Article (Scientific journals)
nextMONARCH: Abemaciclib Monotherapy or Combined With Tamoxifen for Metastatic Breast Cancer.
Hamilton, Erika; Cortes, Javier; Ozyilkan, Ozgur et al.
2020In Clinical Breast Cancer
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Keywords :
Cyclin-dependent kinase 4 and 6; Endocrine therapy; HER2(−); Hormone receptor-positive; MBC; oncology
Abstract :
[en] BACKGROUND: Abemaciclib is a selective cyclin-dependent kinase 4 and 6 inhibitor administered continuously for hormone receptor-positive (HR(+)), human epidermal growth factor receptor 2-negative (HER2(-)) advanced breast cancer. Abemaciclib is associated with dose-dependent early-onset diarrhea. nextMONARCH evaluated abemaciclib monotherapy (with or without prophylactic loperamide) and combined with tamoxifen for endocrine refractory metastatic breast cancer (MBC) after chemotherapy. PATIENTS AND METHODS: nextMONARCH is an open-label, controlled, randomized, phase II study of women with endocrine-refractory HR(+), HER2(-) MBC previously treated with chemotherapy. Patients received abemaciclib 150 mg plus tamoxifen 20 mg (A+T), abemaciclib 150 mg every 12 hours (A-150), or abemaciclib 200 mg plus prophylactic loperamide (A-200). The primary objective was progression-free survival (PFS). PFS analyses tested superiority of A+T to A-200 and informal noninferiority of A-150 to A-200. The secondary objectives included the objective response rate (ORR), safety, and pharmacokinetics. RESULTS: The median PFS was 9.1 months for A+T versus 7.4 months for A-200 (hazard ratio, 0.815; 95% confidence interval, 0.556-1.193; P = .293). The A-200 PFS was comparable to that with A-150 at 6.5 months (hazard ratio, 1.045; 95% confidence interval, 0.711-1.535; P = .811). The ORR was 34.6%, 24.1%, and 32.5% for A+T, A-150, and A-200, respectively. No new safety signals were identified. The incidence and severity of diarrhea (62.3%; grade 3, 7.8%) with A-200 was similar to that with A-150 (67.1%; grade 3, 3.8%). The pharmacokinetics were comparable to previous observations. CONCLUSIONS: The addition of tamoxifen to abemaciclib did not significantly improve PFS or ORR compared with abemaciclib monotherapy but confirmed the single-agent activity of abemaciclib in heavily pretreated HR(+), HER2(-) MBC. Dose reductions and antidiarrheal medication generally managed diarrhea while maintaining efficacy.
Disciplines :
Author, co-author :
Hamilton, Erika
Cortes, Javier
Ozyilkan, Ozgur
Chen, Shin-Cheh
Petrakova, Katarina
Manikhas, Aleksey
Jerusalem, Guy  ;  Université de Liège - ULiège > Département des sciences cliniques > Oncologie
Hegg, Roberto
Huober, Jens
Chapman, Sonya C.
Lu, Yi
Hardebeck, Molly C.
Bear, Melissa M.
Johnston, Erica L.
Martin, Miguel
More authors (5 more) Less
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Title :
nextMONARCH: Abemaciclib Monotherapy or Combined With Tamoxifen for Metastatic Breast Cancer.
Publication date :
Journal title :
Clinical Breast Cancer
Publisher :
Cancer Information Group, United States
Peer reviewed :
Peer Reviewed verified by ORBi
Commentary :
Copyright © 2020. Published by Elsevier Inc.
Available on ORBi :
since 10 November 2020


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