S. Kim (Seoul, Korea, Republic of)
Asan Medical Center - University of Ulsan College of MedicineAuthor Of 3 Presentations
Optimal adjuvant/neoadjuvant chemotherapy in triple negative subtype with or without gBRCA mutation (ID 3)
Live welcome (ID 325)
Introduction by the Chair (ID 8)
Presenter Of 3 Presentations
Optimal adjuvant/neoadjuvant chemotherapy in triple negative subtype with or without gBRCA mutation (ID 3)
Live welcome (ID 325)
Introduction by the Chair (ID 8)
Moderator Of 4 Sessions
Author Of 3 Presentations
- Y. Yap (Singapore, Singapore)
- S. Kim (Seoul, Korea, Republic of)
- J. Chiu (Hong Kong, Hong Kong PRC)
- E. Lim (Sydney, AC, Australia)
- R. Broom (Auckland, New Zealand)
- Z. Liu (Zhengzhou, China)
- Y. Sagara (Kagoshima, Japan)
- T. Chao (New Taipei City, Taiwan)
- S. Sherwood (Indianapolis, IN, United States of America)
- R. McNaughton (Indianapolis, IN, United States of America)
- R. Wei (Indianapolis, IN, United States of America)
- M. Toi (Kyoto, Japan)
48P - Abemaciclib combined with adjuvant endocrine therapy in patients from Asia with high risk early breast cancer: monarchE
Abstract
Background
monarchE demonstrated that adjuvant abemaciclib (oral CDK4 & 6 inhibitor)+endocrine therapy (ET) significantly improves invasive disease-free survival (IDFS) in HR+, HER2- high-risk early breast cancer (EBC) compared to ET alone. Here, we report the primary outcome (PO) efficacy and safety data in patients (pts) located in Asia (mainland China, Hong Kong, Japan, Korea, Singapore, and Taiwan), comprising 1,155 (20.5%) of the 5,637 pts of the intent-to-treat (ITT) population.
Methods
Pts with HR+, HER2-, high risk EBC were randomized 1:1 to abemaciclib+ET or ET alone and stratified by prior treatment (txt), menopausal status, and region (North America/Europe; Asia; Other). Exploratory analyses were conducted among pts enrolled from Asia, (median follow-up: ∼19 months in both arms).
Results
In total, 75 IDFS events were observed in pts from Asia (33 in abemaciclib+ET; 42 in ET alone). Abemaciclib+ET demonstrated numerical benefit in IDFS, reflecting a 22.3% reduction in the risk of developing invasive disease [HR (95% CI) = 0.777 (0.493, 1.227)]. Two-year IDFS rates were 93.2% in abemaciclib+ET and 90.1% in ET alone. There was also a numerical improvement in distant relapse free survival (DRFS) [HR (95% CI) = 0.758 (0.455, 1.264)], with 2-year DRFS rates of 94.4% vs 91.7%. The median txt duration of abemaciclib was 17.7 months. In the abemaciclib arm, the most frequent adverse event (AE) was diarrhea (89.5%), most were G1/2 (55.8%/28.7%). More G≥3 AEs and serious AEs were observed with abemaciclib+ET vs ET (53.5% vs 10.5% and 12.1% vs 6.3%), with neutropenia (31.5%) being the most frequent G≥3 AE. Interstitial lung disease occurred in 6.6% pts, G≥3 in 0.3% pts. G≥3 ALT and AST increases occurred in 4.2% and 3.1% pts, respectively.14.5% of abemaciclib-treated pts discontinued abemaciclib or all txt due to AEs.
Conclusions
In pts from Asia with HR+, HER2-, high-risk EBC, abemaciclib plus standard adjuvant ET led to a clinically meaningful improvement in IDFS and DRFS, consistent with benefits demonstrated in the ITT population. Safety was consistent with the known safety profile of abemaciclib. Abemaciclib is the first CDK4 & 6 inhibitor to demonstrate effective and tolerable txt in pts with high-risk EBC, including pts from Asia.
Clinical trial identification
NCT03155997.
Editorial acknowledgement
Eglantine Julle-Daniere.
Legal entity responsible for the study
Eli Lilly.
Funding
Eli Lilly.
Disclosure
Y-S. Yap: Advisory/Consultancy, Personal fees/non-financial support: Eli Lilly; Advisory/Consultancy, Personal fees/non-financial support: Novartis; Advisory/Consultancy, Personal fees/non-financial support: Pfizer; Advisory/Consultancy, Personal fees/non-financial support: AstraZeneca; Advisory/Consultancy, Personal fees/non-financial support: Eisai; Advisory/Consultancy, Personal fees/non-financial support: Roche; Advisory/Consultancy, Personal fees/non-financial support: MSD; Advisory/Consultancy, Personal fees: Inivata. S-B. Kim: Research grant/Funding (self): Novartis; Research grant/Funding (self): Sanofi-Aventis; Research grant/Funding (self): DongKook Pharm Co. Y. Sagara: Honoraria (self), Personal fees: Eli Lilly; Honoraria (self), Personal fees: Pfizer; Honoraria (self), Personal fees: AstraZeneca. S. Sherwood: Shareholder/Stockholder/Stock options, Full/Part-time employment: Eli Lilly. R.E. McNaughton: Full/Part-time employment: Eli Lilly. R.J. Wei: Shareholder/Stockholder/Stock options, Full/Part-time employment: Eli Lilly. M. Toi: Honoraria (self), Research grant/Funding (self): Chugai, Takeda, Pfizer, Taiho, Eisai, AstraZeneca, Eli Lilly, Shimadzu, Yakult; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Kyowa-Kirin; Research grant/Funding (self): JBCRG association; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Daiichi Sankyo; Honoraria (self): MSD; Honoraria (self): Exact Science; Honoraria (self): Novartis; Honoraria (self), Advisory/Consultancy, Honoraria for an advisory meeting: Konica Minolta; Research grant/Funding (self): Astellas; Honoraria (self), Advisory/Consultancy, Honoraria for an advisory meeting: BMS; Honoraria (self), Research grant/Funding (self), Research Fund and Honoraria for lecture: Nippon Kayaku; Research grant/Funding (self): AFI technologies; Advisory/Consultancy: Athenex Oncology, Bertis, Terumo, Kansai Medical Net; Advisory/Consultancy, Research grant/Funding (self): Luxonus; Research grant/Funding (self): Shionogi; Research grant/Funding (self): GL Science; Officer/Board of Directors, Board of directors: JBCRG association, Organisation for Oncology and Translational Research, Kyoto Breast Cancer Research Network. All other authors have declared no conflicts of interest.
- H. Jeong (Seoul, Korea, Republic of)
- J. Jeong (Seoul, Korea, Republic of)
- J. Kim (Seoul, Korea, Republic of)
- J. Ahn (Seoul, Korea, Republic of)
- K. Jung (Seoul, Korea, Republic of)
- S. Koh (Ulsan, Korea, Republic of)
- J. Cheon (Ulsan, Korea, Republic of)
- J. Sohn (Seoul, Korea, Republic of)
- G. Kim (Seoul, Korea, Republic of)
- K. Lee (Goyang, Korea, Republic of)
- S. Sim (Goyang, Korea, Republic of)
- I. Park (Seoul, Korea, Republic of)
- S. Kim (Seoul, Korea, Republic of)
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.
119P - Clinical efficacy of everolimus and CDK4/6 inhibitors in hormone receptor-positive, HER2-negative metastatic breast cancer by treatment sequence
Abstract
Background
In hormone receptor-positive, HER2-negative metastatic breast cancer (HR+ HER2- MBC), cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) and everolimus (EVE) in combination with endocrine treatment comprise the mainstay of treatment. This study aims to evaluate the clinical outcomes by treatment sequence between the two regimens.
Methods
HR+ HER2- MBC patients treated with both CDK4/6 inhibitor and EVE from Jan 2014 to Nov 2020 were retrospectively identified and analyzed.
Results
A total of 88 patients were included in the study. Among those, 51 received CDK4/6i before EVE (C→E group) and 37 received EVE before CDK4/6i (E→C group) in combination with endocrine treatment. More patients in E→C group had endocrine resistance (13.7% vs. 40.5%), had experienced palliative chemotherapy (7.8% vs. 40.5%), and were heavily treated (treated as ≥3rd line, 5.9% vs. 40.5%). The median overall survival was 46.8 months in the C→E group and 38.9 months in the E→C group (p=0.151). The median composite progression-free survival, defined as the time from the start of preceding regimen to the disease progression on the following regimen or death, was 24.8 months vs. 21.8 months (p=0.681). The median PFS2/PFS1 ratio did not differ significantly between groups (0.5 in the C→E group, 0.6 in the E→C group, p=0.775). Ten patients (11.4%) discontinued EVE and 2 patients (2.3%) discontinued CDK4/6i during treatment.
Conclusions
Given that prior CDK4/6i was not associated with worse treatment outcomes to EVE, EVE-based regimen could be considered one of the reasonable treatment options after CDK4/6i.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
K.H. Jung: Honoraria (self), outside this work: AstraZeneca; Honoraria (self), outside this work: Roche; Honoraria (self), outside this work: Celgene; Honoraria (self), outside this work: Novartis; Honoraria (self), outside this work: Takeda. S-B. Kim: Advisory/Consultancy, Research grant/Funding (self), outside this work: Novartis; Research grant/Funding (self), outside this work: Sanofi-Aventis; Research grant/Funding (self), outside this work: DongKook Pharm Co.; Advisory/Consultancy, outside this work: AstraZeneca; Advisory/Consultancy, outside this work: Lilly; Advisory/Consultancy, outside this work: Enzychem; Advisory/Consultancy, outside this work: Dae Hwa Pharmaceutical Co. Ltd.; Advisory/Consultancy, outside this work: ISU Abxis; Advisory/Consultancy, outside this work: Daiichi Sankyo. All other authors have declared no conflicts of interest.