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BCC 2021 | monarchE: patient-reported outcomes

Sara Tolaney, MD, MPH, Dana-Farber Cancer Institute, Boston, MA, discusses patients’ quality of life and side effect perceptions in monarchE (NCT03155997), a study of abemaciclib plus endocrine therapy in the adjuvant treatment of HR+, HER2-, node-positive, high-risk, early breast cancer. Analyzing patient-reported outcomes highlights that the addition of abemaciclib to endocrine therapy did not result in clinically meaningful differences in patient-reported outcomes. This interview took place during the 17th St. Gallen International Breast Cancer Conference.

Transcript (edited for clarity)

This analysis was looking at patient-reported outcomes among patients who are enrolled in the monarchE study. This trial was a trial looking at the addition of abemaciclib to adjuvant endocrine therapy in patients who have high-risk, hormone receptor-positive, HER2-negative breast cancer, and had demonstrated at the primary outcome analysis that adding abemaciclib to endocrine therapy significantly improved disease-free survival...

This analysis was looking at patient-reported outcomes among patients who are enrolled in the monarchE study. This trial was a trial looking at the addition of abemaciclib to adjuvant endocrine therapy in patients who have high-risk, hormone receptor-positive, HER2-negative breast cancer, and had demonstrated at the primary outcome analysis that adding abemaciclib to endocrine therapy significantly improved disease-free survival. And so what we were interested in doing was trying to look at the impact of the addition of abemaciclib to the endocrine therapy in terms of patient-reported outcomes. So really, this study was looking at serial collection of patient-reported outcomes over time.

So in terms of the patient-reported outcome data that we presented from the monarchE study, we found that really with the exception of diarrhea, the addition of abemaciclib to endocrine therapy did not result in clinically meaningful differences in patient-reported outcomes, including patients being bothered by treatment side effects. We also saw that patient-reported diarrhea was similar to the reports of diarrhea that we had from the CTCAE criteria, really showing that it was mainly low-grade diarrhea and that it was really highest within the first few months of treatment and seemed to be manageable with anti-diarrheal treatment or dose modification.

So I think overall, the patient-reported data does show a tolerable profile for abemaciclib when added to endocrine therapy. But certainly at this time, there are a little over 50% of patients that still remain on abemaciclib therapy and are going to be completing their two years of therapy. So we still would love to see longer follow-up, and follow these patients for further patient-reported outcomes with time.

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Disclosures

Institutional Research Funds: AstraZeneca, Lilly, Merck, Nektar, Novartis, Pfizer, Genentech/Roche, Immunomedics/Gilead, Exelixis, Bristol-Myers Squibb, Eisai, Nanostring, Cyclacel, Sanofi, Odonate, Seattle Genetics
Honoraria: AstraZeneca, Lilly, Merck, Nektar, Novartis, Pfizer, Genentech/Roche, Immunomedics/Gilead, Bristol-Myers Squibb, Eisai, Nanostring, Puma, Sanofi, Odonate, Seattle Genetics, Daiichi Sankyo, Athenex, OncoPep, Kyowa Kirin Pharmaceuticals, Kyowa Kirin Pharmaceuticals, CytomX, Certara, Mersana Therapeutics

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