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Clin Breast Cancer. 2019 Aug;19(4):268-277.e1. doi: 10.1016/j.clbc.2019.02.007. Epub 2019 Feb 28.

Efficacy and Safety of Ribociclib With Letrozole in US Patients Enrolled in the MONALEESA-2 Study.

Author information

1
Sarah Cannon Research Institute, Nashville, TN; Tennessee Oncology, Nashville, TN. Electronic address: dyardley@tnonc.com.
2
Sarah Cannon Research Institute, Nashville, TN; Florida Cancer Specialists, Fort Myers, FL.
3
US Oncology Network, McKesson Specialty Health, The Woodlands, TX; Virginia Cancer Specialists, PC, Fairfax, VA.
4
Division of Hematology-Oncology, Northwest Medical Specialties, PLLC, Puyallup, WA.
5
US Oncology Network, McKesson Specialty Health, The Woodlands, TX; Rocky Mountain Cancer Centers, LLP, Aurora, CO.
6
US Oncology Network, McKesson Specialty Health, The Woodlands, TX; Texas Oncology, PA, Tyler, TX.
7
Department of Oncology, Montefiore Medical Center, Bronx, NY.
8
Highlands Oncology Group, Fayetteville, AR.
9
US Oncology Network, McKesson Specialty Health, The Woodlands, TX; Oncology and Hematology Associates of Southwest Virginia, Inc, DBA Blue Ridge Cancer Care, Salem, VA.
10
US Oncology Network, McKesson Specialty Health, The Woodlands, TX; Oncology Hematology Care, Cincinnati, OH.
11
Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center/Wexner Medical Center, Columbus, OH.
12
Virginia Piper Cancer Institute, Allina Health, Minneapolis, MN.
13
Department of Medicine, Duke University Medical Center, Durham, NC.
14
Saint Luke's Cancer Institute, Saint Luke's Health Systems, Kansas City, MO.
15
Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
16
Department of Medicine, Perlmutter Cancer Center at NYU Langone Health, New York, NY.
17
Department of Medicine, Pennsylvania State Cancer Institute, Hershey, PA.
18
Florida Hospital Cancer Institute, Orlando, FL.
19
Georgia Cancer Specialists affiliated with Northside Hospital Cancer Institute, Atlanta, GA.
20
Ironwood Cancer and Research Center, Chandler, AZ.
21
Novartis Pharmaceuticals Corporation, East Hanover, NJ.
22
Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.

Abstract

BACKGROUND:

In the Mammary Oncology Assessment of LEE011's (Ribociclib's) Efficacy and Safety (MONALEESA-2) study, combination treatment with the selective inhibitor of cyclin-dependent kinases 4/6 ribociclib with letrozole significantly improved progression-free survival (PFS) versus letrozole alone in postmenopausal women with hormone receptor-positive HR+/HER2- advanced breast cancer (ABC). Herein we present results from the subset of US patients enrolled in MONALEESA-2.

PATIENTS AND METHODS:

Postmenopausal women with HR+/HER2- ABC without previous treatment for advanced disease were randomized (1:1) to ribociclib 600 mg/d (3 weeks on/1 week off) with letrozole 2.5 mg/d (continuous) or placebo with letrozole. The primary end point was locally assessed PFS.

RESULTS:

Overall, 213 US patients were enrolled in MONALEESA-2 (ribociclib, n = 100; placebo, n = 113). Baseline characteristics were similar between treatment groups and consistent with the global population. With a median follow-up of 27 months, 38 (38%) and 29 (26%) patients in the ribociclib and placebo groups, respectively, had continued to receive treatment. Median PFS was 27.6 months with ribociclib and 15.0 months with placebo (hazard ratio, 0.53). The most common all-cause adverse events were neutropenia (ribociclib, 72.0% [n = 72]; placebo, 4.6% [n = 5]), nausea (ribociclib, 69.0% [n = 69]; placebo, 44.0% [n = 48]), and fatigue (ribociclib, 60.0% [n = 60]; placebo, 50.5% [n = 55]). Two patients (ribociclib, 2.0%; placebo, 0%) experienced febrile neutropenia.

CONCLUSION:

In the US subset of MONALEESA-2, ribociclib with letrozole showed superior efficacy versus letrozole alone. These findings are consistent with the global population and support first-line use of ribociclib with letrozole in patients with HR+/HER2- ABC.

KEYWORDS:

Advanced breast cancer; CDK4/6 inhibitor; First-line; HR(+)/HER2(−); Metastatic; Postmenopausal

PMID:
31160171
DOI:
10.1016/j.clbc.2019.02.007

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