Advanced search
Publication Cover
Current Medical Research and Opinion Volume 37, 2021 - Issue 7
Submit an article Journal homepage
6,103
Views
19
CrossRef citations to date
0
Altmetric
Oncology

Real-world treatment patterns and outcomes of abemaciclib for the treatment of HR+, HER2− metastatic breast cancer

Gebra Cuyun Cartera Eli Lilly and Company, Indianapolis, IN, USACorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0002-6549-0069
ORCID Icon,
Kristin M. Sheffielda Eli Lilly and Company, Indianapolis, IN, USA
,
Anala Gossaib Flatiron Health, Inc., New York, NY, USA
,
Yu-Jing Huanga Eli Lilly and Company, Indianapolis, IN, USA
,
Yajun Emily Zhua Eli Lilly and Company, Indianapolis, IN, USA
,
Lee Bowmana Eli Lilly and Company, Indianapolis, IN, USA
,
Emily Nash Smytha Eli Lilly and Company, Indianapolis, IN, USA
,
Raina Mathurb Flatiron Health, Inc., New York, NY, USA
,
Aaron B. Cohenb Flatiron Health, Inc., New York, NY, USA;c School of Medicine, New York University, New York, NY, USA
,
Erik Rasmussenb Flatiron Health, Inc., New York, NY, USA
,
Shreya Balakrishnab Flatiron Health, Inc., New York, NY, USA
,
Claudia Morato Guimaraesa Eli Lilly and Company, Indianapolis, IN, USA
,
Sarah Rybowskia Eli Lilly and Company, Indianapolis, IN, USA
&
Andrew D. Seidmand Memorial Sloan Kettering Cancer Center, New York, NY, USA
 show all
Pages 1179-1187 | Received 04 Jan 2021, Accepted 26 Apr 2021, Published online: 20 May 2021

References

  • Cardoso F, Senkus E, Costa A, et al. 4th ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4). Ann Oncol. 2018;29(8):1634–1657.
  • Dhillon S. Palbociclib: first global approval. Drugs. 2015;75:541–543.
  • Syed YY. Ribociclib: first global approval. Drugs. 2017;77:799–807.
  • Kim ES. Abemaciclib: first global approval. Drugs. 2017;77:2063–2070.
  • Dickler MN, Tolaney SM, Rugo HS, et al. MONARCH 1, a phase II study of abemaciclib, a CDK4 and CDK6 inhibitor, as a single agent, in patients with refractory HR(+)/HER2(−) metastatic breast cancer. Clin Cancer Res. 2017;23(17):5218–5224.
  • Goetz MP, Toi M, Campone M, et al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35:3638–3646.
  • Johnston S, Martin M, Di Leo A, et al. MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. NPJ Breast Cancer. 2019;5:5.
  • Neven P, Johnston SRD, Toi M, et al. MONARCH 2: subgroup analysis of patients receiving abemaciclib + fulvestrant as first- and second-line therapy for HR+, HER2- advanced breast cancer [abstract]. J Clin Oncol. 2020;38(15):1061–1061.
  • Rugo HS, Tolaney SM, Cortes J, et al. MONARCH 1: final overall survival analysis of a phase 2 study of abemaciclib, a CDK4 and CDK6 inhibitor, as monotherapy, in patients with HR+/HER2- breast cancer, after chemotherapy for advanced disease. Cancer Res. 2017;77(13):CT044.
  • Sledge GW, Jr, Toi M, Neven P, et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor-positive, ERBB2-negative breast cancer that progressed on endocrine therapy - MONARCH 2: a randomized clinical trial. JAMA Oncol. 2020;6(1):116–124.
  • Sledge GW, Jr, Toi M, Neven P, et al. MONARCH 2: abemaciclib in combination with fulvestrant in women with HR+/HER2- advanced breast cancer who had progressed while receiving endocrine therapy. J Clin Oncol. 2017;35(25):2875–2884.
  • Schneeweiss S, Gagne JJ, Glynn RJ, et al. Assessing the comparative effectiveness of newly marketed medications: methodological challenges and implications for drug development. Clin Pharmacol Ther. 2011;90:777–790.
  • Ma X, Long L, Moon S, et al. Comparison of population characteristics in real-world clinical oncology databases in the US: Flatiron Health, SEER, and NPCR [Internet]. New York (NY): Cold Spring Harbor Laboratory; 2020 [cited 2020 Dec 9]. Available from: https://www.medrxiv.org/content/10.1101/2020.03.16.20037143v2
  • Charlson M, Pompei P, Ales K, et al. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40:373–383.
  • Quan H, Li B, Couris C, et al. Updating and validating the Charlson comorbidity index and score for risk adjustment in hospital discharge abstracts using data from 6 countries. Am J Epidemiol. 2011;173:676–682.
  • Griffith SD, Tucker M, Bowser B, et al. Generating real-world tumor burden endpoints from electronic health record data: comparison of RECIST, radiology-anchored, and clinician-anchored approaches for abstracting real-world progression in non-small cell lung cancer. Adv Ther. 2019;36:2122–2136.
  • National Cancer Institute [Internet]. Cancer therapy evaluation program. Bethesda (MD): Common Terminology Criteria for Adverse Events (CTCAE), version 5. 2020 [cited 2020 July 8]. Available from: https://ctep.Cancer.Gov/protocoldevelopment/electronic_applications/ctc.Htm#ctc_50
  • Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumors: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228–247.
  • Feinberg BA, Bharmal M, Klink AJ, et al. Using response evaluation criteria in solid tumors in real-world evidence cancer research. Future Oncol. 2018;14:2841–2848.
  • Rugo HS, Sledge GW, Johnston SRD, et al. The association of early toxicity and outcomes for patients treated with abemaciclib [abstract. J Clin Oncol. 2018;36(15):1053–1053.
  • Rugo HS, Tolaney SM, Huober J, et al. Management of abemaciclib associated adverse events in patients with hormone receptor positive (HR+), HER2- advanced breast cancer: analysis of the MONARCH trials. Ann Oncol. 2018;29(8):viii90–viii121.
  • Rassen JA, Schneeweiss S. Newly marketed medications present unique challenges for nonrandomized comparative effectiveness analyses. J Comp Eff Res. 2012;1:109–111.
  • Di Leo A, O’Shaughnessy J, Sledge GW Jr, et al. Prognostic characteristics in hormone receptor-positive advanced breast cancer and characterization of abemaciclib efficacy. NPJ Breast Cancer. 2018;4(1):41.
  • Mehta RS, Barlow WE, Albain KS, et al. Overall survival with fulvestrant plus anastrozole in metastatic breast cancer. N Engl J Med. 2019;380:1226–1234.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.