Yearly Archives: 2006

Tobacco control: present and future

  • 12/29/2006
  • London, England
  • Robert West
  • British Medical Bulletin 2006 77-78(1):123-136

The history of tobacco control in the twentieth century can be summed up by the phrase ‘too little, too late’. The century saw the proliferation of the most deadly form of tobacco use: cigarette smoking. Until the 1970s, no government took serious action to protect its citizens. In fact, probably the most effective global tobacco control ‘strategies’ to date have not been motivated by health concerns: they have been inaccessible or uneconomic markets for tobacco companies and a cultural taboo on women smoking.

Economic development has led to massive increases in male cigarette smoking in developing countries but even now <10% of women in non-Western countries such as China, Russia and India smoke. With ‘westernization’, this picture is changing. Without drastic action to get current smokers to stop, the annual rate of tobacco-related deaths will grow from 5 million in 2006 to 10 million in 2025.

Without further action to prevent take up of smoking, the subsequent death toll will be even higher. The recently enacted World Health Organization (WHO)-initiated Framework Convention on Tobacco Control (FCTC) can mitigate this impending disaster but only if it is implemented according to the spirit and not just the letter of the articles contained therein. Specific tobacco levies in every country should be the primary means of kick-starting the process, with the proceeds being used exclusively to fund other tobacco control initiatives, including product regulation.

Author’s affiliation:
Department of Epidemiology and Public Health, University College London, 2-16 Torrington Place, London WC1E 6BT, UK

December, 2006|Archive|

Introgen moves toward final test phase of cancer drug

  • 12/29/2006
  • Austin, TX
  • staff

Introgen Therapeutics Inc. said Thursday that it will soon start analyzing the data from its phase III clinical trials for Advexin, a drug to treat head and neck cancer.

The review signals that Introgen is nearing the end of its approval process for its leading product. Phase III is the last clinical trial stage and usually the most expensive and time-consuming.

CEO David Nance said the data from the phase II trials show Advexin helps patients with head and neck cancers.

“Our expanded studies show a larger number of patients with a very high statistically significant survival benefit from Advexin therapy,” said Bob Sobol, senior vice president at the Austin company.

Introgen is waiting for approval from the Food and Drug Administration before it can sell Advexin to the public. The company first applied two years ago.

Advexin is a targeted gene-based therapy intended for head-and-neck cancer patients. It uses the p53 gene, a tumor suppressor, to kill cancer cells.

December, 2006|Archive|

Biocon to file cancer drug results with US database

  • 12/28/2006
  • Kolkata, India
  • Rohit Khanna

Biotech firm Biocon Ltd is planning to submit the results of the post-marketing surveillance study (PMS) of its cancer drug, BIOMAB-EGFR, to the global safety database in US. The database, maintained by a consortium of companies, collects clinical trial data pertaining to the safety and efficacy of new drugs.
Dr Subir Basak, Biocon’s general manager for business development, said: “Head and neck cancer is not studied in the US, while the Indian sub-continent accounts for one-third of the head and neck cancer patients in the world. The PMS study report will be beneficial to the research of cancer the world over”.

The trial results for this drug, touted as being the world’s first humanised monoclonal antibody for cancer, have been published in Journal of Clinical Oncology of US in 2004.

The drug targets the human EGFR, a type of protein found on the surface of both normal and cancer cells. Small proteins circulating in the blood, called epidermal growth factors (EGF), bind with them. This binding stimulates certain biological processes within the cell to promote cell growth in a controlled manner.

In many cells, EGFR is overproduced, leading to abnormal growth. The role of EGFR in malignant cell formation has prompted the development of biological agents, like BIOMAB-EGER, which disrupts and inhibits the EGFR signaling process.

Apart from a large trial going on in North America, Biocon will start PMS trial in India soon. “Results have shown that while the FDA approved drugs increase life of cancer patients by a year at the most, BIOMAB-EGFR increases life by at least three years,” said Dr Basak.

BIOMAB-EGFR, the only monoclonal antibody manufactured in Asia, is indicated for use in combination with radiation therapy and chemotherapy in patients with positive expression of EGFR in squamous cell carcinoma of head and neck cancer.

“There is a scepticism in US about monoclonal antibodies manufactured in India. PMS trial results of the new drug will definitely sound a wake up call to them,” Basak added.

December, 2006|Archive|

Access Pharmaceuticals Receives MuGard Marketing Clearance From The FDA

  • 12/28/2006
  • web-based article
  • press release

Access Pharmaceuticals, Inc. announced today that it had received 501(k) clearance from the Food and Drug Administration to market MuGard in the United States.

MuGard is Access’ proprietary oral rinse product for the management of oral mucositis, the debilitating side-effect which afflicts more than 40% of cancer patients undergoing radiation and chemotherapy. There is currently no well-accepted treatment for mucositis, and the Company believes that MuGard should be a valuable supportive care option for cancer patients. The estimated size of the market for this indication in the U.S. exceeds $1 billion. The Company is actively seeking marketing partners for this product in the U.S. and in other territories.

Rosemary Mazanet, MD, PhD, Acting CEO of Access stated, “This approval marks a major milestone for the company following the decision to focus on the development and commercialization of proprietary products for the treatment and supportive care of cancer patients. We are in active discussions for licensing and manufacturing the product and expect to have more announcements in the future.”

In previously reported clinical studies MuGard prevented significant mucositis in over 40% of patients in a population where the incidence of mucositis normally exceeds 90%. In addition to the management of mucositis, the approved indication for MuGard includes all types of oral wounds, including aphthous ulcers (canker sores) and traumatic ulcers, such us those caused by oral surgery or ill-fitting dentures or braces. This broad-based approval provides the Company with the opportunity to promote the use of the product for several related oral ulcerative conditions.

December, 2006|Archive|

Trip Update, Dec. 27

  • 12/28/2006
  • Costa Mesa, CA
  • Michelle Thompson

Merry Christmas and warmest wishes for you and yours from sunny Costa Mesa, California.

It is hard to believe I have actually arrived. Upon first waking this morning, in a momentary haze, I was thinking, “How many miles can I make today? How’s the weather? The wind? And then it hit me, “I’m here!” And it is nothing short of a Christmas miracle.

As I rolled in Christmas night, the sight of my brother John, standing in his driveway waving a checkered flag and holding a dozen yellow roses, is something I will treasure for the rest of my life.

He is my true definition of courage, fighting the odds of a devastating disease. He is the one who deserves all the accolades, and yet he is cheering me on, just as he always has. Humbling is an inadequate word. I now know the true meaning of an overwhelming moment.

Admittedly, with so many weeks and miles passing since leaving our parents’ driveway in Glen Ellyn, it was surreal to arrive. Peddling the last 1/2 mile of the 2,441 mile journey with my sister Donna, I came around a bend and saw an enormous hand-stenciled banner, (compliments of my brother-in-law Charlie) that read “Congratulations Michelle, you made it!” After crashing through the finish line, there were many tears and hugs as John, his wife Tracy, my sister Donna, her husband Charlie, along with cheering neighbors filled the driveway. It was the perfect family reunion, immensely joyful.

To have been able to share this celebration with our parents, Jack and Joan Thompson, the heart and soul of our family, would have been the only addition that could have made this moment more spectacular. They have been an integral part of this family effort since I began pedaling. Although they were deeply missed, without question they were with us in spirit. They had just returned home to Chicago after traveling here for the Thanksgiving Holiday. Originally I had hoped to arrive closer to Thanksgiving rather than Christmas, but Mother Nature and the 12 or so “non-pedaling days” reeked havoc with the master plan.)

In fact, a Christmas arrival would not have been possible if not for my sister Donna, without whom I would still be pedaling somewhere in the Mojave Desert! Meeting me near the California border, acting as my “route scout” and taking BOB (my trailer) allowed me to double my daily miles. She lit my way with headlights through the dark, difficult desert roads and beyond, one day following me until midnight. I am fairly certain I aged her a few years as she waited for me to join her 6 miles down from the summit of the Cajon Pass, yet she still hung in there. Without a doubt route2outsmartcancer has truly been a family effort.

Since Christmas night we have spent much needed time together as a family, sharing stories and of course many laughs. I will be staying on the west coast for the week and look forward to catching up with my brother and family, as well as continuing my work to reach our goal of raising $50K in pledges for my brother and his family. Although the bike-a-thon has ended, this journey for John has just begun as he works everyday to recover strength, eat, drink and talk. After seeing him on Christmas, I am more committed than ever and believe route2outsmartcancer has much yet to accomplish.

The first words my brother spoke to all of us on Christmas were “I am going to kick this, you wait and see, I am going to kick this.” And we know he will. He has already beaten the odds and will continue to do so, with the continued prayers, support and friendship of each and every person who makes up the “route2outsmartcancer community.” This is a community I am so deeply proud to know and that I pray will continue to grow with your help.

I have been told repeatedly this organization restores one’s faith in human kindness, and I couldn’t agree more. It is a community made up of people who share a belief in the power of faith, family, friends, and the belief that each of us can make a difference. The outpouring of kindness and generosity is appreciated beyond words. Each and every pledge and prayer we have received and hope to continue to receive have had an incredible impact on my brother’s recovery. Every person I have met along the route, every e-mail, kind word of encouragement, letter and phone call, has been an inspiration. You have been a blessing and are now a part of our extended family.

Thank you for taking the time to care about my brother, my family, and my ride. I have had the opportunity to witness humanity at its finest through the efforts of each and every person who has joined with route2outsmartcancer. In a sometimes cynical world that often discourages an effort such as this, with my deepest gratitude, thank you for your support. I ask that you continue to help us by spreading the word as we will keep working until we reach our goal!

Many of you have shared personal stories of your own battle. I believe you will win the battle and beat the odds, just as my brother will, made possible through the love and support of your family, friends, good doctors, second opinions, and faith. Throughout the 2 month ride, you’ve inspired me with your courage and have made route2outsmartcancer even more meaningful. Please know you were close in my thoughts as I crossed the finish line and hugged my brother.

On behalf of me, John, and our family, we wish for you and your loved ones the same gifts that have been shared with us through the route2outsmartcancer community, these being faith, support, friendship, courage, humor, and unconditional love.

Warmest regards,

December, 2006|Archive|

Human Papillomavirus Tied to Oral Cancer

  • 12/28/2006
  • New York, NY
  • staff

Human papillomavirus (HPV) infection from oral sex may have increased rate of tonsillar cancer, a study from Sweden hints.

Reports from both the US and Finland have documented a rise in the incidence of tonsillar cancer. This occurred in the absence of any increase in smoking or alcohol consumption, two well-known causative factors for the malignancy. This led Dr. Eva Munck-Wikland, from the Karolinska Institute in Stockholm, and colleagues to look for other epidemiologic trends that might explain the growing incidence of tonsillar cancer.

HPV is known to be associated with tonsillar cancers. Whether an increase in HPV-positive cases drove the recent increase in incidence, however, was unclear.

In their study, reported in the International Journal of Cancer, the investigators found that the incidence of tonsillar cancer rose by 2.8-fold in Sweden during the study period, 1970 to 2002. Cases of the disease in women rose by 3.5-fold, while cases in men increased by 2.6-fold.

At the same time, the proportion of HPV-positive cases of tonsillar cancer increased 2.9-fold, the report indicates. In the 1970s, 23.3 percent of cases were HPV-positive compared with 68 percent in 2000 to 2002.

This may be related to patterns of sexual behavior, with high-risk HPV-16 infections, not uncommon in the genital area, also becoming more common in the mouth due to an increase in oral sex, Munck-Wikland and colleagues note

They hypothesize that an “epidemic” of HPV infection in the oral cavity, due to changed sexual habits, “may contribute to the significant increase in incidence of tonsillar cancer.”

If HPV does, in fact, cause tonsillar cancer, it might stimulate interest in developing a vaccine for preventing the malignancy, they suggest.

International Journal of Cancer, December 1, 2006.

December, 2006|Archive|

The clinical significance of the positive surgical margin in oral cancer

  • 12/26/2006
  • Winnipeg, Manitoba, Canada
  • Abdulaziz Binahmed, Richard W Nason, and Ahmed A Abdoh
  • Oral Oncol, December 13, 2006

The objective of surgical management of squamous cell carcinoma of the oral cavity is adequate resection with a clear margin. This study examines the significance of the positive surgical margin.

An historical cohort of 425 patients from the cancer registry of the Province of Manitoba with squamous cell carcinoma of the oral cavity treated with surgery +/-radiotherapy was examined. A Cox’s proportional hazard model was used to examine the independent effect of surgical margins on five-year survival. Seventy-two percent of tumors involved the tongue and floor of mouth, and 43% of patients presented with Stage III and IV disease. The 5-year absolute and disease specific survivals were 62% and 74.5% respectively.

Survival was related to age >65 years (P=0.0177), T-Stage (P=0.0002), and N-Stage (P=0.0465). Patients with clear margins had a survival rate of 69% at 5 yrs (median survival >60 mos) compared to 58% with close (median survival >60 mos) and 38% with involved margins (median survival 31 mos, P=.0000). After controlling for significant prognostic factors, involved surgical margins increased the risk of death at 5 years by 90% (HR 1.9, 95% CI 1.2,2.9, P=0.0026). The status of the surgical margin is an important predictor of outcome. The surgical margin, in contrast to the other prognostic indicators, is under the direct control of the surgeon.

Authors’ affiliation:
Department of Oral and Maxillofacial Surgery, Winnipeg, Man., Canada

December, 2006|Archive|

Hypothyroidism after radiotherapy for patients with head and neck cancer.

  • 12/26/2006
  • Tochigi, Japan
  • H Ozawa et al
  • Am J Otolaryngol, January 1, 2007; 28(1): 46-9

We report on 2 cases of hypothyroidism presenting clinical symptoms that occurred after radiotherapy for cancer of the head and neck and on the results of estimating thyroid function in patients with head and neck cancer who received radiotherapy.

The first patient underwent total laryngectomy for laryngeal cancer without sacrificing the thyroid gland and partial gastrectomy for gastric cancer. Radiotherapy of the neck was carried out postoperatively.

Two years later, the patient developed chest pain; pericardial effusion was detected, leading to a diagnosis of myxedema caused by hypothyroidism. The second patient received radiotherapy alone for laryngeal cancer. Two months later, low serum sodium concentration and anemia were detected in this patient.

The cause of these changes was subsequently found to be hypothyroidism. Based on our experience with these 2 cases, we measured thyroid function in 35 patients who had undergone neck radiation for head and neck cancer at our hospital over the past 10 years. Hypothyroidism was observed in 13 of the 35 patients (37%).

The prevalence of hypothyroidism was 46% (6/13) for patients treated with both radiation and surgery, as compared with 32% (7/22) for those who received radiation alone. The risk factors responsible for hypothyroidism were not evident from the statistical analysis of these cases.

We believe that thyroid function should be evaluated periodically in patients who have undergone neck radiation because it is often difficult to diagnose hypothyroidism only from clinical symptoms.

H Ozawa, H Saitou, K Mizutari, Y Takata, and K Ogawa

Authors’ affiliation:
Department of Otolaryngology, Keio University School of Medicine, Tokyo, Japan; Department of Otolaryngology, Saiseikai Utsunomiya Hospital, Tochigi, Japan

December, 2006|Archive|

Switching to Smokeless Won’t Cut Dangers

  • 12/26/2006
  • Pennsylvania, USA
  • Dr. Howard R. Tolchinksky

As public smoking bans gain momentum throughout Pennsylvania, there is a growing concern within the health care community that smokers may be tempted to switch to smokeless tobacco products in situations where they are barred from lighting up.

Big tobacco is paying attention. The industry is promoting new flavored chew and spit-free products that they market as being more convenient and socially acceptable than smoking or using traditional chew. These products repackage tobacco into a more socially acceptable but equally addictive nicotine delivery system.

Increased public awareness of the hazards of smoking and smoking bans are cutting into the profits of leading cigarette manufacturers, which may be behind the industry’s increased focus on smokeless products. The impact is already being felt: smokeless tobacco sales in the United States topped $3 billion last year, while the number of cigarettes sold fell to the lowest level in more than 50 years.

Many dentists and physicians are troubled by the industry’s new emphasis on smokeless tobacco. Some advertising may leave the impression that smokeless tobacco is somehow safer than smoking, or is a smart alternative for people who are trying to quit smoking. Sadly, neither is true.

The amount of nicotine absorbed by the body from smokeless tobacco is three to four times higher than the amount delivered by a cigarette. A person who uses eight to 10 dips or chews a day ingests the same amount of nicotine as a heavy smoker who has 30 to 40 cigarettes a day. Therefore, smokeless tobacco users become just as easily addicted to nicotine as smokers and quitting smokeless tobacco can be more difficult than giving up cigarettes.

As a practicing dentist since 1973 and serving since 2004 as the Pennsylvania State Dentist, I firmly believe that using any type of tobacco product will hurt you. Smokeless tobacco carries with it a multitude of health risks that are equally as damaging and deadly as those caused by smoking. You might not get lung cancer using chew, but other types of cancer are still a serious risk.

Oral cancer and other cancers that attack your mouth, throat and digestive system are disfiguring and deadly. Chewing tobacco contains 28 known carcinogens. According to the Centers for Disease Control and Prevention, each year, about 30,000 Americans learn they have mouth and throat cancer, and nearly 8,000 Americans die of these diseases. Only about half of people with diagnosed mouth or throat cancer survive more than five years.

The short-term side effects of smokeless tobacco use can include cracked, bleeding and receding gums, as well as eroded tooth enamel, which can increase your risk of cavities. Since chewing tobacco contains high amounts of sugar, prolonged use can cause tooth decay and loss. The results of using chew tobacco can also include mouth sores, tooth abrasion and erosion, increased tooth decay, tooth discoloration, bad breath and – of course – nicotine dependence.

The best advice to tobacco users, whether they smoke or chew, is to quit. The commonwealth offers resources to assist those who want to quit or want advice on how to educate their children on the health risks so they never start. Pennsylvania’s toll-free quit line, (800) QUIT-NOW, is staffed around the clock with professional counselors. The state also offers helpful tips to quit at, keyword: health.

If you are not using a tobacco product, I encourage you to not fall victim to the efforts by big tobacco companies to convince consumers that there is any safe form of tobacco product. It does not exist.

Dr. Howard R. Tolchinsky is the Pennsylvania State Dentist.

December, 2006|Archive|

High-Risk Human Papillomavirus Affects Prognosis in Patients With Surgically Treated Oropharyngeal Squamous Cell Carcinoma

  • 12/19/2006
  • Milan, Italy
  • Lisa Licitra et al.
  • Journal of Clinical Oncology, Vol 24, No 36 (December 20), 2006: pp. 5630-5636

Human papillomavirus (HPV) DNA tumors actively integrating the E6 and E7 oncogenes have a distinct biologic behavior resulting in a more favorable prognosis. To which extent the viral integration by itself, and/or the associated wild-type (wt) TP53 status, and/or a functional p16 contribute to prognosis is unclear.

Patients and Methods:
To clarify how the presence of high-risk (HR) -HPV, TP53, and p16INK4a status interact with clinical outcome, we considered a retrospective series of 90 consecutive oropharyngeal cancer patients treated primarily with surgery.

Seventeen (19%) patients showed integrated HPV 16 DNA (HPV positive), wt TP53 in all but two patients, normal p16INK4a in 15 assessable patients, and p16 expression in all 17 patients. Thirty-five patients (39%), two of whom were HPV positive, harbored TP53 mutations. p16INK4a deletion and p16 null immunophenotype occurred in 28 and 58 patients, respectively, and was similarly distributed in both patients with mutated TP53 (48% and 82%, respectively) and in patients with wt TP53 (46% and 77%, respectively). Statistical analysis showed that HPV-positive status significantly affects all investigated end points: overall survival (P = .0018), incidence of tumor relapse (P = .0371), and second tumor (P = .0152), whereas TP53 and p16INK4a status and p16 expression were not prognostic by themselves.

Our molecular and clinical results are in agreement with previous findings but provide additional information into the biologic mechanisms involved in HR-HPV oropharyngeal cancer in comparison to HPV-negative tumors. According to the reduced risk of relapse and second tumors associated with HR-HPV positivity of oropharyngeal cancer, the therapeutic strategy and follow-up procedures should be reviewed.

Lisa Licitra, Federica Perrone, Paolo Bossi, Simona Suardi, Luigi Mariani, Raffaella Artusi, Maria Oggionni, Chiara Rossini, Giulio Cantù, Massimo Squadrelli, Pasquale Quattrone, Laura D. Locati, Cristiana Bergamini, Patrizia Olmi, Marco A. Pierotti, Silvana Pilotti

Authors’ affiliation:
From the Head and Neck Cancer Medical Oncology Unit, Unit of Experimental Molecular Pathology, Medical Statistics and Biometry, Department of Head and Neck Surgery, Department of Pathology, Radiotherapy Department, and Department of Experimental Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori; and Fondazione Italiana per la Ricerca sul Cancro (FIRC) Institute of Molecular Oncology, Milan, Italy

December, 2006|Archive|