10/31/2005 New York, NY press release WebWire (www.webwire.com) ImClone Systems Incorporated and Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) has notified ImClone Systems that it has accepted for filing the company’s supplemental Biologics License Application (sBLA) for Erbitux® (Cetuximab), an IgG1 monoclonal antibody, in the treatment of Squamous Cell Carcinoma of the Head and Neck (SCCHN). The application seeks approval for use of Erbitux in combination with radiation for locally or regionally advanced head and neck cancer, and as monotherapy in patients with recurrent and/or metastatic disease where prior platinum-based chemotherapy has failed or where platinum-based therapy would not be appropriate. The companies also announced that the Erbitux sBLA has been granted priority review. The FDA grants priority review to biologics that potentially offer a significant therapeutic advance over existing therapies for serious or life-threatening diseases. Based on the priority review designation, the FDA has six months from the submission date of August 30, 2005, to take action on the sBLA filing. About Head and Neck Cancer According to the American Cancer Society, approximately 40,000 Americans will be diagnosed with head and neck cancer this year, including cancers of the tongue, mouth, pharynx and larynx. In addition, it is estimated that more than 11,000 will die from the disease in 2005 in the U.S. About Erbitux ® (Cetuximab) On February 12, 2004, the FDA approved Erbitux for use in the United States in combination with irinotecan in the treatment of patients with EGFR-expressing, metastatic [...]

10/30/2005 Japan Madhup Rastogi et al. Japanese Journal of Clinical Oncology 2005 35(10):572-579 Objective: The purpose of this study was to evaluate the efficacy of radiotherapy and concurrent mitomycin-C (MC) plus 5-fluorouracil (5FU) infusion in locally advanced squamous cell carcinoma of the head and neck (SCCHN). Methods: Sixty-nine patients with SCCHN (6 Stage III and 63 Stage IV patients) were treated with external beam radiotherapy (70 Gy) and simultaneous intravenous chemotherapy with 5FU (600 mg/m2/day, Days 1–5) and MC (10 mg/m2, Days 5 and 36). Results: After a mean follow-up of 28.5 months, 59.4% of patients were alive without disease. Complete response was seen in 76.8% of patients. The 3 years overall survival, locoregional relapse-free survival and disease-free survival was 62.3, 89.8 and 49.5%, respectively. Treatment was well tolerated (Grade III mucositis in 43.5% and Grade II leukopenia in 5.8%). Conclusions: This concurrent chemoradiotherapy regimen offers a curative option for our patients where primary and nodal disease is fairly large resulting in hypoxic radioresistant tumors. Authors: Madhup Rastogi(1), Madhu Srivastava(1), Kundan S. Chufal(2), M. C. Pant(1), Kirti Srivastava(1) and Madanlal B. Bhatt(1) Authors' affiliations: (1) Department of Radiotherapy, King George's Medical University, Lucknow, Uttar Pradesh and (2) Department of Oncology, Batra Hospital and Medical Research Center, New Delhi, India

10/29/2005 Washington, DC Denise Mann WebMD (www.webmd.com) With cancer survivor Lance Armstrong winning his seventh Tour de France, and walks, runs and other highly visible fund-raising opportunities -- often overflowing with survivors and their families -- taking place almost ubiquitously across the map, it certainly seems that doctors are finally winning, or at least making some significant strides -- in the war against cancer. But are they? The word "cancer" still strikes a chord of fear in most people, but the truth is that today many cancers including breast, colon and prostate may no longer be the death sentences that they once were. Others like melanoma and pancreatic cancer, however, are still proving somewhat vexing and insurmountable. But ultimately, we are turning a corner: survival statistics are up for many cancers, smoking is down, and some of the best minds in the world are trying to crack the cancer codes. Today, Armstrong is seen as an anomaly, but that may not always be the case. "Lance Armstrong is such an inspirational story that cancer is not only not a death sentence, but he can say, 'I beat it and I am doing something about' it by setting up a foundation and speaking out," says Thomas Glynn, PhD, the director of cancer science and trends at the American Cancer Society (ACS) in Washington, D.C. "I think as survival rates continue to rise, we will see people like him who shine and not only survive disease and actually do well with it." [...]

10/27/2005 England G. J. Granström British Dental Journal (2005); 199, 511. doi Implant failure was higher in irradiated patients, but not greatly so. This retrospective study evaluated 631 implants placed in 107 cancer patients who had received radiotherapy over a 25 yr period. At the end of the period, 71 patients were alive (mean survival time of 16 yrs), and 36 had died (9.8), and 484 implants were still active and stable. Age and gender matched healthy controls received 614 implants, and 76 implants failed during a mean follow-up of 7.2 yrs. Six of the 100 controls died of cardiovascular disease during the period. Implant failure was significantly higher in the cancer patients, irrespective of when they received radiotherapy and of whether they also had chemotherapy. Most implant failure was early, before loading. There was a relationship of failure to radiation dose, and some failures occurred as long as 20 yrs later. The authors recommend use of long fixtures, fixed retention and hyperbaric oxygen, which all improved implant survival. Highest failure rates were in the frontal bone, zygoma, mandible and nasal maxilla.

10/26/2005 New York, NY staff www.cancerpage.com The difference in quality of life (QOL) between head and neck cancer patients who undergo surgery and those who opt for nonsurgical therapies has narrowed considerably, new research suggests. It has generally been assumed that QOL for these patients is better when treated with concurrent chemotherapy and radiation than with surgery and radiation, study co-author Dr. Gerry F. Funk, from the University of Iowa Hospitals and Clinics in Iowa City, and colleagues report. Yet, few studies have addressed this topic. As reported in the Archives of Otolaryngology: Head & Neck Surgery for October, the researchers assessed QOL and functional outcomes in 54 matched patients who were treated with surgery and radiation or concurrent chemotherapy and radiation. All of the subjects had stage III or IV squamous cell cancer of the oropharynx, hypopharynx or larynx. No significant difference was seen between the groups in overall QOL or in eating, speech, aesthetics and social disruption, the report indicates. The Beck Depression Inventory score was worse for concurrent chemotherapy and radiation-treated patients, but not significantly different from the score in the surgery and radiation group. The authors believe that the gap in QOL between these treatment approaches has narrowed because nonsurgical therapies have become more aggressive, while just the opposite has occurred with surgical treatments. "Although the assumption that preserving an organ will uniformly result in a higher QOL seems reasonable, the complexities of human adjustment and the multitude of potential treatment effects, from both surgery-based or [...]

10/26/2005 Ireland Deborah Condon irishhealth.com Around 400 new cases of oral cancer are diagnosed in Ireland every year, yet the condition continues to receive little attention here, a major conference will be told later this week. 'Oral Cancer - the Patient's Journey' is the theme of this year's Royal College of Surgeon's (RCSI) annual scientific meeting. Speakers will include Dr Joe Briscoe, a retired dentist who was himself diagnosed with the disease in 1989. Oral cancer is cancer that occurs in the mouth (oral cavity). The mouth is made up of many parts, such as the lips, tongue, the inside of the cheeks and the salivary glands. It also refers to the oropharynx, which consists of the back one-third of the tongue, the soft palate, the tonsils and the back of the throat. The disease is three times more common in men than women. Men who live in urban areas and who smoke and drink are particularly at risk. Overall, smoking, drinking alcohol and poor diet are major risk factors. Both men and women are advised to attend their dentist at least once a year for a routine check-up. This allows for problems to be detected as early as possible. Like other cancers, the outlook improves significantly the earlier oral cancer is detected. Unlike other cancers however, it has the advantage of having two professional groups who are trained to detect it - doctors and dentists. All dentists are trained to detect oral cancer and precancerous lesions. The vast majority [...]

10/26/2005 Orlando, FL staff Ivanhoe.com Research presented this week at the 47th Annual Meeting of the American Society for Therapeutic Radiology and Oncology in Denver offers new hope to people with head and neck cancers. Eric Horwitz, M.D., from Fox Chase Cancer Center in Philadelphia, says, "Not only did this clinical trial show efficacy with our regimen, but it appears to significantly increase the probability of survival when compared to the current standard treatment." The current standard treatment is chemotherapy. Currently, there are few options for people with head and neck cancers who develop a second tumor or for those whose disease comes back in a place that has already been radiated. Researchers studied patients with recurrent squamous-cell head and neck cancer or a second tumor that had developed in a previously radiated area. More than 100 patients from the United States and Canada were enrolled in the study. Patients were given a new combination treatment. One part of that treatment consisted of hyperfractionated radiation therapy, in which the patients were given radiation twice a day for five days every two weeks for four cycles. Patients also received chemotherapy with cisplatin (Platinol) and paclitaxel (Taxol, Onxol or Paxene) every day for two weeks for four cycles. Patients receiving chemotherapy alone have an average survival of six months to eight months. The results of this new study show 50 percent of patients receiving the combination treatment survived for at least one year. Nearly 26 percent survived two years. This extended survival [...]

10/24/2005 The Netherlands Jolijn Brouwer et al. Laryngoscope, October 1, 2005; 115(10): 1813-1817 Objectives/Hypothesis: The detection of distant metastases during screening influences the choice of treatment in patients with head and neck squamous cell carcinoma. A previous study in the authors' institution showed that chest computed tomography (CT) scan was the most important screening technique. Different clinical risk factors in patients with head and neck squamous cell carcinoma for the development of distant metastases were identified. Study Design: Retrospective cohort study. Methods: To evaluate the authors' diagnostic strategy, the accuracy of screening for distant metastases with chest CT in 109 consecutive patients with head and neck squamous cell carcinoma with risk factors between 1997 and 2000 was retrospectively analyzed. Results: Preoperative screening with CT revealed 20 patients (18%) with lung metastases and 1 liver metastasis. Despite negative screening with chest CT, 9 (11%) patients developed distant metastases within 12 months during follow-up. Sensitivity of the chest CT was 73%; the specificity was 80%. Conclusion: Although chest CT frequently detects distant metastases, there seems to be a need for a more sensitive and whole-body screening technique. Authors: Jolijn Brouwer, Remco de Bree, Otto S Hoekstra, Richard P Golding, Johannes A Langendijk, Jonas A Castelijns, and C Rene Leemans Authors' affiliation: From the Departments of Otolaryngology, Head and Neck Surgery (j.b., r.d.b., r.c.l.), Clinical Epidemiology and Biostatistics (o.h.s.), Nuclear Medicine and Positron Emission Tomography Research (o.h.s.), Radiology (r.p.g., j.a.c.), and Radiation Oncology (j.a.l.), VU University Medical Center, Amsterdam, The Netherlands

10/23/2005 Milwaukee, WI Kawanza Newson Milwaukee Sentinel Jouranl (www.braneton.com) Byron Liebner is a sun lover, and he has several tiny scars to prove it. But it's the spot on his left forehead that he likes to talk about most. The skin there is dry and red, like a bad sunburn, and is a visual reminder of the high doses of radiation he receives each weekday to prevent his cancer from spreading into his eye. For the past five weeks, Liebner has had a mesh mask placed over his face to hold his head perfectly still and had his feet tied together to prevent wiggling so high-intensity radiation can be blasted into the nerve above his eye for 438 seconds. He's scheduled for seven weeks of radiation. "They have to be careful because it's a delicate situation," said Liebner, 84. "They told me I could lose clusters of hair in the back because the radiation goes right through the head," he said. "But I wouldn't care if I lost it because I don't have that much hair anyway." Surgery was not a feasible option for Liebner because his eyeball would have been removed, and he may have still needed radiation therapy later. Throughout the United States, cancer patients are benefiting from technological advancements that increase the precision of radiation treatment to the tumor while decreasing damage to the normal tissue or organs surrounding it. More precise treatment means patients can get higher doses of radiation over a shorter time span, and [...]

10/23/2005 Italy staff CancerConsultants.com According to an early on-line publication in the Journal of Clinical Oncology, a type of immunotherapy targeted against cancer cells appears to provide some anticancer responses in patients with advanced nasopharyngeal cancer that has stopped responding to radiation and chemotherapy. Nasopharyngeal carcinoma (NPC) is a type of head and neck cancer. Stage IV NPC refers to cancer that has spread from its site of origin and invaded nearby tissues or more distant areas of the body. Standard treatment for stage IV NPC typically includes radiation therapy and chemotherapy. However, a large portion of these patients will stop responding to these standard therapies and are left with very limited treatment options. NPC is a type of cancer that often appears related to infection with the Epstein-Barr virus (EBV). These cancer cells express specific antigens (proteins) on their surface associated with EBV. Immunotherapy is a type of therapy that stimulates the immune system to recognize and attack cancer cells within the body. Researchers have been evaluating ways in which to stimulate the immune system to recognize very specific antigens on cancer cells, such as the EBV antigens. Researchers from Italy recently conducted a small clinical trial to evaluate a type of immunotherapy for the treatment of 10 patients with advanced NPC that has stopped responding to chemotherapy and radiation therapy. Immunotherapy was used to stimulate the immune system to attack the cancer cells that displayed EBV antigens. Overall, the immunotherapy produced anticancer activity: 20% of patients experienced a [...]