FDA News Impacts Cancer Patients

Source: National Anemia Action Council (www.anemia.org) Author: staff The U.S. Food and Drug Administration (FDA) ordered specific changes for the use of erythropoeisis-stimulating agents (ESAs) to treat anemia in patients receiving chemotherapy. The label changes will state treatment should only begin when a patient’s hemoglobin level drops to 10 g/dL and removes the mention of 12 g/dL as an upper hemoglobin level of treatment because the safety of ESA use at that level is not yet known. The labeling will also advise not to use ESAs when chemotherapy is given to cure patients, which based on a doctor’s discretion, could include treatment designed to prevent cancer from coming back. The announced label changes reflect most of the recommendations from the Oncology Drugs Advisory Committee’s meeting March 13, 2008. Not included is advice from the committee to limit use of the drug for patients with breast cancer or head and neck cancer, despite recent studies showing more rapid tumor growth or shortened survival when these patients received treatment with ESAs. The drug’s manufacturer, Amgen, announced the revised product labeling for ESAs will be released to both physicians and patients soon. The FDA and Amgen agreed on a majority of the new label, but could not reach agreement on a couple points, prompting the FDA to invoke new authority to mandate drug label changes.

Gene Expression Profiling Identifies Genes Predictive of Oral Squamous Cell Carcinoma

Source: Cancer Epidemiology Biomarkers & Prevention, 10.1158/1055-9965 Authors: Chu Chen et al Oral squamous cell carcinoma (OSCC) is associated with substantial mortality and morbidity. To identify potential biomarkers for the early detection of invasive OSCC, we compared the gene expressions of incident primary OSCC, oral dysplasia, and clinically normal oral tissue from surgical patients without head and neck cancer or preneoplastic oral lesions (controls), using Affymetrix U133 2.0 Plus arrays. We identified 131 differentially expressed probe sets using a training set of 119 OSCC patients and 35 controls. Forward and stepwise logistic regression analyses identified 10 successive combinations of genes which expression differentiated OSCC from controls. The best model included LAMC2, encoding laminin-2 chain, and COL4A1, encoding collagen, type IV 1 chain. Subsequent modeling without these two markers showed that COL1A1, encoding collagen, type I 1 chain, and PADI1, encoding peptidyl arginine deiminase, type 1, could also distinguish OSCC from controls. We validated these two models using an internal independent testing set of 48 invasive OSCC and 10 controls and an external testing set of 42 head and neck squamous cell carcinoma cases and 14 controls (GEO GSE6791), with sensitivity and specificity above 95%. These two models were also able to distinguish dysplasia (n = 17) from control (n = 35) tissue. Differential expression of these four genes was confirmed by quantitative reverse transcription-PCR. If confirmed in larger studies, the proposed models may hold promise for monitoring local recurrence at surgical margins and the development of second primary oral cancer [...]

Disease-Free Period Predicts Response to Salvage Therapy for Oral Cancer

Source: Abkhazia (www.abkhazia.com) Author: Ramaz Mitaishvili In patients with locally recurrent carcinomas of the oral cavity and oropharynx, a disease-free interval of more than 1 year and tumor tissue negative for EGFR (epidermal growth factor receptor) expression predict a good response to salvage surgery. That's the conclusion of physicians in Brazil who studied the outcomes of 111 patients following salvage surgery for locally recurrent squamous cell carcinomas of the oral cavity and oropharynx at Hospital A. C. Camargo in Sao Paulo. Local recurrence in such patients carries a poor prognosis, and clinical factors alone are insufficient for identifying those who would benefit from further treatment, Dr. Luiz Paulo Kowalski and associates note in their paper in the July issue of the Archives of Otolaryngology--Head and Neck Surgery. They therefore analyzed the prognostic significance of EGFR, matrix metalloproteinases 2 and 9, and vascular endothelial growth factor expression. In multivariate analysis, disease-free survival and EGFR expression status were the only variables associated with an independent significantly high risk of death. Patients with a disease-free interval of less than 1 year (hazard ratio 1.97) and those with overexpression of EGFR (HR 4.20) had the worst prognosis. In their suggested treatment algorithm for patients with resectable local recurrence, Dr. Kowalski's group recommends surgery for all patients with a disease-free interval of > 1 year and for those with clinical stage I or II. They also believe that surgery is worthwhile for patients with higher stage tumors if they are EGFR-negative. They suggest other options [...]

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