Loading
Adding two years of the CDK4/6 inhibitor abemaciclib to standard hormone therapy after surgery cut the risk of the cancer coming back by a quarter in women with node-positive, high-risk disease.
Open-label phase 3 trial of 5,637 patients with hormone-receptor-positive, HER2-negative early breast cancer at high risk of recurrence (four or more positive nodes, or one to three nodes with grade 3, tumour 5 cm or more, or high Ki-67), randomised to standard endocrine therapy with or without two years of abemaciclib. Primary endpoint was invasive disease-free survival (iDFS).
At the pre-planned interim analysis, iDFS was improved (HR 0.75; 2-year iDFS 92.2% vs 88.7%). The benefit widened with time: at five years iDFS was 83.6% vs 76.0%, a 7.6-point absolute difference (HR 0.68), well after abemaciclib had stopped. It was the first adjuvant CDK4/6 inhibitor to succeed after palbociclib failed in PALLAS and PENELOPE-B.
Women with hormone-receptor-positive, HER2-negative breast cancer that has spread to lymph nodes and has other high-risk features can now be offered two years of abemaciclib alongside their hormone therapy, with a durable reduction in relapse. It does not apply to node-negative or low-risk disease, and the diarrhoea and cost are real trade-offs to discuss.
Shares Miguel Martín, NATALEE, monarchE, High-risk early HR-positive breast cancer.
Shares Miguel Martín, High-risk early HR-positive breast cancer, CDK4/6, CDK4/6 inhibitors.
Shares Abemaciclib, CDK4/6, Eli Lilly (incl. Loxo), CDK4/6 inhibitors.
Shares monarchE, Dormant cells and minimal residual disease, Endocrine therapy (SERMs, AIs, SERDs), Toxicity and quality of life are undervalued.
Shares Abemaciclib, CDK4/6, Eli Lilly (incl. Loxo), CDK4/6 inhibitors.
Shares Abemaciclib, CDK4/6, Estrogen receptor (ERα), Eli Lilly (incl. Loxo).
Shares Abemaciclib, Eli Lilly (incl. Loxo), CDK4/6 inhibitors, Endocrine therapy (SERMs, AIs, SERDs).
Shares Abemaciclib, Eli Lilly (incl. Loxo), CDK4/6 inhibitors, Endocrine therapy (SERMs, AIs, SERDs).