Oncology Ny
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Although the optimal route of administration of opioids is by mouth, some patients may require alternative routes during the course of their illnesses for several reasons. These include bowel obstruction, severe emesis, or severe dysphagia. In these cases, the alternatives include the subcutaneous or rectal route. ⋯ Iontophoresis can provide a rapid drug delivery rate, but no clinical studies exist to document the long-term effectiveness of this method in controlling pain. The transmucosal route is recommended only for those opioids with high solubility, such as buprenorphine, the fentanyl series, and methadone. Oral transmucosal fentanyl (Actiq) provides a rapid onset of pain relief and is appropriate for treating episodes of breakthrough pain.
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The Food and Drug Administration (FDA) Modernization Act, signed into law on November 21, 1997, represents a sweeping review of existing standards for the approval, labeling, and promotion of prescription medicines. Certain sections of the act will influence access that oncologists and their patients have to new treatments and to information about those treatments. Major impacts of the act include: (1) continued funding of drug reviews by the FDA to assure a continuing stream of new drugs to prevent and treat disease; (2) providing greater flexibility in drug approval by permitting approval on the basis of one clinical trial and confirmatory evidence, and by instituting "fast track" designation to certain drugs that will permit approval on the basis of surrogate end points; (3) improving the access of physicians and patients to developing treatments by instituting a clinical trials databank and by authorizing the use of investigational products in emergencies; and (4) loosening restrictions on dissemination by drug companies of health, economic, and off-label use information, while maintaining incentives to investigate new uses for developing products.
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Discussed herein are selected oral fluorinated pyrimidines that are converted to 5-fluorouracil (5-FU) in vivo to exert antitumor activity. These agents include capecitabine (Xeloda), tegafur-uracil (UFT) plus leucovorin (Orzel), and S-1 (BMS247616). ⋯ These regimens also have the potential for improved therapeutic activity by achieving higher 5-FU concentrations in the tumor or by biochemically modulating 5-FU. Phase III trials in patients with advanced colorectal carcinomas are comparing the antitumor activity of these agents with that of intravenous 5-FU plus leucovorin.
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Three oral 5-fluorouracil (5-FU) therapies have been approved by the US Food and Drug Administration or are in development for the treatment of patients with breast cancer: capecitabine, UFT, and 5-FU/eniluracil. Capecitabine has been approved for breast cancer patients whose disease is paclitaxel-resistant, and either anthracycline-resistant or for whom further anthracycline use is not indicated. A response rate of 20% was observed in an open-label phase II trial of capecitabine in heavily pretreated patients with metastatic breast cancer. ⋯ The overall response rate was 38% among 21 patients, and diarrhea was the most common toxicity. Many questions remain unanswered about the optimal use of oral 5-FU agents in breast cancer. There seems little question that these agents have substantial activity and will find a place in the therapeutic armamentarium.