New Drug Trial Shows Reduced Risk Of Breast Cancer Recurrence For Some Early-Stage Patient...

According to a new study, a new drug used for patients in the early stage of the most common kind of breast cancer (HR+/HER2 – breast cancer) helped significantly reduce the risk of the cancer returning after treatment. 

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In 2017, the US Food and Drug Administration (FDA) approved the Novartis drug ribociclib, marked under the brand Kisqali, for individuals with cancer that has spread to other parts of the body. The drug ideally helps patients live longer by slowing the disease’s growth and spread. 

The results of a late-stage trial in people who have early-stage cancer were recently presented at the American Society of Clinical Oncology conference in Chicago, as the drug has not been identified yet to help that particular patient population. 

“Breast cancer is often diagnosed at an earlier stage, but because it is picked up early, as in stage two or three, before it has spread, does not necessarily mean that those patients are not at risk of a potential recurrence,” said Novartis’ Dr. Shreeram Aradhye, president for global development and the company’s chief medical officer, according to CNN.

“Having seen that benefit, it made perfect sense to assess whether the same benefit can now be extended to a group of patients with breast cancer who are at a much earlier stage of their disease.”

Oncologists have long been looking for a treatment for patients who are recovering from cancer that will keep them cancer-free as long as possible/indefinitely. Some individuals genetically could be at higher risk of developing cancer after recovering from it. Typical treatment after recovery involves using endocrine therapy to reduce the risk of the cancer returning. This therapy is meant to slow or stop the growth of hormone-sensitive cancer cells. 

For patients with HR+ or HER-breast cancer, there’s a 10% – 40% chance that the cancer will return. According to a recent trial using Kisqali with endocrine therapy, there’s a 25% reduced risk of recurrence in early breast cancer. 

The trial from Novartis was randomized and controlled, according to reports, utilizing data from 5,100 patients at 425 sites in 21 countries. The participants were pre and post-menopausal women and men, and all were followed for three years. The data showed that “Kisqali improved the percentage of people with invasive disease-free survival to 90.4% at three years, compared with 87.1% without it, in patients with early HR+/HER2- breast cancer,” according to CNN

90% of breast cancer patients are diagnosed in the early stages, meaning a large population of individuals could benefit from the drug, however, the difficulty lies in the cost of the treatment, which according to a recent analysis would be around $15,000. Dr. Dennis J. Slamon was the trial’s lead investigator who discussed these results and how beneficial this treatment could actually be.

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“These landmark results will fundamentally change how we treat patients with stage II and III HR+/HER2- early breast cancer who are in need of new, well-tolerated options that prevent their cancer from coming back. This could help streamline treatment decisions for healthcare providers and keep many more at-risk patients cancer-free without disrupting their daily lives.”

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Dr. Sara Tolaney, a breast medical oncologist who presented research at the same event, but was not involved in this specific trial, stated that this is some of the most exciting news to be discussed at this year’s conference. 

“I think we should definitely pay attention to this. A 25% relative risk reduction is substantial, as more [patients] are followed for longer, the benefit will appear even larger. I think it really does suggest that we can do better for our patients,” Tolaney said.

“I think this is a very important addition to our quest toward trying to cure more patients with breast cancer,” said Goel, who was not involved in the research.

“I think that this is a huge help in this space because we do have these high-risk patients who are at very high risk for disease recurrence. Our cure rate is not 100%, but a drug like this could get [us] there. I think this is going to change the landscape for a lot of patients,” said Dr. Anupama Goel, an assistant professor of medicine, hematology and medical oncology.