Article (Scientific journals)
nextMONARCH Phase 2 randomized clinical trial: overall survival analysis of abemaciclib monotherapy or in combination with tamoxifen in patients with endocrine-refractory HR + , HER2- metastatic breast cancer.
Hamilton, Erika; Cortes, Javier; Ozyilkan, Ozgur et al.
2022In Breast Cancer Research and Treatment, 195 (1), p. 55 - 64
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Keywords :
Cyclin-dependent kinase 4 and 6; Endocrine therapy; HER2-negative; Hormone receptor-positive; MBC; Overall survival; Aminopyridines; Benzimidazoles; Tamoxifen; abemaciclib; Female; Humans; Progression-Free Survival; Tamoxifen/therapeutic use; Aminopyridines/adverse effects; Antineoplastic Combined Chemotherapy Protocols/adverse effects; Benzimidazoles/adverse effects; Breast Neoplasms/drug therapy; Breast Neoplasms/pathology; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Receptor, ErbB-2; Oncology; Cancer Research
Abstract :
[en] [en] PURPOSE: Resistance to endocrine therapy poses a major clinical challenge for patients with hormone receptor-positive (HR +), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). We present the preplanned 24-month final overall survival (OS) results, alongside updated progression-free survival (PFS), and objective response rate (ORR) results. METHODS: nextMONARCH is an open-label, controlled, randomized, Phase 2 study of abemaciclib alone or in combination with tamoxifen in women with endocrine-refractory HR + , HER2- MBC previously treated with chemotherapy. Patients were randomized 1:1:1 to: abemaciclib 150 mg and tamoxifen 20 mg (A + T), abemaciclib 150 mg (A-150), or abemaciclib 200 mg and prophylactic loperamide (A-200). OS was the main prespecified secondary endpoint. PFS, ORR, and safety at 24 months were compared to previously reported primary analysis results. RESULTS: Of the 234 patients enrolled, 12 were receiving study treatment at data cutoff (28Jun2019). Median follow-up was 27.2 months. Median OS was 24.2 months in the A + T arm, 20.8 months in A-150, and 17.0 months in A-200 (A + T versus A-200: HR 0.62; 95%CI [0.40, 0.97], P = 0.03 and A-150 versus A-200: HR 0.96; 95%CI [0.64, 1.44], P = 0.83). PFS and ORR results at 24 months were consistent with the primary analysis. The safety profile corresponded with previous reports. CONCLUSION: The addition of tamoxifen to abemaciclib demonstrated greater OS benefit than monotherapy. This study confirmed the single-agent activity of abemaciclib in heavily pretreated women with endocrine-refractory HR + , HER2- MBC, as well as the previously reported primary PFS and ORR results, with no new safety signals observed. Trial Registration Identifier: NCT02747004.
Disciplines :
Author, co-author :
Hamilton, Erika ;  Breast and Gynecologic Research Program, Sarah Cannon Research Institute/Tennessee Oncology PLLC, 250 25th Ave North, Suite 200, Nashville, TN, 37203, USA.
Cortes, Javier;  International Breast Cancer Center (IBCC), Quironsalud Group, Barcelona, Spain ; Faculty of Biomedical and Health Sciences, Department of Medicine, Universidad Europea de Madrid, Madrid, Spain
Ozyilkan, Ozgur;  Department of Medical Oncology, Baskent University, Adana, Turkey
Chen, Shin-Cheh;  Chang Gung Memorial Hospital, Chang Gung University, Linkou, Taoyuan City, Taiwan
Petrakova, Katarina;  Masarykuv Onkologický Ustav, Brno, Czech Republic
Manikhas, Aleksey;  City Clinical Oncology Center, St. Petersburg, Russia
Jerusalem, Guy  ;  Centre Hospitalier Universitaire de Liège - CHU > > Service d'oncologie médicale
Hegg, Roberto;  Centro de Referência da Saúde da Mulher, Hospital Pérola Byington/FMUSP, São Paulo, Brazil
Huober, Jens;  Breast Center, University of Ulm, Ulm, Germany ; Breast Center, Cantonal Hospital, St Gallen, Switzerland
Zhang, Wei;  Eli Lilly and Company, Indianapolis, IN, USA
Chen, Yanyun;  Eli Lilly and Company, Indianapolis, IN, USA
Martin, Miguel;  Instituto de Investigación Sanitaria Gregorio Marañón, Universidad Complutense, CIBERONC, GEICAM, Madrid, Spain
Language :
Title :
nextMONARCH Phase 2 randomized clinical trial: overall survival analysis of abemaciclib monotherapy or in combination with tamoxifen in patients with endocrine-refractory HR + , HER2- metastatic breast cancer.
Publication date :
August 2022
Journal title :
Breast Cancer Research and Treatment
Publisher :
Springer, Netherlands
Volume :
Issue :
Pages :
55 - 64
Peer reviewed :
Peer Reviewed verified by ORBi
Funders :
Eli Lilly and Company [US-IN] [US-IN]
Funding text :
The present study was funded by Eli Lilly and Company. Writing and editorial support were provided by Eli Lilly and Company. The authors are grateful to the patients, their families, and caregivers for participating in nextMONARCH. The authors also thank the study investigators and site staff for their participation.
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