MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer.
By M. Goetz, Masakazu Toi, Mario Campone, J. Sohn, S. Paluch-Shimon, J. Huober, I. Park, O. Trédan, Shin-Cheh Chen, L. Manso and 8 more. Journal of Clinical Oncology, 2017
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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.
Subfields: Oncology, Pulmonary and Respiratory Medicine
View Paper: https://www.semanticscholar.org/paper/386e9b87bfd6ed105efadcda57081a32c331bc73
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Citations in the corpus
- Overall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer (2018, neutral): “Capecitabine 66 (27) 43 (24) 36 (27) 36 (26) 20 (18) 24 (28)”
- Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2−, Node-Positive, High-Risk, Early Breast Cancer (monarchE) (2020, background): “This intriguing observation has been reported previously in a randomized study of a CDK4/6 inhibitor plus ET.20 The most frequently reported AE in the abemaciclib arm was diarrhea.”
- 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) (2020, background): “The last 2 years have seen the establishment of cyclindependent kinase (CDK)4/6 inhibitors combined with endocrine therapy (ET) as the standard of care for ER-positive/HER2-negative ABC in view of the OS benefit seen in several trials,(36-42) both in the first- and second-line settings, substantial ”