S. Sim (Goyang, Korea, Republic of)

National Cancer Center

Author Of 1 Presentation

 On-Demand ePoster Display

103P - Long-term results and bone-protective effect of everolimus added to letrozole and ovarian function suppression for premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer: an updated analysis of the LEO study

Abstract

Background

In phase II LEO study, everolimus (EVE) plus letrozole (LET) with ovarian suppression resulted in longer progression-free survival (PFS) in tamoxifen-exposed premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer with visceral metastases. Here, we report an updated survival for the LEO study, along with the results of exploratory analyses on bone turnover marker changes and bone-specific progressive disease.

Methods

Patients who were exposed to or progressed on tamoxifen as adjuvant or palliative treatment were randomly assigned (2:1) to the EVE (leuprorelin+LET+EVE) or LET arm (leuprorelin+LET).

Results

With a median follow-up of 51 months, Median PFS was 17.5 months in EVE arm and 13.8 months in LET arm (p=0.245). PFS favored EVE arm in patients with baseline visceral metastases (median PFS, 16.4 vs 9.5 months, p=0.040), and patients with bone metastases (median PFS, 17.1 vs 10.9, p=0.003). No differences in the OS were observed (median OS, 48.3 vs. 50.8 months, p=0.948). One-year cumulative incidence of bone-specific disease progression was 6.0% in EVE arm, and 23.4% in LET arm (Hazard ratio 0.26, p<0.001). Bone markers at 6 and 12 weeks after treatment decreased in EVE arm, whereas they were increased or stationary in LET arm. Skeletal-related events occurred 6.5% and 11.1% of the patients in the EVE and LET arm, respectively.

Conclusions

EVE plus LET with ovarian-suppression prolonged PFS in patients with baseline visceral or bone metastases and offered bone-protective effect in the overall study population. However, these clinical benefits were not translated into an OS benefit.

Clinical trial identification

NCT02344550 Original release date: 31 December 2020.

Legal entity responsible for the study

The authors.

Funding

Novartis and Dongkook Pharma Co, Ltd.

Disclosure

K.H. Jung: Honoraria (self): Roche; Honoraria (self): AstraZeneca; Honoraria (self): Celgene; Honoraria (self): Novartis; Honoraria (self): Takeda. J.H. Sohn: Research grant/Funding (self): MSD; Research grant/Funding (self): Roche; Research grant/Funding (self): Novartis; Research grant/Funding (self): AstraZeneca; Research grant/Funding (self): Lilly; Research grant/Funding (self): Pfizer; Research grant/Funding (self): Bayer; Research grant/Funding (self): GSK; Research grant/Funding (self): CONTESSA; Research grant/Funding (self): Daiichi Sankyo. K.S. Lee: Honoraria (self): Roche; Honoraria (self): Lilly; Honoraria (self): Novartis; Honoraria (self): MSD; Non-remunerated activity/ies, drug supply: Dong-A ST. S-B. Kim: Research grant/Funding (self): Novartis; Research grant/Funding (self): Sanofi-Aventis; Research grant/Funding (institution): DongKook Pharm Co.; Advisory/Consultancy: Novartis; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Lilly; Advisory/Consultancy: Enzychem; Advisory/Consultancy: Dae Hwa Pharmaceutical Co. Ltd; Advisory/Consultancy: ISU Abxis; Advisory/Consultancy: Daiichi Sankyo. All other authors have declared no conflicts of interest.

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