Study: Vaccine for Breast, Ovarian Cancer Has Potential

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Vaccine May Help Slow Spread of Lung Cancer

Experimental Vaccine Targets a Protein Linked to Many Cases of Non-Small-Cell Lung Cancer

Oct. 21, 2011 -- A cancer vaccine shows potential to slow the spread of cancer among lung cancer patients, a study shows.

The experimental vaccine targets a protein linked to more than half of all cases of non-small-cell lung cancer, the most common form of lung cancer.

The study is published in The Lancet Oncology.

The study was conducted in Europe and included 148 patients with advanced lung cancer. It was led by ?Elisabeth Quiox, MD, a professor of pneumonology at the Universite de Strasbourg, France.

The patients were divided into two groups. Both groups received standard chemotherapy while one group received the experimental vaccine known as TG4010. The vaccine stimulates the immune system to destroy cancer cells.

The researchers hoped to stop the progression of the disease in at least 40% of the patients enrolled in the six-month study. If they reached that goal, they would consider the trial a success. To determine that, each participant underwent a CT scan every six weeks to see if the disease had spread.

At the end of the study, 32 of the 74 patients (43.2%) who had received the vaccine showed no signs of disease progression. Meanwhile, 35% of the study participants who received standard chemotherapy showed similar results.

The researchers write that the trial was a success and that the results suggest that the combination of vaccine and chemotherapy "translates to a better long-term outcome compared with a response obtained with chemotherapy alone."

The vaccine appeared to have other benefits as well. More patients in the vaccine group responded to treatment than patients who received only chemotherapy -- 41.9% compared to 28.4%. Also, for those patients who did respond to treatment, those given injections of the TG4010 vaccine had an average overall survival of 23.3 months, nearly twice that of patients in the comparison group.

The researchers also discovered a potential biomarker that may allow doctors to better determine which patients are most likely to benefit from the vaccine, if it reaches the market.

According to the study, patients with a normal number of a specific type of natural killer cells did much better with the vaccine than patients with an increased number of the cells. Natural killer cells are a form of white blood cell that helps the body fight off cancer cells and cells infected with viruses.

These observations "point to the importance of patients' biological status as a predictor for success of therapeutic vaccination, and suggest that analysis of biological parameters should be part of the clinical developments in cancer immunotherapy," the researchers write.

This is a very important point, says Harry Raftopoulos, MD, an oncologist at the Monter Cancer Center in Lake Success, N.Y., who reviewed the study for WebMD.

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C. Diff Vaccine Shows Promise

Vaccine to Prevent Infection With Diarrhea Bug Passes Early Hurdle

Oct. 21, 2011 -- A new vaccine shows promise for preventing infection with the potentially dangerous diarrhea bug Clostridium difficile, or C. diff.

In two industry-funded studies of nearly 100 healthy people, the vaccine also proved safe. No serious side effects were associated with its use.

The vaccine targets two toxins, A and B, produced by C. diff that attack the lining of the gut and cause diarrhea, cramping, and other symptoms.

Each year, C. diff strikes about 500,000 Americans, mostly in hospitals and nursing homes.?

The new vaccine, being developed by Sanofi-aventis, is one of several vaccines in early testing.

Ginamarie Foglia, DO, MPH, clinical director at Sanofi-aventis, presented the findings today at the annual meeting of the Infectious Diseases Society of America in Boston.

There's a huge need for a vaccine to prevent the disease, Foglia tells WebMD. Althoughdiarrhea is its hallmark symptom, C. diff infection can lead to colitis, perforated colon, and even death.

"We see the vaccine being targeted at high-risk people -- the elderly and those with chronic conditions that increase their chance of being hospitalized and being on antibiotics," she says.

More than 90% of hospital infections with C. diff occur in people who have received antibiotic treatment.

The fact that the vaccine specifically targets the two toxins that cause disease is important, says Kevin Garey, PharmD, MS, of the University of Houston School of Pharmacy. He was not involved with the work.

"If you can mount an antibody response to the two toxins, you [would] predict that you have an effective vaccine," he tells WebMD.

Still, these are the very early days, Garey says. "You’d expect the vaccine to be safe in healthy volunteers. Now they have to prove it is safe in high-risk people," he says.

The new studies involved 48 people aged 18 to 55 and 48 people aged 65 and older. Thirty-six people in each group received one of three doses of the vaccine. The rest got placebo.

Everyone got a C. diff shot at the beginning of the study and boosters one month and two months later.

Among the findings:

At two months, everyone aged 18 to 55 and older people who got the highest dose showed immunity to toxin A in the form of at least a fourfold increase in C. diff antibodies.

"We used that as a [measure] because up to 60% of Americans have antibodies due to exposure at some point in their lives," Foglia says.

Also, 75% of the younger adults had at least a fourfold increase in antibodies against toxin B at two months. By two weeks later, 75% of the older adults showed such an increase.At eight months, antibody levels against both toxins were higher than at the start of the study, no matter what a person's age or what dose was received. But they were no longer four times higher.No one who got placebo had an increase in antibodies at any point in the studies.

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