FDA approves Strativa Pharmaceuticals’s Oravig(TM) buccal tablets for treatment of oropharyngeal candidiasis

Source: www.biospace.com Author: press release Strativa Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Oravig (miconazole) buccal tablets for the treatment of oropharyngeal candidiasis (OPC), more commonly known as thrush, in adults and children age 16 and older. Oravig is the first and only local, oral prescription formulation of miconazole – an antifungal medication – approved for this use in the U.S. Oravig, which adheres to the gum, utilizes innovative buccal tablet technology enabling once-daily dosing that delivers miconazole directly at the local site of infection throughout the day with minimal systemic absorption. Oravig is easy-to-use and provides patients with a flavorless, odorless and convenient treatment option that does not interfere with daily activities such as eating and drinking. Oravig will be offered in a 50 mg dosage strength and is expected to be available in retail pharmacies in the third quarter of 2010. "The FDA approval of Oravig underscores Strativa's commitment to improving patients' overall treatment experience by bringing to market new products that fulfill patient needs," said John A. MacPhee, President, Strativa Pharmaceuticals. "Oravig offers patients suffering from thrush a proven effective treatment in a discreet and convenient once-daily formulation." The FDA approval was based on two pivotal Phase III clinical trials. The first study demonstrated that Oravig completely resolved signs and symptoms of OPC at rates similar to Mycelex® Troche (clotrimazole) administered five times per day in HIV-positive patients. This randomized, double-blind, double-dummy trial was conducted in 577 HIV-positive patients in 28 [...]

Free screening for head and neck cancer

Source: www.komu.com Author: Alyson Myles Doctors examined hundreds of Mid-Missourians at the Ellis Fischel Cancer Center today. The free cancer screenings were a part of national Head and Neck Cancer Awareness Week. The screenings were a part of a walk-in clinic, so appointments were not necessary. The National Cancer Institute estimates that 50,000 Americans have some form of head or neck cancer. Ear, nose and throat doctor at the Ellis Fischel Cancer Center Jeff Jorgensen said 85% of of head and neck cancers are related to tobacco use. "The bottom line is we are trying to get people to stop smoking. And stop using any tobacco products for that matter," Jorgensen said. Norman Larson was one of the 150 people who attended the screening. He was a smoker during his young adult life, but was not concerned that he had cancer. He came to the screening because he was in Columbia visiting his mother. "It was more curiosity than anything. Any sort of screening I think is a good idea espcially if it finds something early," Larson said. If a doctor did find anything suspicious during the screenings, the patient could make an appointment to come in for a more thorough exam. Some symptoms of head and neck cancer are: * A sore in your mouth that doesn't heal or increases in size * Persistent pain in your mouth * Lumps or white, red or dark patches in your mouth * Thickening of your cheek * Difficulty chewing or swallowing [...]

Accelerated schedule of radiotherapy for HNSCC is more effective than conventional fractionation

Source: Lancet Oncology 4-2010 Author: Staff An accelerated schedule of radiotherapy for squamous-cell carcinoma of the head and neck (HNSCC) is more effective than conventional fractionation, and since it does not require additional resources it might be a suitable new global standard baseline treatment for radiotherapy of HNSCC, according to a study published online April 9 in the Lancet Oncology. The findings of the study called the International Atomic Energy Agency (IAEA) trial showed that accelerated radiotherapy (increasing the number of treatments from five to six a week) prevented local disease recurrence and improved disease-free survival, with no increase in late radiation-induced side-effects, in HNSCC patients in resource-limited settings. Jens Overgaard, MD, chief of the experimental clinical oncology department at Aarhus University Hospital in Denmark and international colleagues from Asia, Europe, the Middle East, Africa and South America recruited 908 patients with HNSCC of the larynx, pharynx and oral cavity who were eligible for curative radiotherapy from Jan. 6, 1999 to March 31, 2004. Patients were randomly assigned to an accelerated schedule of six fractions of radiotherapy per week of 2 Gy (458 patients) or to a conventional radiotherapy schedule of five fractions per week of 2 Gy (450 patients), up to a total dose 66-70 Gy in 33-35 fractions, according to Overgaard and colleagues. The median treatment time was 40 days in the accelerated group and 47 days in the conventional group. Five year locoregional control was 12 percent better in patients given the accelerated regimen (42 percent) compared with [...]

2010-04-16T11:09:55-07:00April, 2010|Oral Cancer News|

HPV-Positive head and neck cancer: favorable prognosis does not lead to clear choices for changes in treatments

Source: OncologyStat Author: Thomas F. Pajak CHANDLER, Ariz. (EGMN) - Human papillomavirus infection is clearly a prognostic factor in patients with head and neck cancer. But whether HPV status can be used to guide treatment decisions is far from clear, according to speakers at a head and neck cancer symposium sponsored by the American Society for Radiation Oncology. The Investigator's Perspective Across trials that tested different regimens in heterogeneous populations with head and neck cancer, patients with HPV-positive disease have had at least a one-half reduction in the risk of death, relative to their counterparts with HPV-negative disease, began Dr. Maura L. Gillison, a professor of medicine and epidemiology at Ohio State University in Columbus. "Clearly, HPV tumor status is prognostic," she said, citing multiple factors that might explain why HPV-positive patients have better survival outcomes. Certain attributes that track with HPV positivity - better performance status, younger age, lower T stage, and absence of anemia - are also favorable prognostic factors, she noted. And HPV positivity confers a better response to both radiation therapy and induction chemotherapy. In addition, data from the RTOG (Radiation Therapy Oncology Group) 0129 trial of chemoradiation show that HPV-positive patients are less likely than their HPV-negative peers to experience a locoregional failure and to develop second primaries, although rates of distant metastases are similar. "What we can conclude at this point is that the relative survival for the HPV-positive patient appears independent of therapy, as long as that therapy is within the standard of [...]

2010-04-19T22:22:16-07:00April, 2010|Oral Cancer News|

Congress urges major league baseball to ban smokeless tobacco

Source: Associated Press Author: Howard Fendrich WASHINGTON — After hounding Major League Baseball and its players union over steroids, Congress now wants the sport to ban smokeless tobacco. "Good luck," San Francisco Giants reliever Brandon Medders said. "Guys do what they do. We work outside. It's been part of the game for 100 years." At a hearing Wednesday, House Energy and Commerce Committee chairman Henry Waxman, a California Democrat, and Health Subcommittee chairman Frank Pallone, a New Jersey Democrat, called on baseball and its players to agree to bar major leaguers from using chew, dip or similar products during games. MLB executive VP Robert Manfred and MLB Players Association chief labor counsel David Prouty told lawmakers they agree that smokeless tobacco is harmful — Manfred said a ban in the majors is "a laudable goal" — but both pointed out that any ban would have to be agreed to through collective bargaining. They said their sides are willing to discuss the topic during future negotiations; baseball's labor contract is due to expire in December 2011. "I can tell you, anecdotally, there are plenty of players who are against it, who think, 'Of course it should be banned.' There are plenty of players who use it. Do they think it should be banned? I don't know," the union's Prouty said in an interview after the 3 1/2-hour hearing. "We can go back to the players and say, 'Congress feels strongly about this. You ought to think about it. Look what's happened [...]

2010-04-19T22:22:51-07:00April, 2010|Oral Cancer News|

As if disease is not enough; another cancer battle has to be fought. Costs

Source: online.wsj.com/ Author: Laura Landro Cancer patients can turn to support groups when dealing with the rigors of treatment. It's far more difficult to get help with the growing financial burdens of care. The new health-care legislation contains some provisions that aim to help cancer patients and survivors in the future, including limits on out-of-pocket costs, insurers who impose caps on benefits and premiums for patients with pre-existing conditions. But some provisions won't fully kick in for four years. In the meantime, patient advocacy groups are stepping up programs to help identify patients under duress from financial woes and steer them to help. The Patient Access Network and four other non-profit groups that help insured patients with all or part of co-payments for medications paid out a total of $274.7 million last year, an increase of 52.7% over the previous year. Applications for aid rose more than 26% in the same period. The groups, which are funded by drug companies, foundations and private donations, provide grants of up to $10,000 per year to qualified patients, according to Julie Reynes, president of the Patient Access Network. The Cancer Support Community last year introduced a new guide, "Coping with the Cost of Care," and is piloting a program to screen cancer patients in hospitals and clinics around the country for emotional and financial problems in order to identify those who need referrals to mental-health counselors and financial-assistance resources. "There are many resources to help, but this information isn't getting out to patients [...]

Nutritional sciences investigator wins NIH challenge grant

Source: uanews.org (University of Arizona) Author: Jeff Harrison Kirsten Limesand's research focuses on how to restore salivary gland function in cancer patients. Each year approximately 40,000 people in the U.S. are diagnosed with some form of head and neck cancer. The majority of those patients will have surgery to remove the tumors, followed by one or more rounds of radiation therapy to kill any lingering cancer cells. A common side effect of radiation to this area is damage to the adjacent, normal salivary glands. Patients commonly experience a dry mouth that can lead to oral sores and infections, cavities, difficulty chewing and swallowing food and loss of taste. Kirsten Limesand, an assistant professor of nutritional sciences in the University of Arizona College of Agriculture and Life Sciences, has received a two-year NIH Challenge Grant worth nearly $1 million to study this problem. Specifically, Limesand is examining the role of autophagy in salivary glands in response to radiation therapy. Autophagy is an ongoing process where cells digest and recycle their proteins and organelles. This helps starving cells break down and redirect components from non-essential to essential cell functions. The process and the mechanics behind it are not well understood, but autophagy appears to have some role in preventing and fighting disease and infection. It also, in some cases, could make those problems worse. Side effects from radiation therapy begin within a few days and can continue for one to two years. Because saliva is essential for maintaining oral health, salivary gland [...]

Comparing the HPV vaccines

Source: www.hemonctoday.com Author: Debbie Blamble, PharmD, BCOP HPVs are double-stranded DNA viruses that affect epithelial cells. More than 100 strains of HPV have been detected. Approximately 40 strains are known to infect genital mucosa, of which about 15 strains are known to cause cancer. HPV types 16 and 18 are the most common cancer-causing strains, leading to about 70% of all cervical cancer cases worldwide. HPV types 6 and 11 are associated with about 90% of all cases of genital warts. Cervical intraepithelial neoplasia is an abnormality of the cervical epithelium associated with HPV infection and is thought to be a precursor to cervical cancer. CIN is classified into three grades: 1, 2, 3. With CIN-1, mild dysplasia is present and affects only the lowest third of the cervical epithelium; 70% to 90% of CIN-1 lesions undergo spontaneous regression. CIN-2 and CIN-3 show moderate to severe dysplasia and affect the lowest two-thirds to full thickness of the cervical epithelium, respectively. More than half of CIN-2 and CIN-3 cases are estimated to persist or progress to squamous cell cancer. Persistent HPV infection may also lead to cervical adenocarcinoma in situ. In the United States, screening with the Pap test identifies these precancerous lesions and has led to a decrease in the rates of cervical cancer. These precancerous lesions may develop less than five years after HPV infection. HPV infection HPV infection is most frequently acquired through sexual contact. It is estimated that more than 80% of men and women in the [...]

Smoking-attributable cancer mortality in California, 1979–2005

Source: Tob Control 2010;19:i62-i67 doi:10.1136 Author: David W Cowling1, Juan Yang2 Background: The adult smoking prevalence has declined more in California than the rest of the US in the past 2 decades. Further, California has faster declines in cancer mortality, lung cancer incidence and heart disease mortality. However, no study has examined smoking-related cancer mortality between California and the rest of the US. Methods: The smoking-attributable cancer mortality rate (SACMR) from 1979 to 2005 in California and the rest of the US are calculated among men and women 35 years of age or older using the Joinpoint regression model to calculate the SACMR annual percentage change. The SACMR is the sum of the smoking-attributable death rates of 10 smoking-attributable cancers. Results: The SACMR has declined more in California (25.7%) than the rest of the US (8.9%) from 1979 to 2005. California men had a lower SACMR than the rest of the US over the entire study period, with the difference tripling from 7.4% in 1979 to 23.9% in 2005. The difference of female SACMR between California and the rest of the US went from 17.9% higher in 1979 to 13.4% lower in 2005. Conclusions: California's SACMR decrease started 7 years earlier than the rest of the US (1984 vs 1991), and California experienced an accelerated decline of SACMR compared to the rest of the US overall and among men and women from 1979 to 2005. Although the SACMR started declining before the creation of the California Department of Public Health, [...]

Sylvester surgeons perform first removal of throat cancer in south Florida using surgical robot

Source: www.healthcanal.com Author: staff Surgeons from the Department of Otolaryngology at UHealth – the University of Miami Health System have performed the first removal of throat cancer in South Florida using a surgical robot. The operation was performed March 22nd at the University of Miami Hospital by Francisco Civantos, M.D., associate professor of otolaryngology and member of the Head and Neck Cancer Site Disease Group at Sylvester Comprehensive Cancer Center, and Giovana Thomas, M.D., associate professor of otolaryngology and member of the Head and Neck Cancer Site Disease Group at Sylvester. They were accompanied by Raymond J. Leveillee, M.D., professor of urology, who is an experienced urologic robotic surgeon. Traditional surgery for various head and neck cancers requires large incisions – extending from the lip, across the chin and to the neck before entering the mouth or throat. Numerous times surgeons need to cut through the lower jaw and move aside vital nerves to gain access to the back of the mouth and throat. By using the da Vinci® Surgical System, surgeons insert the slender instruments into the mouth to reach the base of the tongue, tonsils, and throat. "As a surgeon," says Civantos, "using a surgical robot allows for greater precision and dexterity to remove cancerous tumors from tight spaces in the mouth and throat." The University of Miami Hospital's da Vinci® System consists of robotic arms that replicate a surgeon's motions. Throughout a robot-assisted surgery, patients are positioned as they would be during laparoscopic surgery, with surgical team [...]

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