BRIDGEWATER, N.J., May 31 /PRNewswire-FirstCall/ -- Sanofi-aventis U.S. announced today that key study results from the company's leading chemotherapeutic agents, Eloxatin(R) (oxaliplatin injection) and Taxotere(R) (docetaxel) Injection Concentrate, will be presented at the 42nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Atlanta, Georgia. A total of 430 abstracts from studies involving Taxotere(R) or Eloxatin(R) (185 and 245 respectively) were accepted at the meeting's scientific sessions, including four Eloxatin(R) abstracts and three Taxotere(R) abstracts for podium presentations. The meeting begins on June 2 and runs through June 6.
In particular, significant studies include the use of Eloxatin(R)-based regimens in patients with pancreatic cancer and patients with stomach (gastric) cancer, two tumor types under investigation, as well as patients with colorectal cancer. Key Taxotere(R) study results include its use in treating patients with lung cancer, breast cancer, as well as head and neck cancer, a not yet approved indication. Additional study findings on the use of Taxotere(R) and Eloxatin(R) in other indications and/or in combination with other agents, including biologic compounds, will be presented.
Among the key data to be presented at the meeting during podium presentations or poster discussions are the following:
Key Eloxatin(R) clinical studies:
Abstract #LBA4004 - Phase III trial of gemcitabine (30-minute infusion) versus gemcitabine (fixed-dose-rate infusion [FDR]) versus gemcitabine + oxaliplatin (GEMOX) in patients with advanced pancreatic cancer: Results from the Eastern Cooperative Oncology Group (ECOG) study ECOG6201. Sunday, June 4, 3:15 - 3:30, Bldg C, Level 1, Hall C1, Oral Presentation.
Abstract #LBA4017 - Randomised multicentre phase III study comparing capecitabine with fluorouracil and oxaliplatin with cisplatin in patients with advanced oesophagogastric cancer: The REAL 2 trial. Monday, June 5, 11:30 - 11:45, Bldg C, Level 1, Hall C3, Oral Presentation.
Abstract #3510 - Safety and efficacy of oxaliplatin/fluoropyrimidine regimens with or without bevacizumab as first-line treatment of metastatic colorectal cancer (mCRC): Final analysis of the TREE-Study. Monday, June 5, 4:45 - 5:00, Bldg C, Level 1, Hall C4, Oral Presentation.
Abstract #3504 - OPTIMOX2, a large randomized phase II study of maintenance therapy or chemotherapy-free intervals (CFI) after FOLFOX in patients with metastatic colorectal cancer (MRC). A GERCOR study. Monday, June 5, 3:00 - 3:15, Bldg C, Level 1, Hall C4, Oral Presentation.
Key Taxotere(R) clinical studies:
Head and Neck Cancer
Special Session - Docetaxel added to induction therapy in head and neck cancer. Sunday, June 4, 1:00 - 1:15, Bldg C, Level 1, Hall C4, Oral Presentation.
Abstract #7034 - Comparison of docetaxel and vinca alkaloid, alone or in combination with other chemotherapy agents, in the first-line treatment of advanced non-small cell lung cancer (NSCLC): A meta-analysis. Saturday, June 3, 8:00 - 12:00, Bldg A, Level 3, Room A314, Poster Discussion.
Metastatic Breast Cancer
Abstract #LBA516 - A randomized phase III trial of trastuzumab plus docetaxel with or without carboplatin first line in HER2 positive metastatic breast cancer (MBC): Main Time to Progression (TTP) analysis. Sunday, June 4, 10:45 - 11:00, Bldg C, Level 1, Hall C1, Oral Presentation.
Adjuvant Breast Cancer
Abstract #LBA519 - Docetaxel (T) given concurrently with or sequentially to anthracycline-based (A) adjuvant therapy (adjRx) for patients (pts) with node-positive (N+) breast cancer (BrCa), in comparison with non-T adjRx: First results of the BIG 2-98 Trial at 5 years median follow-up (MFU). Monday, June 5, 9:00 - 9:15, Bldg C, Level 1, Hall C1, Oral Presentation.
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
-- 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 65 years or older
-- 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
-- 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 www.eloxatin.com.
Indications and Usage
In Breast Cancer:
-- In the United States TAXOTERE(R) is approved for the treatment of
patients with locally advanced or metastatic breast cancer after
failure of prior chemotherapy,
-- TAXOTERE(R) is approved in combination with doxorubicin and
cyclophosphamide (TAC regimen) for the adjuvant (post surgery)
treatment of patients with operable, node-positive breast cancer.
In Non-Small Cell Lung Cancer (NSCLC):
-- TAXOTERE(R), 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 for this condition,
-- TAXOTERE(R) is also approved, as a single agent, for the treatment of
patients with locally advanced or metastatic NSCLC after failure of
prior platinum-based chemotherapy.
In Prostate Cancer:
-- TAXOTERE(R) is approved for use in combination with prednisone for the
treatment of patients with androgen-independent (hormone-refractory)
metastatic prostate cancer.
In Stomach Cancer:
-- TAXOTERE(R) is approved in combination with cisplatin and
5-fluorouracil for the treatment of patients with advanced stomach
(gastric) cancer, including cancer of the gastro esophageal (GE)
junction, who have not received prior chemotherapy for advanced
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
For more information about TAXOTERE(R), visit www.taxotere.com. For full prescribing information, including boxed WARNING, call 800-633-1610.
Sanofi-aventis 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 (NYSE:SNY)
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