1/10/2006 New Haven, CT Paul M. Weinberger et al. Journal of Clinical Oncology, 10.1200/JCO.2004.00.3335 Purpose: We sought to determine the prevalence of biologically relevant human papillomavirus (HPV) in oropharyngeal squamous cell carcinoma (OSCC). Retinoblastoma (Rb) downregulation by HPV E7 results in p16 upregulation. We hypothesized that p16 overexpression in OSCC defines HPV-induced tumors with favorable prognosis. Methods: Using real-time polymerase chain reaction for HPV16, we determined HPV16 viral load in a cohort of 79 OSCCs annotated with long-term patient follow-up. A tissue microarray including these cases was also analyzed for p53, p16, and Rb utilizing in situ quantitative protein expression analysis. Seventy-seven tumors were classified into a three-class model on the basis of p16 expression and HPV-DNA presence: class I, HPV-, p16 low; class II, HPV+, p16 low; and class III, HPV+, p16 high. Results: Sixty-one percent of OSCCs were HPV16+; HPV status alone was of no prognostic value for local recurrence and was barely significant for survival times. Overall survival was improved in class III (79%) compared with the other two classes (20% and 18%; P = .0095). Disease-free survival for the same class was 75% versus 15% and 13% (P = .0025). The 5-year local recurrence was 14% in class III versus 45% and 74% (P = .03). Only patients in class III had significantly lower p53 and Rb expression (P = .017 and .001, respectively). Multivariable survival analysis confirmed the prognostic value of the three-class model. Conclusion: Using this system for classification, we define the molecular profile [...]

1/10/2006 Tallahassee, FL Cliff Rapp, LHRM First Professionals Insurance Co. Every year, oral cancer kills more people in the United States than cervical cancer, malignant melanoma or Hodgkin’s disease. Ninety percent of all oral cancers are squamous cell carcinoma, and oral cancer has one of the lowest five-year survival rates of all major cancers. Malpractice claims alleging “failure to diagnose oral cancer” often are the most difficult to defend and are the most expensive of all dental claims. An analysis of Physician Insurer’s Association of America (PIAA) closed-claim data reveals oral cancer claims are on the rise nationwide. Indefensible cases fall into three categories: failure to follow up on a lesion with marginal clinical suspicion (most often a failure to biopsy); failure to re-examine a lesion and the patient’s medical history; and office-systems failure, allowing a patient or diagnostic reports to slip through the cracks. Dentists should view all lesions, lumps and bumps as possible cancer. Although most lesions are benign, squamous cell carcinoma often is found on the mucosa – facilitating the argument that diagnostic measures are readily available. Closely monitor patients who have suspicious lesions until a definitive diagnosis is made. Thoroughly document possible traumatic origin of a lesion. When patients explain a suspicious clinical sign or symptom, get “ proof” and consider a biopsy. Institute a fail-safe follow-up system. Refer patients to a specialist for further diagnostic workup or care, and send a consultation request to promptly facilitate the referral. Include the referral process in your follow-up [...]

1/8/2006 Annapolis, MD Wendi Winters The Capital Online (www.hometownannapolis.com) Hopping into the chair in the dentist's office might be a less-than-thrilling way to spend an afternoon, but for some it could be the difference between life and death. That message struck uncomfortably close to home for Dr. Vernon Sheen the day he found a lump inside a patient's mouth.The patient was his own 74-year-old father, Shuh-ji Sheen. Mr. Sheen had dropped by Annapolis Center for Dental Health and Wellness for a quick checkup from his son while in town on vacation. Some vacation. "The lump was bigger than a grape, and he didn't even know it was there," says Dr. Sheen in amazement. "It was something he'd gotten used to. It was a benign tumor in that soft spot right under the tongue. I sent him to an oral surgeon right away." He may have saved his dad's life. Turns out, dentists are looking for more than cavities these days when they say, "Open wide!" "Nick Petrinko, my dental hygienist, and I are so careful to look inside people's mouths, especially those of smokers or people who might drink to excess," says Dr. Sheen. He recalls another patient who, when asked to open up, exposed an inner check "so eroded it looked like a 'Blooming Onion' from the Outback Restaurant. It was a really bad case of mouth cancer. We sent him to an oncologist immediately. He'd either gotten used to it or thought it would just go away. He'd [...]

1/5/2006 Alexandria, VA RF Ozols et al. J. Clin. Oncol., January 1, 2007; 25(1): 146-62 A Message from the ASCO's President: For the second consecutive year, the American Society of Clinical Oncology (ASCO) is publishing Clinical Cancer Advances: Major Research Advances in Cancer Treatment, Prevention, and Screening, an annual review of the most significant cancer research presented or published over the past year. ASCO developed this report to demonstrate the enormous progress being made on the front lines of cancer research today. The report is intended to give all those with an interest in cancer care-the general public, cancer patients and physicians, policymakers, oncologists, and other medical professionals-an accessible summary of the year's most important cancer research advances. These pages report on new targeted therapies that are improving survival and response rates in hard-to-treat cancers such as kidney cancer, HER-2-positive breast cancer, head and neck cancer, and chronic myelogenous leukemia; the FDA's approval of the world's first preventive vaccine for human papillomavirus (HPV), which has the potential to dramatically reduce the global burden of cervical cancer; and advances in the fast-growing field of personalized medicine, including a new lung cancer test that could help physicians better target treatments and predict prognosis. These advances are only part of the landscape. Survival rates are on the rise, the number of cancer deaths in the United States began declining for the first time since 1930, and new research is showing that the rates of certain common cancers, such as those of the breast [...]

1/5/2006 New York, NY Ellen Simon cantonrep.com Margot Morrell viewed her 2004 ovarian cancer diagnosis as a challenge. “From the minute I was diagnosed, my focus was completely on how do I get over this as fast as possible so I can get back to work,” said Morrell, an author and speaker. More than one-third of the women in America and almost half the men will be diagnosed with cancer sometime in their lives, and for many, the diagnosis will come while they’re working — literally. Many patients hear the diagnosis for the first time when their doctor phones at work. Most continue working while they’re treated. According to a study of 1,433 cancer patients ages 25 to 62 published in the journal “Cancer,” about 59 percent of men and 61 percent of women continued working during cancer treatment. Of those who stopped working, most returned to work the first year after treatment. “Most people want to keep working,” said Barbara Hoffman, a founding board member of the National Coalition for Cancer Survivorship. “Most people, if they are really not able to work will say, ‘I can’t come in this week, or this month, or these four months,’ but they really want to reintegrate to work when they are able to.” Health Insurance Factor One reason: Health insurance. Cathy J. Bradley, of the Massey Cancer Center at Virginia Commonwealth University in Richmond is studying cancer treatment and work. She found that 38 percent of prostate cancer patients said they kept [...]

1/4/2006 Bethesda, MD Vicki Brower Journal of the National Cancer Institute, Vol. 98, No. 1, 9-11, January 4, 2006 In October, the National Cancer Institute made its first nanotechnology research awards worth $33.3 million to 12 research groups and seven hubs. A month later, at the Molecular Targets and Cancer Therapeutics meeting in Philadelphia, a press conference devoted exclusively to nanotechnology highlighted several experimental studies using nanoparticles, including a liposome–nanoparticle gene therapy designed to home in on and kill cancer cells wherever they are throughout the body. Nanotechnology's potential application to cancer seems to be in the news almost weekly, with new uses of the technology for diagnosis and treatment moving rapidly from the lab toward clinical trials. But along with several promising discoveries have come unanswered questions about nanotechnology's safety for human health and the environment. Since the discovery of carbon nanotubes and their unusual properties in 1991, the hope for and hype of nanotechnology's potential to better diagnose and treat cancer have blossomed. In September 2004, the NCI initiated a comprehensive 5-year, $144.3 million research effort, the Alliance for Nanotechnology in Cancer, to develop and translate cancer-related nanotechnology research into clinical practice. Its first awards were $7 million to the Cancer Nanotechnology Platform Partnerships and $26.3 million to seven Centers of Cancer Nanotechnology Excellence, and they span a wide range of technologies and cancer types. Projects funded include developing applications to treat multidrug-resistant tumors, early cancer detection using nanoprobes targeted to angiogenic signatures, DNA-linked dendrimer nanoparticles for diagnosis [...]

1/3/2006 Fort Lee, NJ staff BusinessWeek Online (www.businessweek.com) Researchers have learned caution, and some of the early results are promising. When Matthew During and Michael Kaplitt first went hunting for capital to commercialize their research in gene therapy, their timing couldn't have been worse. It was the fall of 1999, just after teenager Jesse Gelsinger died in a clinical trial of gene therapy -- the use of genes to deliver medicines to diseased cells. Together, During and Kaplitt were able to scrape up an initial $2.5 million. "Maybe we were arrogant to think we could start something at that time," Kaplitt concedes. Today, the two physician founders of Neurologix Inc., in Fort Lee, N.J., are feeling much more upbeat. They're searching for $10 million to fund a pivotal trial in Parkinson's disease, and they expect to find it. Others are also prospecting in the once-neglected field of gene therapy. On Nov. 7, Colgate-Palmolive Inc. (CL ) invested $20 million in Austin-based Introgen Therapeutics Inc. (INGN ), which is pursuing novel remedies for oral cancer. And the Michael J. Fox Foundation is about to award its first ever grant for gene therapy research. The $750,000 will go to San Diego-based Ceregene Inc. (CEGE ), which, like Neurologix, is zeroing in on a treatment for Parkinson's, the disease that afflicts actor Fox. Ceregene also raised $32 million in venture capital last year. Recent success stories in clinics and labs add to the sense that gene therapy is moving back into the mainstream. [...]

1/3/2006 South Carolina Thomas Walle et al. Drug Metab. Dispos., December 28, 2005 Oral cancer, originating from smoking-induced lesions of the basal cells in the complex stratified oral epithelium, is difficult to treat. Early detection of premalignant lesions, e.g., leukoplakia, has suggested the possibility of chemopreventive measures, such as topical application of antimutagenic/antiproliferative dietary or pharmaceutical agents. As an extension of a study in human oral epithelial cell monolayers, we determined carcinogen, i.e. benzo[a]pyrene (BaP), transport, bioactivation and DNA binding in a bioengineered human gingival epithelial tissue construct and the chemopreventive effects of dietary polyphenols. Short-term experiments showed that both types of compounds can traverse this tissue as well as be effectively taken up by the tissue. The model cigarette smoke carcinogen BaP very slowly, but to a great extent, accumulated in the tissue with maximal uptake at 24 h. Such exposure clearly resulted in DNA binding of BaP by the tissue. This DNA binding was associated with BaP-induced cytochrome P450 (CYP) 1B1 as well as CYP1A1 expression, as evidenced by mRNA measurements. Co-treatment of the oral tissue with dietary polyphenols, including resveratrol and quercetin, and BaP, resulted in significant inhibition of the BaP-DNA binding. Using fluorescence microscopy as well as simultaneous autoradiography, we also demonstrated that quercetin indeed penetrates the entire stratified tissue layer, but that quercetin was also oxidized within the cells. Thus, this bioengineered oral tissue construct opens up improved ways of understanding and preventing/treating smoking-induced oral cancer. Authors: Thomas Walle, U Kristina Walle, David Sedmera, and [...]

1/3/2006 Copenhagen, Denmark press release PRNewswire (www.prnewswire.com) Genmab A/S announced today that HuMax-EGFr has been designated a Fast Track Product by the US Food and Drug Administration (FDA). This designation covers patients with head and neck cancer who have previously failed standard therapies. Genmab presented positive results from the Phase I/II study of HuMax-EGFr in May 2005. Fast Track Product status allows the FDA to facilitate the development and expedite the review of a drug if it is intended for the treatment of a serious or life-threatening condition, and if it demonstrates the potential to address unmet medical needs for such a condition. This fast track designation gives Genmab the opportunity to submit a Biologics License Application (BLA) in sequential sections, and have these sections reviewed as they are submitted, thus saving development time. A BLA is the biologic products' equivalent to a New Drug Application and is the final stage before a drug is approved for the market by the FDA. Fast track status also opens the possibility for receiving a priority review or accelerated approval of the BLA where the review time would be halved to just 6 months. "We are very pleased that HuMax-EGFr has been designated a Fast Track product and is now poised to move forward to pivotal studies which we hope to begin this year," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. About HuMax-EGFr HuMax-EGFr is a fully human, high-affinity antibody targeted at the Epidermal Growth Factor receptor (EGFr). EGFr is [...]

1/3/2006 Baltimore, MD Britt C Reid, R Gary Rozier Oral Oncol, December 20, 2005 This study investigated whether receiving continuous regular care with the same primary care provider had an independent association with stage at diagnosis for head and neck cancers (HNCA) in a Medicare population. The study database (N=10,662) linked files from the Surveillance, Epidemiology, and End Results Program 1991-2000 for patients with cancers of the oral cavity, pharynx, and larynx with their files from the Center for Medicare and Medicaid Services Program. Continuity of care displayed a statistically significant independent association and dose-response pattern with stage at diagnosis when the provider was an internist but not a general or family physician. An independent statistically significant association between continuity of care with an internist and stage at diagnosis was found for oral cavity tumors (adjusted odds ratio [AOR]=0.85; 95%CI=0.73-0.99), but not pharyngeal tumors (AOR=1.02; 95%CI=0.74-1.41). Laryngeal tumors were borderline statistically significant at p-value=0.07 (AOR=0.84; 95%CI=0.69-1.02). Regular continuous care from the same primary care provider displayed an independent association with early diagnosis of HNCA when the anatomic site was the oral cavity and the provider was an internist, but not when the provider was a general or family physician. Primary care physicians including general/family physicians may represent a relevant group for encouraging increased opportunistic HNCA screening efforts among their patients. Authors affiliation: Department of Health Promotion and Policy, Health Services Research Program, Room 3A-08, School of Dentistry, University of Maryland