Monthly Archives: October 2005

Cervical Cancer Vaccine Gets Injected With a Social Issue

  • 10/31/2005
  • Washington, DC
  • Rob Stein
  • Washington Post (www.washingtonpost.com)

A new vaccine that protects against cervical cancer has set up a clash between health advocates who want to use the shots aggressively to prevent thousands of malignancies and social conservatives who say immunizing teenagers could encourage sexual activity.

Although the vaccine will not become available until next year at the earliest, activists on both sides have begun maneuvering to influence how widely the immunizations will be employed.

Groups working to reduce the toll of the cancer are eagerly awaiting the vaccine and want it to become part of the standard roster of shots that children, especially girls, receive just before puberty.

Because the vaccine protects against a sexually transmitted virus, many conservatives oppose making it mandatory, citing fears that it could send a subtle message condoning sexual activity before marriage. Several leading groups that promote abstinence are meeting this week to formulate official policies on the vaccine.

In the hopes of heading off a confrontation, officials from the companies developing the shots — Merck & Co. and GlaxoSmithKline — have been meeting with advocacy groups to try to assuage their concerns.

The jockeying reflects the growing influence that social conservatives, who had long felt overlooked by Washington, have gained on a broad spectrum of policy issues under the Bush administration. In this case, a former member of the conservative group Focus on the Family serves on the federal panel that is playing a pivotal role in deciding how the vaccine is used.

“What the Bush administration has done has taken this coterie of people and put them into very influential positions in Washington,” said James A. Morone Jr., a professor of political science at Brown University. “And it’s having an effect in debates like this.”

The vaccine protects women against strains of a ubiquitous germ called the human papilloma virus. Although many strains of the virus are innocuous, some can cause cancerous lesions on the cervix (the outer end of the uterus), making them the primary cause of this cancer in the United States. Cervical cancer strikes more than 10,000 U.S. women each year, killing more than 3,700.

The vaccine appears to be virtually 100 percent effective against two of the most common cancer-causing HPV strains. Merck, whose vaccine is further along, plans to ask the Food and Drug Administration by the end of the year for approval to sell the shots.

Exactly how the vaccine is used, however, will be largely determined by the Advisory Committee on Immunization Practices, a panel of experts assembled by the Centers for Disease Control and Prevention in Atlanta. The panel issues widely followed guidelines, including recommendations for childhood vaccines that become the basis for vaccination requirements set by public schools.

Officials of both companies noted that research indicates the best age to vaccinate would be just before puberty to make sure children are protected before they become sexually active. The vaccine would probably be targeted primarily at girls but could also be used on boys to limit the spread of the virus.

“If you really want to have cervical cancer rates fall as much as possible as quickly as possible, then you want as many people to get vaccinated as possible,” said Mark Feinberg, Merck’s vice president of medical affairs and policy, noting that “school mandates have been one of the most effective ways to increase immunization rates.”

That is a view being pushed by cervical cancer experts and women’s health advocates.

“I would like to see it that if you don’t have your HPV vaccine, you can’t start high school,” said Juan Carlos Felix of the University of Southern California in Los Angeles, who leads the National Cervical Cancer Coalition’s medical advisory panel.

At the ACIP meeting last week, panel members heard presentations about the pros and cons of vaccinating girls at various ages. A survey of 294 pediatricians presented at the meeting found that more than half were worried that parents of female patients might refuse the vaccine, and 11 percent of the doctors said they themselves thought vaccinating against a sexually transmitted disease “may encourage risky sexual behavior in my adolescent patients.”

Conservative groups say they welcome the vaccine as an important public health tool but oppose making it mandatory.

“Some people have raised the issue of whether this vaccine may be sending an overall message to teenagers that, ‘We expect you to be sexually active,’ ” said Reginald Finger, a doctor trained in public health who served as a medical analyst for Focus on the Family before being appointed to the ACIP in 2003, in a telephone interview.

“There are people who sense that it could cause people to feel like sexual behaviors are safer if they are vaccinated and may lead to more sexual behavior because they feel safe,” said Finger, emphasizing that he does not endorse that position and is withholding judgment until the issue comes before the vaccine policy panel for a formal recommendation.

Conservative medical groups have been fielding calls from concerned parents and organizations, officials said.

“I’ve talked to some who have said, ‘This is going to sabotage our abstinence message,’ ” said Gene Rudd, associate executive director of the Christian Medical and Dental Associations. But Rudd said most people change their minds once they learn more, adding that he would probably want his children immunized. Rudd, however, draws the line at making the vaccine mandatory.

“Parents should have the choice. There are those who would say, ‘We can provide a better, healthier alternative than the vaccine, and that is to teach abstinence,’ ” Rudd said.

In a statement, the conservative Family Research Council said it will “monitor the development of these vaccines, the FDA drug approval process, the development of recommendations for their use and the marketing of these vaccines.”

“While we welcome medical advances such as an HPV vaccine, it remains clear that practicing abstinence until marriage and fidelity within marriage is the single best way of preventing the full range of sexually transmitted diseases,” the group said.

The council is planning to meet on Wednesday to discuss the issue. On the same day, the Medical Institute for Sexual Health in Austin, which advises conservative groups on sexuality and health issues, is convening a one-day meeting to develop a position statement.

Both companies acknowledged the concerns and said they have been working to alleviate them by meeting with groups across the political spectrum.

“It is not our intention in any way, shape or form to promote our vaccine as a substitute for any other prevention approach, be it abstinence or screening,” Merck’s Feinberg said.

He added there is no evidence to suggest that vaccinating children will promote sexual activity.

“We hope when people understand more about what the disease is and how it can be prevented that their concerns will have been allayed,” Feinberg said.

Alan M. Kaye, executive director of the National Cervical Cancer Coalition, likened the vaccine to wearing a seat belt.

“Just because you wear a seat belt doesn’t mean you’re seeking out an accident,” Kaye said.

October, 2005|Archive|

FDA Accepts Erbitux® (Cetuximab) sBLA Submission For The Treatment Of Squamous Cell Carcinoma Of The Head And Neck And Grants Priority Review

  • 10/31/2005
  • New York, NY
  • press release
  • WebWire (www.webwire.com)

ImClone Systems Incorporated and Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) has notified ImClone Systems that it has accepted for filing the company’s supplemental Biologics License Application (sBLA) for Erbitux® (Cetuximab), an IgG1 monoclonal antibody, in the treatment of Squamous Cell Carcinoma of the Head and Neck (SCCHN). The application seeks approval for use of Erbitux in combination with radiation for locally or regionally advanced head and neck cancer, and as monotherapy in patients with recurrent and/or metastatic disease where prior platinum-based chemotherapy has failed or where platinum-based therapy would not be appropriate.

The companies also announced that the Erbitux sBLA has been granted priority review. The FDA grants priority review to biologics that potentially offer a significant therapeutic advance over existing therapies for serious or life-threatening diseases. Based on the priority review designation, the FDA has six months from the submission date of August 30, 2005, to take action on the sBLA filing.

About Head and Neck Cancer
According to the American Cancer Society, approximately 40,000 Americans will be diagnosed with head and neck cancer this year, including cancers of the tongue, mouth, pharynx and larynx. In addition, it is estimated that more than 11,000 will die from the disease in 2005 in the U.S.

About Erbitux ® (Cetuximab)
On February 12, 2004, the FDA approved Erbitux for use in the United States in combination with irinotecan in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are refractory to irinotecan-based chemotherapy and for use as a single agent in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are intolerant to irinotecan-based chemotherapy. The effectiveness of Erbitux for the treatment of colorectal cancer is based on objective response rates. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Erbitux in metastatic colorectal cancer patients.

Erbitux binds specifically to the epidermal growth factor receptor (EGFR, HER1, c-ErbB-1) on both normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha. The EGFR is constitutively expressed in many normal epithelial tissues, including the skin and hair follicle. Over-expression of EGFR is also detected in many human cancers including those of the colon and rectum.

Important Safety Information
Severe infusion reactions, rarely fatal and characterized by rapid onset of airway obstruction (bronchospasm, stridor, hoarseness), urticaria and hypotension, have occurred in approximately 3 percent (20/774) of patients with the administration of Erbitux. Most reactions (90 percent) were associated with the first infusion of Erbitux despite the use of prophylactic antihistamines. Severe infusion reactions require immediate and permanent discontinuation of Erbitux therapy. Caution must be exercised with every Erbitux infusion as there were patients who experienced their first severe infusion reaction during later infusions. A 1-hour observation period is recommended following the Erbitux infusion. Longer observation periods may be required in patients who experience infusion reactions.

Severe cases of interstitial lung disease (ILD), which was fatal in one case, occurred in less than 0.5 percent of 7 percent of patients receiving Erbitux.

Dermatologic toxicities, including acneform rash (11 percent of 774 patients, grade 3/4), skin drying and fissuring, inflammatory or infectious sequelae (e.g., blepharitis, cheilitis, cellulitis, cyst) and paronychial inflammation (0.4 percent of 774 patients, grade 3) were reported. Sun exposure may exacerbate any skin reactions.

Hypomagnesemia (abnormallhy low magnesium level) has been reported with Erbitux when administered as a single agent and in combination with multiple different chemotherapeutic regimens. The incidence of hypomagnesemia (both overall and severe [NCI CTC grades 3 & 4]) was increased in patients receiving Erbitux alone or in combination with chemotherapy as compared to those receiving best supportive care or chemotherapy alone based on ongoing, controlled clinical trials in 244 patients. Approximately one-half of these patients receiving Erbitux experienced hypomagnesemia and 10-15 percent experienced severe hypomagnesemia. Electrolyte repletion was necessary in some patients, and in severe cases, intravenous replacement was required. Patients receiving Erbitux therapy should be periodically monitored for hypomagnesemia, and accompanying hypocalcemia and hypokalemia during, and up to 8 weeks following the completion of, Erbitux therapy.

Other serious adverse events associated with Erbitux in clinical trials (n=774) were fever (5 percent), sepsis (3 percent), kidney failure (2 percent), pulmonary embolus (1 percent), dehydration (5 percent in patients receiving ERBITUX plus irinotecan, 2 percent receiving Erbitux as a single agent) and diarrhea (6 percent in patients receiving Erbitux plus irinotecan, 0.2 percent with Erbitux as a single agent).

Additional common adverse events seen in patients receiving Erbitux plus irinotecan (n=354) or Erbitux as a single agent (n=420) were acneform rash (88 percent/90 percent), asthenia/malaise (73 percent/48 percent), diarrhea (72 percent/25 percent), nausea (55 percent/29 percent), abdominal pain (45 percent/26 percent), vomiting (41 percent/25 percent), fever (34 percent/27 percent), constipation (30 percent/26 percent) and headache (14 percent/26 percent).

October, 2005|Archive|

Mitomycin and Fluorouracil in Combination with Concomitant Radiotherapy: A Potentially Curable Approach for Locally Advanced Head and Neck Squamous Cell Carcinoma

  • 10/30/2005
  • Japan
  • Madhup Rastogi et al.
  • Japanese Journal of Clinical Oncology 2005 35(10):572-579

Objective:
The purpose of this study was to evaluate the efficacy of radiotherapy and concurrent mitomycin-C (MC) plus 5-fluorouracil (5FU) infusion in locally advanced squamous cell carcinoma of the head and neck (SCCHN).

Methods:
Sixty-nine patients with SCCHN (6 Stage III and 63 Stage IV patients) were treated with external beam radiotherapy (70 Gy) and simultaneous intravenous chemotherapy with 5FU (600 mg/m2/day, Days 1–5) and MC (10 mg/m2, Days 5 and 36).

Results:
After a mean follow-up of 28.5 months, 59.4% of patients were alive without disease. Complete response was seen in 76.8% of patients. The 3 years overall survival, locoregional relapse-free survival and disease-free survival was 62.3, 89.8 and 49.5%, respectively. Treatment was well tolerated (Grade III mucositis in 43.5% and Grade II leukopenia in 5.8%).

Conclusions:
This concurrent chemoradiotherapy regimen offers a curative option for our patients where primary and nodal disease is fairly large resulting in hypoxic radioresistant tumors.

Authors:
Madhup Rastogi(1), Madhu Srivastava(1), Kundan S. Chufal(2), M. C. Pant(1), Kirti Srivastava(1) and Madanlal B. Bhatt(1)

Authors’ affiliations:
(1) Department of Radiotherapy, King George’s Medical University, Lucknow, Uttar Pradesh and
(2) Department of Oncology, Batra Hospital and Medical Research Center, New Delhi, India

October, 2005|Archive|

Cancer: the Good, the Bad, and the Ugly

  • 10/29/2005
  • Washington, DC
  • Denise Mann
  • WebMD (www.webmd.com)

With cancer survivor Lance Armstrong winning his seventh Tour de France, and walks, runs and other highly visible fund-raising opportunities — often overflowing with survivors and their families — taking place almost ubiquitously across the map, it certainly seems that doctors are finally winning, or at least making some significant strides — in the war against cancer.

But are they?

The word “cancer” still strikes a chord of fear in most people, but the truth is that today many cancers including breast, colon and prostate may no longer be the death sentences that they once were. Others like melanoma and pancreatic cancer, however, are still proving somewhat vexing and insurmountable. But ultimately, we are turning a corner: survival statistics are up for many cancers, smoking is down, and some of the best minds in the world are trying to crack the cancer codes.

Today, Armstrong is seen as an anomaly, but that may not always be the case. “Lance Armstrong is such an inspirational story that cancer is not only not a death sentence, but he can say, ‘I beat it and I am doing something about’ it by setting up a foundation and speaking out,” says Thomas Glynn, PhD, the director of cancer science and trends at the American Cancer Society (ACS) in Washington, D.C. “I think as survival rates continue to rise, we will see people like him who shine and not only survive disease and actually do well with it.”

Judah Folkman, MD, the Andrus Professor of Pediatric Surgery and professor of cell biology at Harvard Medical School and director of the vascular biology program at Children’s Hospital, both in Boston, agrees: “Lance Armstrong is really amazing, and the fact that we can do it once means you can maybe do it again,” he says.

Here’s how we are doing so far.

Multifront War Waged

Make no mistake, “we are winning this war, but progress has been slower than we would have expected in 1971 when war [on cancer] was declared by President Richard Nixon,” says Glynn.

Calling it a “multifront” war, Glynn tells WebMD that “there is no such thing as one cure for cancer because we are dealing with hundreds of different diseases all gathered under the [category] cancer.”

When President Nixon declared war, the “assumption was that to beat cancer, a switch needed to be turned off and we just needed to find that switch,” he says. “What we are finding out is that there are multiple switches and different things that turn them on and off.”

Victories in the Fight Against Cancer

In 2005, there will be 1,372,910 new cancer cases in the U.S. and 570,280 cancer deaths (about 1,500 per day), according to statistics from the ACS.

Overall, “if you look across the board, there are very few cancers in which we are not seeing declines in mortality,” Glynn says. “We are seeing reductions in prostate, colorectal, and breast cancers, and stomach cancer has basically fallen off of the edge of the earth in the U.S.,” he says. “In lung cancer among men, we are seeing a drop, and we will be seeing a drop among women by 2010,” he predicts. Still, lung cancer remains the top cancer killer in both sexes, according to the ACS. It is responsible for nearly one in three cancer deaths in men and about one in four among women.

According to the latest ACS statistics, death rates for all cancer sites combined decreased 1.5% per year from 1993 to 2001 in men and 0.8% per year from 1992 to 2001 in women.

“Five-year survival for all cancers combined used to be about 50% and now it’s 75%,” Glynn says. “We have made a lot of progress in early detection,” he says. “Fewer than 1/2 of all women were receiving mammograms several years ago and now it’s close to 80%, we have mapped the human genome, which will eventually lead to individual treatment and prevention, and smoking is down in women to under 20%,” he says.

Five-year survival describes the percentage of people still alive within a five-year period after diagnosis or treatment of cancer.

The Katie Couric Curve

Survival is way up in colon cancer because it is caught earlier due to routine colonoscopy (which is the method recommended by most major medical institutions), says Vijay Trisal, MD, an assistant professor of oncological surgery at the City of Hope National Cancer Center in Duarte, Calif. After her husband died of colon cancer, NBC newswoman Katie Couric had a colonoscopy live on national television. In the following weeks and months, the numbers of people across the country having colonoscopies increased more than 20%, according to researchers at the University of Michigan Health System and the University of Iowa.

“We are picking up earlier cancers and that’s making a difference, and part of the difference is also very good chemotherapy for colon cancer,” he says. For example, it used to be that if colon cancer had spread to the liver, “survival was nine to 11 months, but now we can resect the liver and chemotherapy kills the microscopic disease, so we seeing survival in the range of 50%,” he tells WebMD.

Overall, “advances in cancer have been in treating the microscopic disease,” he says. “Chemotherapy for breast cancer and colon cancer has significantly improved because we can kill the small disease that is not visible and regrows either in the vicinity of the cancer or spreads throughout the body.” Chemotherapy can knock out errant cancer cells along with the main tumor.

The rates of colorectal cancer have dropped between 1998 and 2001 in both men and women. Prostate and female breast cancer rates have continued to increase, although at a slower rate than in the past. However, the increase may be due to increased detection because of higher rates of screening using prostate specific antigen test for prostate cancer and breast X-ray or mammography for breast cancer.

New Warriors Join Battle

New “smart” drugs are also promising weapons in this war. “This year, there has been enormous progress in the angiogenesis inhibitors, and it is the first year that there has been a significant increase in survival of the three top cancers – colon, breast, and lung — due to antiangiogenic therapies being introduced,” Folkman tells WebMD. Antiangiogenic drugs, also called angiogenesis inhibitors, starve tumors to death by cutting off their blood supply.

For example, Avastin targets a protein called vascular endothelial growth factor (VEGF), which plays a role in making new blood vessels for tumors (a process called angiogenesis). This drug was approved in the U.S. for colon cancer in February 2004, and by January 2005 it had been approved in 27 other countries, he says.

Other antiangiogensis drugs being used include thalidomide and Tarceva. Tarceva blocks tumor cell growth by targeting a protein called HER1/EGFR that is important for cell growth in advanced nonsmall cell lung cancer. Tarceva “blocks three angiogenic proteins and really is an angiogenic inhibitor,” Folkman says. Thalidomide became notorious in the 1960s when it was prescribed to pregnant women to ease morning sickness, but was found to cause severe birth defects by limiting the blood flow to developing limbs. As a result, many children were born limbless or with severely shortened limbs. Now scientists are capitalizing on these same blood-limiting properties to help block the blood supply to tumors.

Treatment No Longer Worse Than the Disease

“[These drugs] have changed our thinking,” he says. “We don’t use the word cure, but we now think of converting cancer to a chronic manageable disease like diabetes,” he says. “When you see these patients, they are not very sick, their hair doesn’t fall out, they don’t have massive diarrhea and their spouses stay with them,” he says. New treatments have decreased the toxicity and decreased the chance of drug resistance, he explains. “There are at least 40 other antiangiogenic drugs in the pipeline and some are doing very well,” he says.

The bottom line is that “you can live with cancer today,” he says.

Coming Soon?

“The newer things are biomarkers of angiogensis or blood tests that are so sensitive they can pick up a 1-millimeter tumor in a mouse just before it switches on,” he says. “Say you have colon cancer. We could do a urine or blood test every four months and if levels of a certain protein stays flat, you are fine, but if it goes up we know the cancer may be returning,” he says.

“Drugs like angiogenesis inhibitors that are approved are not as toxic as older cancer therapies, so you can take them for longer times, you don’t develop resistance as fast and this is intersecting with biomarkers where we can diagnose cancers earlier and earlier,” he says. “We are beginning to ask why do we care where the cancer is,” he says. “If test is rising, why not treat with nontoxic antiangiogensis inhibitor until the numbers come down?”

Other targeted drugs include Erbitux for colon cancer and herceptin for breast cancer. Both are considered antibodies, which are produced in a laboratory to target a very specific portion of foreign substances. Another drug, Gleevec, is a small-molecule drug that targets abnormal proteins that form inside cancer cells and stimulate uncontrolled growth. It is approved for certain forms of leukemia and rare stomach cancers.

Overall, these new drugs “absolutely do help, but so far they are not revolutionary in seeing a halving of incidence of death rates or mortality rates,” he says. “But they certainly suggest that we are making progress and are perhaps on the edge of making revolutionary progress,” ACS’ Glynn says. “We are in the early stage of drug development and need to now how best to use these drugs.”

Cancer: the Bad and the Ugly

“Some tumors are ugly,” says Robert J. Morgan Jr., MD, the section head of neuro-oncology and a physician in the division of medical oncology and therapeutics research at the City of Hope National Medical Center in Duarte, Calif. For example, there has been little progress with treating and beating brain cancer, he says. “There are two problems,” Morgan tells WebMD. “The first is finding an effective agent and the second is making sure this agent can cross the blood-brain barrier and get to the tumor,” he says.

In 2005, doctors will diagnose 18,500 malignant tumors of the brain or spinal cord in the U.S. and approximately 12,760 people will die from these tumors, according to the ACS.

“Pancreatic cancer too turns out to be difficult to detect and treat,” he says. In fact, pancreatic cancer is the fourth leading cause of cancer death.

Another cancer that doctors have not mastered yet is ovarian cancer. “Unfortunately, we do not have a reliable screening test for ovarian cancer because it’s a tumor that is 100% curable if caught in stage I with surgery alone or surgery and chemotherapy, whereas once it has traveled the chances of cure can drop to as low 5%,” he says.

A good screening tool for lung cancer could also help doctors turn a corner on the disease that recently took the life of ABC News Anchor Peter Jennings. “People are being hammered to not smoke, but a large number of patients who don’t smoke do develop lung cancers,” he says. “We do know that tumors are different in smokers vs. nonsmokers and we need a better screening test because low-dose spiral computed tomography (CT) scans are expensive, insurance doesn’t pay, and it has a high rate of false-positives leading to unnecessary surgeries to remove the suspicious nodules.”

Melanoma is also proving tricky, says City of Hope’s Trisal. “The major reason is that we don’t have any effective therapy for melanoma except surgical therapy,” he tells WebMD. “We don’t have any effective chemotherapy drugs, and we have been looking to vaccines and biological therapy, but the response rate is minimal.” Biological therapies such as interferon utilize substances that occur naturally in the body to attack cancer cells.

“Earlier detection of melanoma is very effective and we are picking it up earlier now [due to routine skin checks], but it will take 10 years to see if we made a difference,” he says. But right now, “it’s an all-or-none phenomenon, [meaning that] if you have metastatic (spreading) melanoma in the lymph nodes, we are fighting a losing battle.” If not, it looks good. It’s a big watershed area where people will either be OK or not be OK.”

Summing It All Up

“President Richard Nixon declared war against cancer about 30 years ago, and we were woefully lacking in biology of cancer and how it worked, we thought it was one disease, and I think only in the last five years that we are starting to understand that the biology of tumors are quite different,” City of Hope’s Morgan says. “It turned out to be a lot more complicated than we thought, but we are heading to a much broader understanding of biology.

“I’d have to give us a C-plus/B-minus in treating advanced cancer because we still have to use a lot of toxic treatments to obtain good results and we still don’t have anything to cure cancer, but we are clearly improving,” he says. “For new agent development, we get a B-plus, and for understanding the biology of cancer, we also get a B-plus, “he says. “For screening, we get a B because we have good screening tools for colon, breast, and our effort is clearly an A, but we could use more funding for prevention.”

However, “we haven’t received an A in anything except in certain types of cancer,” he says.

Published Aug. 12, 2005.

Sources:
Thomas Glynn, PhD, the director of cancer science and trends, American Cancer Society, Washington, D.C., Judah Folkman, MD, Andrus Professor of Pediatric Surgery, professor of cell biology, Harvard Medical School. Vijay Trisal, MD, assistant professor of oncological surgery, City of Hope National Cancer Center, Duarte, Calif. Robert J. Morgan Jr., MD, head of neuro-oncology, division of medical oncology and therapeutics research, City of Hope National Medical Center, Duarte, Calif.

October, 2005|Archive|

Osseointegration in irradiated cancer patients: an analysis with respect to implant failures

  • 10/27/2005
  • England
  • G. J. Granström
  • British Dental Journal (2005); 199, 511. doi

Implant failure was higher in irradiated patients, but not greatly so.

This retrospective study evaluated 631 implants placed in 107 cancer patients who had received radiotherapy over a 25 yr period. At the end of the period, 71 patients were alive (mean survival time of 16 yrs), and 36 had died (9.8), and 484 implants were still active and stable. Age and gender matched healthy controls received 614 implants, and 76 implants failed during a mean follow-up of 7.2 yrs. Six of the 100 controls died of cardiovascular disease during the period.

Implant failure was significantly higher in the cancer patients, irrespective of when they received radiotherapy and of whether they also had chemotherapy. Most implant failure was early, before loading. There was a relationship of failure to radiation dose, and some failures occurred as long as 20 yrs later. The authors recommend use of long fixtures, fixed retention and hyperbaric oxygen, which all improved implant survival. Highest failure rates were in the frontal bone, zygoma, mandible and nasal maxilla.

October, 2005|Archive|

Treatments for Head and Neck Cancer Result in Similar Quality of Life

  • 10/26/2005
  • New York, NY
  • staff
  • www.cancerpage.com

The difference in quality of life (QOL) between head and neck cancer patients who undergo surgery and those who opt for nonsurgical therapies has narrowed considerably, new research suggests.

It has generally been assumed that QOL for these patients is better when treated with concurrent chemotherapy and radiation than with surgery and radiation, study co-author Dr. Gerry F. Funk, from the University of Iowa Hospitals and Clinics in Iowa City, and colleagues report. Yet, few studies have addressed this topic.

As reported in the Archives of Otolaryngology: Head & Neck Surgery for October, the researchers assessed QOL and functional outcomes in 54 matched patients who were treated with surgery and radiation or concurrent chemotherapy and radiation. All of the subjects had stage III or IV squamous cell cancer of the oropharynx, hypopharynx or larynx.

No significant difference was seen between the groups in overall QOL or in eating, speech, aesthetics and social disruption, the report indicates.

The Beck Depression Inventory score was worse for concurrent chemotherapy and radiation-treated patients, but not significantly different from the score in the surgery and radiation group.

The authors believe that the gap in QOL between these treatment approaches has narrowed because nonsurgical therapies have become more aggressive, while just the opposite has occurred with surgical treatments.

“Although the assumption that preserving an organ will uniformly result in a higher QOL seems reasonable, the complexities of human adjustment and the multitude of potential treatment effects, from both surgery-based or nonoperative intervention, render this assumption invalid for many patients,” the investigators conclude.

SOURCE:
Arch Otolaryngol Head Neck Surg 2005;131:879-885.

October, 2005|Archive|

Little attention given to oral cancer

  • 10/26/2005
  • Ireland
  • Deborah Condon
  • irishhealth.com

Around 400 new cases of oral cancer are diagnosed in Ireland every year, yet the condition continues to receive little attention here, a major conference will be told later this week.

‘Oral Cancer – the Patient’s Journey’ is the theme of this year’s Royal College of Surgeon’s (RCSI) annual scientific meeting. Speakers will include Dr Joe Briscoe, a retired dentist who was himself diagnosed with the disease in 1989.

Oral cancer is cancer that occurs in the mouth (oral cavity). The mouth is made up of many parts, such as the lips, tongue, the inside of the cheeks and the salivary glands. It also refers to the oropharynx, which consists of the back one-third of the tongue, the soft palate, the tonsils and the back of the throat.

The disease is three times more common in men than women. Men who live in urban areas and who smoke and drink are particularly at risk. Overall, smoking, drinking alcohol and poor diet are major risk factors.

Both men and women are advised to attend their dentist at least once a year for a routine check-up. This allows for problems to be detected as early as possible. Like other cancers, the outlook improves significantly the earlier oral cancer is detected.

Unlike other cancers however, it has the advantage of having two professional groups who are trained to detect it – doctors and dentists. All dentists are trained to detect oral cancer and precancerous lesions. The vast majority of patients referred to hospital with potentially malignant lesions come from dentists.

At the conference, Dr Briscoe will be emphasising the importance of regular dental examinations, as well as highlighting how dentists are at the frontline when it comes to diagnosing the disease. The issue will also be discussed by other Irish and international speakers. The conference takes place in Dublin on October 27 and 28.

October, 2005|Archive|

Survival Boost for Head and Neck Cancers

  • 10/26/2005
  • Orlando, FL
  • staff
  • Ivanhoe.com

Research presented this week at the 47th Annual Meeting of the American Society for Therapeutic Radiology and Oncology in Denver offers new hope to people with head and neck cancers.

Eric Horwitz, M.D., from Fox Chase Cancer Center in Philadelphia, says, “Not only did this clinical trial show efficacy with our regimen, but it appears to significantly increase the probability of survival when compared to the current standard treatment.” The current standard treatment is chemotherapy.

Currently, there are few options for people with head and neck cancers who develop a second tumor or for those whose disease comes back in a place that has already been radiated.

Researchers studied patients with recurrent squamous-cell head and neck cancer or a second tumor that had developed in a previously radiated area. More than 100 patients from the United States and Canada were enrolled in the study. Patients were given a new combination treatment. One part of that treatment consisted of hyperfractionated radiation therapy, in which the patients were given radiation twice a day for five days every two weeks for four cycles. Patients also received chemotherapy with cisplatin (Platinol) and paclitaxel (Taxol, Onxol or Paxene) every day for two weeks for four cycles.

Patients receiving chemotherapy alone have an average survival of six months to eight months. The results of this new study show 50 percent of patients receiving the combination treatment survived for at least one year. Nearly 26 percent survived two years.

This extended survival is not without risk. Researchers say the side effects of the treatment were significant. However, Dr. Horwitz adds, “These patients were among those with the most serious cancers.” Eight of the patients had fatal side effects.

The next step for this research is a phase III randomized trial which will compare this treatment to chemotherapy alone.

SOURCE: The American Society of Therapeutic Radiation and Oncology in Denver, Oct. 16-20, 2005

October, 2005|Archive|

Screening for Distant Metastases in Patients With Head and Neck Cancer: Is Chest Computed Tomography Sufficient?

  • 10/24/2005
  • The Netherlands
  • Jolijn Brouwer et al.
  • Laryngoscope, October 1, 2005; 115(10): 1813-1817

Objectives/Hypothesis:
The detection of distant metastases during screening influences the choice of treatment in patients with head and neck squamous cell carcinoma. A previous study in the authors’ institution showed that chest computed tomography (CT) scan was the most important screening technique. Different clinical risk factors in patients with head and neck squamous cell carcinoma for the development of distant metastases were identified.

Study Design:
Retrospective cohort study.

Methods:
To evaluate the authors’ diagnostic strategy, the accuracy of screening for distant metastases with chest CT in 109 consecutive patients with head and neck squamous cell carcinoma with risk factors between 1997 and 2000 was retrospectively analyzed.

Results:
Preoperative screening with CT revealed 20 patients (18%) with lung metastases and 1 liver metastasis. Despite negative screening with chest CT, 9 (11%) patients developed distant metastases within 12 months during follow-up. Sensitivity of the chest CT was 73%; the specificity was 80%.

Conclusion:
Although chest CT frequently detects distant metastases, there seems to be a need for a more sensitive and whole-body screening technique.

Authors:
Jolijn Brouwer, Remco de Bree, Otto S Hoekstra, Richard P Golding, Johannes A Langendijk, Jonas A Castelijns, and C Rene Leemans

Authors’ affiliation:
From the Departments of Otolaryngology, Head and Neck Surgery (j.b., r.d.b., r.c.l.), Clinical Epidemiology and Biostatistics (o.h.s.), Nuclear Medicine and Positron Emission Tomography Research (o.h.s.), Radiology (r.p.g., j.a.c.), and Radiation Oncology (j.a.l.), VU University Medical Center, Amsterdam, The Netherlands

October, 2005|Archive|

On-target cancer treatment

  • 10/23/2005
  • Milwaukee, WI
  • Kawanza Newson
  • Milwaukee Sentinel Jouranl (www.braneton.com)

Byron Liebner is a sun lover, and he has several tiny scars to prove it. But it’s the spot on his left forehead that he likes to talk about most.

The skin there is dry and red, like a bad sunburn, and is a visual reminder of the high doses of radiation he receives each weekday to prevent his cancer from spreading into his eye.

For the past five weeks, Liebner has had a mesh mask placed over his face to hold his head perfectly still and had his feet tied together to prevent wiggling so high-intensity radiation can be blasted into the nerve above his eye for 438 seconds. He’s scheduled for seven weeks of radiation.

“They have to be careful because it’s a delicate situation,” said Liebner, 84.

“They told me I could lose clusters of hair in the back because the radiation goes right through the head,” he said. “But I wouldn’t care if I lost it because I don’t have that much hair anyway.”

Surgery was not a feasible option for Liebner because his eyeball would have been removed, and he may have still needed radiation therapy later.

Throughout the United States, cancer patients are benefiting from technological advancements that increase the precision of radiation treatment to the tumor while decreasing damage to the normal tissue or organs surrounding it.

More precise treatment means patients can get higher doses of radiation over a shorter time span, and in some cases, it allows patients to have additional treatment if a tumor recurs.

However, though there are many radiological options available, it’s important that patients remember each option may not necessarily be the best treatment for them, said J. Frank Wilson, chair of radiation oncology at Milwaukee’s Froedtert and Medical College Cancer Center.

“Serious difficulties arise when the patient is aware of many options and has pre-selected what they think they need,” he said. “Patients should take all the time they need to make sure they’ve gotten the opinions they need and the information they need to make an informed decision.”

Liebner is treated with a targeted radiation treatment known as tomotherapy.

The tomotherapy machine was developed by Madison-based TomoTherapy Inc. and includes a computed tomography, or CT, scanner that allows doctors to determine a tumor’s precise location and monitor any changes it may undergo during the treatment.

Also, the machine houses a multi-leaf collimator, or a set of bars that quickly moves in and out to adjust radiation delivery while the patient lies on a couch that slowly moves toward the center of the machine. Thus, each radiation beam is hitting a slightly different point with varying intensity.

As a result, tomotherapy treatment takes slightly longer than standard radiation treatment, with set up about 30 minutes compared with 15, but experts say that the extra time ensures that the tumor receives the optimum dose of radiation each day.

“It’s truly revolutionary technology for delivering radiation therapy,” said Minesh Mehta, chairman of the department of human oncology at the University of Wisconsin Medical School.

“Clearly, there are many patients for whom this is a clear advantage and others a modest advantage,” he said. “But still, there are some where other technologies are just as good, so we use this on a very individualized basis.”

The University of Wisconsin Comprehensive Cancer Center and the Department of Human Oncology installed the world’s first clinical tomotherapy research system in February 2001. It was used to treat tumors in dogs seen through the University of Wisconsin Veterinary School. The first human patient received treatment using the system in May 2004.

“Traditional radiation works well for many tumors we treat, but when these tumors are located near critical structures or if they need re-irradiation or if it’s in a site that’s usually difficult to treat such as the head and neck, then tomotherapy works best,” said Beth Erickson, a professor of radiation oncology at the Medical College of Wisconsin and Liebner’s radiation oncologist.

For example, tomotherapy in the cervix spares the small bile duct and kidney from intense radiation, and using it for the pancreas limits the amount of radiation to the liver, stomach and small intestine, she said.

Liebner says that he’s doing fine, though each treatment causes his eye opening to become smaller. However, he’s not worried about losing his vision and says that he’ll continue to spend time with his wife, six children and 20 grandchildren.

“I’m a firm believer in the Lord Jesus and I go to him for guidance,” he said.

“He’s always been there for me and as long as I have him on my side, I have faith that he will see me through,” Liebner said.

According to the American Cancer Society, radiation therapy is one of the most common treatments for cancer and is used in more than half of all cancer cases. It can be used alone or in combination with surgery, chemotherapy or immunotherapy, also known as biologic therapy. Immunotherapy is an emerging form of cancer treatment that uses things such as vaccines or antibodies to stimulate a patient’s immune system to fight against the cancer.

It’s commonly believed that a patient can have one round of radiation therapy per lifetime, though there’s increasing evidence that repeat radiation with chemotherapy may be beneficial in patients with head and neck cancer, said Stuart Wong, a head and neck oncologist at Froedtert who is the lead investigator of a multi-center clinical trial testing this theory.

Radiation therapy can be delivered either externally, such as through tomotherapy, but also internally using radioactive implants that are placed inside the tumor.

For prostate cancer patients, internal radiation can be achieved through permanent placement of radioactive seeds. The seeds, which are about the size of a grain of rice, give off radiation that kills the cancer cells over several weeks.

There are two seeds commonly used – Iodine-125 or Palladium-103 – though some doctors are beginning to use Cesium-131 seeds, said Rakesh Jagetia, a radiation oncologist with Radiation Oncology Associations at St. Luke’s Medical Center in Milwaukee.

Each seed emits a different radiation dose; cesium delivers a higher dose of radiation over a shorter time period, he said.

For example, cesium will deliver about 90 percent of its total radiation dose in less than 33 days, Jagetia said. By comparison, iodine can take between nine and 12 months.

Over the past decade, several advancements have emerged that allow precise treatment of tumors.

Gamma Knife is used to treat inoperable tumors deep within patients’ brains. The knife involves no surgical incision, but rather 201 intersecting beams of low-level gamma radiation. The beams enter the patient’s head and intersect at one centralized point to destroy tumor cells. But, because the gamma rays are low level and come from different directions, surrounding tissue does not undergo the degree of damage seen with many other radiation treatments.

And more physicians are looking into “gating systems” that allow monitoring of tumor movement so that radiation is delivered only when it can be hit directly. The technique is highly effective for lung cancer, where breathing consistently moves the tumor in and out of the treatment field. However, the technique in this instance depends heavily on the patient being able to control their breathing, said Elizabeth Gore, an associate professor of radiation oncology at the Medical College of Wisconsin.

Experts say that though technology has greatly improved cancer care, it’s important not to lose sight of how those treatments affect the patient’s quality of life or chance of survival.

With that in mind, the next step is to learn more about the biology of tumors so physicians will know which tumors will respond best to radiation.

“Our ultimate goal is to use biology to improve outcomes,” Mehta said.

October, 2005|Archive|