2/4/2005 Toronto, Ontario, Canada pharmalive.com Viventia Biotech Inc. announced today that its lead drug candidate Proxinium(tm) has been granted orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of advanced, recurrent head and neck cancer. The US Orphan Drug Act provides financial, regulatory and marketing incentives to companies to help facilitate the development and marketing of drugs for the treatment of rare diseases or conditions that affect fewer than 200,000 patients in the United States. Orphan drug designation entitles Viventia to various incentives, including seven years of exclusive marketing rights if Proxinium(tm) receives marketing approval by the FDA. Historically, many orphan drugs have received expedited regulatory review because they have been developed to treat serious or life-threatening illnesses, leading to more rapid approval times. About head and neck cancer: Head and neck cancer, comprising cancers of the larynx, tongue, mouth, oral cavity, and pharynx, is the sixth most common form of cancer globally. In the United States alone over 50,000 new cases of head and neck cancer are diagnosed annually. Despite aggressive measures, such as radical surgery, radiation and/or chemotherapy, as well as concerted efforts from clinicians to eradicate these tumors, long-term survival rates have not improved in the last 30 years and the five year survival rate remains less than 40%. As more than two-thirds of patients will present with advanced disease, curative treatments are often not possible. Compounding the poor prognosis for survival are the often devastating effects these tumors and their treatment [...]

2/4/2005 John McKenzie New England Journal of Medicine as reported by abcnews.go.com A study published in today's New England Journal of Medicine offers encouraging news about a novel way to fight cancer. It finds that injecting a type of liquid radiation, called Bexxar, into patients with lymphoma — a cancer of the immune system — can fight the disease more quickly and with fewer side effects that existing treatments. The approach might eventually be used on a variety of cancers. "This is the first time we're using injectable radiation to treat cancer," said Dr. Andrew Zelenetz, a hematologic oncologist at Memorial Sloan-Kettering Cancer Center in New York. The radioactive drug is delivered intravenously and works like a guided missile. It travels throughout the body, homing in on a specific protein found on the cancer cells. "And when it latches on to it, it now has radiation attached to it and the radiation is essentially there at the site where you want it, radiating the tumor and not radiating other tissues," said Dr. Mark Kaminski, director of the Multidisciplinary Lymphoma Clinic at the University of Michigan Cancer Center. When Bexxar was used to combat non-Hodgkin's lymphoma, 59 percent of patients remained cancer-free during the five years of study. "These results are very similar to the results we're getting with state-of-the-art chemotherapy," said Zelenetz. "However, the distinct advantage here is that it is much more user-friendly for the patient." Few Side Effects The liquid radiation treatment is completed in just one week, [...]

3/2/2005 Syed S.A. Qadri et al. Ann Thorac Surg 2005;79:990-995 Background: Even after apparently curative resection, lung cancer recurrence continues to lead to high mortality levels. The aim of this study was to assess the effects of cyclooxygenase-2 (COX-2) inhibitor on local and systemic recurrent tumor growth. Methods: C57BL/6 mice underwent mammary fat pad inoculation with 3LL cells. After two weeks growth, flank tumors were resected completely and followed for recurrent tumor growth. Postresection mice were randomized to receive placebo alone (group 1) or the selective COX-2 inhibitor, rofecoxib (group 2), daily for two weeks by tube feeding. Recurrent tumor growth kinetics were compared for both groups. Two weeks following primary tumor excision animals were sacrificed, after which lungs were resected and pulmonary metastatic burden was assessed using the lung-body weight ratio. Apoptotic and mitotic indices were established for recurrent tumors and lungs, using hematoxylin and eosin histology. Results: Two weeks postexcision of the primary tumor, recurrent tumors in the placebo group were significantly greater than the treatment group (p = 0.002). While primary tumors were typically encapsulated and not adherent, recurrent tumors in the placebo group were invasive, adherent to the chest wall and the overlying wound. In contrast, recurrent tumors in the treatment group were nonadherent to the chest wall. Moreover, postoperative pulmonary metastatic burden was significantly reduced in treated animals. Histologic examination revealed increased apoptosis as well as an increase in the apoptosis-mitosis ratio in treated animals. Conclusions: Primary tumor excision was associated with accelerated local and [...]

2/2/2005 New York, NY Journal of Clinical Oncology January 2005 as reported by Medscape (www.medscape.com) Chemotherapy combined with chemoradiotherapy allows organ preservation in patients with advanced resectable cancer of the tongue or hypopharynx, according to a report in the January 1st issue of the Journal of Clinical Oncology. The base of the tongue and hypopharynx are good candidates for organ preservation because of the potential compromise of speech and swallowing resulting from surgery, the authors explain. Dr. Susan G. Urba from University of Michigan Medical Center, Ann Arbor, and colleagues investigated the benefits of two cycles of induction chemotherapy followed by chemoradiotherapy for responders in a phase II trial of 59 patients with advanced resectable cancer of the tongue base (n=37) or hypopharynx (n=22). Fifty-eight percent had stage IV and 42% had stage III disease. Seventy-eight percent of the patients had a 50% or greater response to induction chemotherapy at their primary tumor site, the authors report. Of the 43 patients that went on to receive concurrent chemoradiotherapy, 32 (54%) achieved a documented histologic complete response, the results indicate, and 9 additional patients achieved a complete clinical response, but did not undergo the recommended biopsies. Overall, the researchers note, 44 patients (75%) were deemed organ preservation successes; they did not require salvage surgery of the primary tumor immediately following completion of the treatment because of their excellent responses to therapy. Apart from one death attributed to the induction chemotherapy, the report indicates, the treatment was well tolerated, the researchers report. [...]

2/2/2005 Richard C. Semelka, MD Medscape Radiology Medscape Radiology Editor's Note: Richard Semelka, MD, is one of the preeminent practitioners of abdominal MRI in the United States and is a frequent contributor to Medscape Radiology. The hot-button issues raised in this opinion piece call into question some of the current practices surrounding the use of CT scanning. It's the opinion of this editor that a topic of importance, such as the safety and health of patients referred for diagnostic imaging evaluation, merits a broad dialogue in an open, spontaneous, and timely forum. --------------------------- Hippocrates is credited with the expression "First, do no harm" (ca 460-ca 377 B.C.), which has become the oath of all physicians in their doctoral graduation. The radiology community adheres to the fundamental precept of ALARA (as low as reasonably achievable) in order to limit patients' exposure to harmful radiation. "First, Do No Harm": The Present-Day Fallacy In recent years, there has been an increased awareness of the rights of patients and their need for information and protection. The regulations of the recently implemented Health Insurance Portability and Accountability Act (HIPAA) is one example of efforts to protect patients. The obligation of physicians to provide information on diseases and treatment options has always been important, but has come under greater emphasis in the modern medical environment. Despite this, one egregious example in which patients are not provided sufficient information to make informed decisions on their healthcare involves the limited information provided to them on diagnostic imaging tools, [...]

2/1/2005 JB Thomsen, JA Sorensen, and A Krogdahl J Oral Pathol Med, February 1, 2005; 34(2): 65-9 Background: Sentinel lymph node biopsy, step sectioning and immunohistochemistry have changed detection of tumor deposits. Isolated tumor cells (ITC) are detected more frequently than earlier because of a changed level of detection. Methods: A total of 108 sentinel lymph nodes from 30 patients with T1/T2 cN0 oral cancer were re-classified histologically to find possible ITC and to describe technical pitfalls. Results: Primarily we found metastatic spread in 12 of 108 sentinel lymph nodes: five macrometastasis and seven micrometastasis. After re-classification, we found seven lymph nodes with macrometastasis, five with micrometastasis and two with ITC. Conclusion: The ITC are probably precursors of micrometastasis waiting to grow and should be treated as such. Benign inclusions and dendritic cells did not cause problems, but can mimic ITC.

1/30/2005 Bruce Ames and Lois Swirsky Gold "Cancer Prevention and the Environmental Chemical Distraction" This is an edited version of a chapter titled 'Cancer Prevention and the Environmental Chemical Distraction', by Bruce Ames and Lois Swirsky Gold, in Politicizing Science: the Alchemy of Policymaking, Michael Gough ed., Hoover Institute Press, Stanford, California (2003). Blaming synthetic chemicals for a 'cancer epidemic' is flawed science that makes for dubious policy. Entering a new millennium seems a good time to challenge some old ideas about cancer cause and prevention, which in our view are implausible, have little supportive evidence, and might best be left behind. In this essay, we summarise data and conclusions from 15 years of work, raising five issues that involve toxicology, nutrition, public health, and US government regulatory policy: 1. There is no cancer epidemic other than that due to smoking. 2. The dose makes the poison. Half of all chemicals tested, whether natural or synthetic, cause cancer in high-dose rodent cancer tests. Evidence suggests that this high rate is due primarily to effects that are unique to high doses. The results of these high-dose tests have been used to regulate low-dose human exposures, but are not likely to be relevant. 3. Even Rachel Carson was made of chemicals: natural v synthetic chemicals. Human exposure to naturally occurring rodent carcinogens is ubiquitous and dwarfs the exposure of the general public to synthetic rodent carcinogens. 4. Errors of omission. The major causes of cancer (other than smoking) do not involve exposures [...]

1/30/2005 www.advocate.com Diane Harper, a researcher at Norris Cotton Cancer Center in Lebanon, N.H., has studied the link between human papillomavirus infection and cervical cancer for 20 years. Harper now believes she may have found a vaccine that protects against the two strains of HPV that are linked to 70% of cervical cancers. The vaccine, made by GlaxoSmithKline, was tested from 2000 to 2003 on 1,113 women ages 15 to 25 from the United States, Canada, and Brazil. In women who received three injections and follow-up testing, the vaccine was 100% effective. In those who received only one or two injections, the vaccine proved to be 91% effective. The vaccine offers protection for three to five years. No side effects, except for pain or redness at the injection site, were reported, said Harper, who added that she is an independent researcher and is not paid by GlaxoSmithKline. "It offers such an advantage for women and such a change in health care, one that we will actually see in the next five years," Harper said of the vaccine. If approved by the Food and Drug Administration, it could be available early next year. "I'm extremely excited about the possibilities." According to preliminary findings, said Harper, the vaccine may protect against HPV-associated diseases such as anal cancer, vaginal cancer, vulvular cancer, esophageal cancer, abnormal Pap smears, and mouth or oral cancer. "It's going to take us 20 to 30 years to get the data, but we're really hopeful this has long-term protective [...]

1/30/2005 U.S. Dept. of Health & Human Services: Report on Carcinogens, 9th edition For the first time alcoholic beverages have been listed as a known human carcinogen by the U.S. Department of Health and Human Services in its "Report on Carcinogens" 9th edition. The report states that consumption of alcoholic beverages is causally related to cancers of the mouth pharynx larynx and esophagus and that studies indicate that the risk is most pronounced among smokers and at the highest levels of consumption. The effect of a given level of alcoholic beverage intake on cancers of the head and neck is influenced by other factors, especially smoking, but that smoking does not explain the increased cancer hazard associated with alcoholic beverage consumption according to the report. There is evidence that suggests a link between alcoholic beverage consumption and cancer of the liver and breast. Potential Hazard The report was first ordered by Congress in 1978 to educate both the public and health professionals in the recognition that many cancers are apparently induced by chemicals in the home workplace general environment and from the use of certain drugs. It identifies "potential" cancer hazards. A listing in the report does not by itself establish that a substance presents a cancer risk to an individual in daily life, according to press releases. However the "known" category is reserved for those substances for which there is sufficient evidence of carcinogenicity from studies in humans that indicates a cause and effect relationship between the exposure and [...]

1/27/2005 CL Hashimoto et al. Am J Gastroenterol, February 1, 2005; 100(2): 275-82 Objective: Patients with primary head and neck cancer show a predisposition to develop esophageal cancer. The aim of this study was to investigate in these patients: the prevalence of esophageal cancer comparing the value of chromoendoscopy using Lugol's solution examination to standard endoscopy, in the early diagnosis of esophageal cancer. Methods: Prospective observational study at a state general university hospital in Sao Paulo, Brazil. 326 consecutive adult patients with primary head and neck cancer were evaluated. A standard endoscopy was performed, followed by a 2% lugol's dye spray chromoendoscopy and histopathologic study. The prevalence of esophageal cancer was defined. The results of the two endoscopic methods were compared. Results: Twenty-four patients with esophageal cancer and high-grade intraepithelial neoplasia were detected and had a prevalence of 7.36%. Chromoendoscopy and standard endoscopy were equivalent to the diagnosis of advanced and invasive esophageal cancer. However, standard endoscopy diagnosed 55% of high-grade intraepithelial neoplasia, in comparison to chromoendoscopy that detected 100%. Conclusions: Patients with primary head and neck cancer should be considered as high risks for the presence of esophageal cancer. Lugol's dye chromoendoscopy diagnosed high-grade intraepithelial neoplasia, which went unnoticed with standard endoscopy. It permits a more exact detection of lesion boundaries and facilitates a more precise targeting of biopsy fragments. Authors: CL Hashimoto, K Iriya, ER Baba, T Navarro-Rodriguez, MC Zerbini, JN Eisig, R Barbuti, D Chinzon, and JP Moraes-Filho Authors' affiliation: Department of Gastroenterology, Faculty of Medicine, University [...]