Thousands of women with the world’s most common type of breast cancer could benefit from a blockbuster drug that helps them live longer and cuts their risk of the disease coming back by a quarter.
More than 2 million people around the world are diagnosed each year with this disease, which is the most frequent type of cancer. Although treatments have improved in recent decades, many patients will later experience a recurrence of the cancer. If recurrence occurs, it usually occurs at a more advanced stage.
Now, “very promising” research presented at the annual meeting of the American Society of Clinical Oncology (ASCO), the world’s largest cancer conference, suggests that a new targeted therapy drug, called ribociclib, could change the landscape. Trial results show that this drug can increase survival and significantly reduce the chances that the cancer will come back.
Ribociclib has been shown in the past to be beneficial for the survival of breast cancer patients whose disease has spread. However, in the new study, the researchers found that it can also improve the situation for patients in much earlier stages of the disease, even those whose cancer has not yet spread to the lymph nodes.
The findings excited researchers and oncologists at the ASCO annual meeting in Chicago because the data suggests that the drug, also known as Kisqali, could ward off the threat of cancer recurrence in a broad population and change global practice.
Ribociclib is a selective treatment called a small molecule inhibitor. Its effect is focused on proteins present in breast cancer cells called CDK4 and CDK6, which modulate cell growth, including that of cancer cells.
The drug’s late-stage trial showed that it reduced the risk of recurrence by 25% when used with standard hormone therapy, rather than hormone therapy alone, after traditional treatments. It has already received approval from regulatory authorities, including in the United Kingdom and the United States, to treat breast cancer that has spread to other parts of the body.
However, its use in early stages, when tumors can still be surgically removed, is considered a much bigger advance because of the huge number of patients it could help.
Breast cancer patients are typically offered surgery and chemotherapy or radiation therapy before hormone-blocking drugs are given to try to stop the disease from coming back.
The addition of ribociclib to hormone therapy showed a “significant improvement” in disease-free survival times in patients with early-stage hormone receptor-positive, HER2-negative breast cancer, the study revealed.
Hormone receptor-positive, HER2-negative breast cancer is the most common subtype of the disease, accounting for nearly 70% of all reported breast cancer cases in the United States.
“Currently, approved targeted therapies can only be used in a small population of patients diagnosed with early-stage hormone receptor-positive, HER2-negative breast cancer, leaving many without an effective therapeutic option to reduce cancer risk. risk of cancer recurrence,” said Dr. Dennis Slamon, lead author and director of clinical and translational research at the UCLA Jonsson Comprehensive Cancer Center, in Los Angeles.
About a third of people with hormone receptor-positive, HER2-negative stage two cancer experience a recurrence after receiving standard treatment, and more than half of people with stage three cancer will see their cancer come back, Slamon explained.
“Therefore, there is a significant unmet need both to reduce the risk of recurrence and to provide a tolerable treatment option that keeps patients cancer-free without disrupting their daily lives.”
The Natalee study involved 5,101 patients who were given ribociclib for three years in combination with five years of hormone therapy, or hormone therapy alone.
After three years, 90.4% of patients who took ribociclib remained disease-free, compared with 87.1% in the group who received hormone therapy alone. Ribociclib also showed more favorable results in terms of overall survival, recurrence-free survival, and distant disease-free survival, the investigators noted.
“Although early stage, these results are very promising and suggest that adjuvant ribociclib will have a role in stage two or higher hormone receptor-positive, HER2-negative breast cancer,” said Rita Nanda, MD, an ASCO expert in Chicago, who was not involved in the study.
Dr. Kotryna Temcinaite, Head of Research Communications for Breast Cancer Now, welcomed the results as positive news for patients. “Researchers found that, when combined with hormone therapy, ribociclib significantly reduces the chances of disease recurrence in women with estrogen receptor-positive, HER2-negative primary breast cancer.”
“We know that many women and their loved ones are concerned that breast cancer will come back after treatment, so new treatments like ribociclib, which can reduce this risk, are incredibly well received.”
“This treatment must now be rapidly submitted for authorization and evaluation for use by the National Health Service, so that this group of patients with primary breast cancer has the opportunity to benefit from it as soon as possible.”
Dr Catherine Elliott, director of research and partnerships at Cancer Research UK, said: “While further research is needed, early results from the ongoing trial with Natalee are promising.”
“The combination of ribociclib and hormone therapy could provide a new treatment option for people with this type of early-stage breast cancer, thereby reducing the risk of disease recurrence and improving survival.”.
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