Drug 'Xeloda' Extends Survival for Some Breast Cancer Patients

A drug called Xeloda can prolong the life of some women whose breast cancer is not wiped out by a standard treatment, according to a new clinical trial.

Oncologists said the results "change the practice".

"This drug is already approved, and we have been using it for a long time in cancer treatment," said Dr. Stephen Malamud, an oncologist at Mount Sinai in New York.

Xeloda (capecitabine) is a pill, so it is easy to take and is "much less toxic" than standard chemotherapy, Malamud noted, who did not participate in the new research.

"More importantly," he said, "he extended the overall survival in this study."

In 1998, Xeloda was approved in the United States for advanced breast cancer that spread to remote sites in the body. The new trial, conducted in Japan and South Korea, tested the drug for a group of different patients.

It focused on 910 women whose breast tumors were not completely eliminated by chemotherapy and standard surgery. In addition, they all had a cancer that did not have a protein called HER2 - which meant they could not benefit from breast cancer drugs that target HER2, such as Herceptin.

These women have a fairly high risk of their cancer progressing, according to trial researchers, led by Dr. Masakazu Toi, from Kyoto University in Japan.

In the study, Xeloda improved these chances. It reduced the risk of relapse or death in patients by 30% over five years.

At that time, 74% were still alive and without recurrence, compared to just under 68% of women who had received placebo pills in addition to standard treatment.

"It's not a panacea, by any means," Malamud said. "But it's a good" back door "treatment to improve women's results."

Dr. Elizabeth Comen is a medical oncologist at the Memorial Sloan Kettering Cancer Center in New York. She said that doctors have already started using Xeloda for women like the trial, according to preliminary reports. (The trial was effectively stopped early, in 2015, when it became apparent that Xeloda had benefits.)

"This is a historical test," said Mr. Comen. "This is really, in my opinion, a change of practice."

The women in the study all had breast tumors that had not yet spread to distant sites of the body. But many have had cancer in the nearby lymph nodes.

They had all received standard chemotherapy before surgery, but still had "residual" cancer left behind.

The You team randomly assigned the patients to one of the two groups. Most women in both groups received radiation, and those with hormone-sensitive breast cancer started taking hormone medications.

Only one group received Xeloda, while women in the other group received placebo pills. The treatment was administered in six or eight "three week" cycles, with two weeks on the drug, one week off.

Five years later, 89 percent of Xeloda patients were still alive compared to just under 84 percent of patients receiving placebo.

The difference was greater for women with "triple-negative" breast cancer; This means that their cancer is not only lacking in HER2 but is not as sensitive to the hormone, which limits its treatment options.

Of these women, 79 percent of Xeloda patients were alive after five years, compared with 70 percent of patients receiving placebo.

The main side effect - affecting almost three-quarters of patients - was hand-foot syndrome. It is red and swollen palms and soles of the feet. It is similar, says Malamud to a "bad sunburn", and it disappears once the drug is stopped.

According to Comen, the dosage of Xeloda for a patient can be individualized to help manage side effects. The dose can be lowered, for example, or a patient may take a short "vacation" drug, she said.

Regarding access to the drug, Malamud and Comen said they would be surprised if an insurer would not pay. Malamud said he had not encountered any coverage problems.

"This study is a demonstration that cancer cells that are not killed by some drugs can still be killed by others," said Comen.

And, she added, this "leads home" the fact that researchers continue to progress against breast cancer difficult to treat.

The trial was funded by the Advanced Clinical Research Organization and Japan Breast Cancer Research Group