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Abstract
What is this summary about?
This article summarizes the results of a study called monarcHER. The study included participants with a certain type of aggressive breast cancer called HR+, HER2+ advanced breast cancer (ABC) that had their disease worsen or return after multiple previous therapies. This summary intends to help you understand the impact of a non-chemotherapy treatment called abemaciclib in people with HR+, HER2+ ABC.
When the study was planned, HER2-targeted therapy (ie trastuzumab) was standard treatment and was typically combined with chemotherapy and endocrine therapy (ie fulvestrant). However drug resistance can develop when HER2+ targeted therapy is used for a long time, making it less effective and allowing cancer to grow or spread to other parts of the body. When this happens, few chemotherapy-free options are available. Because of the chemotherapy side effects, this is not desirable. There is an urgent need to develop new, effective, safe, and tolerable treatment options for patients with HR+, HER2+ ABC. The monarcHER study compared the effects of abemaciclib plus trastuzumab with or without fulvestrant compared to the standard of care treatment.
What were the results?
Participants were randomly assigned to 1 of 3 groups: Group A (abemaciclib, trastuzumab and fulvestrant), Group B (abemaciclib and trastuzumab), or Group C (trastuzumab and standard of care chemotherapy). The study compared the length of time patients took study treatments without worsening or dying from their breast cancer. This is called the progression free survival (PFS). Participants in Group A had a longer median PFS than those in groups B and C (8.3 months, 5.7 months and 5.7 months respectively). There was no notable difference in PFS between participants in Groups B and C.
Additionally, the study looked at the side effects with each treatment group. The most common side effect which is considered severe or lifethreatening was neutropenia, defined as decreased white blood cell levels. Neutropenia may lead to an increased risk of getting infections. However, the percentage of patients experiencing neutropenia was similar in all groups A, B and C (27%, 22% and 26%, respectively). Patients in groups A (79%) and B (78%) who received abemaciclib experienced similar rates of diarrhea.
What do the results mean?
The data from the monarcHER study suggest that the combination of abemaciclib, trastuzumab, and fulvestrant may offer a chemotherapy-free option for patients with HR+, HER2+ ABC who have experienced worsening of disease despite multiple prior therapies.
This is an abstract of the Plain Language Summary of Publication article.
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Link to original article here
Acknowledgments
The authors and Eli Lilly and Company thank the patients and their families for participation in the trial. The trial would not have been successful without the support from study investigators and their staff, the Assessment Committee members, and the clinical trial team.
Praven Shetty of Eli Lilly Services India Pirvate limited, provided graphical designing support for this plain language summary of publication. Eli Lilly funded the medical writing support and journal publishing costs of this plain language summary of the publication.
Financial & competing interests disclosure
Dr. Tolaney receives institutional research funding from AstraZeneca, Lilly, Merck, Nektar, Novartis, Pfizer, Genentech/Roche, Immunomedics/Gilead, Exelixis, Bristol-Myers Squibb, Eisai, Nanostring, Cyclacel, Odonate, and Seattle Genetics; has served as an advisor/consultant to AstraZeneca, Eli Lilly, Merck, Nektar, Novartis, Pfizer, Genentech/Roche, Immunomedics/Gilead, Bristol-Myers Squibb, Eisai, Nanostring, Puma, Sanofi, Puma, Silverback Therapeutics, G1 Therapeutics, Athenex, OncoPep, Kyowa Kirin Pharmaceuticals, Daiichi-Sankyo, Ellipsis, Infinity, 4D Pharma, and Samsung Bioepsis Inc., Chugai Pharmaceuticals, BeyondSpring Pharmaceuticals, OncXerna, OncoSec Medical Incorporated, Certara, Mersana Therapeutics, CytomX, Seattle Genetics. Dr. Goel receives research funding from Eli Lilly and Company and G1 Therapeutics; and is an advisor/consultant for Pfizer, Novartis, and Eli Lilly and Company. Drs. Appiah, Huynh and Chen are employees and/or stock shareholders of Eli Lilly and Company. Dr. André reports grants to his institution from AstraZeneca, Pfizer, Novartis, Roche, and Eli Lilly and Company, outside of the submitted work.