Long-term patient-reported outcomes from monarchE: Abemaciclib plus endocrine therapy as adjuvant therapy for HR+, HER2-, node-positive, high-risk, early breast cancer.

Background: In monarchE, abemaciclib demonstrated a sustained benefit in invasive disease-free survival and a tolerable safety profile at 42-months median follow-up. With no expected disease-related symptoms, therapies in the adjuvant setting should preserve quality of life (QoL). With all patients off abemaciclib, we report updated patient-reported outcomes (PROs) for the full 2-year treatment period and follow-up.

Methods: Patients completed PROs including FACT-B, FACT-ES, and FACIT-Fatigue at baseline, 3, 6, 12, 18, and 24 months during treatment, and 1, 6, and 12 months after treatment discontinuation. Mixed effects repeated measures model estimated changes from baseline within and between arms for QoL scales and individual items. Meaningful changes were prespecified and no statistical testing was performed. Frequencies of responses to items associated with relevant adverse events and treatment bother were summarized.

Results: At baseline, completion rates for PRO instruments were >96 %. Mean changes from baseline for all QoL scales were numerically similar within and between arms (ie, less than prespecified thresholds). The same was observed for all individual items, except diarrhea. Within abemaciclib arm, meaningful differences for diarrhea were observed at 3 and 6 months (mean increases of 1.19 and 1.03 points on 5-point scale, respectively). During treatment, most patients in both arms (69-78 %) reported being bothered "a little bit" or "not at all" by side effects. Overall, patterns for fatigue were similar between arms. During post-treatment follow-up, PROs in both arms were similar to baseline.

Conclusion: PRO findings confirm a tolerable and reversible toxicity profile for abemaciclib. QoL was preserved with the addition of adjuvant abemaciclib to endocrine therapy, supporting its use in patients with HR+, HER2-, high-risk early breast cancer.

Competing Interests: Declaration of Competing Interest SMT reports serving as a consulting or advisory role for Novartis, Pfizer, Merck, Eli Lilly and Company, AstraZeneca, Genentech/Roche, Eisai, Sanofi, Bristol Myers Squibb, Seattle Genetics, CytomX Therapeutics, Daiichi Sankyo, Gilead, OncXerna, Zymeworks, Zentalis, Blueprint Medicines, Reveal Genomics, ARC Therapeutics, Infinity Therapeutics, Myovant (now Sumitovant Biopharma), Zetagen, Umoja Biopharma, Artios Pharma, Menarini/Stemline, Aadi Biopharma, Bayer, Incyte Corp, Jazz Pharmaceuticals, Natera; and research funding (to institute) from Genentech/Roche, Merck, Exelixis, Pfizer, Eli Lilly and Company, Novartis, Bristol Myers Squibb, Eisai, AstraZeneca, NanoString Technologies, Gilead, Seattle Genetics, OncoPep, Daiichi Sankyo, outside of the submitted work. VG reports personal fees for advisory board membership for AstraZeneca, Daiichi Sankyo, Eisai, Eli Lilly and Company, Exact Sciences, Gilead, Merck Serono, MSD, Novartis, Pfizer, Olema Oncology, Pierre Fabre; personal fees as an invited speaker for AstraZeneca, Daiichi Sankyo, Eli Lilly and Company, Exact Sciences, Gilead, GSK Novartis and Zentiva; personal fees for expert testimony for Eli Lilly and Company, outside of the submitted work. JHS reports no known competing financial interest or personal relationships that could have appeared to influence the submitted work. JC reports honoraria from Glaxo, AstraZeneca, Roche, Novartis, Pharmamar, Eisai, Eli Lilly and Company, Daichii Sankyo, Gilead, Seagen, MSD, Pierre Fabre, and Pfizer; serves as a consulting or advisory role for AstraZeneca, Roche, Novartis, Pharmamar, Eisai, Eli Lilly and Company, Glaxo, Daichii Sankyo, Gilead, Seagen, Deciphera, and Pfizer; and travel expenses from Novartis, Gilead, Pharmamar, and Daichii-Sankyo, outside of the submitted work. MHA reports no known competing financial interest or personal relationships that could have appeared to influence the submitted work. MT reports fees from Eli Lilly and Company for speaker’s bureau, outside of the submitted work. CB reports grants and research support to their institution from Nektar, Pfizer, Polyphor, Amgen, Daiichi Sankyo, Sanofi, Exelixis, Regeneron, Novartis, GSK, Janssen, OBI Pharma, Eli Lilly and Company, Seagen, Roche, Bristol-Myers Squibb, MSD, Merck Serono, AstraZeneca, Novocure, Aveo Oncology, Takeda, TRIO, PharmaMar, Celgene, PPD, Syneos Health, Labcorp, ICON, IQVIA, Parexel, Nuvisan, PSI, Worldwide, Gilead Sciences, Bayer, and Servier; ownership or stocks from Tummi and MEDSIR; and serves on the advisory boards and consulting with Boehringer-Ingelheim, GSK, Novartis, Pfizer, Roche/Genentech, Eisai, Bayer, MSD, AstraZeneca, Zodiac, Eli Lilly and Company, Sanofi, and Daiichi, outside of the submitted work. KM reports no known competing financial interest or personal relationships that could have appeared to influence the submitted work. RW, MMunoz, BSA, AML are employees and/or stock shareholders of Eli Lilly and Company. MMartin reports research grants from Roche, PUMA and Novartis; consulting/advisory fees from AstraZeneca, Amgen, Taiho Oncology, Roche/Genentech, Novartis, PharmaMar, Eli Lilly and Company, PUMA, Taiho Oncology, Daiichi Sankyo, Menarini/Stemline, and Pfizer; speakers’ honoraria from AstraZeneca, Lilly, Amgen, Roche/Genentech, Novartis, and Pfizer, outside of the submitted work. SRDJ reports grants or contracts from Pfizer, Puma Biotechnology, Eli Lilly and Company, AstraZeneca, Novartis, and Roche–Genentech for research funding to institute for laboratory studies and clinical trials; consulting fees from Eli Lilly and Company, AstraZeneca, Puma Biotechnology, Pfizer, Novartis, and Sanofi Genzyme for consulting or an advisory role; and payment or honoraria from Pfizer, Eisai, AstraZeneca, and Roche–Genentech for speaker's bureau, outside of the submitted work. PKL reports no known competing financial interest or personal relationships that could have appeared to influence the submitted work. NH reports honoraria for lectures and/or consulting froom Amgen, AstraZeneca, Daiichi-Sankyo, EPG Communication, Gilead, Eli Lilly and Company, MEDSCAPE, MSD, Novartis, Pierre-Fabre, Pfizer, Roche, Sandoz, Sanofi, Seagen, Springer, Viatris, and Zuelligpharma; ownership interest in Minority ownership as Co-Director West German Study Group (WSG), outside of the submitted work.

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