Skip Navigation

healthnewslink
Cancer Newsletter
December 10, 2007


In This Issue
• FDA Panel Says No to Avastin for Advanced Breast Cancer
• Cancer Patients Gain From Reporting Symptoms Online
• Experimental Drug Fights Prostate Cancer
• Immune Proteins Warn of Early Lung Cancer
 

FDA Panel Says No to Avastin for Advanced Breast Cancer


WEDNESDAY, Dec. 5 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel recommended Wednesday that the cancer drug Avastin should not be used to treat women with advanced breast cancer.

In a close vote, 5-4, the advisers decided the drug's ability to slow down the growth of tumors did not outweigh the increased risk of blood clots and other cardiovascular troubles among users, the Associated Press reported. In rare cases, patients taking Avastin with standard chemotherapy have died.

Avastin was approved to treat colon cancer in 2004, and lung cancer in 2006. It works by cutting off the tumor's blood supply.

"Everybody wants to offer metastic breast cancer patients hope, but we shouldn't offer them false hope," panel member Natalie Compagni-Portis, a patient representative with Breast Cancer Action in San Francisco, said during the meeting, according to the AP. "We have to raise the bar in terms of safety."

"These patients are terminal, and it's our job to make their lives better, not to say that it's OK to have a stroke or that it's manageable," Maha Hussain, an oncologist at the University of Michigan and the advisory panel's chairwoman, said during the meeting. "You didn't show that patients are living better or that they're living longer."

In trial results submitted to the FDA by the drug's U.S. maker, Genentech Inc., use of Avastin (bevacizumab) did boost the progression-free survival of women with advanced breast cancer by an average of 5.5 months, when combined with the chemotherapy drug paclitaxel. Progression-free survival refers to survival without any advancement of the malignancy.

However, the same Genentech study of 722 patients showed that patients reaped no gain in terms of their overall survival after taking Avastin.

Another company-funded trial, this time including 462 patients with advanced breast cancer, showed similar results, with Avastin having no effect on overall survival.

At the same time, the FDA said, the drug has "major safety issues," including hypertension, clotting events, left ventricular heart dysfunction, heart attack, gastrointestinal perforation and proteinuria (excess protein in urine). A special FDA staff review of the data found that rates of grades 3 to 5 toxicities rose by more than 20 percent when cancer patients received Avastin on top of regular chemotherapy.

Furthermore, in the Avastin-paclitaxel trial, the rate of patient deaths linked to Avastin use was 1.7 percent (six out of 363 users) compared to no deaths among the 348 participants who did not receive the drug, the FDA noted.

In its approval submission statement to the FDA, Genentech contended that, "Analysis of the safety and efficacy data in total demonstrates a highly favorable risk-benefit profile for bevacizumab in combination with paclitaxel that supports full approval of bevacizumab for the treatment of locally recurrent and metastatic breast cancer."

The FDA is not obligated to follow the recommendations of its advisory panels, but usually does. A decision is expected by Feb. 23, the AP reported.

Avastin is not traditional chemotherapy, but instead is a monoclonal antibody that robs tumors of their blood supply. It has been found to boost the survival of patients with metastatic colorectal cancer and non-small-cell lung cancer when added to chemotherapy and used as a first-line treatment.

But the drug has its downside. In an analysis of pooled data from five randomized controlled trials involving more than 1,700 patients with metastatic colon, breast or lung cancers, Genetech researchers found that 3.8 percent of patients experienced blood clots while on the drug, compared to 1.7 percent of those who took standard chemotherapy alone.

Patients who were 65 or older appeared to be at special risk for clots while taking Avastin, according to the study, which was published in August in the Journal of the National Cancer Institute.

The exact link between Avastin and cardiovascular risk remains unclear, although the Genentech team speculated that a vascular endothelial growth factor (VEGF), a natural compound that boosts blood vessel growth, may play a role.

More information

Find out more about breast cancer and its treatment at the American Cancer Society  External Links Disclaimer Logo.


top

Cancer Patients Gain From Reporting Symptoms Online


FRIDAY, Nov. 30 (HealthDay News) -- Having cancer patients report to doctors on their symptoms and side effects online may improve their care, a new study finds.

Even the sickest cancer patients are willing and capable of reporting their symptoms online, says a team from Memorial Sloan-Kettering Cancer Center in New York City.

"Cancer care has become increasingly complex, causing office visits to become more compressed. This makes it challenging for the clinician to comprehensively assess each patient's symptoms in that brief window of time," study author Dr. Ethan Basch, a medical oncologist, said in a prepared statement.

"Because cancer therapies can be highly toxic, early detection of symptoms and timely treatment is vital. What is exciting to us about online self-reporting is that patients can alert clinicians to crucial symptoms in real time," Basch said.

The study included 107 lung cancer patients receiving outpatient chemotherapy who had access to a secure Internet patient reporting system developed by Basch and his colleagues. The patients were able to access the Symptom Tracking and Reporting (STAR) site using computers in waiting room kiosks and at home to report cancer symptoms and chemotherapy-related side effects.

The patients were followed for up to 16 months and 40 visits. All of the patients used the waiting room kiosks at some or all of their office visits, and an average of 78 percent logged onto the system at any given office visit. Patients were more likely to use STAR if they had prior computer experience.

The study found that 98 percent of patients found STAR easy to use, 90 percent said it was useful, and 77 percent believed it improved the quality of their discussions with clinicians.

The study appears in the Dec. 1 issue of the Journal of Clinical Oncology.

More information

The U.S. National Cancer Institute has more about coping with cancer.


top

Experimental Drug Fights Prostate Cancer


WEDNESDAY, Nov. 7 (HealthDay News) -- In mice, an investigational agent called VN/14-1 proved effective in treating human prostate cancer, say researchers at the University of Maryland in Baltimore.

The five-week study found that daily injections of VN/14-1 in mice implanted with human prostate cancer cells resulted in up to a 50 percent reduction in tumor volume.

VN/14-1 blocks the breakdown of vitamin A-derived retinoic acid, the researchers explained. The drug appears to tackle cancer in multiple ways.

"This potent agent causes cancer cells to differentiate, forcing them to turn back to a non-cancerous state -- which is what we expected it would do -- but it also stops cancer growth by arresting the cell cycle and pushes cells to die by inducing programmed cell death," senior investigator Vincent C.O. Njar, associate professor in the department of pharmacology and experimental therapeutics in the School of Medicine, said in a prepared statement.

"These functions were unexpected and wonderfully surprising. I am not aware that any drug currently used to treat prostate cancer targets so many pathways," said Njar, whose lab developed VN/14-1.

The findings were to be presented Tuesday at an American Association for Cancer Research meeting.

Vitamin A is converted by the body into retinoic acid, which maintains the normal growth of cells. Prostate cancer cells contain five to eight times less retinoic acid than normal prostate cells. VN/14-1 is designed to block the breakdown of retinoic acid in cancer cells.

More information

The American Academy of Family Physicians outlines prostate cancer treatment options  External Links Disclaimer Logo.


top

Immune Proteins Warn of Early Lung Cancer


THURSDAY, Oct. 11 (HealthDay News) -- British researchers say they've spotted key immune system proteins that could give doctors early warning of lung cancer.

A team at Nottingham City Hospital analyzed blood samples from 104 people with different types of lung cancer and 50 others who were cancer-free.

The samples were tested for autoantibodies -- immune system proteins that are directed at the body's own tissues in response to specific chemical signals. The researchers focused their search on a panel of seven autoantibodies associated with solid tumors. The autoantibodies are triggered when cancerous changes are taking place.

The team detected all seven autoantibodies, and very high levels of at least one of them, in almost 80 percent of the blood samples from the lung cancer patients. The autoantibodies were also found in eight out of the nine cancer patients whose cancer had not infiltrated the lymph nodes, indicating the cancer had not yet spread elsewhere, and the patients still had an 80 percent chance of being cured.

Only one healthy participant had more than one of the seven autoantibodies, the researchers reported Oct. 11 in the online edition of the journal Thorax.

Previous research suggests that these autoantibodies can be detected as early as five years before the clinical symptoms of cancer appear.

The researchers believe a blood test for the seven autoantibodies could be used for smokers and others at high risk for lung cancer. If there's a positive result, patients could be referred for further tests, such as CT or MRI scanning.

More information

The U.S. National Cancer Institute has more about lung cancer screening.


top