Treatment Combination Effective in Some Women With Advanced Breast Cancer

Abemaciclib plus fulvestrant is a safe and effective treatment combination for women with hormone receptor-positive and human epidermal growth factor receptor 2-negative advanced breast cancer who experienced disease progression while receiving endocrine therapy, according to a recent study.

In the MONARCH-2 trial, the researchers evaluated 669 women from August 2014 to December 2015 who had hormone receptor-positive and human epidermal growth factor receptor 2-negative advanced breast cancer. All patients experienced disease progression while receiving neoadjuvant or adjuvant endocrine therapy for 12 or fewer months, or while receiving first-line endocrine therapy for metastatic disease. During the trial, participants were randomly assigned to receive either 150 mg abemaciclib (n = 446) or 150 mg placebo (n = 223) twice daily on a continuous schedule, plus 500 mg fulvestrant per label.
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The researchers defined the primary outcome as investigator-assessed progression-free survival (PFS), and the secondary outcomes as overall survival, objective response rate (ORR), duration of response, clinical benefit rate, quality of life, and safety.

Results of the study indicated that abemaciclib plus fulvestrant significantly extended PFS, compared with fulvestrant alone. Abemaciclib plus fulvestrant resulted in an ORR of 48.1% among participants with measurable disease, compared with 21.3% of participants receiving placebo. Commonly reported adverse events among participants receiving abemaciclib plus fulvestrant were diarrhea, neutropenia, nausea, and fatigue.

“Abemaciclib at 150 mg twice daily plus fulvestrant was effective, significantly improving PFS and ORR and demonstrating a tolerable safety profile in women with hormone receptor-positive and human epidermal growth factor receptor 2-negative [advanced breast cancer] who progressed while receiving [endocrine therapy],” the researchers concluded.

—Christina Vogt

Reference:

Sledge GW, Toi M, Neven P, et al. MONARCH 2: abemaciclib in combination with fulvestrant in women with HR+/HER2- advanced breast cancer who had progressed while receiving endocrine therapy [Published online June 3, 2017]. J Clin Oncol. doi:10.1200/JCO.2017.73.7585.