95% confidence interval (CI) [0.82;0.96], p=0.03) compared to vinca-alkaloid regimens in this patient population. The comparison was done on a total of 1,638 patients who received TaxotereŽ regimens and 1,229 who received vinca-alkaloid regimens.

The meta-analysis also demonstrated that the benefit derived from TaxotereŽ therapy persisted after exclusion of the vindesine study (HR = 0.90 [0.83;0.98]) and also when monotherapy regimens were excluded from the analysis (HR = 0.89 [0.82;0.97]).

While neutropenia was a common adverse event in the trials, it was significantly less frequent with TaxotereŽ (Odds Ratio* (OR) = 0.60; 95%CI [0.39;0.92, p=0.019]) 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, (OR = 0.60 [0.39;0.96], p=0.034).

"This is the first meta-analysis that demonstrated significant benefits in both survival and in toxicity for patients receiving TaxotereŽ-based chemotherapy compared to compared to vinca alkaloid-based regimens in first-line advanced NSCLC," said Jean-Yves Douillard, Professor and Head of the Department of Medical Oncology at the Centre R Gauducheau in Saint Herblain, France and principal investigator of the meta-analysis.

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

About the meta-analysis

As some data in comparative studies have suggested possible differences in survival and safety, an exhaustive meta-analysis was performed on published and unpublished data to assess the potential benefit of TaxotereŽ based regimens in comparison with vinca alkaloid-based therapy regimens, in terms of overall survival and toxicity.

MEDLINE, CANCERLIT and Cochrane Library searches were supplemented by information from clinical study reports and manual searching of relevant meeting proceedings. Only randomized trials comparing TaxotereŽ-based chemotherapy to vinorelbine or vindesine-based chemotherapy were included. Outcomes recorded were Overall Survival and neutropenia. Fixed effects models were used to estimate the pooled hazard ratio (HR) and the odds ratio (OR) of neutropenia. An HR or OR less than 1 indicates that TaxotereŽ is superior to vinca alkaloids. Heterogeneity was assessed using the Cochran Q-test.

* Odds Ratio: The "odds" of an event is the ratio of the chance of it occurring to the chance of it not occurring. The odds ratio is a measure of the relative benefit of the experimental treatment, comparing the odds of an event in the intervention group to the odds of an event in the control group.

About Lung Cancer

-- There will be more than 174,000 new cases of lung cancer this year in the United States, and more than 162,000 people will die of the disease.

-- When lung cancer is treated at an early stage and has not spread, the five-year survival rate is 50%. However, only 16% of lung cancers are diagnosed at this early stage.

-- Lung cancer has been the most prevalent cancer worldwide, since 1985, and by 2002, it accounted for nearly 1.4 million new cases with 1.2 million deaths.

About TAXOTEREŽ

In the US and in Europe TaxotereŽ, in combination with cisplatin, is approved for the treatment of patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not received prior chemotherapy, and it also is approved, as a single agent, for patients with unresectable locally advanced or metastatic NSCLC after failure of prior platinum-based chemotherapy.

IMPORTANT SAFETY INFORMATION

WARNING: TaxotereŽ treatment can cause serious, physically limiting, and potentially life-threatening side effects, such as infection, low blood-cell counts, allergic reaction, and retention of excess fluid (edema).

TaxotereŽ should not be given to patients with low white-blood-cell counts, abnormal liver function, or a history of allergic reactions to TaxotereŽ or any of the ingredients in TaxotereŽ.

Before each TaxotereŽ treatment, all patients treated with TaxotereŽ must receive another medicine called dexamethasone. This drug can help reduce the risk of fluid retention (edema) and allergic reactions.

TaxotereŽ should be administered only under the supervision of a qualified physician experienced in the use of anticancer treatments. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.

Treatment-related acute myeloid leukemia (AML) has occurred in patients given anthracyclines and/or cyclophosphamide, including use with TaxotereŽ in adjuvant therapy for breast cancer.

The most common severe side effects are low white-blood-cell count, anemia, fatigue, diarrhea, and mouth and throat irritation. Low white-blood-cell count can lead to life-threatening infections. The earliest sign of infection may be fever, so tell your doctor right away if you have a fever.

Other common side effects from TaxotereŽ include nausea, vomiting, hair loss, rash, infusion-site reactions, odd sensations (such as numbness, tingling, or burning) or weakness in the hands and feet, nail changes, muscle and/or bone pain, or excessive tearing.

Patients 65 years of age or older may experience some side effects more frequently than younger patients.

Because of the potential risk of fetal harm, pregnant women should not receive TaxotereŽ. Women of childbearing potential should avoid becoming pregnant during treatment with TaxotereŽ.

Before receiving TaxotereŽ, tell your doctor if
-- You have any allergies
-- You are taking any other medicines - including nonprescription (over-
the-counter) drugs, vitamins, and dietary or herbal supplements

When taking TaxotereŽ, contact your doctor if
-- You have symptoms of an allergic reaction (warm sensation, tightness in
your chest, itching/hives, or shortness of breath)
-- You experience any other side effects

For more information about TAXOTEREŽ, visit http://www.taxotere.com. For full prescribing information, including boxed WARNING, call 800-633-1610.

About sanofi-aventis

Sanofi-aventis is the world's 3rd largest pharmaceutical company, ranking number 1 in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY ).


Source: sanofi-aventis

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