Safety advisories in anemic cancer patients
Amgen sent a "dear doctor" letter in January 2007 that highlighted results from a recent anemia of cancer trial, and warned doctors to consider use in that off-label indication with caution.Amgen advised the U.S. Food and Drug Administration (FDA) regarding the results of the DAHANCA 10 clinical trial. The DAHANCA 10 data monitoring committee found that three-year loco-regional cancer control in subjects treated with Aranesp was significantly worse than for those not receiving Aranesp (p=0.01).In response to these advisories, the FDA released a Public Health Advisory
on 9 March 2007, and a clinical alert for doctors on 16 February 2007, about the use of erythropoiesis-stimulating agents (ESAs) such as epogen and darbepoetin. The advisory recommended caution in using these agents in cancer patients receiving chemotherapy or off chemotherapy, and indicated a lack of clinical evidence to support improvements in quality of life or transfusion requirements in these settings. In addition, on 9 March 2007, drug manufacturers agreed to new black box warnings about the safety of these drugs. On 22 March 2007, a congressional inquiry into the safety of erythropoietic growth factors was reported in the news media. Manufacturers were asked to suspend drug rebate programs for physicians and to also suspend marketing the drugs to patients. Several publications and FDA communications have increased the level of concern related to adverse effects of ESA therapy in selected groups.
They can be either benign growths or malignant growths. The malignant growths can either have primary or secondary causes. Adenomatous polyps are considered precursors to cancer and cancer becomes invasive once malignant cells cross the muscularis mucosa and invade the cells below. Any cellular changes seen above the lamina propria are considered non-invasive and are labeled atypia or dysplasia. Any invasive carcinoma that has penetrated the muscularis mocos has the potential for lymph node metastasis and local recurrence which will require more aggressive and extensive resection. The Haggitts criteria is used for classification of polyps containing cancer and is based on the depth of penetration. The Haggitts criteria has level 0 through level 4, with all invasive carcinoma of sessile polyp variant by definition being classified as level 4. Level 0: Cancer does not penetrate through the muscularis mucosa. Level 1: Cancer penetrates through the muscularis mucosa and invades the submucosa below but is limited to the head of the polyp. Level 2: Cancer invades through with involvement of the neck of polyp. Level 3: Cancer invades through with involvement of any parts of the stalk. Level 4: Cancer invades through the submucosa below the stalk of the polyp but above the muscularis propria of the bowel wall. Adenomas
Neoplastic polyps of the bowel are often benign hence called adenomas. An adenoma is a tumor of glandular tissue, that has not (yet) gained the properties of cancer.The common adenomas of the colon (colorectal adenoma) are the tubular, tubulovillous, villous, and sessile serrated (SSA).