Would you consider adding adjuvant ribociclib for a patient who has already received 2 years of endocrine therapy and is eligible for ribociclib according to the NATALEE trial?
Answer from: Medical Oncologist at Academic Institution
Since the NATALEE trial excluded patients who received more than 12 months of neoadjuvant or adjuvant endocrine therapy, I would probably not consider ribociclib for your patient, as she is too far out from initiation of endocrine therapy.
Comments
Medical Oncologist at San Mateo Medical Center I have added CDK4/6 inhibitors to ongoing endocrin...
Medical Oncologist at University of Wisconsin School of Medicine and Public Health I agree that I would usually not recommend beyond ...
Medical Oncologist at McLeod Health Seacoast Hospital There is a thought-provoking viewpoint by Tannock ...
Medical Oncologist at Missouri Cancer Associates Ian is always insightful and logical. The editoria...
Medical Oncologist at Munson Medical Center I agree with the importance of the paper mentioned...
Answer from: Medical Oncologist at Community Practice
In NATALEE, patients could have received at most 12 months of prior adjuvant endocrine therapy before starting ribociclib. The FDA approval is anchored on that evidence base and does not provide data for initiating ribociclib after 2 years of ongoing ET. I would NOT personally recommend Kisqali at t...
Answer from: Medical Oncologist at Community Practice
NATALEE Trial Overview
Trial Name: NATALEE (New Adjuvant Trial With Ribociclib [LEE011])
Phase: III, randomized, open-label, multicenter
Enrollment: 5,101 patients across 20 countries
Sponsor: Novartis
ClinicalTrials.gov ID: NCT03701334
Patient Population
Eligibility: Adults with stage I...
Answer from: Medical Oncologist at Community Practice
Currently, there are insufficient data to support the efficacy or safety of starting ribociclib after 2 years of endocrine therapy have already been completed. That being said, recommendations for adjuvant CDK4/6 inhibitors should be individualized, but specifically, the clinical benefit of ribocicl...
Answer from: Medical Oncologist at Community Practice
The biological rationale for this question is whether the micrometastatic disease that has already survived two years of endocrine therapy would remain sensitive to CDK4/6 inhibition or not? Resistance mechanisms to both endocrine therapy and CDK4/6 inhibitors include Rb loss, activation of alternat...
I have added CDK4/6 inhibitors to ongoing endocrin...
I agree that I would usually not recommend beyond ...
There is a thought-provoking viewpoint by Tannock ...
Ian is always insightful and logical. The editoria...
I agree with the importance of the paper mentioned...