State of Science: A Tragic Drug Trial, Questioning Chemo and Immune Improvements

Trial Cut Short After Baby Deaths

A trial involving sildenafil, better known as Viagra, was halted last July after the deaths of 11 babies. The drug was given to 93 pregnant women whose fetuses had severe abnormal growth, according to a statement from the Amsterdam University Medical Center, the hospital leading the research. Researchers had hoped the medicine, typically used to treat erectile dysfunction and high blood pressure in adults, would increase placental blood flow and encourage fetal growth, says Marc van den Broek, science communication officer at the hospital. The newborn deaths, from lung disease, could be linked to an adverse reaction to the medicine, he says.

No Chemo, No Problem

Many women with early stage breast cancer don’t benefit from chemotherapy, a large international study found.

The paper, published in July in The New England Journal of Medicine, focused on 6,711 women ages 23 to 75 with an intermediate risk of cancer returning after surgical removal of a tumor. In the past, many of them would have received chemotherapy as part of their treatment. The researchers wanted to find out if chemotherapy, which can have toxic side effects, was necessary.

The women all had tumors that had not spread to their lymph nodes. After tumor removal, the participants were split into two groups: One received a hormone-blocking drug and chemotherapy, and the other received only the hormone blocker. The groups were followed for nearly a decade. Researchers concluded that chemotherapy made no difference in the women’s recovery. Nine years after treatment, almost all the women from both treatment groups were still cancer-free.

“This expands the group of patients who can be safely treated without chemotherapy,” says Patrick Borgen, head of the Maimonides Breast Cancer Center in Brooklyn, New York, who was not involved in the study. “It is an enormous step in the right direction.”