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Data to be Presented at ASCO 2007 Highlights sanofi-aventis,Commitment to Cancer Care and Research

al 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,
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