GSK Initiates First Global Phase III Study of TYKERB(R) (lapatinib) in Head and Neck Cancer

2/26/2007 Barcelona, Spain press release PRNewswire (www.prnewswire.com) GlaxoSmithKline (GSK) today announced the start of an international Phase III trial of its investigational cancer treatment TYKERB(lapatinib) in squamous cell carcinoma of the head and neck (SCCHN). This announcement coincided with the International Meeting on Innovative Approaches in Head & Neck Oncology, Barcelona, Spain, February 22-24 supported by the European Society for Therapeutic Radiology and Oncology (ESTRO), where GSK presented results from a Phase I study of lapatinib in SCCHN. Lapatinib is an investigational drug that is not yet approved for marketing by any regulatory body. This large adjuvant trial will compare the effectiveness of oral lapatinib versus placebo given in high-risk patients following surgery. SCCHN is the sixth most common cancer worldwide (1): 600,000 people are diagnosed with SCCHN annually (1), 40,000 in the United States (2) and 100,800 in Europe alone.(3) 40,000 people die from the disease every year.(3) The design of this Phase III trial was based on recent results from two large-scale, independent randomized studies which have established the addition of chemotherapy to radiation therapy as the new standard of care in the post-operative treatment of high-risk SCCHN patients with additional use of chemotherapy.(4, 5) However, research suggests that approximately one quarter to one third of advanced head and neck cancers that are primarily treated with surgery and radiation therapy come back following treatment.(4, 5) "The initiation of this trial represents another exciting step towards understanding the role of lapatinib in other tumor types beyond breast cancer," says [...]

2009-04-14T11:37:39-07:00February, 2007|Archive|

More Teens Are Saying, ‘Have a Cigar’

2/26/2007 Atlanta, GA staff Atlanta Journal-Constitution (ajc.com) Slowly but surely, American kids have gotten the message that cigarette smoking is stinky, smelly and a hazard to your health. Now, if only they would believe the same about cigars. While cigarette consumption declined in the United States by 10 percent from 2000 to 2004, cigar consumption jumped 28 percent, according to a recent report published in the American Journal of Public Health. Other studies have found that teens who smoke cigars are definitely behind some of that increase. For instance, a 2004 survey conducted in Cleveland found that 23 percent of the 4,409 teens polled preferred cigars, compared to 16 percent choosing cigarettes. And the increase may not yet have peaked, said John Banzhaf, executive director of Action on Smoking and Health, a national legal action anti-smoking organization based in Washington, D.C. "Many of the factors that began leading to the [cigar] increase are still present," Banzhaf said. They include the perception that cigars look fashionable and the fact that high-profile politicians and others are seen smoking them regularly, he said. "We have Arnold (Schwarzenegger, California's governor), smoking cigars and occasionally, Bill Clinton," he said. "More and more women are smoking cigars." But it's not just politicians and women who are fueling the image that cigars are hip, said Scott Goold, director of Tobacco Freedom, an Albuquerque, N.M.-based group. "Our popular culture is filled with images of cigars," he said. Your neighbor passes them out, for instance, when the family has [...]

2009-04-14T11:37:06-07:00February, 2007|Archive|

Glaxo cancer drug

2/25/2007 London, England Katherine Griffiths Telegraph.co.uk GlaxoSmithkline will start an advanced trial of its experimental breast cancer drug to test its efficacy against tumours in the head and neck. GSK has filed Tykerb for approval with America's Food and Drug Administration and European regulators as a breast cancer drug. A decision by the FDA is expected on March 13 and in Europe in September. Analysts and doctors believe it will experience the same levels of demand as Herceptin, which is now widely available on the NHS after patients sued their local primary care trusts to get access to the drug. As well as looking highly effective against certain forms of breast cancer, Tykerb has shown early signs of combating other forms of cancer, such as brain tumours. Analysts believe Tykerb will fall into the category of blockbuster drugs, with sales of more than £500m. GSK, headed by chief executive Jean-Pierre Garnier, announced last night it would start a Phase III trial in patients who have just had surgery, giving them the drug in the hope it will stop another tumour from growing. GSK presented data at a medical meeting in Barcelona at the end of last week from a Phase I study. The drug taken jointly with chemotherapy and radiotherapy had a positive response in 89pc of patients. Paolo Paoletti, vice president of GSK's Oncology Development Centre, said: "Having already shown such promise as a breast cancer treatment, we are excited to continue investigating lapatinib [Tykerb]. "We think it may [...]

2009-04-14T11:36:39-07:00February, 2007|Archive|

Surgeons blast cancer hold-ups that can kill

2/25/2007 London, UK staff This London (www.thisislondon.co.uk) Cancer patients are having to wait months beyond recommended dates for treatment to prevent the disease returning, say frustrated consultants. After tumours are removed by surgery, patients should get follow-up radiotherapy within 28 days, according to Royal College of Radiologists guidelines. But in many areas the wait is much longer. In Kent, for instance, the waiting time for breast cancer patients is at least three months. Three patients have seen the disease return during the long gap between operation and radiotherapy. Peter Jones, consultant surgeon in Maidstone, says: 'We believe that it's totally unacceptable.' Explaining why he is going public with news of the situation on tomorrow night's Channel 4 Dispatches programme, NHS: Where Did All The Money Go?, he says: 'We have been left with no alternative but to bring this to the attention of the media.' He is backed by Dr David Dodwell at Cookridge Hospital in Leeds, who says: 'Delayed radiotherapy for a range of cancers increases the risk of local recurrence and other problems. That's in head and neck cancers and sarcomas, cervix cancer and lung cancer, as well as breast cancer.' Five UK radiotherapy units have an average wait of 28 days, which means many patients are waiting longer. In two centres, more than three-quarters of patients are missing the 28-day window. But although the Department of Health has set targets for initial cancer treatment, there is none set for post-operative therapy. Shadow Health Minister Mike Penning said: [...]

2009-04-14T11:35:49-07:00February, 2007|Archive|

Dying to build

2/25/2007 Toronto, Ontario, Canada Paul Taylor Globe and Mail (www.theglobeandmail.com) Construction workers have double the risk of the general population of developing head, neck and esophageal cancers, according to a landmark study by Canadian researchers. "They work in dusty environments and are exposed to all kinds of hazardous substances," said lead researcher James Brophy, executive director of the Occupational Health Clinics for Ontario Workers. "We actually know from other studies that workers -- particularly construction workers -- are bearing an elevated risk for a whole range of cancers." The new study, based on data gathered through the Windsor Regional Cancer Centre, is one of the first to focus on head, neck and esophageal cancers. It is being published todayin the International Journal of Occupational and Environmental Health. Head and neck cancers primarily involve the upper respiratory passages, such as the nose, mouth and throat. The esophagus is the hollow, muscular tube that carries food and liquids from the throat to the stomach. Among other potentially harmful chemicals, those in the construction trades can come into contact with asbestos and silica -- two well-known carcinogens -- when working in older buildings. Dr. Brophy, who holds an academic post at the University of Windsor, said very little research is now being done to measure the link between different jobs and cancer risks. That means "there is no way to identify potential populations at risk and to do something to try to prevent these exposures."

2009-04-14T11:35:26-07:00February, 2007|Archive|

Antibody Signal May Redirect Inflammation To Fuel Cancer

2/21/2007 San Francisco, CA staff BioCompare News (news.biocompare.com) As evidence mounts that the body's normally protective inflammation response can drive some precancerous tissues to become fully malignant, UCSF scientists report discovering an apparent trigger to this potentially deadly process. Typically, the "innate" immune system's Pac-Man-like white blood cells, or leukocytes, engulf and destroy invading microbes when receptors on their surface receive a signal from serum in the blood --often an antibody produced by a B cell in the separately evolved "acquired" immune system. Now UCSF researchers have found that in the presence of precancerous tissue, leukocyte antibody receptors can also be activated to turn on a dangerously different program: inducing leukocytes to boost cell growth, increase the number of blood vessels and "remodel" tissue in the area -- all of which help cancer develop. The finding adds a critical and surprising detail to the emerging view that inflammation, usually a helpful response to invading pathogens, can become misdirected and fuel cancer. The new research was presented today (February 19) by UCSF scientist Lisa M. Coussens, PhD, at the annual meeting of the American Association for the Advancement of Science (AAAS) in a session titled "healthy aging: inflammation and chronic diseases." "Immunologists have known for decades that B cells of the so-called adaptive or acquired immune system are activated following a bacterial infection and in response, produce antibodies that signal leukocytes to attack," said Coussens, associate professor of pathology in the UCSF Cancer Research Institute. "But in precancerous tissue in mice, [...]

2009-04-14T11:34:31-07:00February, 2007|Archive|

Smokers Who Switch to Oral Tobacco Still at Risk

2/21/2007 web-based article staff www.emaxhealth.com An American Cancer Society study of more than 116,000 men finds that cigarette smokers who switched to spit tobacco products had a higher risk of dying prematurely from tobacco-related diseases than former smokers who stopped using all forms of tobacco. The study is the first to compare death rates among those who quit using tobacco entirely with those who switch (switchers). Previous studies have examined morbidity and mortality among the two groups separately but have not compared them. In the United States, tobacco use is responsible for one in five deaths, and an annual toll of 438,000 deaths. Smoking accounts for at least 30 percent of all cancer deaths, and is associated with increased risk for 15 types of cancer. It is also a major cause of heart disease, cerebro-vascular disease, chronic bronchitis and emphysema and is associated with gastric ulcers. In 2003, about three percent of U.S. adults used spit tobacco in the past month. In the new study, Jane Henley, MSPH, and colleagues from the American Cancer Society and Centers for Disease Control and Prevention's Office on Smoking and Health used data from the massive Cancer Prevention Study II (CPS-II) to compare tobacco-related disease among male smokers who quit using tobacco entirely to men who quit smoking cigarettes but switched to using spit tobacco. The authors also compared mortality rates of men who never used any tobacco products to those of switchers and smokers who quit using tobacco entirely. The study's principal finding [...]

2009-04-14T11:33:59-07:00February, 2007|Archive|

Enteral nutrition support of head and neck cancer patients

2/19/2007 New York, NY A Raykher et al Nutr Clin Pract, February 1, 2007; 22(1): 68-73 Patients with head and neck cancer are at high risk for malnutrition due to dysphagia from the tumor and treatment. Despite difficulty with oral intake, these patients usually have a normal stomach and lower gastrointestinal tract. Enteral nutrition support via percutaneous endoscopic gastrostomy (PEG) administered in the home by the patient helps to prevent weight loss, dehydration, nutrient deficiencies, treatment interruptions, and hospitalizations. It also improves quality of life. Successful management of these patients requires orderly care and follow-up by a multidisciplinary nutrition team. Authors: A Raykher, L Russo, M Schattner, L Schwartz, B Scott, and M Shike Author's affiliation: Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY

2009-04-14T11:33:31-07:00February, 2007|Archive|

Ruling may impact FDA’s authority

2/19/2007 Springfield, MA Robert Cohen The Republican (www.masslive.com) Abigail Burroughs fought head and neck cancer for 18 months, desperately seeking access to promising experimental drugs after chemotherapy and radiation therapy failed. She was unable to get into a clinical trial for ImClone's now widely available Erbitux, because it was for colon cancer patients only, and she failed to meet the clinical trial inclusion criteria for Iressa, an AstraZeneca cancer drug that later proved largely unsuccessful. At the end of May 2001, Burroughs was finally accepted into a clinical trial for OSI Pharmaceutical's subsequently approved cancer drug Tarceva, but she was too ill to travel from Virginia to the Texas testing site. She died two weeks later at age 21. "It was a horrible, horrible nightmare. When your child is terminally ill, you want to do everything you can," said her father, Frank Burroughs of Fredericksburg, Va. "People just want a chance to live when they are facing death." Burroughs soon formed the Abigail Alliance, an organization dedicated to helping cancer patients and others with life-threatening illnesses break down barriers imposed by the Food and Drug Administration and the pharmaceutical industry to obtaining potentially helpful experimental drugs outside the clinical trial setting. His relentless campaign has resulted in a court ruling that threatens to shake the foundations of the FDA's regulatory authority covering pharmaceuticals and lead to greatly expanded use of unapproved medications that haven't been fully tested for safety or effectiveness. The legal battle, ironically, comes as medical experts, members [...]

2009-04-14T11:32:56-07:00February, 2007|Archive|

Oral Cancer Cases to Increase 11 Percent This Year

2/13/2007 Phoenix, AZ press release Yahoo News (news.yahoo.com) Zila, Inc. noted with dismay that while the American Cancer Society (ACS) celebrated new data with a headline "Cancer Deaths Down for Second Year", the same data showed a marked increase in the number of expected new cases and deaths due to oral cancer. "The ACS data, published in 'Cancer Facts & Figures 2007', projects 34,360 new cases of Oral Cavity & Pharynx Cancer - a remarkable 11 percent increase over the 30,990 cases that ACS projected for 2006, and a 20 percent increase among males," notes Frank Bellizzi, president of Zila Pharmaceuticals, Inc., marketer of the ViziLite® Plus with TBlue630 system for the early detection of oral abnormalities that could lead to cancer. Nearly as many women will be diagnosed with oral cancer as with cervical cancer this year. ACS projects that total deaths due to oral cancer will rise nearly two percent to 7,550 in 2007, from 7,430 in 2006. "As the ACS celebrates a decline in many cancers," Dr. Bellizzi added, "it is critical to note that oral cancer remains a common cancer type in men, and a critical threat to women. Early detection is the key to reducing death and minimizing the quality-of-life impact of this insidious disease. As the ACS reports, the 5-year survival rate when oral cancer is detected early is 81.3 percent, but late detection results in a survival rate of only 26 percent. "Dentists across America are moving rapidly to adopt the three-minute, non-invasive, [...]

2009-04-14T11:32:17-07:00February, 2007|Archive|
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