CNN –
A drug used in people with the early stages of the most common type of breast cancer — HR+/HER2 breast cancer — significantly reduced the risk of the cancer coming back after treatment, according to a new study.
The U.S. Food and Drug Administration approved Novartis’ drug ribociclib, marketed under the brand name Kisqali, in 2017 for people with cancer that has spread to other parts of the body. It helps them live longer by slowing the growth and spread of the disease. The results of a late-stage study in people with early-stage cancer were presented Friday at the American Society of Clinical Oncology conference in Chicago. The drug is not yet indicated for this group of patients.
“Having seen this benefit, it made perfect sense to assess whether the same benefit can now be extended to a group of breast cancer patients who are at a much earlier stage in their disease,” Dr. Shreeram Aradhye, President for Global at Novartis, said the company’s chief medical officer at a news conference on Friday. “Breast cancer is often diagnosed at an earlier stage, but because it’s caught early, like stage two or three, before it has spread, it doesn’t necessarily mean that these patients aren’t at risk for a possible recurrence.”
Oncologists say there is a need for well-tolerated treatments that can keep patients cancer-free in the long term. Studies show that even after successful treatment for an initial cancer, some people are at high risk of a recurrence, which can last for decades.
Typically, doctors use endocrine therapy after initial treatment to reduce the risk of the cancer coming back. Also known as hormone therapy, it slows or stops the growth of hormone-sensitive cancer cells.
Endocrine therapy generally works well, but patients with HR+ or HER breast cancer still have a 10 to 40 percent chance of the cancer coming back, some studies show. HR+/HER2 breast cancer tested positive for progesterone and estrogen receptors and negative for HER2.
Some people may see benefits from a drug called Verzenio, but it’s not used in patients who have certain conditions, such as those who don’t have lymph node involvement.
The new study found that when added to endocrine therapy, Kisqali reduced the risk of recurrence by 25% in a broad population of early breast cancer patients.
The drugmaker Novartis study was a randomized controlled trial, the gold standard of research, involving 5,100 patients at 425 sites in 21 countries. The participants were pre- and postmenopausal women and men who were followed for three years.
The study found that Kisqali improved the percentage of people with invasive disease-free survival at three years to 90.4%, compared to 87.1% without this option in patients with HR+/HER2 early-stage breast cancer.
Side effects included elevated liver enzymes, diarrhea and neutropenia, a condition in which the body has too few neutrophils, a type of white blood cell that helps fight infection.
For some patients, the cost of the drug can be a sensitive issue. The price is up to $15,000 per month. That comes from a recent analysis that suggests it’s not a cost-effective treatment, even with its current use in people with advanced cancer.
But a large number of people will benefit from such a drug. About 90% of breast cancer patients are diagnosed in the early stages.
“These groundbreaking results will fundamentally change the way we treat patients with HR+/HER2 early stage II and III breast cancer who need new, well-tolerated options to prevent their cancer from coming back,” said the lead researcher of the study, Dr. Dennis J. Slamon, director of clinical and translational research at UCLA Jonsson Comprehensive Cancer Center and chair and executive director of Translational Research In Oncology. “Meeting this unmet need in such a broad patient population could help optimize treatment decisions for healthcare providers and keep many more at-risk patients cancer-free without impacting their daily lives.”
according to dr Sara Tolaney, a breast cancer oncologist at the Dana-Farber Cancer Institute, who was not involved in the study but will be presenting research at the event, says doctors that this is “one of the most exciting” news presented at this year’s conference .
“I think we should definitely pay attention to that,” Tolaney said. A 25% reduction in relative risk is significant, she said, and she hopes to have longer-term data on these patients. She believes that the more people tracked over time, the greater the benefits will appear.
“I think it really suggests that we can do better for our patients,” Tolaney said.
dr Anupama Goel, assistant professor of medicine, hematology and medical oncology at Mount Sinai Tisch Cancer Center, said the results of the study were long-awaited and “very good.”
“I think this is a very important addition to our quest to cure more breast cancer patients,” said Goel, who was not involved with the research.
“I think this is a huge help in this area because we have these high-risk patients who are at very high risk of the disease coming back. “Our cure rate isn’t 100%,” she said, but a drug like this could get her there. “I think this will change the situation for many patients.”
dr Alberto Montero, director of the breast cancer program at Ohio’s UH Seidman Cancer Center and professor at Case Western Reserve University School of Medicine, said it was a “significant advance” with “very significant results” but “greatest advances.” in oncology — and breast cancer in particular — is really incremental, and that’s okay.”
Montero said the new findings could mean patients would have to take a different drug for three years, which could have potential side effects.
“I think you always have to weigh, ‘What’s the risk to the individual patient versus then what’s the benefit to them?’ Because as an oncologist, we have to think about the toxicity of everything we do and think about, ‘Will does this improve outcomes for a patient in a meaningful way?” he said.
In general, advances like this are important for the development of better cancer treatments, Montero said.
“There are incremental advances, and they are quite significant.”