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.

Genentech won FDA approval to market Avastin as a general lung cancer treatment, potentially reviving sales growth for the firm’s second largest product. The FDA cleared the drug to treat the most common form of lung cancer, used in combination with chemotherapy, the California based company said. Avastin, previously used as a Colon cancer therapy, helped lung cancer patients live more than 2 months longer than those on chemotherapy alone.

While colorectal sales have slowed, Genentech believes that Avastin sales for lung cancer treatments may start near $400M in 2007 and reach $1.3B by 2010. Genentech had received initial approval of Avastin two years ago, and is currently testing Avastin on 25 types of tumors.

Lung cancer kills more Americans than any other type of cancer. The disease accounts for almost 30% of cancer-related deaths in the U.S., Genentech said, citing the American Cancer Society. About 60% of people with lung cancer die within a year of being diagnosed, according to the American Lung Assn.’s website.

Avastin’s average cost for a course of lung cancer treatment is about $56,000, Genentech said. The typical monthly cost at the dose required for advanced lung cancer is about $8,800. The company said it’s starting a program to cap the cost at $55,000 a year for eligible patients regardless of whether they have health insurance.

Lung cancer patients treated with an experimental new drug in addition to standard chemotherapy lived more than one third longer than patients treated with chemotherapy alone, according to new data posted at 2Breathe.net, as they review a small phase II study carried out by a British biotech company, Antisoma plc, enrolled 70 patients with non-small cell lung cancer, the most common type of lung cancer. 

Researchers reported that patients treated with AS1404 on top of standard chemotherapy lived 14 months compared to 8.8 month for patients who solely received chemotherapy alone.

AS1404 is one of a new class of drugs called Vascular Disrupting Agents (VDAs) that work by selectively destroying established tumor blood vessels, the blood supply that enables a tumor to survive and grow.

Researchers said AS1404 is able to distinguish between the tumor’s blood supply and the more permeable and less-well organized capillary network of healthy organs.

If the early results with AS1404 are confirmed in larger phase III trials, this would be a significant increase in life expectancy for patients suffering from lung cancer, which has one of the lowest survival outcomes of any cancer.

The referenced study is one of three currently underway testing various aspects of AS1404. Positive data has been announced in a trial testing its use in prostate cancer, as well as promising early data from an ongoing ovarian cancer trial. If approved for use, Antisoma is expected to license AS1404 to a number of different companies.