3/3/2006 Philadelphia, PA staff 10NBC HealthWatch (www.nbc10.com) Treatments for oral cancers can be very difficult and even disfiguring. But now, local doctors are the first in the world to use robotic surgery for cancerous head and neck tumors. The surgery spares patients the devastating side effects of more traditional surgery. The revolutionary technique was developed in Philadelphia. The surgery robot is changing 57-year-old Philip Preston's life without destroying his appearance. When Preston was told he had cancer at the base of his tongue, he and his wife, Beverly, felt like they had been slapped. "I was blown away. I couldn't believe it," Beverly Preston said. The second punch came when they learned what surgery would mean. "A very big incision, very devastating destructive cuts through a lip, a jaw bone, through the teeth," said Dr. Robert O'Malley, of the Hospital of the University of Pennsylvania. Many people end up with facial deformities. They can have trouble speaking and swallowing. They may need reconstructive surgery or a tracheotomy -- a tube inserted into the neck to breathe. But Preston became one of the first people in the world to have another option. Surgeons at the Hospital of the University of Pennsylvania told him they could remove the cancerous tumor and avoid the traditional side effects. Surgeons control the robot from a nearby console. The robot gives doctors a 3-D image and lets doctors use miniature surgical instruments that fit directly into the mouth and reach areas that are impossible for their [...]

3/1/2006 Beijing, China Hepeng Jia [email protected] Are China's regulations too lax? China in November became the first country to have approved two drugs based on gene therapy. The approvals have fueled quick growth in the field, but they may be a sign that China's drug regulation is too lax, experts caution. China's State Food and Drug Administration in October 2003 approved Gendicine to treat head and neck cancers. The drug uses an adenovirus to deliver the tumor suppressor gene p53 into tumor cells. Ins November 2005, the agency approved Shanghai Sunway Biotech's H101, also an adenovirus, which targets cancer cells that lack p53. More than 50% of all cancers have abnormal expression of p53 (Oncology 13, 148–154; 1999). In the West, the approach to gene therapy has been cautious since the death in 1999 of 18-year-old Jesse Gelsinger in a gene therapy trial at the University of Pennsylvania. More recently, French researchers used the technique to treat ten children with the so-called 'bubble boy' disease, but that trial was put on hold in 2003 after two of the children developed leukemia. In China, however, both the government and the public have embraced the technology. The success of the two approved products has boosted the number of gene therapy trials in China from 5 in late 2003 to 19 in 2006. "The huge numbers of highly cooperative patients, the low cost for research and clinical trials and the positive support from the government has enabled China to lead the world in [...]

3/1/2006 New York, NY staff Cancerpage.com The use of subcutaneous amifostine to reduce the toxic effects of radiation therapy and chemotherapy is feasible in patients with head and neck cancer, Swiss physicians report. However, nausea and vomiting and hypotension are relatively common adverse events associated with the drug. Amifostine (Ethyol; Essex-Chemie AG, Lucerne, Switzerland) is an organic thiophosphate that protects normal tissues from free radicals produced by radiation therapy or chemotherapy. It is FDA approved as an intravenously administered drug, but subcutaneous administration is believed to have less toxic effects. Dr. Mahmut Ozsahin and colleagues at Centre Hospitalier Universitaire Vaudois in Lausanne retrospectively evaluated 33 consecutive patients treated with accelerated concomitant-boost radiation therapy, 26 of whom also received cisplatin alone or cisplatin plus fluorouracil. The parotid glands were included in the planning radiation therapy volume. According to their report in the Archives of Otolaryngology Head and Neck Surgery for February, the patients received a 200-mg dose of the oral anti-emetic dolasetron mesylate 1 to 2 hours prior to amifostine treatment. Amifostine 500 mg was injected subcutaneously into the abdomen 15 to 30 minutes prior to radiation therapy. Fifteen patients appeared to be tolerant to amifostine, whereas 11 discontinued its use because of nausea and vomiting and 6 discontinued because of hypotension. Acute effects of treatment included grades 1 to 3 dysphagia, mucositis and skin erythema. Late toxic effects included grade 2 or higher xerostomia in 8 of 19 patients who received at least 20 amifostine injections and in 9 of [...]

3/1/2006 Washington, D.C. press release US Food and Drug Administration (www.fda.gov) The Food and Drug Administration (FDA) today announced the approval of Erbitux (cetuximab) for use in combination with radiation therapy to treat patients with squamous cell cancer of the head and neck (SCCHN) that can not be removed by surgery (unresectable SCCHN). This is the first drug approved for head and neck cancer that has shown a survival benefit in this population. Erbitux was also approved today for use alone (monotherapy) to treat patients whose head and neck cancer has spread (metastasized) despite the use of standard chemotherapy. "Patients suffering from all forms of cancer have a common goal – to treat the disease and prolong life," said Steven Galson, MD, Director of FDA's Center for Drug Evaluation and Research. "We consider this approval an important advance in the treatment of head and neck cancer because it has been shown to help some patients live longer. The approval of Erbitux monotherapy to shrink tumors in patients with metastatic disease who no longer respond to other forms of treatment is also important. Patients need as many effective treatment options as possible." Erbitux, which received a priority review, is the first drug approved to treat head and neck cancer since methotrexate became available in the 1950s. Approval of Erbitux in combination with radiation therapy was based on a study that showed it prolonged survival by 20 months compared to treatment with radiation alone. Approval of Erbitux monotherapy was based on evidence [...]

2/28/2006 Bethesda, MD Ken Garber Journal of the National Cancer Institute, Vol. 98, No. 5, 298-300, March 1, 2006 Oncolytic virus research got a welcome boost last November when Chinese regulators approved the world's first oncolytic viral therapy for cancer, Shanghai Sunway Biotech's genetically modified adenovirus H101. "It's fantastic for the field," said John Bell, Ph.D., of the Ottawa Health Research Institute in Canada. "We needed to have something that was a success, and so I think this is a good first start." Oncolytic viruses are live viruses that selectively kill cancer cells. Shanghai Sunway Biotech expects to begin marketing H101 in July for treating head and neck cancer. The company is also testing the virus in lung cancer and has bought the rights to Onyx-15, an almost identical virus that Onyx Pharmaceuticals took into phase III trials in 2000 but later dropped after its marketing partner bailed out. Now the Chinese effort has breathed new life into the Onyx virus. Sunway's next step, says company president Hu Fang, M.D., is to compare it with H101 in a Chinese trial. The company will then apply to test one of the viruses in Europe and the United States. "The first choice is Onyx-15, but we can't exclude the H101," Hu said. Virus Interruptus The Chinese resurrection of Onyx-15 gives it a second chance after the aborted U.S. run that began in 1996. That year, Onyx biochemist Frank McCormick, Ph.D.—now the director of the University of California, San Francisco, Comprehensive Cancer Center—had [...]

2/28/2006 Cleveland, OH David J. Adelstein et al. Journal of Clinical Oncology, Vol 24, No 7 (March 1), 2006: pp. 1064-1071 Purpose: A retrospective review with long-term follow-up is reported from the Cleveland Clinic Foundation studying radiation and concurrent multiagent chemotherapy in patients with locoregionally advanced squamous cell head and neck cancer. Patients and methods: Between 1989 and 2002, 222 patients were treated with 4-day continuous infusions of fluorouracil (1,000 mg/m2/d) and cisplatin (20 mg/m2/d) during weeks 1 and 4 of either once daily or twice daily radiation therapy. Primary site resection was reserved for patients with residual or recurrent primary site disease after chemoradiotherapy. Neck dissection was considered for patients with N2 or greater disease, irrespective of clinical response, and for patients with residual or recurrent neck disease. Results: With a median follow-up of 73 months, the Kaplan-Meier 5-year projected overall survival rate is 65.7%, freedom from recurrence rate is 74.0%, local control without the need for surgical resection rate is 86.7%, and overall survival rate with organ preservation is 62.2%. Including patients undergoing primary site resection as salvage therapy, the overall local control rate is 92.4%. Regional control rate at 5 years is 92.4%. Among patients with N2-3 disease, regional control was significantly better if a planned neck dissection was performed. Distant control at 5 years was achieved in 85.4% of patients and was significantly worse in patients with hypopharyngeal primary sites and patients with poorly differentiated tumors. Conclusion: Concurrent multiagent chemoradiotherapy can result in organ preservation and [...]

2/27/2006 East Lansing, MI Barbara A. Conley Journal of Clinical Oncology, Vol 24, No 7 (March 1), 2006: pp. 1023-1025 Treatment of advanced squamous cell cancers of the head and neck (HNSCC) can be a frustrating endeavor. Early diagnosis may be missed by delay on the part of patients or their physicians and dentists. Patients are often elderly and have multiple medical or social comorbidities. HNSCC is an interdisciplinary disease, with optimum management requiring the input of the medical, radiation, and surgical oncologist, as well as pathologist, dentist, speech pathologist, social worker, and a dedicated home caregiver. The necessary specialists for optimum management may not be present near the patient's home, necessitating ad hoc clinical teams or further delay and dislocation of the patient and caregiver for an extended treatment period. Numerous phase II and phase III studies have been performed with the hope of improving survival and preserving organ function in locally advanced disease. We now know that survival is improved by radiation administered concurrent with chemotherapy, but there are added toxicities.1 We also know that radiation with chemotherapy can result in survival that approximates the survival obtained by radical surgery followed by radiation therapy, especially if surgical salvage is performed at early signs of residual or recurrent disease.2,3 We know less about what the optimal radiation regimen or chemotherapy regimen should be for an individual patient. Currently, standard therapy for locally advanced HNSCC could be radiation administered daily, twice daily, or in a concomitant boost regimen, with or [...]

2/27/2007 Norfolk, VA Nancy Young HamptonRoads.com Freddie Cano had cancer. He doesn't anymore. In 1998, he noticed a lump on his neck. It turned out to be a tumor at the base of his tongue that wrapped all the way around his left carotid artery. Surgery, chemotherapy, radiation and success followed. The cancer was killed. But the treatment that vanquished the cancer also destroyed Cano's salivary glands, so he constantly drinks water to keep his mouth from getting dry. It takes longer to eat, because of scar tissue in his throat that must periodically be thinned. For a time after the treatment, one foot "dropped" when he walked. "The chemo was short-circuiting the brain waves to my feet." The dream, Cano said, is "the treatments end and everything is fine again. It doesn't happen." Like many cancer survivors, he's not complaining about the side effects. The Norfolk resident is just happy about the main effect: He's alive and making the most of it. He recently celebrated his 60th birthday by getting his first tattoo, a Navy anchor, on his left biceps. But whether they complain or not, there's growing concern that cancer survivors are not getting the care they need to live the fullest lives possible. In the past few years, national organizations including the Institute of Medicine and the Lance Armstrong Foundation have called for more systematic long-term follow-up for adult cancer survivors. In the United States, men have a nearly 50-50 chance of developing cancer in their lifetimes, [...]

2/25/2006 Taiwan P.N. Chen et al. This Article Oral squamous cell carcinoma (OSCC) is the most common malignancy of the oral cavity. Here, we provide molecular evidence associated with the anti-metastatic effect of silibinin by showing a marked inhibition of the invasion and motility of SCC-4 tongue cancer cells, with 89% and 66.4% of inhibition, respectively, by 100 µM of silibinin. This effect was associated with a reduced expression of MMP-2 and u-PA, together with an enhanced expression of TIMP-2 and PAI-1. Silibinin also exerted an inhibitory effect on the phosphorylation of ERK1/2. Additionally, pre-treatment of SCC-4 cancer cells with 10 and 20 µM of U0126, a specific MEK inhibitor, resulted in a reduced expression of MMP-2 (18.7 and 51.4%) and u-PA (19.2 and 48.9%) concomitantly with a marked inhibition of cell invasion (13.7 and 45.7%). Finally, silibinin was evidenced by its inhibition of the metastasis of Lewis lung carcinoma (LLC) cells in vivo. These results suggested that silibinin can reduce the invasion and metastasis of tumor cells, and such a characteristic may be of great value in the development of a potential cancer therapy. Authors: P.-N. Chen1,2, Y.-S. Hsieh1,a, C.-L. Chiang2, H.-L. Chiou3, S.-F. Yang1, and S.-C. Chu2,a Authors' affiliations: 1 Institute of Biochemistry, 2 Department of Food Science, Central Taiwan University of Science and Technology, No. 11 Pu-tzu Lane, Pu-tzu Road, Taichung 406, Taiwan 3 School of Medical Technology, Chung Shan Medical University, No. 110, Section 1, Chien Kuo N. Road, Taichung 402, Taiwan; and

2/23/2006 Larchmont, NY press release Genetic Engineering News (www.genengnews.com) ImClone Systems Incorporated today issued the following statement regarding the announcement that Merck KGaA, Darmstadt, Germany, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the EMEA (European Medicines Agency), for its application to extend the use of ERBITUX(Cetuximab), an IgG1 monoclonal antibody, to the treatment of squamous cell carcinoma of the head and neck (SCCHN): "We are pleased that our partners, Merck KGaA, may soon be able to offer ERBITUX to head and neck cancer patients in the European Union. This is the first new modality of treatment for this disease state since chemoradiation began use over thirty years ago," stated Eric K. Rowinsky, M.D., Chief Medical Officer of ImClone Systems. The CHMP opinion recommends marketing authorization by the European Commission for the use ERBITUX in combination with radiation in patients with locoregionally advanced SCCHN. The license application is based on the results from a randomized, international phase III trial (IMCL-9815), conducted by ImClone Systems and Merck KGaA, which examined the impact of combining ERBITUX with radiation on locoregional control and overall survival in 424 patients with locally or regionally advanced SCCHN. About Head and Neck Cancer In Europe alone, around 100,800 people are diagnosed with head and neck cancer and almost 40,000 die from the disease every year.(1) Head and neck cancer is the sixth most frequently occurring cancer worldwide.(2) Head and neck cancer includes cancers of the tongue, [...]