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. 2023 Feb 3:15:17588359231151840.
doi: 10.1177/17588359231151840. eCollection 2023.

Efficacy and safety results by menopausal status in monarchE: adjuvant abemaciclib combined with endocrine therapy in patients with HR+, HER2-, node-positive, high-risk early breast cancer

Shani Paluch-Shimon  1 , Patrick Neven  2 , Jens Huober  3 , Irfan Cicin  4 , Matthew P Goetz  5 , Chikako Shimizu  6 , Chiun-Sheng Huang  7   8 , Hans Joachim Lueck  9 , Jane Beith  10 , Eriko Tokunaga  11 , Jessica Reyes Contreras  12 , Rosane Oliveira de Sant'Ana  13   14 , Ran Wei  15 , Ashwin Shahir  15 , Sarah C Nabinger  15 , Tammy Forrester  15 , Stephen R D Johnston  16 , Nadia Harbeck  17
Affiliations

Efficacy and safety results by menopausal status in monarchE: adjuvant abemaciclib combined with endocrine therapy in patients with HR+, HER2-, node-positive, high-risk early breast cancer

Shani Paluch-Shimon et al. Ther Adv Med Oncol. .

Abstract

Background: Abemaciclib is the first and only cyclin-dependent kinases 4 and 6 inhibitor approved for adjuvant treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, and high-risk early breast cancer (EBC), with indications varying by geography. Premenopausal patients with HR+, HER2- tumors may have different tumor biology and treatment response compared to postmenopausal patients.

Objectives: We describe the efficacy and safety of abemaciclib plus endocrine therapy (ET) for the large subgroup of premenopausal patients with HR+, HER2- EBC in monarchE.

Design: Randomized patients (1:1) received adjuvant ET with or without abemaciclib for 2 years plus at least 3 additional years of ET as clinically indicated.

Methods: Patients were stratified by menopausal status (premenopausal versus postmenopausal) at diagnosis. Standard ET (tamoxifen or aromatase inhibitor) with or without gonadotropin-releasing hormone agonist was determined by physician's choice. Invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) by menopausal status were assessed at data cutoff on 1 April 2021 (median follow-up of 27 months).

Results: Among randomized patients, 2451 (43.5%) were premenopausal and 3181 (56.4%) were postmenopausal. The choice of ET for premenopausal patients varied considerably between countries. Treatment benefit was consistent across menopausal status, with a numerically greater effect size in premenopausal patients. For premenopausal patients, abemaciclib with ET resulted in a 42.2% and 40.3% reduction in the risk of developing IDFS and DRFS events, respectively. Absolute improvement at 3 years was 5.7% for IDFS and 4.4% for DRFS rates. Safety profile for premenopausal patients was consistent with the overall safety population.

Conclusion: Abemaciclib with ET demonstrated clinically meaningful treatment benefit for IDFS and DRFS versus ET alone regardless of menopausal status and first ET, with a numerically greater benefit in the premenopausal compared to the postmenopausal population. Safety data in premenopausal patients are consistent with the overall safety profile of abemaciclib.

Keywords: abemaciclib; early breast cancer; high risk; monarchE; premenopausal.

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Conflict of interest statement

SPS reports fees for from Pfizer for corporate-sponsored research; fees for speaker’s bureau, honoraria, consultancy from Roche, Novartis, Pfizer, and AstraZeneca; fees for consultancy from Eli Lilly and Company and Gilead; and fees for speaker’s bureau and consultancy from MSD, outside the submitted work. PN reports institutional fees for consultancy from Pfizer, Novartis, Eli Lilly and Company, Roche, and Astrazeneca; institutional fees for advisory board participation from Pfizer, Novartis, Eli Lilly and Company, Roche, and Sanofi; institutional fees for lecturing and attendance at scientific exchange meetings, and research funding from Kom op Tegan Kanker, outside the submitted work. JH receives fees for advisory board participation from Eli Lilly and Company, Novartis, Roche, Pfizer, Hexal, AstraZeneca, MSD, Celgene, and Abbvie; fees for corporate-sponsored research from Celgene, Novartis, Hexal, and Eli Lilly and Company; and fees for travel expenses from Roche, Pfizer, Novartis, Celgene, and Daiichi Sankyo, outside the submitted work; IC has nothing to disclose, outside the submitted work; MPG reports institutional fees for consultancy from Eli Lilly and Company, Biovica, Novartis, Sermonix, Context Pharm, Pfizer, AstraZeneca, Eagle Pharmaceuticals; personal fees from Genomic Health; institutional grant from Pfizer, Eli Lilly and Company, Sermonix; institutional honoraria for advisory board participation from ARC Therapeutics, Blueprint Medicines, Sanofi Genzyme, Biotheranostics; personal fees for CME presentation from Research to Practice, Clinical Education Alliance, Medscape; personal fees for session moderating from Curio Science; personal fees for serving as a panelist from Total Health Conferencing, outside the submitted work; CS reports grants for corporate-sponsored research from Eli Lilly and Company, outside the submitted work. CSH reports personal fees and grants for advisory board participation and speaker’s bureau from Eli Lilly and Company, Novartis, and Daiichi Sankyo; grants, personal fees, and non-financial support for advisory board participation, and speaker’s bureau from Pfizer, Roche and AstraZeneca; grants from EirGenix and OBI Pharma, grants and personal fees for speaker’s bureaus from MSD; outside the submitted work. HJL reports fees for corporate-sponsored research and travel support from Eli Lilly and Company, outside the submitted work. JB reports institution fees for advisory board participation from Eli Lilly and Company, Roche, and Pfizer, outside the submitted work. ET reports personal fees for lectures from Eli Lilly and Company, AstraZeneca and Daiichi Sankyo, outside the submitted work. JRC reports corporate-sponsored research fees from Eli Lilly and Company. ROS reports corporate-sponsored research fees from Eli Lilly and Company. RW, AS, SCN, TF are employees and stock shareholders of Eli Lilly and Company. SRDJ reports personal fees for consulting, advisory role, speaker’s bureau, and research funding from AstraZeneca, Novartis, Pfizer; personal fees for consulting, advisory role, research funding from Eli Lilly and Company, Puma Biotechnology; personal fees for speaker’s bureau from Eisai; and personal fees for speaker’s bureau, research funding from Roche/Genentech, outside the submitted work. NH reports personal fees for lectures and consulting from AstraZeneca, Eli Lilly and Company, Novartis, and Pfizer, outside the submitted work.

Figures

Figure 1.
Figure 1.
First ET by country in premenopausal and postmenopausal patientsa. aCountries with enrollment ⩾100 patients. ET, endocrine therapy.
Figure 2.
Figure 2.
Kaplan–Meier plot of IDFS by menopausal status: (a) premenopausal and (b) postmenopausal. CI, confidence interval; ET, endocrine therapy; IDFS, invasive disease-free survival; HR, hazard ratio.
Figure 3.
Figure 3.
Kaplan–Meier plot of DRFS by menopausal status: (a) premenopausal and (b) postmenopausal. CI, confidence interval; DRFS, distant relapse-free survival; ET, endocrine therapy; HR, hazard ratio.
See this image and copyright information in PMC

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