10/24/2006 Raleigh, NC staff Biocompare Life Science News (news.biocompare.com) Scientists at Duke University's Institute for Genome Sciences & Policy have developed a panel of genomic tests that analyzes the unique molecular traits of a cancerous tumor and determines which chemotherapy will most aggressively attack that patient's cancer. In experiments reported in the November 2006 issue of the journal Nature Medicine, the researchers applied the genomic tests to cells derived from tumors of cancer patients. They found that the tests were 80 percent accurate in predicting which drugs would be most effective in killing the tumor. The Duke team plans to begin a clinical trial of the genomic tests in breast cancer patients next year. The new tests have the potential to save lives and reduce patients' exposure to the toxic side effects of chemotherapy, said Anil Potti, M.D., the study's lead investigator and an assistant professor of medicine in the Duke Institute for Genome Sciences & Policy. The tests are designed to help doctors select and initiate treatment with the best drug for a patient's tumor instead of trying various drugs in succession until the right one is found, Potti said. "Over 400,000 patients in the United States are treated with chemotherapy each year, without a firm basis for which drug they receive," said Joseph Nevins, Ph.D., the study's senior investigator and a professor of genetics at the Duke Institute for Genome Sciences & Policy. "We believe these genomic tests have the potential to revolutionize cancer care by identifying the [...]

10/24/2006 Tokyo, Japan Takeshi Nishioka et al. Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyl111 Objective: This study sought to evaluate the efficacy and safety of a novel treatment regimen, intra-arterial cisplatin infusion plus external/high-dose-rate radiotherapy. Methods: Superselective intra-arterial infusion of cisplatin (100-120 mg) was performed concomitantly with external radiotherapy in four patients with locally advanced carcinoma of the tongue. A high-dose-rate brachytherapy boost was performed after combination therapy in all patients. Brachytherapy was performed after external radiotherapy, and the treatment schedule was twice daily, with a fraction of 600 cGy up to a total of 30-48 Gy. Results: All patients completed the therapy as scheduled. There were no vascular or neurological complications. Grade III acute radiation mucositis developed in all patients but this did not necessitate a treatment break. With a mean follow-up period of 35 months, loco-regional control was obtained for all patients. Conclusions: The combination of weekly administration of intra-arterial cisplatin plus external/high-dose-rate radiotherapy seems effective for advanced carcinoma of the tongue. Authors: Takeshi Nishioka 1, Akihiro Homma 2, Yasushi Furuta 2, Hidefumi Aoyama 3, Fumiyuki Suzuki 2, Keiichi Ohmori 4, Takeshi Asano 3, Daisuke Yoshida 3, Hiroki Shirato 3, and Satoshi Fukuda 2 Authors' affiliations: 1 Laboratory of Radiation Therapy, Department of Health Science, School of Medicine, Hokkaido University, N12 W5, Kita-ku, Sapporo, Japan. 060-0812 2 Department of Otolaryngology, Head and Neck Surgery, School of Medicine 3 Department of Radiology, School of Medicine 4 Department of Radiology, School of Dentistry, Hokkaido University, Sapporo, Japan

10/23/2006 United Kingdom press release Medical News Today (www.medicalnewstoday.com) In its September meeting 2006, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) gave a positive opinion to include the use of docetaxel in combination with the current standard treatment - cisplatin and 5 - fluorouracil - for the induction treatment of patients with inoperable locally advanced squamous cell carcinoma of the head and neck. On October 18, the US Food and Drug Administration (FDA) gave its approval to the new treatment as well. According to Steven Galson, M.D., director of FDA's Center for Drug Evaluation and Research, it will “provide prescribers with a new treatment option that has been shown to help slow the spread of the disease and prolong patients' survival.” This drug - label extension of Taxotere (docetaxel) was possible due to the EORTC 24971 phase III, open label randomized trial, involving 358 patients, evaluating the benefit derived from docetaxel - based combination in inoperable locally advanced head and neck cancer. Patients treated with the regimen prior to surgery or radiation had significantly longer median overall survival compared to a standard treatment of cisplatin and 5-fluorouracil; with a 28 percent risk reduction of the, 18.6 vs 14.5 months (p=0.0128). Patients receiving the docetaxel-based regimen also had a significantly longer time-to-disease progression of 11.4 months, compared with 8.3 months (P=0.015) for the patients receiving standard therapy. These results have been associated to an improvement of the safety profile. ”Very few treatment options [...]

10/23/2006 Stockholm, Sweden Anthony S. Gunnell et al. Cancer Epidemiology Biomarkers & Prevention, 10.1158/1055-9965.EPI-06-0399 Background: A majority of studies have implicated the involvement of cigarette smoking in cervical cancer development, although its mechanism of action remains unclear. We conducted a large population-based case-control study to address the potential interaction between smoking and human papillomavirus type 16 (HPV-16) in development of cervical cancer in situ (CIS). Methods: Information on risk factors for CIS was collected via interview, and archival cervical smears were tested for HPV-16 DNA presence in cases (n = 375) and controls (n = 363). Adjusted odds ratios (OR) for the effects of smoking, HPV-16 presence/absence, and load at first smear (taken, on average, 9 years before diagnosis) were calculated. Results: The risk for CIS among current smokers who were HPV-16 positive at time of first smear was >14-fold [adjusted OR, 14.4; confidence interval (95% CI), 5.6-36.8] compared with HPV-16-negative current smokers. In contrast, the risk for CIS among HPV-16-positive nonsmokers was only 6-fold (adjusted OR, 5.6; 95% CI, 2.7-11.5), compared with HPV-16-negative nonsmokers. HPV-16-positive smokers with high viral load at time of first smear exhibited a high risk for CIS (adjusted OR, 27.0; 95% CI, 6.5-114.2) compared with HPV-16-negative smokers. Within nonsmokers, however, high HPV-16 load contributed only a 6-fold increased risk compared with HPV-16-negative nonsmokers (adjusted OR, 5.9; 95% CI, 2.4-14.6). Interaction was observed (P = 0.03) between duration of smoking and HPV-16 presence in CIS development. Conclusion: Results suggest a synergistic effect between smoking and both [...]

10/21/2006 Cleveland, OH M Nelson et al. Arch Otolaryngol Head Neck Surg, October 1, 2006; 132(10): 1041- Objective: To determine if the development of hypothyroidism has an effect on the outcome of advanced-stage head and neck squamous cell carcinoma. Design: Retrospective database analysis. Setting: Tertiary care center. Patients: The study population comprised 155 patients with advanced-stage head and neck squamous cell carcinoma. Interventions: Patients underwent radiation therapy alone or in combination with chemotherapy and surgery when indicated. MAIN Outcome Measures: Kaplan-Meier analysis was used to assess survival, not adjusting for timing of the detection of hypothyroidism. The following 2 analyses were then performed to adjust for the timing of detection: (1) hypothyroidism was assessed as a time-varying covariate in a Cox proportional hazards model and (2) a landmark analysis was conducted at 9, 12, 15, 18, 21, and 24 months using the Kaplan-Meier method. Results: Of the 155 patients, 59 developed hypothyroidism, defined as a thyrotropin level greater than 5.5 mIU/L (institutional value). An unadjusted Kaplan-Meier analysis indicated that patients who develop hypothyroidism have significantly better survival than patients who do not (P<.001, log-rank test). After adjusting for the timing of hypothyroidism, a Cox proportional hazards analysis indicated that survival was better, but not statistically significant, for patients who developed hypothyroidism (hazard ratio, 0.62; P=.12); results from a landmark analysis supported this finding (P values ranged from .11 to .19). Conclusions: Development of hypothyroidism may be associated with improved survival and increased recurrence-free survival. Larger, prospective studies appear warranted to [...]

10/20/2006 Baltimore, MD Nancy Nairi Maserejian et al. American Journal of Epidemiology 2006 164(6):556-566 The authors prospectively evaluated fruit and vegetable consumption and the incidence of oral premalignant lesions among 42,311 US men in the Health Professionals Follow-up Study. Diet was assessed every 4 years by food frequency questionnaires. The authors confirmed 207 cases of clinically or histopathologically diagnosed oral premalignant lesions occurring between 1986 and 2002. Multivariate-adjusted relative risks were calculated from proportional hazards models. Significant inverse associations were observed with citrus fruits, citrus fruit juice, and vitamin-C-rich fruits and vegetables, indicating 30–40% lower risks with greater intakes (e.g., citrus fruit juice quintile 5 vs. quintile 1 relative risk = 0.65, 95% confidence interval: 0.42, 0.99). Inverse associations with fruits did not vary by smoking status and were stronger in analyses of baseline consumption, with a 10-year lag time to disease follow-up (quintile 5 vs. quintile 1 relative risk = 0.41, 95% confidence interval: 0.20, 0.82; p = 0.01). No associations were observed with total vegetables or with ß-carotene-rich or lycopene-rich fruits and vegetables. For current smokers, green leafy vegetables (ptrend = 0.05) and ß-carotene-rich fruits and vegetables (ptrend = 0.02) showed significant linear trends of increased risk (one additional serving/day relative risk = 1.7). The risk of oral premalignant lesions was significantly reduced with higher consumption of fruits, particularly citrus fruits and juices, while no consistent associations were apparent for vegetables. Authors: Nancy Nairi Maserejian1,2,3, Edward Giovannucci1,4,5, Bernard Rosner4, Athanasios Zavras2 and Kaumudi Joshipura1,2,6 Authors' affiliations: 1 Department [...]

10/20/2006 Rockville, MD Patricia Shehan All Headline News (www.allheadlinenews.com) On Wednesday, the Food and Drug Administration (FDA) approved a new form of drug treatment for patients who have inoperable, locally advanced squamous cell carcinoma of the head and neck (SCCHN). The approved drug, Taxotere Injection Concentrate (docetaxel; Sanofi-Aventis, Paris, France), is to be used in combination with chemotherapy drugs (cisplatin and fluorouracil) before radiothermy treatment. Taxotere was studied in a random trial of 358 patients. One group was given Taxotere in combination with the chemotherapy drugs. The other group received only the chemotherapy drugs. The results comparing the additional use of Taxotere showed a longer survival time (18.6 months versus 14.2 months) and a longer time to progression of disease or death (11.4 months versus 8.3 months) than the group who only received the chemotherapy drugs. Patients with SCCHN represent approximately 3 percent of all new diagnosed cases of cancer in the U.S. According to the Director of FDA's Center for Drug Evaluation and Research, Steven Galson, M.D., "Today's approval will provide prescribers with a new treatment option that has been shown to help slow the spread of the disease and prolong patients' survival." There were some of the usual adverse side effects experienced when comparing the study patients on Taxotere with those who were not on the drug treatment.

10/20/2006 Austin, TX press release PRnewswire.com Introgen Therapeutics, Inc today reported updated data from several clinical studies which demonstrate the activity of Advexin p53 therapy in patients with cancers of the head and neck, lung, breast and esophagus. Additional results showing utility of Advexin in the inherited cancer known as Li-Fraumeni Syndrome were also reported. Evaluation of molecular and clinical biomarkers was able to predict patient populations most likely to benefit from Advexin therapy. Data were presented over the weekend at the annual meeting of the International Society for Cell and Gene Therapy in Chiba City, Japan by Sunil Chada, Ph.D., Introgen's associate vice president of Clinical Research and Development. The international meeting joined hundreds of clinicians and researchers to discuss the progress of novel cancer treatments. Dr. Chada commented, "Advexin shrinks tumors, halts tumor growth, and improves symptoms in patients with multiple types of cancer. Patients with tumors having abnormal p53 were shown to have improved outcomes following Advexin therapy. These observations are consistent with the presence of p53 abnormalities in the majority of cancers. Aberrant p53 is the molecular target of Advexin therapy." Dr. Robert E. Sobol, Introgen's senior vice-president of Medical and Scientific Affairs, stated, "We have advanced our analyses of Advexin efficacy in recurrent, squamous cell carcinoma of the head and neck. These patients have limited effective treatment options. The Advexin tumor response rate defined by a 30 percent reduction in tumor size was 10.3 percent for the overall population and 26.5 percent for the clinical [...]

10/18/2006 Los Angeles, CA press release UCLA News (www.newsroom.ucla.edu) The UCLA School of Dentistry has received two research awards from the National Institutes of Health which, combined with the school's ongoing NIH-funded saliva research studies, are building UCLA's reputation as a center for excellence in oral fluid research. A major five-year, $12.5-million UO1 grant from the National Institute of Dental and Craniofacial Research, an arm of the NIH, will fuel the development of a functional prototype of the Oral Fluid NanoSensor Test (OFNASET), a handheld clinical device for point-of-care saliva diagnostics. In addition, a five-year, $2.5-million NIH RO1 grant will support efforts to identify the diagnostic signatures of Sjögren's Syndrome in the saliva of individuals affected by that auto-immune disease. "The UCLA School of Dentistry is proud to provide leadership in the national effort to investigate and innovate in the promising area of saliva diagnostics," said Dr. No-Hee Park, dean of the School of Dentistry. David Wong, a professor in the division of oral biology and medicine and the associate dean of research at the UCLA School of Dentistry, the director of the UCLA Dental Research Institute and a member of UCLA's Jonsson Cancer Center, is the principal investigator for both grants. Predating the new awards, the School of Dentistry's current saliva research studies supported by the NIH include the Human Salivary Proteome Project, the UCLA Collaborative Oral Fluid Diagnostic Research Center, and the Genomics and Proteomics for Progressing Oral Precancer study. Earlier this year, as a product of those [...]

10/18/2006 Orlando, FL staff wftv.com Throat and neck cancer surgeries can leave patients with serious side effects such as scars and speech problems. But with the help of a robot, two surgeons are the first in the world to treat these types of cancers without making even one incision. John McCauley had tongue cancer surgery 20 years ago. And she recently had to have it again. "The recovery from my first surgery for tongue cancer was… very raw. It was a raw area, it was tender, and it was quite painfull to be honest," she said. But the second time, a robot did much of the work. In the past, surgeons cut across the throat to remove the tumor. But the robot operates in the mouth so the incisions are small and are made on the inside of the body. "Now, we do remove the entire tumor but we don't have to do things such as wide incisions on the neck or breaking or splitting the jaw bone and moving the tongue aside," said Dr. Bert O'Malley Jr., a head & neck surgeon. "The robot allows me to move my hands on the joysticks of the robotic console, and it's as if my hands were made this small, and I could get them right into the mouth to do the operation," he said. Two surgeons partner on each operation. One operates the console, one is by the patient's side. Patients lose less blood and can actually talk and swallow more [...]