Cancer Therapy Center

The drug Avastin, used for both colorectal and lung cancer, has been linked to two potentially serious complications, the drug’s manufacturer warned Friday.

The first complication, labelled hypertensive encephalopathy, patients with an established history of very high blood pressure had unusually severe blood pressure that affected the brain. One case resulted in death.

The other complication, called reverisble posterior leukoencephalopathy syndrome (PPLS) is a rare neurologic disorder that can cause problems ranging from visual disturbance to headache to seizures.

 Doctors are being cautioned that they should discontinue Avastin in patients who develop RPLS, and should be more cautious about prescribing the drug for patients with existing high blood pressure.

Forbes is one of many reporting on new research showing that annual CT scans detected lung tumors at their earliest stages in 85% of patients. Moreover, when followed quickly by surgery, the 10 year survival rate was greater than 92%, according to a study to be published in the New England Journal of Medicine

“We’ve shown that this saves lives,” said study co-author David F. Yankelevitz, a professor of radiology and cardiothoracic surgery at Weill Cornell Medical College in New York City. “What we’d like to see is this brought into the health-care system in some way, and a lot of people have to be involved in this process. All of the other issues have to come up — who gets it, how frequently, who pays for it, and this needs to be a dialogue amongst lots of people.”

The study results prompted strong reactions throughout the medical community.

“The findings are quite impressive,” said Dr. Robert Smith, director of cancer screening at the American Cancer Society. “The results are from multiple institutions and show that the model that they have for screening can be exported and successfully applied in other settings.”

“It’s a major, major finding,” said Dr. Len Horovitz, a pulmonary specialist with Lenox Hill Hospital in New York City. “If you get somebody at stage one, you’re basically saying that you can cure them of lung cancer, which is our number one [cancer] killer and usually is diagnosed all too late.”

The findings are especially significant as lung cancer is the leading cause of cancer deaths, a fact attributed to inadequate detection of malignant tumors. In 1993, the Early Lung Cancer Action Project found that more than 80% of people diagnosed with lung cancer had stage I disease. The most recent research confirmed that early intervention was effective enough to justify screening large numbers of asymptomatic but high-risk patients.

This latest study involved screening 31,567 asymptomatic people who were at risk for lung cancer either because they had a history of cigarette smoking, had had occupational exposure, or had been exposed to secondhand smoke. Investigators then estimated the 10-year survival rate among those with stage I lung cancer.

Of the total group, 484 participants were diagnosed with lung cancer, 412 of them (85 percent) with stage I disease. Within this subgroup, the estimated 10-year survival rate was 88 percent. Among the 302 participants with stage I cancer who underwent surgery within one month of diagnosis, the survival rate was 92 percent. The eight participants who did not receive treatment died within five years of their diagnosis.

“Survivability at 10 years was 88 percent if it was stage I, and the easiest way to find this is spiral CT,” Horovitz said. “If you can pick them up early, you can certainly cure them for 10 years, if not for life. By the time symptoms show up, it’s much, much harder.”

Screening was even more valuable for people who were at the highest risk (for example, older people and former and current smokers).

The cost of a low-dose CT is below $200, the study authors stated, while the cost of surgery for stage I lung cancer is less than half the cost of late-stage treatment.

The technology is already available and being used, Smith said, although it’s not formally recommended by any expert group.

The result of this study, as well as other large, ongoing studies, may influence doctors to adopt this screening in mass.

A warning is being recommended for certain post-menopausal women who use the drug tamoxifen to treat breast cancer. A federal health advisory panel says women carrying a variant of a certain gene face a greater risk of the cancer recurring when using Tamoxifen, and has recommended that its label be changed to warn patients and urge genetic testing.

The drug, which has been on the market for nearly 30 years, is used to treat beast cancer and as a preventative drug for women at risk. It was not immediately clear whether preventative usage in patients carrying the suspect gene would increase the likelihood of cancer occurrence.

NBC5 (Dallas) has an article about a new breast cancer therapy trial at USC:

Radiation treatment for breast cancer patients often drags on for weeks and comes with unpleasant side effects, but a new treatment in clinical trials aims to eliminate those problems.

The Targeted Intraoperative Radiotherapy Trial, or TARGIT, at the University of Southern California is testing intraoperative radiotherapy — a one-time, half-hour procedure that takes place in the operating room while doctors are removing the breast tumor.

There, radiation is delivered directly to breast tissue in a single dose.

“We know that breast cancer most commonly occurs where the original tumor was found, so the advantage of this treatment is that we can target the treatment to the part of the breast that needs the radiation the most,” breast surgeon Dr. Dennis Holmes.

“There’s no nausea, no long term changes. The skin looks almost as though it’s not radiated. So, the side effects are very minimal by comparison,” surgeon Dr. Melvin Silverstein said.

“I just went to sleep and woke up, and it was done,” patient Nancy Bushnell said. “And I was home, cooking dinner that night.”

If approved, this therapy could dramatically change post-surgery breast cancer treatment, eliminating weeks of discomfort.

CHICAGO, Oct 17 (Reuters) - Genta Inc. said on Tuesday its lead cancer drug Genasense received orphan drug designation from regulators in Australia allowing for its use to treat patients with late-stage malignant melanoma, a deadly form of skin cancer.

Genta said the designation was granted for the use of Genasense as treatment for patients with Stage IV malignant melanoma. Orphan drug designation is intended to facilitate the development of drugs that address significant unmet medical needs.

It provides seven years of market exclusivity after approval, grants and tax credits for research and development, and reduced filing fees for marketing applications.

Swiss pharmaceutical company Roche Holding AG asked the European Medicines Agency to approve its drug, Herceptin, as a treatment for advanced breast cancer, the International Herald Tribune reports.

The application is based on a study that showed that “the addition of Herceptin to hormonal therapy doubles the median progression-free survival,” the company said in a statement.

HER2-positive breast cancer, which affects 20 percent to 30 percent of women with breast cancer, is an aggressive form of the disease that requires special attention because the tumors are fast-growing and there is a higher likelihood of relapse.

“This combination offers a new treatment regimen for patients who suffer from a particularly aggressive form of breast cancer, and we are pleased to have been able to progress this application so quickly,” said Eduard Holdener, Global Head of Roche Pharma Development.

Sales of Herceptin are up significantly in the first half of 2006, and expanded approval could allow sales to increase even more.

WASHINGTON (Reuters) - Hormone therapy used to treat prostate cancer that has already spread may save patients from cancer but raise the risk of diabetes and heart disease, U.S. researchers reported on Tuesday.

They said doctors need to monitor such men closely to make sure they do not trade one cause of death for another.

“Men with prostate cancer have high five-year survival rates, but they also have higher rates of noncancer mortality than healthy men,” Dr. Nancy Keating, an assistant professor of health care policy and medicine at Harvard Medical School, who led the study, said in a statement.

“This study shows that a common hormonal treatment for prostate cancer may put men at significant risk for other serious diseases. Patients and physicians need to be aware of the elevated risk as they make treatment decisions.”

Writing in the Journal of Clinical Oncology, Keating and colleagues said they examined the records of 73,000 men age 66 or older who were diagnosed with local or regional prostate cancer.

Men with early prostate cancer can be treated surgically, with radiation or with radioactive seeds implanted carefully around the prostate.

If the cancer has spread, they are often treated to block production of the hormone testosterone, which can fuel prostate cancer.

This is done either by removal of the testes, or more commonly, by regular injections of a gonadotropin-releasing hormone or GnRH agonist drug.

“Our study found that men with local or regional prostate cancer receiving a GnRH agonist had a 44 percent higher risk of developing diabetes and a 16 percent higher risk of developing coronary heart disease than men who were not receiving hormone therapy,” Keating said.

“For men who do require this treatment, physicians may want to talk with their patients about strategies, such as exercise and weight loss, which may help to lower risk of diabetes and heart disease,” Dr. Matthew Smith of Massachusetts General Hospital said in a statement.

Prostate cancer is the most common cancer among men, with more than 234,000 new cases diagnosed in the United States every year. It will kill 27,350 this year, according to the American Cancer Society.

On Tuesday, the Prostate Cancer Coalition released a report showing that deaths from prostate cancer have fallen by 32.5 percent in 10 years in the United States.

It said the mortality rate for black men is the lowest since 1977, but it is still 2.36 times the rate for white men.

The mortality rate was 39.34 per 100,000 in 1993 and dropped to 26.55 per 100,000 in 2003, mostly due to better screening but also because of better treatments, according to the coalition and the American Cancer Society.

An article by the Inter Press Service News Agency writes about the correlation between atmospheric nuclear tests (specifically in French Polynesia) and a significant increase in Thyroid Cancer. The tests (192 tests in total, 42 of which were atmosphereic in nature) were widely criticized by Polynesian inhabitants 40 years ago, with two in particular (Aldébaran in 1966 and Phoebe in 1971) releasing much more radiation than had been previously acknowledged.

Up to 150,000 people inhabited the islands in the region at the time. Some 20,000 other people worked at nuclear test sites during the 30 years of testing.

The change in the French government’s position comes after Florent de Vathaire, a researcher at the National Institute for Health and Medical Research (INSERM, after its French name) reported that the nuclear tests closely correlate with the appearance of thyroid cancer typically associated with radioactivity.

Florent de Vathaire, head of the epidemiological cancer unit at INSERM found “a statistically significant relation” between the nuclear tests and the incidence of thyroid cancer. De Vathaire studied some 240 cases of thyroid cancer reported in the islands.

On July 17 this year, de Vathaire presented his findings to the ministry of defence, and urged it to declassify military reports that he said confirm the findings.

“I would like to study the data contained in the classified documents, which would allow us to confirm in a more precise manner the nature of the health dangers represented by the tests,” de Vathaire told IPS. Cancer victims and their relatives in the French Polynesia have made similar demands.

“So far, the French authorities have said that the nuclear bomb tests did not represent any danger,” Patrice Bouveret, director of the Observatory of French Nuclear Weapons, an independent group, told IPS. “Now, the same authorities are saying that there was indeed a ’slight’ risk.”

But this admission too comes on the basis of reports by military officers, he said. “Nobody else has seen the original documents to verify such claims. If the victims would have these official reports, they could act legally and demand that justice be done.”

The questions are not confined to the south Pacific islands. France carried out 17 tests in Reggane region in the Algerian Sahara in 1961 and 1962, just before Algerian independence.

German biotech firm Medigene announced that the European Medicines Agency had recommended an orphan drug designation (which ensures exclusivity in the European market for 10 years after marketing approval) for drug candidate EndoTAG-1.

The drug, a combination of Paclitaxel and a carrier system, targets newly formed blood vessels and destroys them, starving tumors of their blood supply. Last month, the U.S. Patent Office granted similar exclusivity, awarding patent protection for EndoTAG-1 as a drug for the treatment of various types of cancer.

The FDA has approved a new drug, Zolinza (manufactured by Pantheon Inc. for Merck & Co) to treat a rare and slow-growing skin cancer, cutaneous T-cell lymphonma. The drug is approved for treatment when the disease persists, gets worse, or comes back after treatment with other medicines.

The approval was won after a study of the safety and effectiveness of Zolinza were evaluated in two clinical trials involving 107 patients with CTCL, each administered the drug after their disease came back or other treatments had failed. Of those patients, 30% saw improvement for an average benefit of 168 days. Some side effects were observed, with the most common serious side effects being blood clots in the lungs, dehydration,deep vein thrombosis, and anemia.

The drug has not been studied in pregnant women, though animal studies suggest Zolinza may harm the fetus.