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Prof. Suk-Ah Lim, MONALEESA-7 gives meaning … “Can be used without ovarian control”
Comparison with chemotherapy as a follow-up study … Expectation of change in the medical setting
“Even if there is an intestinal metastasis, it means that MONALEESA-7 can think of endocrine therapy and CDK 4/6 inhibitors before chemotherapy.”
This is Professor Seok-Ah Lim’s evaluation at Seoul National University Hospital on the MONALEESA-7 study by Kiscali (RiboxyClip, Novartis), which has shown the effect of improving survival in patients with premenopausal metastatic breast cancer as the first CDK 4/6 inhibitor last year.
Last year, Novartis released the results of the MONALEESA-7 clinical study conducted by Keith Cali at the American Society for Clinical Oncology (ASCO 2019).
This study received attention by leading participation in Korea as a follow-up clinical trial to the MONALEESA-3 clinical study, in which Kiscali improved progression-free survival (PFS) than existing endocrine therapy.
Breast cancer is high in premenopausal women in Asian countries, including Korea, as opposed to Western women, which are common among women in their 60s and 70s.
Therefore, clinical studies conducted mainly in postmenopausal women were difficult to apply, as they are in the domestic reality.
Unlike in the West, where the survival rate of breast cancer patients is constantly increasing, it is the main reason why the survival rate is decreasing in the East.
In particular, the metastatic breasts that appear in premenopausal women are more aggressive than postmenopausal women, so more active treatment is required.
Among these, hormone receptor positive and HER2 negative breast cancer, which are targets of CDK 4/6 inhibitors, are based on hormone therapy, but premenopausal women tend to chemotherapy primarily due to lack of evidence for CDK 4/6 inhibitors.
Also, if chemotherapy is difficult or has a high degree of rejection, endocrine therapy after ovarian resection and the like has been tried to create a condition such as menopause.
Consequently, in Korea, premenopausal women also attempted to combine CDK 4/6 inhibitors and endocrine therapy, and as a result, led to MONALEESA-7.
The findings were positive. A comparison of the endocrine-only therapy group (GnRH agonist + aromatase inhibitor) in premenopausal women compared to the ribociclib group on endocrine therapy resulted in a 29% reduction in risk of death (HR = 0.712) .
In addition, the period to receive subsequent chemotherapy was 36.9 months, with a relative risk ratio (HR) of 0.596 and a median progression-free survival (PFS2) that led to secondary treatment of 32.3 months with a relative risk ratio. of 0.682.
The first author of this study, Professor Seok-Ah Lim, Department of Hematology and Oncology, Seoul National University Hospital, gave MONALEESA-7 meaning in two ways.
One is that this study secured the basis for endocrine therapy + CDK 4/6 inhibitor combination therapy in patients with premenopausal metastatic breast cancer, and the other was that Korea led these data.
“There is a significant difference in terms of statistically significant improvement in overall survival when used with endocrine therapy as the primary treatment,” said Professor Lim. “It is different from other CDK 4/6 inhibitors.”
In addition, he added: “Previously, patients with premenopausal breast cancer were allowed to receive benefits only after removal of the ovaries. Now, patients without ovaries can use kiscali while using inhibitors of ovarian function.” .
However, Professor Lim said: “It is different that combined therapy of endocrine therapy and CDK 4/6 inhibitor is as effective as chemotherapy (since the control group of MONALEESA-7 is endocrine therapy). There is, but I hope Korea can participate too. ”
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