The US Food and Drug Administration (FDA) has approved Taxotere (docetaxel, manufactured by Sanofi-Aventis) for combination therapy with cisplatin and 5-fluorouracil to treat locally advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) prior to chemoradiotherapy and surgery. All patients involved in the clinical trial had inoperable tumors or potentially operable tumors but unlikely to be cured by surgery alone. Approval was based on results of TAX 324, a Phase 3 randomized open-label international trial involving over 500 patients assigned to either a Taxotere/Platinum/Fluorouracil (TPF) arm or a platinum/fluorouracil arm (PF). Taxotere-added arm showed longer median overall survival (O.S.) rate of 70.6 months versus non-Taxotere arm of 30.1 months. Both arms had similar grade 3/4 toxicities although Taxotere-treated arm had more febrile neutropenia, neutropenic infection, and grade 3/4 neutropenia. Non-taxotere treated arm had more grade 3/4 thrombocytopenia, stomatitis, lethargy, and vomiting. Other grade 3/4 events common to both treatments included nausea, anorexia and constipation. Taxotere is already approved for treating breast cancer, lung cancer, prostate cancer, and gastric (stomach) cancer. Source: sanofi-aventis.
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September 26, 2007 Update from the FDA website According to the FDA website, pain drug Fentora (fentanyl buccal tablet) has been linked to serious and fatal side effects in cancer patients who were not appropriately screened for the receiving the drug. The manufacturer of the drug, Cephalon, issued letters to physicians and healthcare professionals on the proper use of the drug in the right patient type. Here is part of the letter relating to Key safety information for Fentora:
- Do not use Fentora in opioid non-tolerant patients
- Use Fentora only for labeled indications
- Do not prescribe Fentora for patients with acute pain, postoperative pain, headache/migraine, or sports injuries
- Fentora is not a generic version of Actiq. Therefore, do not substitute Fentora for Actiq or other fentanyl-containing products
- Follow dosing instructions carefully:
- For unrelieved breakthrough pain (BTP), patients should not take mor than 2 Fentora tablets per BTP episode
- Patients must wait at least 4 hours before treating another BTP episode with Fentora
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One of the concern oncologists have when treating “older” patients ages 70 or above is whether these patients may tolerate the full range of side effects that accompany dose intensive chemotherapy, and some oncologists are more conservative when treating the elderly patient population. In a recent study published in the Cancer medical journal, Dr. Michelle Shayne and colleagues looked at 115 community oncology practices and 976 patients who had received chemotherapy between 2002 and 2005 for various types of cancers and tumors to look at how elderly patients experience side effects from the dosage of chemotherapy they received.
The side effects in particular included severe neutropenia (abnormal decrease in the number of neutrophils in the blood) and febrile neutropenia (reduced white blood cells used to fight an infection). The researchers found that older patients tend to receive lower dose chemotherapy even though patients who received 85% or more of the relative dose intensity of chemotherapy did not show significant increase in neutropenia side effects. Thus this would suggest that older patients may tolerate the high dose chemotherapy they would need to improve their chances of fighting cancer, and oncologists should take this study into consideration when designing the cancer fighting regimen for an older patient. (More …)
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According to Reuters, food coloring Red 2G, also known as E 128, is being reviewed by the European Food Safety Authority (EFSA) for its potential to cause cancer. This color is used to some sausages and burger meat, and is currently already banned in Australia. When ingested by animals, this coloring is converted into a chemical called aniline, which may affect the cell’s genes and causing cancer. Although EFSA isn’t calling a ban on E128, it is no longer using a “maximum daily intake recommendation” on foods with Red 2G.
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US Food and Drug Administration (FDA) announced that gadolinium-based contrast agents used to enhance the quality of magnetic resonance imaging (MRI) has been linked to risks for nephrogenic systemic fibrosis (NSF) in patients with severe kidney insufficiency. NSF is a debilitating and potentially fatal disease. Patients who may be at risk for developing NSF include those who have chronic liver disease or may be getting a liver transplant. Patients with normal kidney function or have mild to moderate kidney insufficiency did not show reports of NSF. It is recommended that patients receiving gandolinium-based imaging agents should first be screened for kidney problems. NSF symptoms include thickening skin, connective tissues, and internal organs. One of the results may be risk of broken bones. There is no current treatment for NSF. Gadolinium-based contrast agents approved for use in the US include Magnevist (gadopentetate dimeglumine), Ominiscan (gadodiamide); OptiMARK (gadoversetamide); MultiHance;(gadobenate dimeglumine);and Prohance (gadoteridol). Source: FDA.