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Blog Archives: Nov 2004 - present
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"THE NECESSITY FOR CLINICAL TRIALS EVALUATING BEVACIZUMAB TREATMENT IN PATIENTS WITH MALIGNANT ASCITES
Based on the preclinical and clinical data outlined above, we strongly suggest that the efficacy and safety of the i.p. application of bevacizumab for the treatment of malignant ascites be assessed in stringently designed clinical studies. Bevacizumab is generally well tolerated and has an acceptable toxicity profile consisting primarily of hypertension and proteinuria. Other rare but important adverse effects, however, include delayed wound healing, arterial thrombosis, and bleeding [118]. Finally, a potentially serious adverse effect of bevacizumab is gastrointestinal perforation and, although comparably infrequent, this potentially life-threatening complication has generated significant clinical interest. Overall, gastrointestinal perforation was found to be an uncommon but well-documented side effect of treatment in the phase III trials of bevacizumab, as well as in subsequent surveillance trials, with a reported incidence of 1%–2% [106, 107, 109, 119]. Though strong evidence identifying specific risk factors is lacking, investigators have urged caution when treating patients with known bowel implants or a large tumor burden, prior radiation, and recent surgery or bowel obstruction [106, 119, 120]."
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