KISQALI (ribociclib) - Cancer du sein

Key points

Approval of reimbursement of KISQALI (ribociclib) in association with letrozole for the treatment of locally advanced or metastatic HR+/HER2- breast cancer, as initial hormone therapy-based treatment or after previous hormone therapy treatment with an interval of more than 12 months in menopausal women, in the absence of life-threatening visceral involvement in the short term.

Therapeutic improvement?

Therapeutic improvement with respect to letrozole alone.

Role in therapeutic strategy?

While at the localised stage, the objective of treatment is curative, at the locally advanced or metastatic stage and despite the treatments available, HR+/HER2- breast cancer is still a practically incurable, systematically life-threatening disease, impacting patients’ quality of life.6

At the advanced stage (locally advanced or metastatic), the objective of treatment must be to prolong overall survival while maintaining or improving quality of life.

In the absence of life-threatening symptomatic visceral metastases in the short term, the therapeutic strategy is based on hormone therapy.

According to the most recent European Society for Medical Oncology7 (ESMO) and the National Comprehensive Cancer Network8 (NCCN) guidelines from 2021, the addition of a CDK4/6 inhibitor (IBRANCE (palbociclib), KISQALI (ribociclib) or VERZENIOS (abemaciclib)) to an aromatase inhibitor is recommended as a first-line approach for women initially diagnosed at an advanced stage or experiencing late or early recurrence in respect of adjuvant hormone therapy. Association with fulvestrant is also a first-line therapeutic option for women initially diagnosed at an advanced stage or experiencing late or early recurrence in respect of adjuvant hormone therapy (NCCN). ESMO specifies that this alternative should only be preferred if an interval of less than 12 months has elapsed since the last anti-aromatase dose was taken.

Moreover, the NCCN states that non-steroidal aromatase inhibitors alone (anastrozole or letrozole) remain first-line alternatives at the advanced stage (for women initially diagnosed at an advanced stage or experiencing late recurrence in respect of adjuvant hormone therapy) unless they were previously administered in the context of an adjuvant treatment discontinued less than 12 months previously (early recurrence) and concomitant non-steroidal aromatase inhibitor treatment with fulvestrant is also a therapeutic option.

The latest guidelines of the Ile-de-France breast care network9 and the American Society of Clinical Oncology10 (ASCO) are strictly comparable to those of the ESMO mentioned above.

However, the ASCO specifies that CDK 4-6 inhibitor treatment must be limited to patients who have never been exposed to this therapeutic class in a metastatic context.

Role of the medicinal product:

KISQALI (ribociclib) is a first-line treatment for locally advanced or metastatic HR+ and HER2- breast cancer, in the absence of life-threatening symptomatic visceral involvement in the short term, following an initial diagnosis at this stage or in the event of late recurrence after more than 12 months.