CDK4/6 inhibitors in novel adjuvant ASCO guideline for breast cancer. Are patients protected enough?
Benefit-to-harm ratio for CDK4/6 inhibitors in the adjuvant setting: too many unanswered questions.
On May 20, the Journal of Clinical Oncology updated their guidelines about the use of CDK4/6 inhibitors (abemaciclib 2 years based on MonarchE, or ribociclib 3 years based on NATALEE) in the adjuvant setting of endocrine-receptor-positive (ER+), HER2 negative, breast cancer.
The authors are recommending 3 years of ribociclib which is not (yet) FDA approved in this indication (recommandation 2).
In a video analysis with Vinay Prasad, we made the following points :
1- informative censoring likely biased the reported iDFS benefit (invasive disease free survival)
2 - the reported benefit is limited by high number needed to treat in both trials (NNT = 30 in NATALEE)
3 - toxicity concerns, including financial toxicity !
Check out our video analysis here.
Both trials were remarkably unimpressive. How the authors can recommend these medicines for breast cancer when their benefit in breast cancer patients is unestablished with a straight face is stultifying.