Early breast cancer patients with a high risk of recurrence now have access to the new treatment option.
The TGA has registered ribociclib, a cyclin-dependant kinase inhibitor, as an adjuvant treatment for early breast cancer.
The decision last month was based on the interim findings of the open label phase 3 NATALEE trial, which compared the efficacy and safety of ribociclib plus a non-steroidal aromatase inhibitor compared to a NSAI alone.
The interim findings, published in the NEJM last year, found that ribociclib in combination with an NSAI reduced the risk of invasive disease, recurrence or death in 25% of more than 5000 patients (including almost 200 Australian patients) with hormone receptor-positive, human epidermal growth factor receptor 2-negative stage II and III early breast cancer.
Dr Sally Baron-Hay, a NSW-based medical oncologist who was involved in the NATALEE trial, said the TGA’s decision meant all patients with a high risk of occurrence had access to an effective and tolerable treatment, regardless of nodal involvement.
“Patients diagnosed with HR+/HER2- early breast cancer remain at risk of recurrence for decades,” she said. “Approximately one-third of those with stage II disease and more than half of those with stage III disease will have a recurrence.
“What we continue to see with the NATALEE data is not only the benefit of the addition of ribociclib in reducing the risk of recurrence in those high risk-patients with N2+ disease recurrence, but for the first time we are seeing a clear clinical benefit in those high-risk patients with no nodal involvement.”
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Research from Inherited Cancers Australia (funded by Novartis Australia, the manufacturer of ribociclib) suggests that recurrence is the biggest fear for nine out of 10 Australians living with breast cancer.
The data from Project Shirley, described as the country’s first research project into the impact of early breast cancer diagnosis, indicates most early breast cancer patients are open to treatments that reduce their risk of recurrence – even if their risk is small – due to the negative impact that the fear of recurrence has on their quality of life.
Results from Project Shirley were presented at last month’s St Gallen International Breast Cancer Conference and are expected to be published later this year.
