Monthly Archives: September 2009

Induction with Docetaxel, Cisplatin, and 5-FU provides survival benefits beyond 5 years in head and neck cancer

Author: Chris Berrie

Induction with docetaxel, cisplatin, and 5-fluorouracil (5-FU) provides sustained significant survival advantages beyond 5 years compared with cisplatin and 5-FU in patients with locally advanced squamous cell cancer of the head and neck.

Jochen Lorch, MD, Head and Neck Oncology Programme, Dana Farber Cancer Institute, Harvard University, Boston, Massachusetts, presented a 5-year follow-up analysis of the multicentre, randomised, open-label, phase 3 Cisplatin and Fluorouracil Alone or With Docetaxel in Head and Neck Cancer (TAX 324) at the joint 15th Congress of the European Cancer Organisation (ECCO) and 34th Congress of the European Society for Medical Oncology (ESMO).

The benefits of docetaxel in combination with cisplatin and 5-fluorouracil (TPF) was shown in the original TAX 324 and TAX 323 studies. Results of the follow-up were presented here on September 22.

TAX 324 included 501 patients with measurable, nonmetastatic stages III and IV squamous cell carcinoma of the head and neck, with a primary tumour location in the oral cavity, oropharynx, larynx or hypopharynx, and unresectable disease. A World Health Organization (WHO) performance status (PS) of 0/1 and no prior chemotherapy or radiotherapy were also specified.

Patients were randomised to induction therapy of TPF (n = 255) or cisplatin plus 5-fluorouracil (PF) on days 1 to 4, every 3 weeks for 3 cycles (n = 246). The induction treatments were followed by chemoradiotherapy with carboplatin area under the curve (AUC) 1.5, weekly and daily radiotherapy (5 days/week).

In the original study, there was a significant 13% improvement (62% vs 49%) in 3-year overall survival (OS) with TPF over PF (P = .006), with median survivals of 71 months versus 30 months.

The current 5-year, long-term follow-up included 440 patients (88%), and showed a significant 10% improvement (52% vs 42%) for TPF over PF (P = .014), with median survivals of 71 months versus 35 months.

According to disease site subgroups here, the median survivals showed, respectively: oropharynx, not reached versus 65 months (P = .045); hypopharynx, 32 versus 20 months (P = .29); larynx, 58 versus 25 months (P = .29); and oral cavity, 37 versus 14 months (P = .70).

However, as Dr. Lorch noted for laryngeal and hypopharyngeal tumours, “If these patients recur, there is a surgical salvage option.” Thus for progression-free survival rather than overall survival, there was indeed a significant benefit for these patients (P = .0365).

According to tumour staging, the beneficial trend for TPF over PF for stage III at 3 years (71 vs 51 months; P = .07) was lost at 5 years (90 vs 65 months; P = .26). In contrast, the main benefit was for stage IV at both 3 years (59 vs 25 months; P = .02) and 5 years (59 vs 25; P = .03).

For toxicity, Dr. Lorch noted that there were no significant differences at 3 years and at 5 years.

1. Funding for this study was provided by Sanofi-Aventis.
2. Presentation tile: Long-Term (Five-Year) Results of TAX324: A Phase III Trial of Sequential Therapy Comparing TPF With PF in Patients With Locally Advanced Squamous Cell Cancer of the Head and Neck. Abstract 8502

September, 2009|Oral Cancer News|

For Apple, accessibility is much more than lip service

Author: Chris Foresman

We have discussed the advancements Apple has made in accessibility to Mac OS X and even the iPhone in the past, but recent examples show that Apple’s attention to detail in technologies technologies like VoiceOver and Voice Control can make all the difference in the world for users with speech or sight impairments. These technologies are earning Apple awards and the appreciation of users and further separate Apple from the competition.

It was just a few weeks ago when we noted comments from industrial designer Mike Calvo, whose company Serotek is involved in accessibility design, on how well accessibility is engineered into the iPhone. “Apple understands that accessibility should be about far more than developing custom solutions which pay lip service to the idea of accessibility but detract from the out-of-box experience enjoyed by everyone else,” he wrote in his assessment of the iPhone. Now, after the release of iPhone OS 3.1, the Mac-cessibility Network noted that Apple has added an additional 16 improvements to the accessibility features of Apple’s mobile devices. These include controls for cutting and pasting text or even editing video using VoiceOver and Voice Control, reading PDF files, and using Voice Control over a Bluetooth headset. The continued attention to detail shows that Apple doesn’t take accessibility lightly.

This attention to detail has also earned Apple an award from the National Federation for the Blind. Tomorrow, during its first ever Web Accessibility Day conference, the NFB will give an award to Apple recognizing the company for making the iPhone—a device largely defined by its graphical user interface that works with a touchscreen that has no haptic feedback—accessible and useable for those with visual impairments.

In addition to recognition from the NFB, though, Apple’s technology has been recognized by some users recently for enabling them to communicate without the need for costly specialized systems. Users are finding that an iPhone with some specialized software, or even an off-the-shelf Mac with VoiceOver, can replace expensive, clunky text-to-speech devices for far less money. For example, The New York Times detailed the plight of a San Francisco woman who lost her voice due to amyotrophic lateral sclerosis (ALS). She recently supplanted her text-to-speech computer for an iPhone loaded with a $150 text-to-speech app, which lets her “wear her voice around her neck while snuggling with her 5-year-old son.”

That story prompted a letter to the editor from none other than famed film critic Roger Ebert, who lost his voice to throat cancer. He told the Times, “After trying an $8,000 custom device with little computing power and a small, dim screen, I tried the built-in speech software on my MacBook and found it much more practical.” He uses the text-to-speech capability to discuss online news with his wife, for instance. While the expensive custom devices have other features, such as e-mail and Web browsing, disabled for complex insurance reasons, Ebert notes that “[a]nyone who uses a computer and has lost the power of speech knows that e-mail becomes invaluable.”

It’s easy to point to a list of such features and say, “Great job, Apple,” but unless you have ever had to rely on the features, it’s difficult to understand just how important they are. Expensive, specialized devices may always be necessary for some users, but Apple’s focus on accessibility (even iPods have VoiceOver) could make an iPhone or a Mac all that some people need. The personal testimony of such users really drives home how disabilities can make computing and communicating a serious challenge, and how critical technologies like VoiceOver, Voice Control, and Universal Access are to giving these users the ability to participate in what the rest of us simply take for granted.

September, 2009|Oral Cancer News|

Initial COIN study results presented at European Oncology Congress

Author: Staff

• Results inconsistent with data from all Erbitux pivotal studies
• Further analyses planned by the Medical Research Council that conducted the independent COIN study

Berlin/Darmstadt, Germany, September 23, 2009 – The Medical Research Council (MRC), a UK-based, publicly-funded organization dedicated to improving human health, today presented the initial results of the independent Phase III COINa study, which did not meet its primary endpoint of overall survival (OS).1 These findings were presented today at the joint 15th Congress of the European Cancer Organisation (ECCO) and 34th Congress of the European Society for Medical Oncology (ESMO) in Berlin, Germany.

The COIN study was designed to evaluate whether the addition of Erbitux® (cetuximab) to one of two oxaliplatin-based chemotherapy regimens significantly improved outcomes in previously untreated metastatic colorectal cancer (mCRC) patients with KRAS wild-type tumors. The median OS was not statistically significant at 17.0 months in the Erbitux treatment arm compared to 17.9 months for the chemotherapy-alone group (hazard ratio [HR] 1.038; p=0.68).1
“Imbalances in the chemotherapy administered between the different study arms were reported previously in the interim safety analysis,” explained Dr. Wolfgang Wein, Executive Vice President, Oncology, Merck Serono, a division of Merck KGaA, Darmstadt, Germany. “Further analysis of the dose intensity and 2nd-line treatment, and other factors, such as the advanced disease of patients in the study, are ongoing to determine why the COIN results are not aligned with existing evidence from the other randomized, 1st-line studies, including the significant increase in overall survival achieved with the CRYSTAL study.”
Results from the pivotal Phase III CRYSTALb trial also presented earlier today demonstrated that the addition of Erbitux to the standard 1st-line FOLFIRI chemotherapy regimen significantly improved OS in patients with KRAS wild-type tumors (23.5 vs. 20.0 months, HR 0.796, p=0.0094).2 In addition, results from the Phase II OPUSc study, which investigated the benefit of adding Erbitux to the FOLFOX regimen in KRAS wild-type patients, demonstrated:

• Significant improvement in progression-free survival (8.3 vs. 7.2 months, HR 0.567, p=0.0064)

• Significant improvement of response rate (57,3% vs. 34,0%, p=0.0027)

• OS was 22.8 vs. 18.5 months (HR 0.855, p=0.3854).3

a COIN: A Phase III trial comparing either COntinuous chemotherapy plus cetuximab or INtermittent chemotherapy with standard continuous palliative combination chemotherapy with oxaliplatin and a fluoropyrimidine in first line treatment of metastatic colorectal cancer
b CRYSTAL: Cetuximab combined with iRinotecan in first line therapY for metaSTatic colorectAL cancer
c OPUS: OxaliPlatin and cetUximab in firSt-line treatment of mCRC

1. Maughan TS, et al. ECCO/ESMO Congress 2009. Abstract No: 6LBA. Updated information presented at meeting.
2. Van Cutsem E, et al. ECCO/ESMO Congress 2009. Abstract No: 6077. Updated information presented at meeting.
3. Bokemeyer C, et al. ECCO/ESMO Congress 2009. Abstract No: 6079. Updated information presented at meeting.

For more information on Erbitux in colorectal, head & neck and non-small cell lungcancer, please visit:

About Erbitux
Erbitux® is a first-in-class and highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth.

The most commonly reported side effect with Erbitux is an acne-like skin rash that seems to be correlated with a good response to therapy. In approximately 5% of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe.

Erbitux has already obtained market authorization in 77 countries. It has been approved for the treatment of colorectal cancer in 77 countries and for the treatment of squamous cell carcinoma of the head and neck (SCCHN) in 72 countries:

• December 2003 (Switzerland), February 2004 (USA), June 2004 (EU) and followed by other countries: for use in combination with irinotecan in patients with EGFR-expressing mCRC (metastatic colorectal cancer) who have failed prior irinotecan therapy. In addition, Erbitux is also approved for single-agent use in further countries.
• April 2006 (EU) and followed by other countries: for use in combination with radiotherapy for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN). In further countries, Erbitux is also approved as monotherapy in patients with recurrent and/or metastatic SCCHN who failed prior chemotherapy.
• July 2008 (EU): license was updated for the treatment of patients with epidermal growth factor receptor (EGFR) expressing, KRAS wild-type mCRC in combination with chemotherapy and as a single agent in patients who have failed oxaliplatin-and irinotecan-based therapy and who are intolerant to irinotecan.
• July 2008 (Japan): for use in combination with irinotecan in patients with EGFR-expressing mCRC who have failed prior irinotecan therapy
• In November 2008 (EU): license was updated for the use in combination with platinum-based chemotherapy in patients with recurrent and/or metastatic SCCHN

Merck licensed the right to market Erbitux outside the US and Canada from ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, in 1998. In Japan, ImClone Systems, Bristol-Myers Squibb Company and Merck jointly develop and commercialize Erbitux. Merck has an ongoing commitment to the advancement of oncology treatment and is currently investigating novel therapies in highly targeted areas, such as the use of Erbitux in colorectal cancer, squamous cell carcinoma of the head and neck and non-small cell lung cancer. Merck has also acquired the rights for the cancer treatment UFT® (tegafur-uracil) – an oral chemotherapy administered with folinic acid (FA) for the first-line treatment of metastatic colorectal cancer.

Merck is also investigating among other cancer treatments the use of Stimuvax® (formerly referred to as BLP25 Liposome Vaccine) in the treatment of non-small cell lung cancer. The vaccine was granted fast-track status in September 2004 by the FDA. Merck obtained the exclusive worldwide licensing rights from Oncothyreon Inc., Seattle, Washington, USA.
In addition, Merck is developing cilengitide, which is the first in a new class of investigational anti-cancer therapies called integrin inhibitors to reach Phase III of development; it is currently being investigated for the treatment of glioblastoma, SCCHN and NSCLC. Integrin inhibitors are thought to work by targeting the tumor and its vasculature.

Merck is a global pharmaceutical and chemical company with total revenues of € 7.6 billion in 2008, a history that began in 1668, and a future shaped by approximately 33,000 employees in 60 countries. Its success is characterized by innovations from entrepreneurial employees. Merck’s operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

September, 2009|Oral Cancer News|

A different camel is back in the glossies

Author: Andrew Adam Newman

The two largest tobacco companies in the United States voluntarily stopped advertising cigarettes in magazines, with Philip Morris, whose brands include Marlboro, ceasing in 2005 and R. J. Reynolds, whose brands include Camel, at the beginning of 2008.

Now the Camel logo is back prominently in major glossies, including Rolling Stone, Sports Illustrated and Maxim — but not to advertise cigarettes. R. J. Reynolds is advertising Camel Snus, a tobacco packet that wedges in the upper lip and, unlike chewing tobacco, is promoted as “spitless” because low salt content spares users the unpleasantness of public expectoration. Although snus is popular in Sweden, this is the first time it has been marketed in the United States by a major American tobacco company.


The campaign, by Quaker City Mercantile in Philadelphia, pitches Camel Snus (pronounced snoose) as a way around smoking bans. The ads cater to specific magazine audiences, with a recent issue of Rolling Stone promoting snus as “sweaty outdoor festival friendly” and one in Sports Illustrated declaring it “extra inning friendly.” Others call snus “your flight just got canceled friendly,” “ridiculously long conference call friendly” and “fancy hotel friendly.”

David Howard, an R. J. Reynolds spokesman, said that the company had not reversed its magazine policy, but that this was a Camel of another color.

“We do not advertise cigarettes in print right now and have not done that for a couple years, but Camel Snus is not a cigarette,” Mr. Howard said. “This is a different product, and if ultimately you want your adult tobacco consumers to be aware of the product and its attributes, clearly you have to advertise.”

Tobacco companies are fighting to be able to retain the use of their logos. In August, companies including R. J. Reynolds filed a lawsuit seeking to reverse provisions in a recently passed federal tobacco law that will prevent tobacco advertisements from using logos or color in publications that have either more than 15 percent readership, or two million readers, under 18. (Congress banned advertising cigarettes on television in the 1970s.)

With smoking declining — the Department of Agriculture estimates that Americans smoked 371 billion cigarettes in 2006, down from a high of 640 billion in 1981 — tobacco companies are developing smoke-free products. Marlboro has its own version of snus in test markets including Indianapolis and Dallas-Fort Worth.

David Sutton, a spokesman for Altria, the largest United States cigarette maker and parent of Philip Morris, said that “we’ve had very good consumer response” in test markets but he declined to reveal whether the company would introduce Marlboro Snus nationally.

As cigarette revenue has dropped steadily, sales of smokeless tobacco — a catchall that includes snuff, plug and chewing tobacco — have grown. Revenue for the products more than doubled from 1986 to 2006, growing from $798 million to $2.6 billion, according to the Federal Trade Commission. Over the same two decades, tobacco companies more than quadrupled advertising and promotional spending for smokeless products, to $354 million, from $77 million.

Public health advocates agree that snus is less carcinogenic than cigarettes, but is still problematic.

“None of us would say the risk of snus products is the same as smoked products, because it’s not,” said Dr. Jack Henningfield, former chief of pharmacology research at the National Institute on Drug Abuse. “If they switched 100 percent from cigarettes, there is likely a harm reduction.” But the way Camel Snus is marketed might be “harm increasing if people delay quitting because of them,” Dr. Henningfield said.

Smoking prohibitions prompt more smokers to quit, so industry watchdogs are leery of a campaign that flaunts circumventing bans.

“Camel clearly is not marketing snus as a replacement product — it’s a complementary product,” said Gregory N. Connolly, a professor and tobacco researcher at the Harvard School of Public Health. Mr. Connolly said the fact that R. J. Reynolds was marketing snus under the Camel brand rather than one of its smokeless brands like Grizzly or Kodiak suggested it was trying to make Camel cigarette loyalists “dual users.”

With dual use, Mr. Connolly said, “you have two forms of nicotine addiction, and if that’s the future, then we have a real problem, because that’s going to be very difficult to treat.”

Danny McGoldrick, a vice president at Campaign for Tobacco-Free Kids, a Washington advocacy group, said the inconspicuousness of snus, which would likely go undetected even in a classroom, “could entice kids into the habit of tobacco use.”

R. J. Reynolds is also now test-marketing “dissolvables,” which include Camel Orbs, finely ground tobacco in the form of small mint pellets like Tic Tacs, and Camel Strips, which resemble Listerine breath-freshening strips and melt on the tongue. Test cities include Indianapolis and Columbus, Ohio.

For snus, the “early indication is that it it’s largely skewed toward men,” but with dissolvables “we have found that those products probably offer a better opportunity with women tobacco consumers,” Mr. Howard said.

Snus has been used in Sweden since the early 1800s, and today about one million of roughly nine million residents use snus daily, according to Swedish Match, a tobacco company that exited the cigarette business a decade ago to make snus and other smokeless products exclusively. Its General brand of snus is sold at about 500 cigar and tobacco specialty shops in the United States.

About 19 percent of Swedish men (and only 4 percent of women) use snus, according to the company. Correspondingly, the rate of cigarette smoking for men in Sweden is among the lowest in Europe, just 12 percent, the company says, compared to France (30 percent), Germany (37 percent) and Greece (47 percent), according to World Health Organization data, cited by the company. Snus is a “lifestyle product” among Swedes, said Rupini Bergstrom, a Swedish Match spokeswoman, in a telephone interview from Stockholm. “It’s not like the way it is in the U.S., where you have this image of only rednecks using dip or other oral tobacco. If you have bankers sitting in a boardroom here, each will have a snus can on the table.”

Andrew Romeo, a former executive at tobacco companies including Britain’s Gallaher Group, says he believes “snus is a much safer alternative to cigarettes” but understands why R. J. Reynolds is not marketing snus as safer.

“It is worse for public health to put snus across as a complementary product instead of a reduced-harm product, but for R. J. Reynolds it makes total sense,” said Mr. Romeo, who lives in Manhattan. “If Americans have gone from, say, two packs a day down to a pack and a quarter a day — the remainder being what you had smoked in your office or at restaurants — then they’re just trying to sell you this other product to fill your day with tobacco goodness.”

September, 2009|Oral Cancer News|

Charting the path from infection to cancer

Author: Eleanor Mayfield

Few people associate infection with cancer, but close to one-fifth of all cancers in the world are caused by infectious agents, including viruses, bacteria, and other microbes. In developing countries, the number is higher—about one in four—while in industrialized countries, such as the United States, it is about one in 12.

Infectious agents that can cause cancer are extremely common, infecting millions of people around the world. Yet it is rare and takes a long time for an infection to develop into cancer. “You need a lot of things to happen, or not happen, to get from an infection to cancer,” said Dr. Douglas R. Lowy, chief of NCI’s Laboratory of Cellular Oncology and a leader in the molecular biology of tumor viruses.

The microbes responsible for most of the global burden of infection-associated cancer are: the bacterium Helicobacter pylori, which causes gastric cancer; cancer-causing strains of the human papillomavirus (HPV), which cause cervical cancer and other cancers; and the hepatitis B and C viruses, which cause liver cancer. These four microbes alone cause more than 15 percent of all cancers worldwide.

Other cancers known to be associated with infectious agents include leukemia and lymphoma; anal, penile, vaginal, and vulvar cancer; and tongue and throat cancers. Last week, researchers reported new evidence linking aggressive prostate tumors to a virus.

Role of the Immune System
Microbes can lead to cancer by a variety of mechanisms that are not yet fully understood, explained Dr. Allan Hildesheim, chief of NCI’s Infections and Immunoepidemiology Branch. The cancer-causing strains of HPV are known to disrupt the cell cycle and inactivate tumor suppressor proteins such as p53, which enables genetic damage to accumulate and, eventually, a cancer to form, he explained. H. pylori is believed to induce chronic inflammation, which can lead to atrophic gastritis and, over time, increases the risk of developing gastric cancer.

“In the case of the hepatitis B and C viruses, the problem may be less the infection itself than the immune system’s response to it. To fight off the infection, the immune system releases cytokines and other inflammatory proteins that can cause tissue damage,” said Dr. Hildesheim. “Over time this can lead to cirrhosis of the liver, which is a strong predisposing factor for liver cancer.”

Chronic suppression of the immune system is another cause of infection-associated cancer. People infected with the human immunodeficiency virus (HIV), which weakens the immune system, and organ-transplant recipients who take immunosuppressive medications to prevent transplant rejection are more vulnerable to infection-associated cancers than people whose immune systems function normally.

Similar Molecular Process
The molecular chain of events leading to an infection-induced cancer is similar to the process by which noninfectious cancers develop, said Dr. Patrick Moore, who directs the Molecular Virology Program at the University of Pittsburgh Cancer Institute. “The same tumor-suppressor signaling pathways that are mutated in noninfectious cancers are also inactivated by viruses,” said Dr. Moore. “Indeed, it was through research on viral causes of cancer that we learned much of what we now know about cancer-causing genes and tumor-suppressor signaling pathways.”

The two most recently discovered viruses believed to be associated with human cancer were both identified in Dr. Moore’s laboratory. In 1993, a group led by Dr. Moore and his wife Dr generic viagra from india. Yuan Chang discovered the Kaposi sarcoma-associated herpesvirus, also called human herpesvirus-8 (HHV-8), which is the likely cause of Kaposi sarcoma. In 2008, the same team found compelling evidence that a newly discovered virus dubbed the Merkel cell polyomavirus causes most cases of Merkel cell carcinoma, an uncommon but lethal skin cancer.

Opportunities for Intervention
Cancers caused by infection “offer unique opportunities for intervention,” said Dr. Lowy. “We now have two vaccines—against hepatitis B and HPV—that can prevent cancer by preventing infection with the virus. Secondly, at least in theory, you can take aim at genes or proteins made by the infectious agent. The best example to date of this approach is antiretroviral therapy for HIV, which works because it has a much stronger effect on the genes and proteins made by the virus than on the body’s own genes and proteins.”

Many features of infection-associated cancers remain poorly understood. For example, for most of these cancers, only some cases are caused by infection. “Some liver cancers have nothing to do with hepatitis infection,” said Dr. Lowy. “Some oropharyngeal, vulvar, and penile cancers are caused by HPV infection, but others are not. On the other hand, virtually all cases of cervical cancer seem to be caused by HPV.”

Burkitt lymphoma in Africa is almost always caused by the Epstein-Barr virus (EBV), added Dr. Moore, whereas in the United States fewer than half the cases of this disease have a viral cause. “What we previously thought was a single cancer has been shown to be two or more types of cancer that look similar, some caused by a virus and some not.”

Some microbes, including EBV, cause different types of cancer in different parts of the world. “In southern China, nasopharyngeal cancer [a cancer of the throat] is the most common cancer manifestation of EBV infection,” said Dr. Hildesheim. “In sub-Saharan Africa, you rarely see nasopharyngeal carcinoma, but Burkitt lymphoma is relatively common.”

Genetic Susceptibility
The fact that most infections capable of causing cancer are very common, and yet only a small subset of those infected develop cancer, suggests that genetic and other factors may promote or protect against cancer in infected individuals, continued Dr. Hildesheim. “Those of us who study tumors caused by infectious agents have been a bit late joining the genetic revolution,” he said. “There is a tremendous amount we can learn.”

Recently he and his colleagues reported on the link between cervical cancer and single nucleotide polymorphisms (SNPs)—one-letter changes in the human genetic code—in genes involved in the immune response to infections and in the repair of DNA damage. They noted that some genetic polymorphisms are associated with increased risk of persistent HPV infection, a prerequisite for an HPV-induced cancer, while others are associated with the tendency for HPV-infected cells to progress to precancer or cervical cancer. Parallel studies have also confirmed findings by other researchers that certain variations in immune regulation genes known as HLA genes appear to affect cervical cancer risk.

“We are trying to understand how individual genetic factors may interact with HPV infection to predispose, or protect against, persistence of the infection or alter the ability to repair genetic damage caused by persistent HPV infection,” Dr. Hildesheim explained. “We and others are also studying whether differences in the genetics of HPV might explain why some infected individuals develop cancer while others do not and whether differences in the genetics of EBV may help to explain why the pattern of cancers associated with this virus is so different in different parts of the world.”

By better understanding cancer-causing infections, said Dr. Lowy, “the hope is that we will be able to prevent more cancers by preventing the infections that lead to the disease or by treating the infections before they develop into cancer.”


September, 2009|Oral Cancer News|

Flavored cigarette ban takes effect 9/22

Author: Karen Pallarito

New federal law may help deter young smokers, health advocates say

TUESDAY, Sept. 22 (HealthDay News) — Young people who enjoy a hint of vanilla, berry or chocolate when they light up are about to have their favorite smokes snuffed out. A new federal law banning fruit- and candy-flavored cigarettes takes effect Sept. 22.

The prohibition is part of the Family Smoking Prevention and Tobacco Control Act, legislation that grants the U.S. Food and Drug Administration the authority to regulate tobacco products. President Barack Obama signed the measure into law June 22.

Studies show that flavored cigarettes, which have been around for about a decade, disproportionately appeal to America’s youth. Thus, banning the manufacture and sale of kid-friendly flavored cigarettes is a critical step toward deterring young smokers, health advocates said.

“Almost 90 percent of adult smokers start smoking as teenagers. These flavored cigarettes are a gateway for many children and young adults to become regular smokers,” FDA Commissioner Dr. Margaret A. Hamburg said in a news release. “The FDA will utilize regulatory authority to reduce the burden of illness and death caused by tobacco products to enhance our nation’s public health.”

Gregg Haifley, associate director of federal relations for the American Cancer Society Cancer Action Network in Washington, D.C., said, “Banning candy and fruit flavorings in cigarettes can have a significant effect on the reduction of initiation of smoking among youth, as well as reducing the number of youth who go on to regular, daily use.”

The network estimated that 3,500 children a day pick up their first cigarette and 1,000 of them become addicted smokers.

“This is truly a case of an ounce of prevention can prevent a future epidemic,” added Matthew L. Myers, president of the Campaign for Tobacco-Free Kids.

“Flavored tobacco products are clearly intended to introduce a new generation of children to tobacco,” he said.

However, Myers said he’s concerned that some manufacturers are attempting to circumvent the ban by distributing flavored cigarettes marketed as “mini-cigars.”

“The very fact that the manufacturers are doing this is a demonstration of the need for the legislation,” he said.

In a letter to the tobacco industry last week, the FDA clarified the new law and cautioned that the ban applies to all tobacco products that meet the definition of a cigarette, “even if they are not labeled as ‘cigarettes’ or are labeled as cigars or as some other product.”

In the face of the looming federal prohibition and the threat of state litigation, the flavored cigarette market has significantly retrenched in recent years, health advocates noted.

In October 2006, R.J. Reynolds Tobacco Company agreed to stop marketing cigarettes with candy, fruit and alcohol flavors under an agreement with attorneys general in 40 states. The company no longer makes blends such as “Twista Lime” or “Kauai Kolada,” a pineapple and coconut-flavored cigarette, spokesman David Howard confirmed.

“Youth should not smoke; that is a guiding principle of this company,” Howard said. “The bottom line is the brands that we produce are marketed for and intended for and sold to adult tobacco consumers.”

One tobacco industry expert estimated that flavored cigarettes now account for just 1 percent of the cigarette market.

In addition to banning candy-, fruit- and spice-flavored cigarettes, the Family Smoking Prevention and Tobacco Control Act:

  • Eliminates the use of the terms “light,” “low” and “mild” on tobacco products.
  • Authorizes the FDA to create a new Center for Tobacco Products to oversee tobacco regulation in the United States.
  • Requires tobacco manufacturers and importers to fully disclose information about ingredients and additives in tobacco products.
  • Implements regulations banning youth-focused marketing of tobacco products.
  • Requires large, graphic warning labels on the health risks of smoking.

R.J. Reynolds and several other companies recently filed a lawsuit challenging certain marketing provisions of the new law. The suit, filed in federal district court in Bowling Green, Ky., does not challenge the flavored cigarette ban, nor does it challenge the FDA’s authority to regulate the industry.

September, 2009|Oral Cancer News|

Prospective analysis of outcomes and complications of 300 consecutive microvascular reconstructions

Source: Arch Facial Plast Surg. 2009;11(4):235-239
Authors: Michael J. Nuara, MD; Cara L. Sauder, MA, CCC-SLP; Daniel S. Alam, MD

To prospectively follow up patients requiring microvascular reconstruction of head and neck defects to determine preoperative factors predictive of surgical complications.

A prospectively collected database comprising 300 consecutive microvascular head and neck reconstructions performed by a single surgeon (D.S.A.) in a tertiary care hospital over a 6-year period was reviewed in a retrospective manner. Data collected included preoperative medical and surgical history (presence of documented cardiac disease, diabetes mellitus, and hypertension) and previous cancer treatment (surgery or radiation therapy). Postoperative data, including early or late complications, hematocrit during hospitalization, and functional status, were also collected. A multiple linear regression was used to identify predictors of surgical complications and secondarily crossed to determine the strength of the prediction. Statistical significance was set at P = .05.

Patients were stratified into 4 groups based on (1) previous radiation therapy, (2) previous surgery, (3) no previous radiation therapy or surgery, and (4) both previous radiation therapy and previous surgery, with an increased predictability of complications with both. Diabetes also added to the predictability of complications, with a smaller effect. Cardiac disease and hypertension were not predictive.

Previous radiation therapy and surgery are positive predictors for wound complications after microvascular reconstruction. Diabetes may add further risk in this setting.

Author Affiliations:
Head and Neck Institute, Cleveland Clinic Foundation, Cleveland, Ohio (Drs Nuara and Alam); and Division of Otolaryngology, University of Utah, Salt Lake City (Ms Sauder).

September, 2009|Oral Cancer News|

Ultrasonography-guided fine-needle aspiration for the assessment of cervical metastases

Source: Arch Otolaryngol Head Neck Surg. 2000;126:1091-1096
Authors: Marco Knappe, MD et al.

To assess the value of ultrasonography (US) combined with fine-needle aspiration (FNA) cytology for the investigation of lymph node metastases in patients with head and neck cancer.

Comparison of clinical examination (palpation) and preoperative US-FNA examination results of cervical nodes in a sample of patients with head and neck cancer. The histological features of the neck dissection specimens are used to validate these 2 variables.

A head and neck oncology service in a tertiary referral hospital.

A consecutive sample of 56 patients with head and neck squamous cell carcinoma, first seen between April 1, 1996, and July 30, 1998, who had neck dissections performed after the US-FNA examination.

Cervical US-FNA preoperatively, followed by elective or therapeutic radical modified or selective neck dissection.

Main Outcome Measures:
The histological examination results of subsequent neck dissection specimens are used to determine the sensitivity, specificity, and accuracy of US-FNA for individual nodes. Second, the results of node staging by clinical examination and US-FNA examination are compared.

The sensitivity was 89.2%; specificity, 98.1%; and accuracy, 94.5%. Correct node stages were obtained in 52 (93%) of the patients using US-FNA compared with 34 (61%) using palpation.

Ultrasonography combined with FNA is a highly accurate technique for the investigation of cervical lymph node metastases. A more accurate diagnosis may result in more appropriate treatment, particularly in a setting with limited resources. Retropharyngeal nodes, micrometastases, and lymph nodes smaller than 4 mm are limitations of US-FNA. Ultrasonography combined with FNA is a useful technique for the staging of head and neck cancer.

Marco Knappe, MD; Mercia Louw, MMed(AnatPath); R. Theo Gregor, FRCS, PhD

Authors’ affiliation:
From the Departments of Otorhinolaryngology/Head and Neck Surgery (Drs Knappe and Gregor) and Anatomical Pathology (Dr Louw), University of Stellenbosch and Tygerberg Hospital, Tygerberg, South Africa.

September, 2009|Oral Cancer News|

Head, neck cancer treatment often not completed

Author: staff

Incomplete and interrupted radiation treatment is a common problem among Medicare patients with head and neck cancer, a new study has found.

Researchers analyzed data from 5,086 Medicare patients diagnosed with head and neck cancer between 1997 and 2003 and found that nearly 40 percent of them experienced interruptions in radiation therapy or failed to complete the course of therapy.

People who had surgery before radiation treatment were more likely to complete the treatment without interruption than were those who did not have surgery (70 percent versus 52 percent). People with co-existing illnesses, those who had undergone chemotherapy and those whose disease had spread to surrounding lymph nodes were less likely to do so, the study found.

The findings are in the September issue of Archives of Otolaryngology — Head & Neck Surgery.

“Surgical patients may be more likely to complete radiotherapy for several reasons,” wrote Megan Dann Fesinmeyer, of the Fred Hutchinson Cancer Research Center in Seattle, and her research colleagues. “First, characteristics that make patients good candidates for surgery may also make them more likely to complete radiotherapy. Because comorbidities are known to decrease survival in patients with head and neck cancer, healthier patients may be chosen by surgeons to complete more rigorous treatments (e.g., surgery in addition to radiotherapy).”

The study authors added that people “willing to undergo major surgery to treat their disease may also be more motivated to complete a full course of uninterrupted radiation therapy, despite any toxic effects of treatment that may occur.”

More research is needed to determine the factors associated with incomplete or interrupted radiation therapy among those who don’t have surgery, the researchers noted.

September, 2009|Oral Cancer News|

Speaking, eating possible after tonsil cancer surgery with reconstruction

Author: press release

A new technique for reconstructing the palate after surgery for tonsil cancer maintained patients’ ability to speak clearly and eat most foods, a new study shows. The technique, developed at the University of Michigan Comprehensive Cancer Center, is described in the September Archives of Otolaryngology – Head & Neck Surgery.

“This is the area that triggers swallowing, that separates the mouth from the nasal cavity. It affects speech and eating – typically, patients have difficulty eating when they have this kind of tumor and undergo surgery. We can remove the cancer, but there are major quality of life issues,” says study author Douglas Chepeha, M.D., M.S.P.H., associate professor of otolaryngology head and neck surgery and director of the microvascular program at the University of Michigan Health System.

Tonsil cancer develops in the back of the throat, which means surgery could include parts of the palate, the tongue and the jaw. Traditional reconstruction efforts have meant taking a large, round piece of tissue to plug the hole left when the tumor is removed. But this impairs the way the palate and tongue function, and does not restore the complex components of the throat that allow a person to speak and swallow.

With the new technique, surgeons first create a tube from the remaining palate by attaching the palate to the back part of the throat, next to where the tumor was removed. This tube separates the mouth from the nasal cavity and closes during swallowing, allowing patients to eat and speak.

Then the surgeons sew up the defect in the base of the tongue to separate the tongue from the rest of the reconstruction. This ensures that the tongue can move, which improves swallowing and speech. The shape of the remaining defect is irregular, so a template is designed for using transplanted tissue to fill in any other holes left by the surgery.

The tissue used in the reconstruction is a transplant from the arm or another part of the patient’s own body. L-shaped patterns, similar to dress patterns, help the surgeon determine the size and shape of the skin tissue they’ll remove for transplant.

The study followed 25 patients with tonsil cancer. Patients were grouped based on how much of their palate was removed during surgery: less than half or more than half. The patients were followed for an average of five years after the surgery.

Both groups reported few problems with speech. Patients who had more than half their palate removed were more limited in what they could eat and reported some restrictions to eating out in public. Emotional scores were high for both groups, suggesting overall satisfaction with their lives.

“In particular, patients who have less than half their palate removed do very well with this reconstruction. We’re trying to make sure the remaining tongue and palate they have really work. Our goal is to get patients eating in public and back to work,” Chepeha says.

The number of tonsil cancers diagnosed has increased in recent years due to HPV, or human papillomavirus, the virus that is also linked to cervical cancer.

1. Cancer statistics: 12,610 Americans will be diagnosed with throat cancer this year and 2,230 will die from the disease, according to the National Cancer Institute. The tonsils are one of three locations in which throat cancer occurs.

2. Additional authors: Assuntina Sacco; Vanessa Erickson, M.D.; Teresa Lyden; Marc Haxer; Jeffrey Moyer, M.D.; Theodoros Teknos, M.D.; Mark Prince, M.D.; Avraham Eisbruch, M.D.; Carol Bradford, M.D.; and Gregory Wolf, M.D.

Archives of Otolaryngology – Head & Neck Surgery, Vol. 135, No. 9, Sept. 2009

September, 2009|Oral Cancer News|