François-Clément Bidard: A prospective study to document the efficacy of the combo Fulvestrant+Everolimus

Erika Hamilton, Director of Breast Cancer and Gynecologic Cancer Research at Sarah Cannon Research Institute, shared a LinkedIn post by François-Clément Bidard, Vice Chair of Breast Cancer Group at Unicancer, and added:

“Important study. We know PFS of Fulvestrant alone is now in the 1.8 months after CDK. Studies looking at the updated PFS in real-world combinations post-CDK will be quite important.

Here fulvestrant + everolimus shows a PFS a little over 6 months. Not bad.

More studies coming or novel endocrine backbones alone and in combination with CDK, everolimus, PI3, AKT, and others.”

Quoting François-Clément Bidard’s post:

“A paper from the lab now published in Oncogene.
In 2017, at Institut Curie, Fulvestrant+Everolimus became our SoC 2nd line for ER+ HER2- mBC progressing on first line AI+CDK4/6i, but actual efficacy data in the post CDK4/6i setting were lacking. We therefore set up a prospective study to document the efficacy of the combo, with blood draws at multiple timepoints.

Added value:

• Although mentioned in guidelines, there is still almost no data about FUL+EVE given after CDK4/6i. We report here a mPFS of 6.8 months in 57 CDK4/6i pretreated patients (prospective cohort, with informed consent, IRB, NCT02866149). 6.8 months is not too bad… The ORR was 31%.
• ESR1 mutation status at baseline did not influence the PFS.
• ctDNA is -as always- a good biomarker: baseline ctDNA detection (red points on the Figure below) is a prognostic factor, lack of early clearance is a (strong) dynamic prognostic factor.

Limitations include:

• Tumor evaluation schedule was left to investigators, per SoC. This is less stringent than in clinical trials, and likely contributed to a small extension of the mPFS.
• Remember not all patients can cop with EVE side effects. Patients considered as eligible for the combo by their oncologist (and included in our cohort) are fitter than average.

Thanks to the breast cancer team, the circulating tumor biomarker lab and patients who accepted to be part of this study.”

Proceed to the article.
Source: Erika Hamilton/LinkedIn and François-Clément Bidard/LinkedIn

Erika Hamilton is a medical oncologist and the Director of Breast Cancer and Gynecologic Cancer Research at Sarah Cannon Research Institute (USA). In her role, Dr. Hamilton oversees the research program and clinical trial menu for gynecologic and breast cancer from a medical oncology perspective. Dr. Hamilton is a past chair of ASCO’s Scientific Breast Committee a ’21-’22, participant of the ASCO Leadership Development Program, Associate Editor for Clinical Breast Cancer, co-chair for Great Debates and Updates in Women’s Oncology Conference, and a board member of the Susan G. Komen Foundation of Central Tennessee. She is active in the community, volunteering with Gilda’s Club Middle Tennessee, the American Cancer Society’s Hope Lodge, Ovarcome ovarian cancer support organization, Brentwood Baptist Church and the Susan G. Komen Race for the Cure.