Ribociclib (RIB) + tamoxifen (TAM) or a non-steroidal aromatase inhibitor (NSAI) in premenopausal women with hormone receptor-positive (HR+), HER2-negative (HER2-) advanced breast cancer (ABC) who received prior chemotherapy (CT): MONALEESA-7 subgroup analysis.

Authors

null

Sara A. Hurvitz

UCLA Jonsson Comprehensive Cancer Center, Los Angeles, CA

Sara A. Hurvitz , Paul Wheatley-Price , Debu Tripathy , Yen-Shen Lu , Louis Chow , Thomas Denis Bachelot , Roberto Hegg , Stephen K. L. Chia , Denise A. Yardley , Oliver Kong , Jahangir Alam , Ivan Diaz-Padilla , Johan Baeck , Aditya Bardia

Organizations

UCLA Jonsson Comprehensive Cancer Center, Los Angeles, CA, University of Ottawa, Ottawa, ON, Canada, Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, National Taiwan University Hospital, Taipei, Taiwan, Organisation for Oncology and Translational Research, Hong Kong, Hong Kong, Department of Medical Oncology, Centre Léon Bérard, Lyon, France, Hospital Pérola Byington, São Paulo, Brazil, British Columbia Cancer Agency, Vancouver, BC, Canada, Sarah Cannon Research Institute and Tennessee Oncology PLLC, Nashville, TN, Novartis Pharmaceuticals Corporation, East Hanover, NJ, Novartis Pharma AG, Basel, Switzerland, Novartis Pharmaceutical Corporation, East Hanover, NJ, Massachusetts General Hospital Cancer Center, Boston, MA

Research Funding

Pharmaceutical/Biotech Company

Background: Although endocrine therapy (ET) and ovarian function suppression is an established first-line treatment for premenopausal patients (pts) with HR+, HER2– ABC, in some cases first-line CT is administered before ET. In the Phase 3 MONALEESA-7 trial (NCT02278120), RIB + TAM/NSAI and goserelin significantly prolonged progression-free survival (PFS) vs placebo (PBO) + TAM/NSAI and goserelin in premenopausal pts with HR+, HER2– ABC. Here, we report results in pts with and without prior CT for ABC. Methods: 672 pts with ≤1 line of prior CT and no prior ET for ABC were randomized 1:1 to RIB (600 mg/day, 3-weeks-on/1-week-off) or PBO + TAM (20 mg/day) or an NSAI (letrozole [2.5 mg/day] or anastrozole [1 mg/day]) and goserelin (3.6 mg every 28 days). The primary endpoint was PFS. Secondary endpoints included overall response rate (ORR) and safety. Prespecified subgroup analyses were performed in pts with and without prior CT for ABC. Results: 47 (14%) pts in each arm had received prior CT for ABC. The most common reason for treatment discontinuation in the RIB vs PBO arm was disease progression (prior CT: 47% vs 55%; no prior CT: 35% vs 51%). Median PFS was increased in the RIB vs PBO arm both in pts with prior CT (16.6 vs 9.0 months; hazard ratio: 0.547; 95% confidence internal [CI]: 0.314–0.954) and without prior CT (24.7 vs 14.5 months; hazard ratio: 0.566; 95% CI: 0.443–0.724). In pts with measurable disease (n = 559), the ORR was 32% vs 27% for those with prior CT (RIB vs PBO arm; P= 0.262) and 54% vs 38% for those with no prior CT (P= 2.90×10–4). Common all-grade adverse events (≥35% of pts in either arm; RIB vs PBO arm) were neutropenia (prior CT: 77% vs 4%; no prior CT: 76% vs 8%), leukopenia (prior CT: 36% vs 4%; no prior CT: 31% vs 6%), and hot flash (prior CT: 23% vs 36%; no prior CT: 36% vs 33%). Conclusions: Although pt numbers were small, those with prior CT had a numerically shorter PFS and lower ORR vs pts with no prior CT. However, consistent treatment benefit with RIB + TAM/NSAI vs PBO + TAM/NSAI was observed in premenopausal pts with HR+, HER2– ABC, regardless of prior CT for ABC. Clinical trial information: NCT02278120

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Abstract Details

Meeting

2018 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Breast Cancer—Metastatic

Track

Breast Cancer

Sub Track

Hormone Receptor-Positive

Clinical Trial Registration Number

NCT02278120

Citation

J Clin Oncol 36, 2018 (suppl; abstr 1047)

DOI

10.1200/JCO.2018.36.15_suppl.1047

Abstract #

1047

Poster Bd #

128

Abstract Disclosures