12/17/2006 web-based article press release Biotechtalk.net Biomarkers to Play Key Role in Phase 3 Analyses Introgen Therapeutics, Inc. announced important new Advexin clinical data and regulatory updates. Advexin delivers the tumor suppressor p53 that targets a fundamental molecular cancer defect and selectively kills cancer cells. Expanded p53 biomarker studies confirmed with high statistical significance the survival benefit of Advexin therapy in patients with abnormal p53 function. The new results demonstrated that patients with the abnormal p53 biomarker in recurrent squamous cell carcinoma of the head and neck were most likely to have a survival benefit from their use of Advexin therapy. The data was announced as Introgen prepares to initiate the analyses of Phase 3 clinical trial data in support of its registration of Advexin. The U.S. Food and Drug Administration (FDA) has agreed to Introgen’s plans for incorporating p53 and other biomarker analyses in the evaluation of its Advexin Phase 3 clinical trials in recurrent head and neck cancer. Introgen has now analyzed additional head and neck cancer patients for the abnormal p53 molecular biomarker predictive of Advexin activity. The prognostic p53 biomarker is detected in tumor tissues by a routine laboratory test. Tumor samples were evaluated for the abnormal p53 biomarker by an independent laboratory in 28 patients with recurrent head and neck cancer who were treated with Advexin during Phase 2 clinical trials. The results confirm and extend previous Advexin biomarker studies. The abnormal p53 biomarker was associated with statistically significant increases in tumor response and median [...]

12/17/2006 Ottawa, Ontario, Canada staff www.docguide.com Subject: Lack of Survival Benefit and Increased Incidence of Tumour Haemorrhage in Association with Iressa® in Patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN) OTTAWA, CANADA -- December 12, 2006 -- AstraZeneca, following discussions with Health Canada, is informing health care professionals of new safety information regarding Iressa (gefitinib). Iressa is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. Although Iressa is indicated for the treatment of locally advanced non-small cell lung cancer in patients who have failed two prior chemotherapy regimens, its use has been restricted by Health Canada to patients who are currently benefiting from Iressa and whose tumours are EGFR expression status positive or unknown. For continued supply of the drug, patients have had to be registered by a pharmacist into the Iressa Patient Registry (IPR) program. Head and neck cancer is not an approved indication for Iressa, but patients with this diagnosis could have been registered if benefiting from therapy. This letter is to inform health care professional involved in the IPR, of the top-line results from an Iressa study in patients with squamous cell carcinoma of the head and neck (SCCHN) entitled: A phase 3 randomized, stratified, parallel-group, multi-centre, comparative study of Iressa 250 mg and 500 mg versus methotrexate for previously treated patients with squamous cell carcinoma of the head and neck (1839IL/0704, IMEX). · IMEX trial results demonstrate lack of survival advantage for Iressa 250 mg and 500 mg versus methotrexate in patients [...]

12/17/2006 Minneapolis, MN Mike Enright Minnesota Daily (www.mndaily.com) Bill Whalen said his chewing tobacco days began as a football player at the University of Pennsylvania. Whalen regularly chewed a tin a day, which contains the same amount of nicotine as 60 cigarettes. It wasn't until getting married and having kids that he realized he had to stop. "I think every dipper, at some point in their life, realizes it's time to quit," Whalen said. But, when push came to shove, Whalen couldn't beat his addiction. "So I decided to come up with something that was going to be much better," he said. "Something that would allow me to dip … but take away all the carcinogens." Seven years later, Whalen is the CEO and founder of Blue Whale, LLC, and creator of what he calls a smokeless tobacco alternative, made from a blend of more than 20 different kinds of tea leaves. The product, Blue Whale Smokeless, which has been available in Texas since the end of September, is now on its way to Minnesota and should be available in select stores over the next several weeks, said Chris Giannini, the company's director of strategic marketing. And although Blue Whale is not the first smokeless tobacco alternative - others include Smokey Mountain, Bacc-Off and Golden Eagle - it is the only brand that contains nicotine. "The other ones are about as helpful as chewing gum," Whalen said. Blue Whale combines the best of both worlds, he said, because it has [...]

12/10/2006 Washington, DC Laurie Barclay, MD Mescape (www.medscape.com) The American Cancer Society (ACS) has issued nutrition and physical activity guidelines for cancer survivors during phases of treatment and recovery and for others living with advanced cancer. The new recommendations appear in the November/December issue of CA: A Cancer Journal for Clinicians. "Cancer survivors are often highly motivated to seek information about food choices, physical activity, and dietary supplement use to improve their treatment outcomes, quality of life, and survival," write Ted Gansler, MD, MBA, of the 2006 Nutrition, Physical Activity and Cancer Survivorship Advisory Committee, and colleagues. "To address these concerns, the ACS convened a group of experts in nutrition, physical activity, and cancer to evaluate the scientific evidence and best clinical practices related to optimal nutrition and physical activity after the diagnosis of cancer. This report summarizes their findings and is intended to present health care providers with the best possible information from which to help cancer survivors and their families make informed choices related to nutrition and physical activity." More than 10 million Americans are cancer survivors, defined as anyone who has been diagnosed as having cancer, from the time of diagnosis through the rest of life. Topics covered in the new guidelines include nutrition and physical activity issues during the phases of cancer treatment and recovery, living after recovery from treatment, and living with advanced cancer; nutrition and physical activity issues including body weight, food choices, and food safety; issues related to specific cancer sites (breast, colorectal, [...]

12/10/2006 Bethesda, MD Katherine Hobson US News (www.usnews.com) A big, new comprehensive study should provide some comfort to those still worried about a connection between cancer and cellphones: It finds no link and provides more evidence that electromagnetic fields from the phones do not cause tumors of the head and neck. The study, published in the current Journal of the National Cancer Institute (an independent publication no longer associated with the NCI), looked at cellphone records from more than 420,000 people in Denmark who began using the phones between 1982 and 1995. Relying on the country's national cancer registry, researchers looked at cancer cases through 2002 among the cellphone users and the overall population. The results? There was no increased risk of tumors in the brain, salivary glands, eyes, or inner ear. Nor was there a heightened risk of leukemia. In fact, the risk of cancer was slightly less in cellphone users, something lead author Joachim Schuz, head of biostatistics and epidemiology at the Institute of Cancer Epidemiology at the Danish Cancer Center, can't explain but says might be because of chance alone. Early cellphone users might also differ socioeconomically from nonusers in a way that might affect cancer risk, he says. (For example, professional males with high incomes–typical for early adopters of new technology–might have healthier lifestyles.) "We think it's a very strong study," he says. The findings build on the researchers' earlier study looking at the same group, which also found no link but only tracked cellphone users [...]

12/10/2006 Baltimore, MD staff Eurekalert.org Sildenafil and other "impotence drugs" that boost the production of a gassy chemical messenger to dilate blood vessels and produce an erection now also show promise in unmasking cancer cells so that the immune system can recognize and attack them, say scientists at the Johns Hopkins Kimmel Cancer Center. Tests at Hopkins on mice with implanted colon and breast tumors showed that tumor size decreased two- and threefold in sildenafil-treated animals, compared to mice that did not get the drug. In mice engineered to lack an immune system, tumors were unaffected, proof of principle, the scientists say, that the drug is abetting the immune system’s own cellular response to cancer. In a report published in the Nov. 27 issue of the Journal of Experimental Medicine, the Hopkins team says boosted levels of the chemical messenger nitric oxide appear to dampen the effects of a specialized cell that diverts the immune system away from tumors, allowing swarms of cancer-attacking T-cells to migrate to tumor sites in the rodents. Lab-grown cancer cells treated with sildenafil showed similar results, as did tissue samples taken from 14 head and neck cancer and multiple myeloma patients. Sildenafil, marketed under the trade name Viagra, is one of a class of drugs used to treat erectile dysfunction in millions of men, and in recent years, its ability to stimulate the production of NO has been investigated by experts in diseases linked to the activity of blood vessels and blood components. The new [...]

12/10/2006 New York, NY Anthony J. Brown, MD today.reuters.co.uk Findings from a new study confirm that tea extracts applied to the skin promote the repair of damage from radiotherapy, and shed light on the mechanisms involved in the injury. The beneficial effects of the extracts are mostly from their ability to attenuate the body signals that trigger inflammation. Radiotherapy interruption because of toxic effects to the skin may compromise the outcome of cancer treatment, lead author Dr. Frank Pajonk, from the David Geffen School of Medicine at UCLA, told Reuters Health. "So, it is important to have an effective treatment for this problem." According to Pajonk, "tea extracts have been used as a folk remedy for sunburns, which led to their use as a treatment for radiation-induced skin toxicity. They have proven quite successful in this regard, but there were no scientific data" to clarify their effects. In a study reported in the journal BMC Medicine, the researchers analyzed the effects of green or black tea extracts given to 60 patients with skin damage related to radiotherapy for head and neck cancers and cancer in the pelvic region. Treatment with the tea extracts enhanced skin repair, the report indicates. For radiation damage in the head and neck region, the green and black tea extracts were comparable in promoting repair, whereas in the pelvic region, green tea extract was superior, Pajonk said. The tea extracts inhibit a key proteasome, which "is at the center of the inflammatory machinery," explained Pajonk. This [...]

12/8/2006 Hong Kong EH Pow et al. Int J Radiat Oncol Biol Phys, November 15, 2006; 66(4): 981-91 Purpose: To compare directly the effect of intensity-modulated radiotherapy (IMRT) vs. conventional radiotherapy (CRT) on salivary flow and quality of life (QoL) in patients with early-stage nasopharyngeal carcinoma (NPC). Methods and Materials: Fifty-one patients with T2, N0/N1, M0 NPC took part in a randomized controlled clinical study and received IMRT or CRT. Stimulated whole (SWS) and parotid (SPS) saliva flow were measured and Medical Outcomes Short Form 36 (SF-36), European Organization for Research and Treatment of Cancer (EORTC) core quetionnaire, and EORTC head-and-neck module (QLQ-H&N35) were completed at baseline and 2, 6, and 12 months after radiotherapy. Results: Forty-six patients (88%) were in disease remission 12 months after radiotherapy. At 12 months postradiotherapy, 12 (50.0%) and 20 patients (83.3%) in the IMRT group had recovered at least 25% of preradiotherapy SWS and SPS flow respectively, compared with 1 (4.8%) and 2 patients (9.5%), respectively, in the CRT group. Global health scores showed continuous improvement in QoL after both treatments (p < 0.001). However, after 12 months subscale scores for role-physical, bodily pain, and physical function were significantly higher in the IMRT group, indicating a better condition (p < 0.05). Dry mouth and sticky saliva were problems in both groups 2 months after treatment. In the IMRT group, there was consistent improvement over time with xerostomia-related symptoms significantly less common than in the CRT group at 12 months postradiotherapy. Conclusions: IMRT was significantly [...]

12/8/2006 Madrid, Spain R Hitt and MJ Echarri Clin Transl Oncol, November 1, 2006; 8(11): 776-9 Major changes in the treatment of head and neck cancer are possible today because of the knowledge that we have on the molecular biology of these tumors. Different pathways are active in the development of this cancer and field cancerization is a major problem for the cure in early stage disease. Epidermal growth factor signal transduction pathway is now the principal target for this disease. New therapeutic strategies such as monoclonal antibodies and small molecules have appeared, however no more than 20% of the patients have objective responses with these therapies. Consequently, new alternatives of treatment in the basis of the understanding of molecular biology are necessary to increase the number of patients that can be cured in the future. Authors' affiliation: Division of Medical Oncology. Hospital Universitario 12 de Octubre. Madrid. Spain

12/3/2006 internet web article staff CancerConsultants.com According to an article recently published in the Archives of Otolaryngology—Head and Neck Surgery, treatment with cryboalative therapy may help preserve voice function in patients with cancer of the glottis. The glottis is the space directly above the vocal cords. Cancer of the glottis is treated with the surgical removal of the cancer, which is often followed by radiation therapy. Unfortunately, preservation of voice function is often severely impaired with standard treatments—a result that negatively impacts patient quality of life. Researchers continue to evaluate novel ways to preserve quality of life while producing positive outcomes for patients with cancer of the glottis. Researchers from the Cleveland Clinic recently evaluated data regarding voice preservation after cryoablative therapy (use of freezing temperatures to kill cancer cells) in the treatment of patients with cancer of the glottis that had not spread to other sites in the body. This study included 20 patients who initially had their cancer removed with carbon dioxide laser therapy, followed by cryoablation. - At nearly 33 months follow-up, only one patient experienced a cancer recurrence at the site of treatment. - Treatment with carbon dioxide laser therapy and cryoablative therapy was associated with a significant improvement in voice quality. - Long-term voice impairment was improved compared with pretreatment conditions, even among patients requiring the most extensive treatment. The researchers concluded that the combination of carbon dioxide laser surgery and cryoablative therapy may result in better voice quality than standard radiation therapy among patients [...]