CDK4/6 inhibition in early-stage breast cancer: how far is it from becoming standard of care?
Mené dans 21 pays sur 5 760 patientes atteintes d'un cancer du sein HR+ HER2- de stade précoce, cet essai de phase III évalue l'efficacité, du point de vue de la survie sans maladie invasive, et la toxicité de l'ajout, pendant 2 ans, du palbociclib à un traitement endocrinien adjuvant
Although patients with hormone-receptor-positive, HER2-negative, early breast cancerspresent with the best outcome among all breast cancer subtypes, about a third of patientswill relapse at some point, even after receiving standard multimodal treatments. Effortsto improve survival in this population are ongoing, such as through the developmentof new endocrine agents or extended duration of endocrine treatment. Novel strategiesare of considerable interest. CDK4/6 inhibition has been the most successful strategyin the treatment of hormone-receptor-positive, HER2-negative, advanced breast cancer.The three currently approved CDK4/6 inhibitors have shown efficacy in patients withhormone-receptor-positive, HER2-negative, advanced breast cancer, with significantlylonger progression-free survival and even overall survival. Thus, expectations are high for CDK4/6 inhibitors in the adjuvant setting. In themonarchE study, 5637 patients with high-risk, early-stage breast cancer were randomly assigned toreceive standard adjuvant endocrine therapy, with or without abemaciclib 150 mg twicedaily for 2 years. At a preplanned second efficacy interim analysis, 2-year invasivedisease-free survival was 92·2% with abemaciclib versus 88·7% without (hazard ratio[HR] 0·75 [95% CI 0·60–0·93]), a difference that was significant and clinically meaningful.
The Lancet Oncology , commentaire, 2020