Novartis Bone Drug Helped to Shrink Breast Tumors

Novartis AG’s bone drug Zometa shrank breast tumors when given with standard treatment, and reduced the number of mastectomies, a study found.

The treatment nearly doubled the number of women whose cancer went into remission in a trial of 205 patients with breast cancer who hadn’t yet undergone surgery, according to data presented today at the San Antonio Breast Cancer Symposium in San Antonio.

The Novartis-funded study also found that women who were given Zometa with standard chemotherapy saw their tumors reduced by a third when compared with patients who received only chemotherapy, researchers said today. Women on the Zometa regimen also had fewer surgeries to remove their breasts, the study found.

If the results hold up in larger studies, “it would mean fewer patients would have to have mastectomies,” said Robert Coleman, an oncologist at the University of Sheffield in Sheffield, England, in an interview today. “There seems to be a biological effect here. But this is not overnight going to change the management of women with breast cancer.”

The study is part of a larger, 3,400-patient trial, known as Azure, which is exploring whether Zometa, also known as zoledronic acid, can enhance the effect of chemotherapy when given before or after breast cancer surgery.

More Effective Use

While much attention is paid to efforts to develop new cancer-fighting drugs, “a lot of the benefit will come from learning how to use the drugs we have in better ways,” such as by boosting the effectiveness of chemotherapy, said Kelly Marcom, director of the breast program at Duke University’s Comprehensive Cancer Center in Durham, N.C.

The study results could eventually help Novartis broaden the use of Zometa, which had sales of $360 million in the third quarter. The company currently sells Zometa to treat bone complications in cancer patients. The drug, given as an infusion, also is used in lower doses for osteoporosis.

Novartis, based in Basel, Switzerland, sells Zometa in more than 80 countries. It’s sold as Reclast or Aclasta as an infusion to treat osteoporosis.

Breast cancer is the fifth leading cause of death worldwide, with 548,000 deaths in 2007, according to the World Health Organization. It is also the most common form of cancer in women. About 182,000 women in the U.S. will be diagnosed with breast cancer in 2008, according to the American Cancer Society.

The study followed 205 patients who received Zometa once every three to four weeks for six months before breast cancer surgery. Researchers found that 65 percent of Zometa patients underwent a mastectomy compared with 78 percent of those who received chemotherapy.

Remission

Eleven patients who were on the Zometa therapy went into full remission, meaning there were no tumors found in the women’s breasts or lymph nodes, Coleman said.

“That is the more impressive effect” in the study, Coleman said. Even so, 11 patients among 200 in a study “is a pretty small number,” he said, adding that the results “should not be seen as a new way to treat breast cancer until we’ve done further studies.”

Zometa, which belongs to a group of drugs called bisphosphonates, is thought to stimulate cancer-fighting immune cells, choke the growth of blood vessels that feed tumors and cause cancer cells to self-destruct.

While scientists do not know exactly how Zometa works to fight tumor growth, Coleman said the drug probably does not do the job on its own. There seems to be an “exquisite synergy” between the drug and the chemotherapy agents it is being used with, he said.

Source: Bloomberg