Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Mar 2;12(3):382.
doi: 10.3390/jpm12030382.

Feasibility of Adjuvant Treatment with Abemaciclib-Real-World Data from a Large German Breast Center

Dominik Dannehl  1 , Lea L Volmer  1 , Martin Weiss  1 , Sabine Matovina  1 , Eva-Maria Grischke  1 , Ernst Oberlechner  1 , Anna Seller  1 , Christina B Walter  1 , Markus Hahn  1 , Tobias Engler  1 , Sara Y Brucker  1   2 , Andreas D Hartkopf  1   3
Affiliations

Feasibility of Adjuvant Treatment with Abemaciclib-Real-World Data from a Large German Breast Center

Dominik Dannehl et al. J Pers Med. .

Abstract

Abemaciclib significantly improves invasive disease-free survival when combined with endocrine therapy in clinical high-risk patients with HR+/Her2- early breast cancer (eBC). The objective of the following study was to model how many patients with eBC would be available for adjuvant treatment with abemaciclib in a real-world setting. Patients that underwent complete surgical treatment for eBC between January 2018 and December 2020 in a large single-center university hospital in Germany were eligible. Descriptive statistics were used to describe the patient population that could benefit from abemaciclib according to the inclusion criteria of monarchE. Of 1474 patients with eBC, 1121 (76.1%) had a HR+/Her2- subtype. Of these, 217 (19.4%) fulfilled the monarchE inclusion criteria. Within patients that fulfilled the monarchE inclusion criteria, 48.9% received no adjuvant or neoadjuvant chemotherapy. Thus, in a real-world situation, fewer patients will be pretreated with chemotherapy than was the case in monarchE. Breast care units are facing a significant patient burden, since the 2-year abemaciclib therapy requires regular monitoring of toxicities. Specific care concepts to strengthen therapy adherence as well as further studies to deescalate adjuvant systemic treatment and individualize CDK 4/6 inhibitor therapy are therefore needed.

Keywords: CDK 4/6; abemaciclib; breast cancer; monarchE; oncology; systemic therapy.

PubMed Disclaimer

Conflict of interest statement

S.Y.B.: Honoraria from Novartis, Roche, AstraZeneca, Sanofi Aventis. A.D.H.: Speaker and consultancy honoraria from AstraZeneca, Agendia, Exact Sciences Corporation Roche, Novartis, Lilly, MSD, Eisai, Daiichi-Sankyo, Gilead, Teva, Seattle Genetics, and Pfizer. The funders had no role in the design of the study; in the collection, analysis, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

Figures

Figure 1
Figure 1
The database primarily comprised 2257 tumors. After the exclusion of 64 non-dominant bilateral tumors, this corresponded to 2129 patient cases including locoregional recurrence. However, in 172 patients, no information regarding the lymph node involvement could be found. In 534 patients, the Ki67 proliferation marker was not assessed, and 13 patients displayed metastatic disease. Hence, the study population consisted of 1474 patients.
Figure 2
Figure 2
In total, 1474 patients comprised the study cohort, of whom 1121 had a HR+/Her2− breast cancer subtype. 352 of 1121 patients had involved lymph nodes. 69 patients displayed ≥4 pathologic lymph nodes (N2/3), of whom 44 exhibited tumors with a Ki67 ≥ 20% (green) and 25 a Ki67 < 20% (light yellow). A total of 283 patients showed 1–3 pathologic lymph nodes (N1), of whom 130 exhibited tumors with a Ki67 ≥ 20% (green). Of 153 patients with a Ki67 < 20% (light yellow), 7 displayed a high-grade tumor (G3), and 11 patients had a pathological tumor size > 50 mm (T3). Hence, 217 patients fulfilled the monarchE inclusion criteria (bold). A total of 174 patients met the FDA criteria for the approved use of abemaciclib, with a Ki67 ≥ 20% (green).
See this image and copyright information in PMC

References

    1. Moy B., Rumble R.B., Come S.E., Davidson N.E., Di Leo A., Gralow J.R., Hortobagyi G.N., Yee D., Smith I.E., Chavez-MacGregor M., et al. Chemotherapy and Targeted Therapy for Patients with Human Epidermal Growth Factor Receptor 2–Negative Metastatic Breast Cancer That is Either Endocrine-Pretreated or Hormone Receptor–Negative: ASCO Guideline Update. J. Clin. Oncol. 2021;39:3938–3958. doi: 10.1200/JCO.21.01374. - DOI - PubMed
    1. Finn R.S., Martin M., Rugo H.S., Jones S., Im S.-A., Gelmon K., Harbeck N., Lipatov O.N., Walshe J.M., Moulder S., et al. Palbociclib and Letrozole in Advanced Breast Cancer. N. Engl. J. Med. 2016;375:1925–1936. doi: 10.1056/NEJMoa1607303. - DOI - PubMed
    1. Goetz M.P., Toi M., Campone M., Sohn J., Paluch-Shimon S., Huober J., Park I.H., Trédan O., Chen S.-C., Manso L., et al. MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer. J. Clin. Oncol. 2017;35:3638–3646. doi: 10.1200/JCO.2017.75.6155. - DOI - PubMed
    1. Hortobagyi G.N., Stemmer S.M., Burris H.A., Yap Y.-S., Sonke G.S., Paluch-Shimon S., Campone M., Blackwell K.L., Andre F., Winer E.P., et al. Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer. N. Engl. J. Med. 2016;375:1738–1748. doi: 10.1056/NEJMoa1609709. - DOI - PubMed
    1. Schneeweiss A., Ettl J., Lüftner D., Beckmann M.W., Belleville E., Fasching P.A., Fehm T.N., Geberth M., Häberle L., Hadji P., et al. Initial experience with CDK4/6 inhibitor-based therapies compared to antihormone monotherapies in routine clinical use in patients with hormone receptor positive, HER2 negative breast cancer—Data from the PRAEGNANT research network for the first 2 years of drug availability in Germany. Breast. 2020;54:88–95. doi: 10.1016/j.breast.2020.08.011. - DOI - PMC - PubMed