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Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

5157 - Management of abemaciclib associated adverse events in patients with hormone receptor positive (HR+), HER2- advanced breast cancer: analysis of the MONARCH trials


22 Oct 2018


Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care


Cytotoxic Therapy

Tumour Site

Breast Cancer


Hope Rugo


Annals of Oncology (2018) 29 (suppl_8): viii90-viii121. 10.1093/annonc/mdy272


H.S. Rugo1, S.M. Tolaney2, J. Huober3, M. Toi4, V. André5, S. Barriga6, T. Forrester7, G.W. Sledge8, M.P. Goetz9

Author affiliations

  • 1 Breast Cancer Center, UCSF Helen Diller Family Comprehensive Cancer Center, 94115 - San Francisco/US
  • 2 Medical Oncology, Dana-Farber Cancer Institute, 2215 - Boston/US
  • 3 Gynecol. & Obstetrics, Universitaetsfrauenklinik Ulm, 89075 - Ulm/DE
  • 4 Breast Surgery, Kyoto University-Graduate school of medicine, 606-8507 - Kyoto/JP
  • 5 Oncology, Eli Lilly and Company, Paris/FR
  • 6 Oncology, Eli Lilly and Company, Madrid/ES
  • 7 Oncology, Eli Lilly and Company, Indianapolis/US
  • 8 Medical Oncology, Stanford University, Stanford/US
  • 9 Alliance Foundation For Clinical Trials In Oncology, Mayo Clinic, 55905 - Rochester/US

Abstract 5157


Abemaciclib is a CDK4 & 6 inhibitor dosed continuously with demonstrated efficacy and an acceptable safety profile in pts with HR+, HER2-negative advanced breast cancer as monotherapy (MONARCH 1) and in combination with endocrine therapy; with fulvestrant (MONARCH 2) or with non-steroidal aromatase inhibitors (MONARCH 3). The most frequent adverse event (AE) is low-grade diarrhea; neutropenia is the most frequent grade 3/4 AE. We describe the timing and management of common AEs in the MONARCH trials.


Enrollment criteria, study designs and key eligibility criteria of MONARCH 1, 2 and 3 have been reported (Dickler et al. 2017; Sledge et al. 2017; Goetz et al. 2017). Pts were advised to initiate antidiarrheal therapy at first sign of diarrhea and notify the investigator, drink fluids. If not improved within 24 hours to < grade 1, treatment was suspended until diarrhea resolved. Dose reductions required for grade ≥3 or persistent grade 2 diarrhea. For grade 3 neutropenia, abemaciclib was held until < grade 2. The dose was reduced for recurrent grade 3 or grade 4 neutropenia.


Across MONARCH, the median time to onset of diarrhea was between day 6-8. First dose reductions for diarrhea occurred at a median of 28-41 days. Dose holds for diarrhea were brief, constituting 1.7-3.8% off total treatment time. The median time to onset of grade 3/4 neutropenia was 29-36.5 days, and resolved at a median of 11-15 days. AEs were managed by dose adjustments and/or supportive medication (Table).Table: 339P

Summary of Dose Adjustments in Pts Experiencing Diarrhea or Neutropenia
CharacteristicsMONARCH 1 AbemaciclibMONARCH 2 Abemaciclib + FMONARCH 3 Abemaciclib + NSAI
N = 132N = 441N = 327
Diarrhea (any grade), n(%)119 (90.2)381 (86.4)269 (82.3)
Grade 326 (19.7)59 (13.4)31 (9.5)
Incidences per patient, n (%)
160 (50.4)185 (48.6)124 (46.1)
229 (24.4)90 (23.6)52 (19.3)
≥330 (25.2)106 (27.8)93 (34.6)
Outcome, number (%) of events263995802
Not recovered/resolved15 (5.7)106 (10.7)70 (8.7)
Treatment change, n (%)119381269
Dose reduction of study drug27 (22.7)83 (21.8)45 (16.7)
Dose omission32 (24.2)83 (21.8)51 (19.0)
Treatment discontinuation1 (0.8)13 (3.4)6 (2.2)
Antidiarrheal medication, n (%)80 (60.6)333 (75.5)226 (69.1)
Neutropenia (any grade), N (%)49 (37.1)203 (46.0)143 (43.7)
Grade ¾32 (24.2)117 (26.5)78 (23.9)
Treatment change, n (%)
Dose reduction of study drug14 (10.6)44 (10.0)42 (12.8)
Dose omission21 (15.9)72 (16.3)57 (17.4)
Treatment discontinuation07 (1.6)9 (2.8)


The dose adjustment strategy used in the MONARCH studies was effective at managing AEs by dose adjustment and/or supportive medication. Understanding the safety profile of abemaciclib can inform AE management and can extend time on treatment.

Clinical trial identification

NCT02102490 (MONARCH 1), NCT02107703 (MONARCH 2), NCT02246621 (MONARCH 3).

Legal entity responsible for the study

Eli Lilly and Company.


Eli Lilly and Company.

Editorial Acknowledgement


H.S. Rugo: Grants/research support: GSK, Genentech/Roche, Novartis, Pfizer, Merck, Eisai, Plexxikon, Macrogenics, Lilly, OBI (all funding to UC Regents only). V. André, S. Barriga, T. Forrester: Employee and stakeholder: Eli Lilly and Company. M.P. Goetz: Consultant: Eli Lilly and Company, bioTheranostics, Novartis, Genomic Health, Eisai, Biovica, and Sermonix; Grant/Research support from Eli Lilly and Pfizer. All other authors have declared no conflicts of interest.

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