12/3/2004 New Haven, CT Press Release Yahoo! Finance(biz.yahoo.com) CuraGen Corporation announced today it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for CG53135, a novel protein therapeutic being developed for the prevention and treatment of oral mucositis (OM). Under the FDA granted designation CG53135 will be investigated for the prevention of OM in patients receiving hematopoietic stem cell transplantation (HSCT) following myeloablative chemotherapy with or without total body irradiation (TBI). "Oral mucositis is a serious and debilitating side effect resulting from the chemotherapy and radiation used in the treatment of cancer. Patients receiving a bone marrow transplant who develop oral mucositis may experience significant pain which can lead to an inability to eat or drink, and have an increased risk of developing a life-threatening infection," stated Mary E. Taylor, Vice President of Regulatory Affairs at CuraGen. "As we continue to advance CG53135 through Phase II, we are pleased to have received fast track status and look forward to working closely with the FDA to develop this therapeutic." CG53135 is an investigational protein discovered by CuraGen that promotes both epithelial and mesenchymal cell proliferation. Data from the recently completed Phase I program evaluating CG53135 for the prevention of OM in patients receiving high dose chemotherapy followed by hematopoietic stem cell transplantation will be presented on Saturday, December 4th at the 46th Annual Meeting of the American Society of Hematology in San Diego, CA. CG53135 is currently in a Phase II program to evaluate its safety and [...]

12/3/2004 Nikki V Katz Womens Issues (womensissues.about.com) Statistics on women smokers, the side-effects and a new campaign specifically targetting women. According to the U.S. Surgeon's General Report on Women and Smoking (issued in 03/01) and recent research studies, it has been found that: -178,000 women die of tobacco-caused disease each year -Since 1987, lung cancer has been the leading cancer-killer among women -Since 1980, approximately 3 million U.S. women have died prematurely from smoking-related diseases, as well as cigarette-caused burns. -Heart disease is the number one killer of women, and smoking accounts for 20% of deaths from heart disease -Women suffer gender specific risks from tobacco, including harm to their reproductive organs and complications during pregnancy -From 1991 to 1999, smoking increased 30% among high school girls For many decades, tobacco companies have attempted to lure new female customers by associating smoking with a woman's independence and sophistication. Advertising campaigns such as Virginia Slims' "You've Come A Long Way, Baby" and the new "It's A Woman Thing" have presented smoking as signs of freedom and individuality. In the 1970s, women were targeted with advertising for so-called "low tar" and "light" brands, with implied claims of reduced risk that the tobacco companies knew to be false. Current Anti-Smoking Campaign: In June, 2002, the American Legacy Foundation (the national, independent public health foundation established by the 1988 tobacco settlement) is releasing a print campaign in women's magazines. The women featured in this campaign are real women battling tobacco-related illnesses like emphysema, lung [...]

12/3/2004 New York, NY Angela Stewart The Star Ledger With cancer survival rates significantly improved for both adults and children, the American Society of Clinical Oncology said yesterday it is creating a national task force to address the physical, emotional and practical needs of this growing population. There are 9.8 million cancer survivors in the United States, compared to 3 million in 1971. They now represent 3.5 percent of the population. But follow-up care often is lacking, cancer survivors reported in a recent poll, noting that their non-medical needs are going unmet. In an effort to close the gap, the oncology society has formed a Survivorship Task Force that will seek to improve the long- term care of cancer survivors, in large part by better training the oncologists who treat them. "Even if we have the knowledge, if we don't communicate it to patients, it is of no value," said David Johnson, society president, during an annual educational event the organization sponsored at the Millennium Broadway Hotel in midtown. The event featured experts from the National Cancer Institute, some of the leading cancer centers and support groups in the country to discuss issues such as long-term effects of cancer therapy, risk of recurrence and second cancers and psycho-social issues. For many years, medical professionals focused on little other than treatment when it came to cancer patients, admitted Julia Rowland, director of the Office of Cancer Survivorship at the NCI. She said there is a growing movement today, however, to continue [...]

12/2/2004 Adam S. Jacobson, MD; Mark L. Urken, MD, FACS ACS Surgery: Principles & Practice Sources of False Negative PET Scans Using FDG A range of physiologic tracers has been developed for positron emission tomography (PET), with the glucose analogue F-18 fluorodeoxyglucose (FDG) the most commonly used. FDG has a half-life of 110 minutes. Once given to the patient, FDG is taken up by glucose transporters and is phosphorylated by hexokinase to become FDG-6-phosphate (FDG-6-P). Further metabolism of FDG-6-P is blocked by the presence of an extra hydroxyl moiety, which allows FDG-6-P to accumulate in the cell and serve as a marker for glucose metabolism and utilization. Because FDG is nonspecifically accumulated in glycolytically active cells, it demarcates areas of inflammation as well as neoplastic tissue; this can lead to a false positive scan. Muscular activity during the scan can also lead to areas of increased uptake in nonneoplastic tissue. Furthermore, healing bone, foreign-body granulomas, and paranasal sinus inflammation can produce false positive results. False negative scans occur when tumor deposits are very small (3 to 4 mm or less in diameter). Thus, micrometastases are not reliably detected using an FDG-PET image. Furthermore, a false negative scan can occur if the PET is performed too soon after radiation therapy.

12/2/2004 Laurie Barclay, MD Medscape (www.medscape.com) Four cycles of neoadjuvant chemotherapy is a promising approach for treating patients with inoperable advanced head and neck squamous cell carcinoma (HNSCC), according to follow-up data from a 10-year randomized trial published in the Nov. 17 issue of the Journal of the National Cancer Institute. "Chemoradiotherapy is the standard treatment for locally advanced HNSCC; the standard treatment for patients with operable HNSCC is surgery followed by postoperative radiotherapy, with or without adjuvant chemotherapy," write Pier Luigi Zorat, from Ospedale Ca' Foncello in Treviso, Italy, and colleagues. "Although neoadjuvant chemotherapy has a proven role in organ preservation and statistically significantly reduces the incidence of distant metastases, especially in laryngeal and hypopharyngeal cancers, its efficacy in prolonging overall survival has not yet been demonstrated." The investigators compared induction chemotherapy with cisplatin and 5-fluorouracil followed by locoregional treatment (surgery and radiotherapy or radiotherapy alone) with locoregional treatment alone in patients with HNSCC. In this multicenter trial, 237 patients with nonmetastatic stage III or IV HNSCC were randomized to receive four cycles of neoadjuvant chemotherapy followed by locoregional treatment (group A) or locoregional treatment alone (group B). In group A, overall survival at five and 10 years was 23% (95% confidence interval [CI], 15.3% - 30.9%) and 19% (95% CI, 11.6% - 26.4%). In group B, the corresponding survival rates were 16% (95% CI, 9.6% - 23.4%) and 9% (95% CI, 3.5% - 14.7%; P = .13). For operable patients, there was no difference between group A and [...]

12/2/2004 Jukka H. Meurman; Mariano Sanz; Sok-Ja Janket3 Crit Rev Oral Biol Med 15(6):403-413 (2004) During the last two decades, there has been an increasing interest in the impact of oral health on atherosclerosis and subsequent cardiovascular disease (CVD). The advent of the inflammation paradigm in coronary pathogenesis stimulated research in chronic infections caused by a variety of micro-organisms—such as Chlamydia pneumoniae, Helicobacter pylori, and cytomegalovirus—as well as dental pathogens, since these chronic infections are thought to be involved in the etiopathogenesis of CVD by releasing cytokines and other pro-inflammatory mediators (e.g., C-reactive protein [CRP], tumor necrosis factor [TNF-]) that may initiate a cascade of biochemical reactions and cause endothelial damage and facilitate cholesterol plaque attachment. Yet, due to the multi-factorial nature of dental infection and CVD, confirming a causal association is difficult, and the published results are conflicting. The main deficit in the majority of these studies has been the inadequate control of numerous confounding factors, leading to an overestimation and the imprecise measurement of the predictor or overadjustment of the confounding variables, resulting in underestimation of the risks. A meta-analysis of prospective and retrospective follow-up studies has shown that periodontal disease may increase the risk of CVD by approximately 20% (95% confidence interval [CI], 1.08–1.32). Similarly, the reported risk ratio between periodontal disease and stroke is even stronger, varying from 2.85 (CI 1.78–4.56) to 1.74 (CI 1.08–2.81). The association between peripheral vascular disease and oral health parameters has been explored in only two studies, and the resultant relative [...]

12/2/2004 Pathak KA et al. Nature Clinical Practice Oncology (2004) 1, 60-61 Damage to the submandibular salivary glands is an important side effect of head and neck radiation therapy. The resulting xerostomia causes problems with chewing, swallowing and changes to the oral microbial flora, adversely affecting the patient's quality of life. Pathak and colleagues have described a technique for protecting the contralateral submandibular salivary gland from radiation by transferring it to the submental space prior to treatment. This approach has been used previously in patients undergoing neck dissection as part of primary treatment. The new study, however, deals with those patients not requiring neck dissection. A total of 22 patients with oropharyngeal or hypopharyngeal tumors underwent contralateral submandibular salivary gland transfer (SMSGT) as an upfront, day care procedure. The incision was small, extending from the tip of the greater horn of hyoid to the midpoint of the submental space. The operating time was approximately 20 minutes. All patients went on to receive radical radiotherapy within 2 weeks of the procedure. Unstimulated pre-radiation and post-radiation salivary output was measured by cannulating the submandibular ducts. The mean salivary output of the transferred gland was 73% after radiotherapy, compared with only 27% for the untransferred, ipsilateral gland. The authors conclude that SMSGT maintained adequate salivary gland function in these patients and that the procedure was simple, safe and cost effective

12/2/2004 St. Louis Carolyn Bower STLToday.cm Missouri Attorney General Jay Nixon said Tuesday that state legislators should use about $7 million in new tobacco settlement money to pay for a program to stop young people from smoking and using tobacco. Missouri lacks a significant youth smoking prevention program even though the state has received more than $822 million in tobacco settlement money so far, Nixon told sixth-graders at Pattonville's Holman Middle School in St. Ann. Instead, the money went to the general fund to help balance the state's budget. "Not one dollar of that $822 million has been spent to keep young people in Missouri from smoking," he said. Three of every 10 Missouri high school students smoke, one of the highest rates in the country, Nixon said. In fact, the percentage of Missouri high school students who smoke - 30.3 percent - surpasses the percentage of Missouri adults who smoke - 26.6 percent, he said. Nixon said nearly 40 tobacco companies recently signed on to the settlement agreement reached in 1998 between tobacco manufacturers and 46 states. The decision will bring about $7 million in new money to Missouri each year, he said. "This should be earmarked to stop our children from picking up the smoking habit," Nixon said. "We have seen the success of other states in efforts to reduce smoking rates. We have the resources. But do we have the will? It's up to the legislators to take the next step." Nixon said he was working with [...]

11/30/2004 Houston, TX K. Kian Ang The University of Texas M.D. Anderson Cancer Center, Houston, TX Improving the outcome for patients with locally advanced head and neck carcinomas (HNC) by rational modification of radiation fractionation regimens or combinations of radiation with chemotherapy has been the subject of intensive clinical investigations for more than three decades. The two prototypes of biologically sound-altered radiation fractionation regimens are hyperfractionation and accelerated fractionation.1 Hyperfractionation was based on preferential sparing of late-responding tissues when the radiation dose per fraction is reduced. Accelerated fractionation regimens emerged through the recognition that tumor clonogen proliferation occurring during radiotherapy has a detrimental effect on outcome. Results of large randomized trials addressing the optimization of radiation fractionation collectively show that a number of biologically sound altered fractionation schedules improve the locoregional (LR) control rate on the order of 10% to 15%, but have only a modest impact on overall survival. Although several altered fractionation regimens consistently induce more severe acute mucositis than standard 7-week radiotherapy, the general consensus is that late toxicities are not appreciably increased. Scores of clinical trials testing combined-modality therapy have also been published. Meta-analyses of studies completed before 1995 reveal that cytotoxic agents given before or after surgery or radiation do not significantly improve the therapeutic outcome over LR treatment alone. In contrast, chemotherapy given concurrently with radiation improves 2- and 5-year overall survival rates by 8%. Although a variety of cytotoxic agents have been studied, cisplatin is the most extensively investigated, and will be the [...]

11/30/2004 Erika Jonietz Technology Review, Nov. 2004 A new vaccine in the works could prevent cervical cancer. But will it ever reach those who would benefit most? Before the end of the decade, preteens going to the doctor for the usual booster shots—tetanus, diphtheria, and perhaps an annual flu shot—may get a new jab. The vaccine would not only protect them against one of the most common sexually transmitted infections but also prevent cervical cancer—almost eliminating that form of malignancy, in fact, and saving the lives of nearly a quarter million women worldwide each year. But even before studies of the vaccine’s effectiveness are complete, conservative Christian groups are expressing concerns about inoculating adolescents against sexually transmitted infections. A study published in the November 13 issue of British medical journal The Lancet showed that women who received all three doses of the vaccine, made by GlaxoSmithKline, maintained a strong immune response against the virus that causes cervical cancer, and that this immunity lasts for at least two years. The vaccine is one of two being developed against cervical cancer; Merck makes the second. “It's fabulous,” says Diane Harper, who directed the study and who heads research on prevention of gynecological cancer at Dartmouth Medical School. “It's safe, it's easy to make, and it's amazingly effective.” Both the Merck and GlaxoSmithKline vaccines target human papillomavirus, or HPV, the virus that causes cervical cancer. Spread through intimate skin-to-skin contact, HPV can also cause genital warts. There are more than 100 strains of [...]