12/21/2004 Djillali Annane et al. Journal of Clinical Oncology, Vol 22, No 24 (December 15), 2004: pp. 4893-4900 Purpose: To determine the efficacy and safety of hyperbaric oxygen therapy (HBO) for overt mandibular osteoradionecrosis. Patients and Methods: This prospective, multicenter, randomized, double-blind, placebo-controlled trial was conducted at 12 university hospitals. Ambulatory adults with overt osteoradionecrosis of the mandible were assigned to receive 30 HBO exposures preoperatively at 2.4 absolute atmosphere for 90 minutes or a placebo, and 10 additional HBO dives postoperatively or a placebo. The main outcome measure was 1-year recovery rate from osteoradionecrosis. Secondary end points included time to treatment failure, time to pain relief, 1-year mortality rate, and treatment safety. Results: At the time of the second interim analysis, based on the triangular test, the study was stopped for potentially worse outcomes in the HBO arm. A total of 68 patients were enrolled and analyzed. At 1 year, six (19%) of 31 patients had recovered in the HBO arm and 12 (32%) of 37 in the placebo arm (relative risk = 0.60; 95% CI, 0.25 to 1.41; P = .23). Time to treatment failure (hazard ratio = 1.33; 95% CI, 0.68 to 2.60; P = .41) and time to pain relief (hazard ratio = 1.00; 95% CI, 0.52 to 1.89; P = .99) were similar between the two treatment arms. Conclusion: Patients with overt mandibular osteoradionecrosis did not benefit from hyperbaric oxygenation. Authors: Djillali Annane, Joël Depondt, Philippe Aubert, Maryvonne Villart, Pierre Géhanno, Philippe Gajdos, Sylvie Chevret [...]

12/21/2004 Houston, TX K. Kian Ang Journal of Clinical Oncology, Vol 22, No 23 (December 1), 2004: pp. 4657-4659 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.(2,3) 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.(1,4) 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%.(5) Although a variety of cytotoxic agents have been studied, cisplatin is the most extensively investigated, and [...]

12/21/2004 press release Yahoo! Finance (biz.yahoo.com) 90.6% complete responses seen with no evidence of skin toxicity YM BioSciences Inc. today announced preliminary results from a randomized Phase II pivotal trial assessing the efficacy and safety of its EGF receptor monoclonal antibody, TheraCIM h-R3 (nimotuzumab), combined with radiation compared to radiation alone in locally advanced, Stage 3-4, nasopharyngeal carcinoma, a subset of head-and-neck cancer. The study was conducted by YM's licensor, CIMAB S.A. and Biotech Pharmaceuticals Limited, CIMAB's joint-venture partner in China. Of the 130 patients in the intent-to-treat analysis, those in the combination arm were reported to have a 90.6% Complete Response compared to 51.5% in the radiation-alone group. "Complete Response" is defined as the elimination of tumour at the primary site, locoregional lymph nodes and distant metastases. TheraCIM h-R3 was administered intravenously at a dose of 100 mg/person once a week for eight weeks beginning on the first day of radiotherapy. There was no evidence of the acneiform rash commonly associated with administration of therapeutic agents designed to block the EGF receptor system, corroborating the results of a previous study for TheraCIM h-R3 in head-and-neck cancer (Journal of Clinical Oncology, Volume 22, No. 9, May 1, 2004). "No other product targeting the EGF receptor has demonstrated a difference in response rates of this magnitude," said David Allan, Chairman of YM BioSciences. "This result adds further justification to YM's approach of combining TheraCIM h-R3 with radiation or as a monotherapy in a variety of cancers including head-and-neck, metastatic pancreatic and [...]

12/21/2004 Ranjiv Sivanandan et al. Arch Otolaryngol Head Neck Surg. 2004;130:1369-1373. Objective The optimal surgical procedure for the neck in patients with squamous head and neck cancers is controversial. Selective neck dissections have replaced modified radical neck dissections as the procedure of choice for the clinically negative (N0) neck and are now being considered for patients with early-stage neck disease. We report the long-term local recurrence rates in 100 consecutive patients undergoing a radical or modified radical neck dissection for clinically positive (N+) and N0 neck disease and review comprehensively the literature reporting and comparing regional control rates for both neck dissection types. Patients The clinical records of 100 consecutive patients who underwent a comprehensive neck dissection (levels I-V) for squamous head and neck cancers with a minimum of a 2-year follow-up were retrospectively reviewed for primary site of disease, clinical and pathologic neck status, histopathologic grade, neck dissection type, and the site and time of recurrence. Results Complete data were available for 97 patients on whom 99 neck dissections were performed. Three patients died from unknown causes. Seventy-six patients with N+ disease underwent a therapeutic neck dissection, while 24 patients with clinically N0 disease underwent an elective dissection. The overall neck recurrence rate in patients with controlled primary disease was 7%. The neck or regional failure rate for patients completing the recommended adjuvant radiotherapy was 4%. Six (25%) of 24 patients with clinically N0 disease had occult metastases. The recurrence rate for this group was 4%. Conclusion Further study [...]

12/20/2004 Austin, TX press release PRNewswire.com Introgen Therapeutics, and the Board of Regents of The University of Texas System announced today that the United States Patent and Trademark Office has issued to The Board of Regents U.S. patent number 6,830,749 entitled "Recombinant p53 adenovirus methods and compositions." Introgen Therapeutics is the exclusive licensee of this patent. David L. Parker, Ph.D., J.D., Introgen's vice president of Intellectual Property said, "This patent now brings to 18 the total number of U.S. patents that cover aspects of our Advexin product candidate. Furthermore, this patent is of particular importance in that it is our broadest adenoviral p53 patent to date, covering any adenovirus carrying the p53 gene under the control of any promoter." About Advexin: There are two Phase 3 trials of Advexin therapy currently underway in recurrent squamous cell cancer of the head and neck. Introgen has received FDA Fast Track designation for Advexin therapy and Advexin has been designated as an Orphan Drug for the treatment of head and neck cancer under the Orphan Drug Act. Advexin supplies the tumor suppressor p53 protein in very high concentrations in cancer tissue to selectively kill cancer cells. p53 is a normal constituent of cells and is known as a tumor suppressor because it inhibits the growth of tumor cells. One of the major roles of this protein is to eliminate cancerous cells by recognizing when the cell has been damaged by mutations and stopping cell growth to initiate repair. If the cell is damaged [...]

12/19/2004 Tasmania, Australia Ellen Whin Graphic posters featuring images of a man with mouth cancer will be displayed at all tobacco retail outlets in Tasmania from this week. Letters will be sent to Tasmania's 1200 licensed cigarette sellers advising them of the requirement to display the poster. The full-colour image shows a man with cancer invading his lip, mouth and teeth. Tobacco sellers will be required to display it prominently alongside their cigarettes and tobacco products, or risk a $5000 fine. Director of Public Health Roscoe Taylor said the posters would also contain a message encouraging people to contact the Quit health line. "It's a fairly confronting image," Dr Taylor said. The image had been obtained as part of national research into the dangers of smoking and was part of a series from the University of New South Wales, he said. "That particular image was shown by researchers to have the highest impact and it is the image that is scheduled to appear on cigarette packets in the future," Dr Taylor said. He said the aim of the image was to educate people that smoking caused a range of illnesses including cancers and heart disease. "Too many people simply associate smoking with lung cancer but it is an unfortunate fact that tobacco smoke is a poison that causes a whole range of problems starting at the mouth," he said. On January 1, new smoking restrictions come into effect in Tasmania. Smoking will be banned in gaming rooms, cabarets and nightclubs. [...]

12/19/2004 Raleigh, North Carolina Kayce T. Ataiyero newsobserver.com Anti-tobacco push targets baseball When Paul Turner conjures up an image of baseball, he sees a player on the field, his eyes trained on the ball, his mouth chomping on chewing tobacco like a cow with cud. But like an artist with a shiny new set of paintbrushes, Turner, director of the National Spit Tobacco Education Program, is eager to create a different picture of baseball, one in which its players and coaches are tobacco-free. On Saturday, Turner spoke at the N.C. Baseball Coaches Association Conference to encourage coaches to keep their players from using snuff. He pleaded with the audience to help get out his message: Smokeless does not mean harmless. "A lot of people think [snuff]'s safer because the [tobacco] industry uses the term 'smokeless.' What we are trying to say is that any tobacco is bad," he said. "Coaches are great influences; they are role models. We want them to educate their athletes and parents." The National Spit Tobacco Education Program is funded by the N.C. Health and Wellness Trust Fund, which was created in 2000 by the state General Assembly to allocate some of the state's share of the national tobacco settlement to health initiatives. The program works to prevent all spit tobacco use, but Turner said he focuses on baseball because it is so closely associated with the practice. According to the National Cancer Institute, it is estimated that 40 percent to 50 percent of minor league [...]

12/19/2004 Dave Reardon StarBulletin.com You won't see that little bulge in any of their chins, that periodic tight spray of spit, that plastic cup that is not for drinking. The University of Alabama, Birmingham Blazers’ offensive coordinator and former winner of the Heisman Trophy beat the odds and cancer Some might have the urge sometimes, but none of the UAB football players, coaches or staff would ever have the nerve to dip in front of offensive coordinator Pat Sullivan. "I don't think so, not after what he's been through," Blazers head coach Watson Brown said. As far as Sullivan and Brown know, none of the UAB personnel who used smokeless tobacco in the past do anymore, not after what Sullivan went through last year. "I don't really know of anybody who does it now," Sullivan said. Sullivan, the 1971 Heisman Trophy winner as an Auburn quarterback, was diagnosed in August 2003 with squamous cell carcinoma, a form of throat cancer. He underwent surgery the next month to remove three lumps from his neck. Doctors told him he had a 65 percent to 70 percent chance of surviving. The Birmingham, Ala., hometown hero and former NFL player and TCU head coach simply said he would "whip it." And that's what Sullivan did. "It was awfully, awfully difficult. I had to go through three very strong rounds of chemotherapy and I had 33 or 34 treatments of radiation. I probably lost 60 pounds over the course of the year," said Sullivan, who [...]

12/18/2004 Medical News Editor Medical News Today Dutch researcher Laura Bungener has developed a vaccine against cervical cancer. Vaccinated laboratory animals no longer developed the disease and animals which had already developed a tumour, could be treated with the vaccine. Cervical cancer is caused by a virus. The vaccines against cervical cancer induce an immune response to proteins from this virus, rendering it harmless. Laboratory animals which had already developed a tumour, could be treated with a vaccination. Human papillomavirus (HPV) is the virus responsible for cervical cancer. More than one hundred types of the virus are known. Some of these are high-risk types of HPV, which can convert healthy cells into cancer cells. Proteins E6 and E7 from the virus are responsible for this and are an ideal target for treatment because they only occur in malignant cells. The vaccine developed by Bungener, induces a specific immune response against these two proteins. To test the vaccine, Bungener administered two different vaccines to mice. The 'recombinant Semliki Forest virus' and virosomes from the flu virus. The 'recombinant Semliki Forest virus' induces the production of proteins E6 and E7. The virosomes from the flu virus contain the E7 protein. Both vaccines induced an immune response in mice against these proteins. During the immune response, the animals produce cytotoxic T-lymphocytes that are specific for E6 and E7 and prevent the tumour from growing further. Even mice that already had a tumour could be treated with a vaccination of the 'recombinant Semliki Forest [...]

12/18/2004 Medical News Editor Medical News Today Combined positron emission tomography and computerized tomography (PET/CT) can help diagnose occult (hidden) recurrent cancer, possibly a cancer patient's greatest post-treatment fear, report a team of Israeli physicians in the December issue of the Society of Nuclear Medicine's "Journal of Nuclear Medicine." PET and CT scans are standard imaging tools that allow clinicians to pinpoint the location of cancer within the body before making treatment recommendations. PET/CT involves sequential PET and CT imaging on the same device, allowing for simultaneous acquisition of functional (PET) and anatomical (CT) data. "PET/CT was found to indicate the presence of new malignancy and also precisely localize and define the extent of disease" in patients in whom recurring cancer was suspected, explained lead author and SNM member Ora Israel, M.D. The physicians asked the question, "Is FDG-PET/CT Useful for Imaging and Management of Patients With Suspected Occult Recurrence of Cancer?" Their study points to an affirmative answer, said Israel, who also noted the need for these initial results to be confirmed in large studies with more homogenous patient populations. The research team studied 36 cancer patients for whom blood tests showed increasing levels of serum cancer markers during follow-up. "PET/CT was the only test that showed whether recurrent tumors were indeed present," and since anatomic information was obtained, the type of treatment that should be applied could be determined, she said. "This is clinically important, since no treatment could be planned in these patients without the benefit of [...]