MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer

Purpose Abemaciclib, a cyclin-dependent kinase 4 and 6 inhibitor, demonstrated efficacy as monotherapy and in combination with fulvestrant in women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with endocrine t...

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Published inJournal of clinical oncology Vol. 35; no. 32; pp. 3638 - 3646
Main Authors Goetz, Matthew P., Toi, Masakazu, Campone, Mario, Sohn, Joohyuk, Paluch-Shimon, Shani, Huober, Jens, Park, In Hae, Trédan, Olivier, Chen, Shin-Cheh, Manso, Luis, Freedman, Orit C., Garnica Jaliffe, Georgina, Forrester, Tammy, Frenzel, Martin, Barriga, Susana, Smith, Ian C., Bourayou, Nawel, Di Leo, Angelo
Format Journal Article
LanguageEnglish
Published United States 10.11.2017
Subjects
Adult
Aged
Aged, 80 and over
Aminopyridines - administration & dosage
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Aromatase Inhibitors - administration & dosage
Benzimidazoles - administration & dosage
Biomarkers, Tumor
Breast Neoplasms - drug therapy
Double-Blind Method
Female
Humans
Middle Aged
Nitriles - administration & dosage
Postmenopause
Receptor, ErbB-2
Survival Rate
Treatment Outcome
Triazoles - administration & dosage
Online AccessGet full text
ISSN0732-183X
1527-7755
1527-7755
DOI10.1200/JCO.2017.75.6155

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Abstract Purpose Abemaciclib, a cyclin-dependent kinase 4 and 6 inhibitor, demonstrated efficacy as monotherapy and in combination with fulvestrant in women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with endocrine therapy. Methods MONARCH 3 is a double-blind, randomized phase III study of abemaciclib or placebo plus a nonsteroidal aromatase inhibitor in 493 postmenopausal women with HR-positive, HER2-negative advanced breast cancer who had no prior systemic therapy in the advanced setting. Patients received abemaciclib or placebo (150 mg twice daily continuous schedule) plus either 1 mg anastrozole or 2.5 mg letrozole, daily. The primary objective was investigator-assessed progression-free survival. Secondary objectives included response evaluation and safety. A planned interim analysis occurred after 189 events. Results Median progression-free survival was significantly prolonged in the abemaciclib arm (hazard ratio, 0.54; 95% CI, 0.41 to 0.72; P = .000021; median: not reached in the abemaciclib arm, 14.7 months in the placebo arm). In patients with measurable disease, the objective response rate was 59% in the abemaciclib arm and 44% in the placebo arm ( P = .004). In the abemaciclib arm, diarrhea was the most frequent adverse effect (81.3%) but was mainly grade 1 (44.6%). Comparing abemaciclib and placebo, the most frequent grade 3 or 4 adverse events were neutropenia (21.1% v 1.2%), diarrhea (9.5% v 1.2%), and leukopenia (7.6% v 0.6%). Conclusion Abemaciclib plus a nonsteroidal aromatase inhibitor was effective as initial therapy, significantly improving progression-free survival and objective response rate and demonstrating a tolerable safety profile in women with HR-positive, HER2-negative advanced breast cancer.
AbstractList Purpose Abemaciclib, a cyclin-dependent kinase 4 and 6 inhibitor, demonstrated efficacy as monotherapy and in combination with fulvestrant in women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with endocrine therapy. Methods MONARCH 3 is a double-blind, randomized phase III study of abemaciclib or placebo plus a nonsteroidal aromatase inhibitor in 493 postmenopausal women with HR-positive, HER2-negative advanced breast cancer who had no prior systemic therapy in the advanced setting. Patients received abemaciclib or placebo (150 mg twice daily continuous schedule) plus either 1 mg anastrozole or 2.5 mg letrozole, daily. The primary objective was investigator-assessed progression-free survival. Secondary objectives included response evaluation and safety. A planned interim analysis occurred after 189 events. Results Median progression-free survival was significantly prolonged in the abemaciclib arm (hazard ratio, 0.54; 95% CI, 0.41 to 0.72; P = .000021; median: not reached in the abemaciclib arm, 14.7 months in the placebo arm). In patients with measurable disease, the objective response rate was 59% in the abemaciclib arm and 44% in the placebo arm ( P = .004). In the abemaciclib arm, diarrhea was the most frequent adverse effect (81.3%) but was mainly grade 1 (44.6%). Comparing abemaciclib and placebo, the most frequent grade 3 or 4 adverse events were neutropenia (21.1% v 1.2%), diarrhea (9.5% v 1.2%), and leukopenia (7.6% v 0.6%). Conclusion Abemaciclib plus a nonsteroidal aromatase inhibitor was effective as initial therapy, significantly improving progression-free survival and objective response rate and demonstrating a tolerable safety profile in women with HR-positive, HER2-negative advanced breast cancer.
Purpose Abemaciclib, a cyclin-dependent kinase 4 and 6 inhibitor, demonstrated efficacy as monotherapy and in combination with fulvestrant in women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with endocrine therapy. Methods MONARCH 3 is a double-blind, randomized phase III study of abemaciclib or placebo plus a nonsteroidal aromatase inhibitor in 493 postmenopausal women with HR-positive, HER2-negative advanced breast cancer who had no prior systemic therapy in the advanced setting. Patients received abemaciclib or placebo (150 mg twice daily continuous schedule) plus either 1 mg anastrozole or 2.5 mg letrozole, daily. The primary objective was investigator-assessed progression-free survival. Secondary objectives included response evaluation and safety. A planned interim analysis occurred after 189 events. Results Median progression-free survival was significantly prolonged in the abemaciclib arm (hazard ratio, 0.54; 95% CI, 0.41 to 0.72; P = .000021; median: not reached in the abemaciclib arm, 14.7 months in the placebo arm). In patients with measurable disease, the objective response rate was 59% in the abemaciclib arm and 44% in the placebo arm ( P = .004). In the abemaciclib arm, diarrhea was the most frequent adverse effect (81.3%) but was mainly grade 1 (44.6%). Comparing abemaciclib and placebo, the most frequent grade 3 or 4 adverse events were neutropenia (21.1% v 1.2%), diarrhea (9.5% v 1.2%), and leukopenia (7.6% v 0.6%). Conclusion Abemaciclib plus a nonsteroidal aromatase inhibitor was effective as initial therapy, significantly improving progression-free survival and objective response rate and demonstrating a tolerable safety profile in women with HR-positive, HER2-negative advanced breast cancer.Purpose Abemaciclib, a cyclin-dependent kinase 4 and 6 inhibitor, demonstrated efficacy as monotherapy and in combination with fulvestrant in women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with endocrine therapy. Methods MONARCH 3 is a double-blind, randomized phase III study of abemaciclib or placebo plus a nonsteroidal aromatase inhibitor in 493 postmenopausal women with HR-positive, HER2-negative advanced breast cancer who had no prior systemic therapy in the advanced setting. Patients received abemaciclib or placebo (150 mg twice daily continuous schedule) plus either 1 mg anastrozole or 2.5 mg letrozole, daily. The primary objective was investigator-assessed progression-free survival. Secondary objectives included response evaluation and safety. A planned interim analysis occurred after 189 events. Results Median progression-free survival was significantly prolonged in the abemaciclib arm (hazard ratio, 0.54; 95% CI, 0.41 to 0.72; P = .000021; median: not reached in the abemaciclib arm, 14.7 months in the placebo arm). In patients with measurable disease, the objective response rate was 59% in the abemaciclib arm and 44% in the placebo arm ( P = .004). In the abemaciclib arm, diarrhea was the most frequent adverse effect (81.3%) but was mainly grade 1 (44.6%). Comparing abemaciclib and placebo, the most frequent grade 3 or 4 adverse events were neutropenia (21.1% v 1.2%), diarrhea (9.5% v 1.2%), and leukopenia (7.6% v 0.6%). Conclusion Abemaciclib plus a nonsteroidal aromatase inhibitor was effective as initial therapy, significantly improving progression-free survival and objective response rate and demonstrating a tolerable safety profile in women with HR-positive, HER2-negative advanced breast cancer.
Author Barriga, Susana
Manso, Luis
Paluch-Shimon, Shani
Chen, Shin-Cheh
Toi, Masakazu
Park, In Hae
Trédan, Olivier
Garnica Jaliffe, Georgina
Frenzel, Martin
Forrester, Tammy
Goetz, Matthew P.
Di Leo, Angelo
Campone, Mario
Smith, Ian C.
Freedman, Orit C.
Bourayou, Nawel
Sohn, Joohyuk
Huober, Jens
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  organization: Matthew P. Goetz, Mayo Clinic, Rochester, MN; Masakazu Toi, Kyoto University, Kyoto, Japan; Mario Campone, Institut de Cancerologie de l’Ouest, Angers Cedex; Olivier Trédan, Centre Léon Bérard, Lyon; Nawel Bourayou, Eli Lilly, Paris, France; Joohyuk Sohn, Yonsei Cancer Center, Seoul; In Hae Park, National Cancer Center, Goyangsi, South Korea; Shani Paluch-Shimon, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel; Jens Huober, University of Ulm, Ulm, Germany; Shin-Cheh Chen, Chang Gung University
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  fullname: Bourayou, Nawel
  organization: Matthew P. Goetz, Mayo Clinic, Rochester, MN; Masakazu Toi, Kyoto University, Kyoto, Japan; Mario Campone, Institut de Cancerologie de l’Ouest, Angers Cedex; Olivier Trédan, Centre Léon Bérard, Lyon; Nawel Bourayou, Eli Lilly, Paris, France; Joohyuk Sohn, Yonsei Cancer Center, Seoul; In Hae Park, National Cancer Center, Goyangsi, South Korea; Shani Paluch-Shimon, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel; Jens Huober, University of Ulm, Ulm, Germany; Shin-Cheh Chen, Chang Gung University
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  givenname: Angelo
  surname: Di Leo
  fullname: Di Leo, Angelo
  organization: Matthew P. Goetz, Mayo Clinic, Rochester, MN; Masakazu Toi, Kyoto University, Kyoto, Japan; Mario Campone, Institut de Cancerologie de l’Ouest, Angers Cedex; Olivier Trédan, Centre Léon Bérard, Lyon; Nawel Bourayou, Eli Lilly, Paris, France; Joohyuk Sohn, Yonsei Cancer Center, Seoul; In Hae Park, National Cancer Center, Goyangsi, South Korea; Shani Paluch-Shimon, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel; Jens Huober, University of Ulm, Ulm, Germany; Shin-Cheh Chen, Chang Gung University
BackLink https://www.ncbi.nlm.nih.gov/pubmed/28968163$$D View this record in MEDLINE/PubMed
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Snippet Purpose Abemaciclib, a cyclin-dependent kinase 4 and 6 inhibitor, demonstrated efficacy as monotherapy and in combination with fulvestrant in women with...
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SubjectTerms Adult
Aged
Aged, 80 and over
Aminopyridines - administration & dosage
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Aromatase Inhibitors - administration & dosage
Benzimidazoles - administration & dosage
Biomarkers, Tumor
Breast Neoplasms - drug therapy
Double-Blind Method
Female
Humans
Middle Aged
Nitriles - administration & dosage
Postmenopause
Receptor, ErbB-2
Survival Rate
Treatment Outcome
Triazoles - administration & dosage
Title MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer
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