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Review
. 2022 Jan 31:3:3.
doi: 10.21037/tbcr-21-27. eCollection 2022.

Role of abemaciclib in primary breast cancer: a narrative review of MonarchE

Nobuyuki Takahashi #  1 , Chikako Shimizu #  1 , Akihiko Shimomura  1 , Masakazu Toi  2
Affiliations
Review

Role of abemaciclib in primary breast cancer: a narrative review of MonarchE

Nobuyuki Takahashi et al. Transl Breast Cancer Res. .

Abstract

Estrogen affects cyclin signaling which results in proliferation of breast cancer cells. Breast cancers expressing hormone receptors (known as hormone receptor-positive or HR+ breast cancers) are characterized by dysregulation of cyclin-dependent kinase 4 and 6 (CDK4/6) activity due to overexpression and amplification of genes associated with the cell cycle. Inhibition of CDK4/6, in combination with endocrine therapy (ET), have shown significant clinical efficacy in treating HR+, human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer, leading to global approval of this combination. Abemaciclib is a CDK4/6 inhibitor with higher potency and inhibits a wider range of CDKs compared with other CDK4/6 inhibitors. The MonarchE study is a global, open-label, randomized phase III study of the efficacy of 2-year abemaciclib treatment, together with standard adjuvant ET, in patients who underwent surgery for early-stage HR+, HER2- breast cancer with anatomical or pathological high-risk recurrence features. Preplanned interim analysis of the MonarchE study showed significantly improved invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) with the use of abemaciclib-ET combination therapy in comparison with ET alone. This review focuses on the emerging results and limitations of the MonarchE study in determining the way forward from the CDK4/6-ET combination treatment in HR+, HER2- early-stage breast cancer.

Keywords: Abemaciclib; CDK4/6 inhibitors; MonarchE; adjuvant therapy.

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Conflict of interest statement

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tbcr.amegroups.com/article/view/10.21037/tbcr-21-27/coif). CS reports that he is a Steering Committee member of MonarchE and receives a research grant from Eli-Lilly. AS reports that he receives research grant from Chugai Pharmaceutical, AstraZeneca, Daiichi Sankyo, Taiho Pharmaceutical, Mochida Pharmaceutical, Eisai, and serves as a lecture honoraria or lecture chair held by Chugai Pharmaceutical, AstraZeneca, Daiichi Sankyo, Eisai, Eli Lilly, Pfizer, Kyowa Kirin, Novartis, Takeda, MSD. MT reports that he receives research grants from Chugai, Takeda, Pfizer, Kyowa-Kirin, Taiho, JBCRG assoc., Eisai, Eli Lilly, Daiichi-Sankyo, AstraZeneca, Astellas, Shimadzu, Yakult, Nippon Kayaku, AFI technology, Luxonus, Shionogi, GL Science, serves as a lecture honoraria or lecture chair held by Chugai, Takeda, Pfizer, Kyowa-Kirin, Taiho, Eisai, Daiichi-Sankyo, AstraZeneca, Eli Lilly, MSD, Exact Science, Novartis, Konica Minolta, Shimadzu, Yakult, Nippon Kayaku, is an advisory board of Kyowa-Kirin, Daiichi-Sankyo, Eli Lilly, Konica Minolta, BMS, Athenex Oncology, Bertis, Terumo, Kansai Medical Net, is a member of the board of directors (no salary) of JBCRG assoc., KBCRN, OOTR, is an associate editor of Scientific Reports, Breast Cancer Research and Treatment, Cancer Science, Frontiers in Women’s Cancer, Asian Journal of Surgery, Asian Journal of Breast Surgery, and is a deputy editor of International Journal of Oncology. NT has no conflicts of interest to declare.

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