Monthly Archives: May 2009

Induction chemotherapy followed by chemoradiotherapy increased time-to-treatment failure compared to chemoradiotherapy alone in patients with unresectable locally advanced head & neck cancer

Author: press release

The Spanish Head and Neck Cancer Cooperative Group (TTCC) announced today that Induction Chemotherapy (IC) delivered prior to standard ChemoRadiotherapy (CRT), a treatment paradigm defined as sequential therapy, compared to upfront CRT alone, significantly prolonged Time-to-Treatment Failure (TTF) for patients with unresectable Locally Advanced Head and Neck Cancer (LAHNC). The endpoint of Time-to-Treatment Failure was defined as a composite of time-to-disease progression, -to-surgery or other cancer-related treatments, -to-drop-out due to an adverse event, and to death from any cause.

Final results (abstract #6009) from the Phase 3 randomized study were presented by Prof. Ricardo Hitt, of the University Hospital 12 de Octubre, Madrid, in an oral presentation at the 2009 annual meeting of the American Society of Clinical Oncology (ASCO). The results of this study have also been selected for inclusion in the Best of ASCO(R) program. The Best of ASCO(R) is an educational initiative that condenses highlights from ASCO’s Annual Meeting, with the objective of increasing global access to cutting-edge science that is relevant and significant in oncology today.

This study enrolled 439 patients with Locally Advanced Head and Neck Cancer with good performance status, who were randomly assigned to receive standard CRT (cisplatin and fractionated radiation) versus the same treatment preceded by IC, which consisted of cisplatin plus 5-fluorouracil (5-FU) with or without Taxotere(R) (docetaxel) Injection Concentrate. The study was designed to compare the results of those patients who received IC prior to CRT (sequential therapy) and patients who received CRT alone.

The sequential therapy of adding IC to CRT improved Time-to-Treatment Failure (TTF) from 5.0 months to 12.5 months (p< 0.0001), a 7.5 month increase. Furthermore, a secondary endpoint of loco-regional control, was observed in 61.5% of the patients treated with the sequential strategy (IC+CRT) compared to 44.5% of those patients treated with CRT alone (p=0.002). The most frequent severe (grade 3-4) adverse reactions were stomatitis (44% for IC+CRT vs. 31% for CRT) and febrile neutropenia (10% for IC+CRT vs. 1% for CRT). Other adverse events included neutropenia and asthenia. "These study results illustrate that this complex disease deserves a rational and comprehensive management strategy to overcome its pathologic mechanism and the inherent possibility of failure of clinical control," said Prof. Ricardo Hitt, MD, PhD, the study principal investigator, from Medical Oncology Service of the University Hospital 12 de Octubre, Madrid, Spain. Every year more than 640,000 people worldwide are diagnosed with head and neck cancer, and an estimated more than 350,000 will die from the disease. Head and neck cancer is a group of tumors that mostly arise in the cells that line the mucosal surfaces, giving rise to squamous cell carcinoma in the head and neck area, such as the mouth, tongue, tonsils, voice box and throat. "This trial showed that adding Induction Chemotherapy to ChemoRadiotherapy increased failure-free survival while significantly increasing local control in patients with advanced unresectable head and neck cancer," said Fadlo Khuri, MD, Professor and Roberto Goizueta Chair of Hematology and Medical Oncology at Emory University, Atlanta, GA, USA. Dr. Khuri, a renowned head and neck cancer expert, also added: "These data may help define and clarify standard approaches to the treatment of patients with advanced unresectable disease."

New treatment combination proves safe for head and neck cancer patients

Author: press release

Patients undergoing treatment for advanced head and neck cancers may respond well to the addition of gefinitib to chemotherapy, according to a study sponsored by the Eastern Cooperative Oncology Group and chaired by Ethan Argiris, M.D., associate professor of medicine, University of Pittsburgh School of Medicine, and co-leader of the Head and Neck Cancer Program of the University of Pittsburgh Cancer Institute (UPCI). The results will be disclosed at the 45th annual meeting of the American Society of Clinical Oncology (ASCO) on May 30 in Orlando, Fla.

“We found that adding gefinitib to standard chemotherapy was well-tolerated by patients who had already received chemotherapy or were frail,” said Dr. Argiris. “We had hoped this study would improve the survival rate of patients, but while gefinitib did postpone spread of the disease, it did not increase survival rates. The finding that the addition of gefinitib to chemotherapy can delay the growth of head and neck cancer suggests a potential beneficial effect from combination therapy.”

One group of 136 patients in the placebo-controlled study received docetaxel alone, a standard treatment for head and neck cancer. A second group of 134 patients received gefinitib in addition to docetaxel. This was the first phase III randomized trial to examine the addition of gefinitib to chemotherapy for patients with head and neck cancer. Gefinitib, which also is known by the trade name Iressa, is a targeted therapy against the epidermal growth factor receptor (EGFR) with fewer side effects than traditional chemotherapies. Patients were able to take the drug orally and tolerated it well.

Dr. Argiris plans to conduct further studies to identify the subsets of patients most likely to respond to the drug and to examine patients’ quality of life while taking the combination therapy.

Head and neck cancers are a group of biologically similar cancers originating from the upper aerodigestive tract, including the lip, mouth, nasal cavity, paranasal sinuses, pharynx and larynx that affect more than 45,000 individuals in the U.S. each year. Head and neck cancers are strongly associated with environmental and lifestyle risk factors, including tobacco smoking, alcohol consumption and certain strains of the sexually transmitted human papilloma virus.

Jeg Coughlin Sr. Chair filled by OSU’s Gillison


Author: News Staff


Leading human papilloma virus (HPV) expert Maura Gillison, MD, PhD, was officially named to the Jeg Coughlin Sr. Chair in Cancer Research during a special ceremony Wednesday night at the Longaberger Alumni House at The Ohio State University. 

 “This is a dream come true for all of us,” said Coughlin, who was surrounded by his four sons and many members of the extended Coughlin family. “This Chair represents a legacy that will continue forever. Cancer research takes commitment from a financial aspect and more importantly from a research and development side. Dr. Gillison has accomplished so many things already and we truly feel the best is yet to come.”

 Gillison recently joined OSU’s staff after a successful stint as associate professor at Johns Hopkins University School of Medicine in Baltimore, Md., where she was a member of the Sidney Kimmel Comprehensive Cancer Center. She now serves as professor of medicine in the division of hematology and oncology at OSU and is a member of the Cancer Control and Viral Oncology Programs at the Comprehensive Cancer Center.


“Unfortunately, like so many other families, the Coughlins have been touched by cancer,” Gillison said. “Now, they are a family on a mission. They put the same enthusiasm they bring to racing into cancer research. The Coughlin family has made it possible for me to take my research into a much broader direction and to really think outside of the box.”


Focusing on the role that HPV plays in the development of head and neck cancers, Gillison was the first to identify HPV infection as the cause of certain oral cancers and identified multiple sex partners as the most important risk factor for these cancers. At OSU, Gillison is building a program focused on identifying associations between infections and cancers, with the ultimate goal of applying discoveries to prevent and treat the disease.

 The American Society of Clinical Oncology named Gillison’s research on HPV-associated head/neck cancers as one of six major clinical cancer advances of 2007. She is a frequent guest on national television newscasts, a regular on the lecture circuit, and is quoted extensively in a multitude of consumer and medical publications.

 The 6-year-old JEGS Foundation established a named endowment in honor of family patriarch Jeg Coughlin Sr. at OSU’s James Cancer Center in 2005. A privately-funded entity, the JEGS Foundation donates 100-percent of its proceeds to OSU’s Comprehensive Cancer Center-James Cancer Hospital and Solove Research Institute

 Coughlin himself successfully fought bladder cancer, while Team JEGS chef Nicky Morse managed to overcome Hodgkin’s Disease. Sadly, Troy Coughlin’s mother-in-law succumbed to leukemia and John Coughlin’s mother-in-law was lost to brain cancer. Statistically speaking, one in four people contract some form of cancer in their lifetime.

 “To do cancer research, to prevent and cure cancer, it requires resources and requires money,” said Dr. Michael A. Caligiuri of the Solove Research Institute, who was on hand for the ceremony. “This is the spark that gets the whole engine moving. The JEGS Foundation has just put together an enormous gift that will end up curing and preventing cancer. It is through charitable contributions like this one that we will find a cure.”

 The Ohio State University Comprehensive Cancer Center-James Cancer Hospital and Solove Research Institute is one of only 41 NCI-designated Comprehensive Cancer Centers in the United States and the only freestanding cancer hospital in the Midwest. Funding for cancer research at the OSUCCC has quadrupled over the last 10 years. Ranked among the top 20 cancer hospitals in the nation, The James is the 172-bed adult patient-care component of the cancer program at Ohio State University.

May, 2009|Oral Cancer News|

R. J. Reynolds introducing ‘dissolvable’ tobacco

Source: KSPR News

Author: News Staff


Tobacco companies are facing new criticism, accused of targeting your kids.

Not with ads, but with new types of tobacco products.

Like Camel Snus, tea-bags filled with mint-flavored tobacco. R.J. Reynolds says Snus have become so popular, they’re taking the next step — totally dissolvable tobacco The company says it will solve all kinds of problems for traditional smokers.

“They don’t have second hand smoke. They don’t have a litter problem. The product actually dissolves in your mouth as opposed to having to spit or extract something like a patch from your mouth like other smokeless products,” says Tommy Payne of R. J. Reynolds.

The company will soon test three new products: Camel Sticks that dissolve when you suck them, Minty Tobacco Strips that look like breath strips, and Orbs, flavored dissolvable tablets that some say look and taste like candy.

Critics say R. J. Reynolds is doing what it did with Joe Camel — marketing not to adult smokers, but smoker wanna-bes.

“Really what you’re doing with kids actually, it’s kind of like a gateway drug. You’re getting them addicted to nicotine, which then leads them to possibly wanting to do other things,” says Dan Smith of the American Cancer Society.

The Indiana Poison Control Center says just one Camel dissolvable delivers up to 300 percent of the nicotine found in just one cigarette.

Take too many, and nicotine poisoning might set in, and you could develop oral cancer.

R. J. Reynolds says their new “dissolvables” have warning labels, it’s illegal for kids to buy them, and while they’re not completely safe, they’re meant for adults.

May, 2009|Oral Cancer News|

U.S. cancer death rates continue to fall

Author: staff

Some 650,000 people are alive today who wouldn’t be were it not for advances in cancer prevention, detection and treatment over the past 15 years, new statistics show.

The American Cancer Society’s Cancer Statistics 2009 report finds an encouraging 19.2 percent drop in cancer death rates among men from 1990 to 2005, as well as an 11.4 percent drop in women’s cancer death rates during the same time period.

Overall, cancer death rates fell 2 percent per year from 2001 to 2005 in men and 1.6 percent per year from 2002 to 2005 in women. By comparison, between 1993 and 2001, overall death rates in men declined 1.5 percent per year and, between 1994 and 2002, 0.8 percent in women.

“We continue to see a decrease in death rates from cancer in both men and women and this is mainly because of prevention – mostly a reduction in smoking rates; detection which includes screening for colorectal cancer, for breast cancer and for cervical cancer; and also improved treatment,” said report author Ahmedin Jemal, strategic director for cancer surveillance at the American Cancer Society.

“To put this in perspective, the number of lives saved is more than the population of Washington, D.C.,” said Dr. Louis M. Weiner, director of the Lombardi Comprehensive Cancer Center at Georgetown University. “In my mind, that’s a cause for some celebration. However, there are some sobering trends that we have to be aware of. The death rate for cardiovascular disease has dropped much more dramatically over that period than has the death rate from cancer, indicating the difficulty of developing new strategies to reduce the incidence of cancer and also to treat it more effectively. This is a very complex set of diseases. While we have come a long way, we have a lot further to go.”

Hopefully, continued reductions in smoking rates, especially among women, should push cancer rates further down in the future, the researchers noted.

Although some 45 million Americans continue to smoke, for a prevalence rate of about 20 percent, “smoking prevalence is going in the right direction,” Jemal said. “We’re going to see a reduction in lung cancer death rates, although I don’t know when it might be. In particular, we will see a reduction in cancer death rates among women that’s going to drive [down] the overall cancer death rate.”

Better screening could also further fuel the trend. Only 50 percent of Americans over the age of 50 currently get regular screening for colorectal cancer, he said.

Here is a summary of the report’s findings:

  • In 2009, an estimated 1,479,350 new cases of cancer will be diagnosed in the U.S. (766,130 in men and 713,220 in women) and 562,340 people will die of the disease (292,540 men and 269,800 women). This means 1,500 deaths from cancer every day).
  • Between 2001 and 2005, the incidence of cancer in men declined by 1.8 percent per year; from 1998 to 2005 the incidence rate in women dropped 0.6 percent per year. In men, the gains were largely as a result of decreases in the incidence of lung, prostate and colorectal cancer (the three most common cancers). In women, the decline was largely attributable to declines in both breast and colorectal cancer, the two most common tumor types in women.
  • Cancer death rates dropped by 11.4 percent for women between 1991 and 2005, with a 37 percent decline in deaths from breast cancer and a 24 percent decrease in deaths from colorectal cancer.
  • The three leading cancer killers in men are lung, prostate and colorectal cancer. In women, they are lung (accounting for 26 percent of all cancer deaths), breast and colorectal cancer.
  • Men have a 44 percent chance of developing cancer during their lifetime and women a 37 percent chance, although women are more likely to have the disease earlier (before age 60).
  • Lung cancer shows the greatest regional variation in cancer incidence, ranging from a low of 39.6 cases per 100,000 in men and 22.4 per 100,000 in women in Utah to 136.2 in men and 76.2 in women in Kentucky. These statistics correlate directly to smoking rates in the two states, with Utah having the lowest prevalence in adult smoking in the country, and Kentucky the highest.
  • Blacks still assume a disproportionate share of the cancer burden, with black men being 18 percent more likely to develop cancer and 36 percent more likely to die. Black women have a 6 percent lower incidence rate but this is more than made up for with a death rate, which is 17 percent higher than that seen in white women.
  • The five-year survival rate for children with cancer is now 80 percent, up from only 58 percent for those diagnosed in the mid-1970s. But cancer is still the second leading cause of death in youngsters aged 1 to 14 (after accidents), with leukemia being the most common cancer diagnosed.
  • And in a special section, the report finds that cancer survivors are about 14 percent more likely to develop a new cancer than individuals who have never had a cancer diagnosis; almost 900,000 cancer survivors have been diagnosed with more than one cancer. Patients diagnosed with tobacco-related cancers, such as cancers of the oral cavity, lung, esophagus, kidney, and urinary bladder, have the highest risk for a second cancer because smoking is a risk factor for at least 15 types of cancer. Breast cancer survivors comprise almost half of women who develop a second cancer.

Unfortunately, cancer remains the leading killer (surpassing heart disease) for persons under 85, and one-quarter of deaths in the United States still come from cancer, the report stated.

“It’s good news that the death rates for the most common cancers are on the decline, but there are still too many Americans dying of cancer every year,” said Dr. Alan Astrow, director of medical oncology and hematology at Maimonides Cancer Center in New York City. “It’s troubling that African-Americans continue to experience higher rates of mortality from cancer than whites. It’s also troubling that Americans with less education have higher death rates. There are continued high rates of deaths from lung cancer. It’s hard to feel good about 160,000 Americans dying of lung cancer every year. That’s a disturbing statistics which we, as a nation, need to address.”

The report appears online and in the July/August print issue of CA: A Cancer Journal for Clinicians.

Majors to chew it over as big-league tobacco policy isn’t up to snuff

Author: Filip Bondy

Derek Jeter steps to the plate again, his jaw churning ferociously on some foreign, sticky substance. It’s just gum, and Jeter will prove that to the world now and then by blowing a giant bubble. But until the silly pink ball emerges, who knows?

It might be gum, yet it also could be a pouch of smokeless or dip tobacco — that stubborn, traditional chew of choice for baseball players throughout history. And this is exactly what drives Jimmie Lee Solomon crazy, because sometimes he just can’t win. There are enough bad examples in his world. The executive VP of baseball operations for MLB worries that kids will get the wrong idea, and that baseball will be hurled back into the Nicotine Age.

“It’s gum a lot of the time, not tobacco,”says Solomon, who has worked for 16 years to eliminate chewing tobacco and dip from the big-league culture. “Unfortunately, it can have the same, impressionable effect.”

You know the most dangerous of all drugs in baseball? It isn’t steroids, and it isn’t human growth hormone. Those performance enhancers are health terrors in their own right, impacting the very bones of the game. But legal, smokeless tobacco in its multiple chewable forms still provides the addictive poisons linked most conclusively to illness and fatal disease.

The Mayo Clinic identifies an assortment of horrors associated with chewing tobacco, whether it is packaged in the form of leaves, paste or twists: Tooth decay, gum disease, high blood pressure, oral and non-oral cancers.

There are countless, tragic tales of ex-ballplayers who suffered unkind, tobacco-related fates. The most famous of all is probably Babe Ruth, a frequent tobacco chewer, who died at age 52 from complications caused by a cancerous tumor in his throat.

Each year, about 30,000 Americans are diagnosed with throat and mouth cancer, many tobacco-related. According to the Centers for Disease Control, about 20% of high school-aged boys admit to having tried chewing tobacco, in one form or another. Gum that is shredded and packaged like chaw likely only contributes to the trouble.

It is a major national health problem, linked fairly or unfairly to baseball by long-term association. When the sport sprouted in the mid-1800s, chewing tobacco was more popular than smoking. Player preference merely reflected that of society. The general public moved to smoking en masse when tobacco spit was linked to the spread of tuberculosis, but ballplayers kept chewing and spitting to keep their mouths moist and their gloves greased.

Cancer patient held at US airport for missing fingerprint

Author: Tan Ee Lyn

A Singapore cancer patient was held for four hours by immigration officials in the United States when they could not detect his fingerprints — which had apparently disappeared because of a drug he was taking.

The incident, highlighted in the Annals of Oncology, was reported by the patient’s doctor, Tan Eng Huat, who advised cancer patients taking this drug to carry a doctor’s letter when traveling to the United States.

The drug, capecitabine, is commonly used to treat cancers in the head and neck, breast, stomach and colorectum.

One side-effect is chronic inflammation of the palms or soles of the feet and the skin can peel, bleed and develop ulcers or blisters — or what is known as hand-foot syndrome.

“This can give rise to eradication of fingerprints with time,” explained Tan, senior consultant in the medical oncology department at Singapore’s National Cancer Centre.

The patient, a 62-year-old man, had head and neck cancer that had spread but responded well to chemotherapy. To prevent the cancer from recurring, he was put on capecitabine.

“In December 2008, after more than three years of capecitabine, he went to the United States to visit his relatives,” Tan wrote.

“He was detained at the airport customs for four hours because the immigration officers could not detect his fingerprints. He was allowed to enter after the custom officers were satisfied that he was not a security threat.”

Tan said the loss of fingerprints is not described in the packaging of the drug, although chronic inflammation of the palms and soles of feet is included.

“The topmost layer … is the layer that accounts for the fingerprint, that (losing that top layer) is all it takes (to lose a fingerprint),” Tan told Reuters.

“Theoretically, if you stop the drug, it will grow back but details are scanty. No one knows the frequency of this occurrence among patients taking this drug and nobody knows how long a person must be on this drug before the loss of fingerprints.” (Editing by Alex Richardson)

New model suggests role of low vitamin D in cancer development


Author: Staff

In studying the preventive effects of vitamin D, researchers at the Moores Cancer Center at the University of California, San Diego, have proposed a new model of cancer development that hinges on a loss of cancer cells’ ability to stick together. The model, dubbed DINOMIT, differs substantially from the current model of cancer development, which suggests genetic mutations as the earliest driving forces behind cancer.

“The first event in cancer is loss of communication among cells due to, among other things, low vitamin D and calcium levels,” said epidemiologist Cedric Garland, DrPH, professor of family and preventive medicine at the UC San Diego School of Medicine, who led the work. “In this new model, we propose that this loss may play a key role in cancer by disrupting the communication between cells that is essential to healthy cell turnover, allowing more aggressive cancer cells to take over.”

Reporting online May 22, 2009 in the Annals of Epidemiology, Garland suggests that such cellular disruption could account for the earliest stages of many cancers. He said that previous theories linking vitamin D to certain cancers have been tested and confirmed in more than 200 epidemiological studies, and understanding of its physiological basis stems from more than 2,500 laboratory studies.

“Competition and natural selection among disjoined cells within a tissue compartment, such as might occur in the breast’s terminal ductal lobular unit, for example, are the engine of cancer,” Garland said. “The DINOMIT model provides new avenues for preventing and improving the success of cancer treatment.”

Garland went on to explain that each letter in DINOMIT stands for a different phase of cancer development. “D” stands for disjunction, or loss of intercellular communication; “I,” for initiation, where genetic mutations begin to play a role; “N” for natural selection of the fastest-reproducing cancer cells; “O” for overgrowth of cells; “M” for metastasis, when cancer cells migrate to other tissues, where cancer can kill; “I” refers to involution, and “T” for transition, both dormant states that may occur in cancer and potentially be driven by replacing vitamin D.

While there is not yet definitive scientific proof, Garland suggests that much of the evolutionary process in cancer could be arrested at the outset by maintaining vitamin D adequacy. “Vitamin D may halt the first stage of the cancer process by re-establishing intercellular junctions in malignancies having an intact vitamin D receptor,” he said.

According to Garland, other scientists have found that the cells adhere to one another in tissue with adequate vitamin D, acting as mature epithelial cells. Without enough vitamin D, they may lose this stickiness along with their identity as differentiated cells, and revert to a stem cell-like state.

Garland said that diet and supplements can restore appropriate vitamin D levels, and perhaps help in preventing cancer development. “Vitamin D levels can be increased by modest supplementation with vitamin D3 in the range of 2000 IU/day,” he noted.

The researchers noted that many studies show an apparent beneficial effect of vitamin D and calcium on cancer risk and survival of patients with breast, colorectal and prostate cancer. However, there are some studies that have not found such benefit, especially when taking smoking, alcohol and viruses into account. While more research needs to be done, Garland recommends that individuals should have their vitamin D level tested during an annual check up.

Garland and his colleagues have published epidemiological studies about the potential preventive effects of vitamin D for some two decades. Last year, his team showed an association between deficiency in sunlight exposure, low vitamin D and breast cancer. In previous work, they showed associations between increased levels of vitamin D3 or markers of vitamin D and a lower risk for breast, colon, ovarian and kidney cancers.




Other authors on the study include Edward D. Gorham, Sharif B. Mohr and Frank C. Garland, UC San Diego.

The Moores UCSD Cancer Center is one of the nation’s 41 National Cancer Institute-designated Comprehensive Cancer Centers, combining research, clinical care and community outreach to advance the prevention, treatment and cure of cancer. For more information, visit

May, 2009|Oral Cancer News|

Taiwan researchers discover blood marker for metastatic cancer

Author: staff

A Taiwan hospital announced Wednesday it has discovered a blood marker for detecting cancer metastatic cancer.

‘Foreign doctors have discovered blood marker for cancer before, but this is the first time a blood marker has been found for metastatic cancer, or cancers that can spread to other parts of the body,’ Dr Chiang Ming-chung, a member of the research team, told German Press Agency dpa by phone.

‘Currently, hospitals use magnetic resonance imaging (MRI), ultrasound scan, X-ray and other equipment to check for cancer. Such equipment is expensive. In some backward countries, hospitals cannot afford (such equipment), so this new testing method using the blood marker will be very helpful,’ he said.

Researchers at the Tung’s hospital discovered the blood marker – described only as ‘a serological cancer metastatic marker’ – while doing research on a cancer-related gene.

They found there was more secretion of the serological cancer metastatic marker in the sera of patients with metastatic cancer than in the sera of patients with primary cancer.

So they did further study by collecting serum samples from 164 patients with various types of cancer, ultimately concluding that the blood marker is a secretory protein linked to metastatic cancer.

Chiang said the blood marker they found can help screen a dozen types of cancer – including breast cancer, lung cancer, oral cancer and colon cancer – to see if they have spread to other parts of the body.

The Tung’s hospital, in Taichung County, west Taiwan, has applied to the Department of Health (DOH) for permission to use the new screening method on cancer patients.

The hospital has also applied for a patent for the blood marker in Taiwan, the United States and some other countries.

The discovery was reported in the May issue of the international medical journal Cancer Epidemiology, Biomarkers & Prevention.

BioVex to report phase I/II clinical trial results for the front line treatment of head and neck cancer

Author: staff

BioVex Inc, a company developing next generation biologics for the treatment and prevention of cancer and infectious disease, announced that the results from a Phase I/II combination study in previously untreated patients with head and neck cancer will be presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting, which will take place May 29, 2009 – June 2, 2009 in Orlando, FL.

The results are to be presented in an abstract (number 6018) entitled, “Phase I/II dose escalation study of OncoVEX GM-CSF and chemoradiotherapy (CRT) in untreated stage III/IV squamous cell cancer of the head and neck (SCCHN),” at a poster session on Friday, May 29, 2009 from 2:00pm – 6:00pm EDT on Level 2, West Hall F3 of the conference. A poster discussion will take place from 5:00pm – 6:00pm EDT.

Study Rationale
Patients with head and neck cancer often present with bulky disease that is too large or too close to vital organs for surgical removal. These patients typically undergo radiation and chemotherapy treatment prior to surgery. Patients who present with tumor containing lymph nodes are particularly difficult to treat and approximately half of these patients relapse within two years.

In this study, OncoVEX GM-CSF was administered by direct injection, at three dose levels, into tumor containing lymph nodes in combination with standard first line chemo radiotherapy every three weeks for four cycles. All patients then went for surgery. Of the 17 Stage III/IVA (N1-3) patients treated, 16 had N2 or N3 disease.

Study Results
The abstract, now available online at, reports that OncoVEX GM-CSF was well tolerated, with no significant additional side effects noted over and above those which are common with chemoradiation alone. With respect to efficacy, 94% of patients had a complete pathological response noted at surgery, with five patients achieving a complete response after only 2 or 3 viral doses. No patient has recurred locally in the neck at a median follow up of 26 months at the time of abstract submission. Three patients had distant metastatic disease. Two of these were in the low dose group. One additional low dose patient developed a new primary tumor post treatment. OncoVEX GM-CSF was detected in injected and adjacent uninjected tumors at a therapeutic dose.

Dr Robert Coffin, Founder and Chief Technology Officer, for BioVex, said:
“Loco-regional control is extremely important in head and neck cancer where loco regional progression is responsible for the majority of deaths. The two year loco-regional failure rate following front line treatment is around 30% with a further 20% of patients progressing at a distant site. The long term loco-regional control rate of 100% combined with the very high percentage of patients in the mid and high dose groups that remain disease free at up to 36 months from treatment is very encouraging. As a result, OncoVEX GM-CSF clearly warrants further investigation in this setting.”

Philip Astley-Sparke, President & CEO, for BioVex said:
“We are encouraged by these results which echo results in other studies using OncoVEX GM-CSF as a stand alone therapy where it remains the case that no tumor previously eradicated through OncoVEX GM-CSF therapy has been known to recur. The study reported here has demonstrated that combining OncoVEX GM-CSF with standard cancer therapies may also provide clinical benefit. Combinations involving OncoVEX GM-CSF may also allow less aggressive chemo radiation regimens to be employed whilst maintaining similar or better clinical outcomes as compared to more debilitating regimens. Following on from the ongoing pivotal Phase III study in melanoma, we plan to submit a second Phase III protocol in head and neck cancer to the FDA under the SPA procedure this summer.”

Source: BioVex Inc