Does the magnitude of benefit with 2 years of adjuvant abemaciclib outweigh side effects, given that many patients will receive CDK 4/6 inhibitors at breast cancer recurrence, precluding OS benefits?

In terms of balancing benefit in terms of risk reduction of cancer recurrence versus adverse events, this is always an important consideration in introducing a novel therapy. In patients who are at high risk based on the criteria for the trial, namely node positive based on more than 4 nodes or if 1...

I agree with the others. It can definitely be a drug where you have to work with the patient to tolerate (although seems we have gotten much better at controlling the diarrhea) but does have real risks like DVT or the ~1% risk of ILD we see with CDK4/6 inhibitors.

Certainly, that is why, people wit...

I will generally treat stage III ER positive early stage breast cancer with adjuvant abemaciclib. For stage II breast cancer with a high Ki67, this will be an individualized decision.

The patients with the greatest risk-- stage III tumors, would experience the greatest chance of benefit. Since the goal in the adjuvant setting is cure, this seems most meaningful for those at very high risk. For stage II tumors, the risk of significant AE, including death seems to be high.

Yes, in my view, the benefit of abema in this patient population clearly outweighs the risks, or toxicity. MonarchE demonstrated a statistically significant reduction of approximately 30% in the incidence of metastatic disease, in comparison to endocrine therapy alone. This relative risk reduction i...

This is such an excellent question, and all of us have been wondering about it for the last several years. The key here is really to understand the mechanism of resistance for the patients who recurred after the CDK4/6 exposure in an adjuvant setting. I don't think we have that answer - but in the n...