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New Eloxatin(R) and Taxotere(R) Research to Be Presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO)

Posted on: Tuesday, 10 May 2005, 18:00 CDT

PARIS, May 10 /PRNewswire-FirstCall/ -- The sanofi-aventis Group announced today that important results from Eloxatin(R) (oxaliplatin for injection) and Taxotere(R) (docetaxel) Injection Concentrate clinical studies, including studies on colorectal, breast, lung, prostate and gastric cancer, will be presented at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO). The meeting begins on May 13 and runs through May 17, in Orlando, Florida.

A total of 220 abstracts for studies involving Eloxatin(R) and Taxotere(R) will be published, with seven Eloxatin(R) and 10 Taxotere(R) abstracts selected for discussion during the meeting's oral presentation sessions. In particular, one Eloxatin(R) abstract will be part of the Society's Plenary Presentation on Saturday, May 14.

Among the data to be presented at the meeting are the following:

Eloxatin(R) clinical study results

A phase III trial comparing FULV to FULV + oxaliplatin in stage II or III carcinoma of the colon: Results of NSABP Protocol C-07 Monday, May 16, 2005, 7:45 - 8:00 a.m., Gastrointestinal (Colorectal) Cancer Oral Presentation. Abstract #LBA3500

Oxaliplatin/5FU/LV in the adjuvant treatment of stage II and stage III colon cancer: Efficacy results with a median follow up of 4 years Monday, May 16, 2005, 8:00 - 8:15 a.m., Gastrointestinal (Colorectal) Cancer Oral Presentation. Abstract #3501

High-dose bevacizumab improves survival when combined with FOLFOX4 in previously treated advanced colorectal cancer: Results from the Eastern Cooperative Oncology Group (ECOG) study E3200 Saturday, May 14, 2005, 4:40 - 4:55 p.m., Plenary Session 1. Abstract #2

Safety and efficacy of bevacizumab (Bev) when added to oxaliplatin/fluoropyrimidine (O/F) regimens as first-line treatment of metastatic colorectal cancer (mCRC): TREE 1 & 2 Studies Tuesday, May 17, 2005, 11:00 - 12:15 p.m., Gastrointestinal (Colorectal) Cancer Poster Discussion Session, Poster #5. Abstract #3514

Cetuximab in combination with oxaliplatin/5-Fluorouracil (56FU) folinic acid (FA) (FOLFOX) in the first line treatment of patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer: An international phase 2 Study Saturday May 14, 2005, 2:00 - 6:00 p.m., Gastrointestinal Poster Session. Abstract #3535

Taxotere(R) clinical study results

Final Results of TAX325, a randomized controlled phase III trial comparing Taxotere combined with cisplatin (C) and 5-fluorouacil (F) to CF in patients with metastatic gastric adenocarcinoma (MGC) Sunday, May 15, 2005, 2:45 - 3:00 p.m., Gastrointestinal (Noncolorectal) Cancer Oral Presentation. Abstract #4002

Phase I/II study of docetaxel (DOC) and S-1 for patients (pts) with advanced gastric cancer (AGC) Saturday, May 16, 2005, 2:00 - 6:00 p.m., Gastrointestinal (Noncolorectal) Cancer General Poster Session. Poster #K9. Abstract #4064

SWOG 0023 - Analysis of an ongoing Phase III trial of concurrent chemoradiotherapy followed by consolidation Taxotere(R) and gefitinib/placebo maintenance in patients with inoperable stage III non-small cell lung cancer Monday, May 16, 2005, 3:45 - 4:00 p.m., Lung Cancer Oral Presentation. Abstract #7058

SWOG 9504 - Long-term survival in stage IIIb non-small cell lung cancer (NSCLC) treated with consolidation Taxotere(R) following concurrent chemoradiotherapy Monday, May 16, 2005 11:00 a.m. - 12:00 p.m., Lung Cancer II Poster Discussion Session, Poster #9. Abstract #7059

About Eloxatin(R)

Indications and Usage

Eloxatin(R) (oxaliplatin for injection), used in combination with infusional 5-FU/LV, is indicated for

* Adjuvant treatment of stage III colon cancer patients who have

undergone complete resection of the primary tumor. The indication is

based on an improvement in disease-free survival, with no demonstrated

benefit in overall survival after a median follow-up of 4 years

* Treatment of advanced carcinoma of the colon or rectum

Clinical Safety Considerations

Eloxatin(R) should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.

Anaphylactic-like reactions to Eloxatin(R) have been reported and may occur within minutes of Eloxatin(R) administration. Epinephrine, corticosteroids, and antihistamines have been employed to alleviate symptoms, and discontinuation of Eloxatin(R) therapy may be required.

* Eloxatin(R) should not be administered to patients with a history of

known allergy to Eloxatin(R) or other platinum compounds.

Hypersensitivity and anaphylactic/anaphylactoid reactions to

Eloxatin(R) have been reported and were similar in nature and severity

to those reported with other platinum compounds (ie, rash, urticaria,

erythema, pruritus, and, rarely, bronchospasm and hypotension). These

reactions occur within minutes of administration and should be managed

with appropriate supportive therapy. Drug-related deaths from this

reaction have been reported

* Eloxatin(R) may cause fetal harm when administered to a pregnant woman.

Women of childbearing potential should be advised not to become

pregnant while receiving Eloxatin(R). It is not known whether

Eloxatin(R) or its derivatives are excreted in human milk

* Eloxatin(R) has been associated with pulmonary fibrosis (<1% of study

patients), which may be fatal. The combined incidence of cough and

dyspnea was 7.4% (<1% grade 3, no grade 4) in the Eloxatin(R) plus 5-

FU/LV arm compared to 4.5% (no grade 3, 0.1% grade 4) in the 5-FU/LV

alone arm in the adjuvant colon cancer study. In this study, one

patient died from eosinophilic pneumonia in the Eloxatin(R) combination

arm. The combined incidence of cough, dyspnea, and hypoxia was 43% (7%

grade 3 and 4) in the Eloxatin(R) plus 5-FU/LV arm compared to 32% (5%

grade 3 and 4) in the irinotecan plus 5-FU/LV arm in patients with

previously untreated colorectal cancer. In case of unexplained

respiratory symptoms, Eloxatin(R) should be discontinued until

pulmonary investigation excludes interstitial lung disease or pulmonary

fibrosis

* Eloxatin(R) is associated with two types of primarily peripheral

sensory neuropathy: an acute, reversible type of early onset and a

persistent type (>14 days). In patients with advanced colorectal cancer

paresthesias occurred in 77% (all grades) and 18% (grade 3/4) of

previously untreated patients. In previously treated patients, acute

neuropathy occurred in 56% (all grades) and 2% (grade 3/4) of patients;

persistent neuropathy occurred in 48% (all grades) and 6% (grade 3/4)

of patients. In patients with stage II and III colon cancer,

paresthesia was seen in 92% (all grades) and 13% (grade 3/4) of

patients; 21% (all grades), 0.5% (grade 3/4) had residual paresthesia

at 18-month follow-up

* Hepatotoxicity, as evidenced in the adjuvant study by increase in

transaminases and alkaline phosphatase was observed more commonly in

the Eloxatin(R) combination arm.

The incidence of increased bilirubin was similar on both arms. Changes

noted on liver biopsies include: peliosis, nodular regenerative

hyperplasia or sinusoidal alterations, perisinusoidal fibrosis and

veno-occlusive lesions. Hepatic vascular disorders should be considered

and, if appropriate, investigated in case of abnormal liver function

test results or portal hypertension not explained by liver metastases.

* Monitoring of white blood cell count with differential, hemoglobin,

platelet count and blood chemistries (including ALT, AST, bilirubin and

creatinine) is recommended before each Eloxatin(R) cycle

* The safety and effectiveness of Eloxatin(R) plus 5-FU/LV in patients

with renal impairment have not been evaluated. Since the primary route

of platinum elimination is renal, this combination should be used with

caution in patients with preexisting renal impairment. Clearance of

these products may be decreased by coadministration of potentially

nephrotoxic compounds, although this has not been specifically studied

* The incidence of diarrhea, dehydration, hypokalemia, leukopenia,

fatigue and syncope were higher in patients greater than or equal to 65

years old

* Extravasation may result in local pain and inflammation that may be

severe and lead to complications, including necrosis. Injection site

reaction, including redness, swelling and pain, has been reported

* There have been reports of prolonged prothrombin time and INR

occasionally associated with hemorrhage in patients receiving

Eloxatin(R) plus 5-FU/LV while on anticoagulants. Patients receiving

Eloxatin(R) plus 5-FU/LV and requiring oral anticoagulants may require

closer monitoring

* The most common adverse reactions in patients with stage II or III

colon cancer receiving adjuvant therapy were peripheral sensory

neuropathy, neutropenia, thrombocytopenia, anemia, nausea, increase in

transaminases and alkaline phosphatase, diarrhea, emesis, fatigue, and

stomatitis. The most common adverse reactions in patients with advanced

colorectal cancer were peripheral sensory neuropathy, fatigue,

neutropenia, nausea, emesis, and diarrhea

For more information about Eloxatin(R) or for full prescribing information, including BOXED WARNING, visit http://www.eloxatin.com/.

About Taxotere(R)

Indications and Usage

Breast Cancer

Taxotere(R) is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.

Taxotere(R) in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.

Non-Small Cell Lung Cancer (NSCLC)

Taxotere(R), as a single agent, is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy.

Taxotere(R) in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic NSCLC who have not previously received chemotherapy for this condition.

Prostate Cancer

Taxotere(R) in combination with prednisone is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer.

Important safety information

WARNING: Taxotere(R) 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).

Taxotere(R) should not be given to patients with low white-blood-cell counts, abnormal liver function, or a history of allergic reactions to Taxotere(R) or any of the ingredients in Taxotere(R). Before each Taxotere(R) treatment, all patients treated with Taxotere(R) must receive another medicine called dexamethasone. This drug can help reduce the risk of fluid retention (edema) and allergic reactions.

Taxotere(R) 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 Taxotere(R) 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 Taxotere(R) 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 Taxotere(R). Women of childbearing potential should avoid becoming pregnant during treatment with Taxotere(R).

Before receiving Taxotere(R), 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 Taxotere(R), 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

Please see adjacent page for patient information leaflet for detailed information about these side effects, and talk to your doctor about any questions you may have.

For more information about Taxotere(R), visit http://www.taxotere.com/, or see full prescribing information including boxed WARNING. For more information about ongoing clinical trials, please call 1-800-RxTrial or visit http://www.aventisoncology.com/.

About sanofi-aventis

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

The sanofi-aventis Group conducts business in the U.S. through its subsidiaries Sanofi-Synthelabo Inc. and Aventis Pharmaceuticals Inc.

US Contact: Marisol Peron, 908-243-7592, marisol.peron@sanofi-aventis.com

Senior Vice President, Corporate Communications: Nicole Cranois - Vice President, Media Relations: Jean-Marc Podvin Tel.: +33 1.53.77.42.23 - Fax: +33 1.53.77.42.65

sanofi-aventis

CONTACT: US Contact: Marisol Peron, +1-908-243-7592,marisol.peron@sanofi-aventis.com; or Senior Vice President, CorporateCommunications: Nicole Cranois - Vice President, Media Relations: Jean-MarcPodvin, +33-1-53-77-42-23 - Fax: +33-1-53-77-42-65, all for sanofi-aventis

Web site: http://www.sanofi-aventis.com/

Company News On-Call: http://www.prnewswire.com/comp/232375.html

Source: PRNewswire-FirstCall

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