Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer

Slamon, Dennis J.; Neven, Patrick; Chia, Stephen; Fasching, Peter A.; Laurentiis, Michelino De; Im, Seock‐Ah; Petráková, Katarína; Bianchi, Giulia; Esteva, Francisco J.; Martı́n, Miguel; Nusch, Arnd; Sonke, Gabe S.; Cruz‐Merino, Luis de la; Beck, J. Thaddeus; Pivot, Xavier; Sondhi, Manu; Wang, Yingbo; Chakravartty, Arunava; Rodriguez-Lorenc, Karen; Taran, Tetiana; Jérusalem, Guy

doi:10.1056/nejmoa1911149

Cited by 533 publications

(484 citation statements)

References 20 publications

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“…In a subsequent analysis, a significant improvement in OS was observed. 40 At 42 months, the estimated OS was 57.8% (95% CI, 52.0-63.2) in the ribociclib group and 45.9% (95% CI, 36.9-54.5) in the placebo group. 40 Comparison across multiple trials, including those in the second-line settings, studying the combination of fulvestrant with palbociclib or abemaciclib have shown statistically significant improvement in PFS.…”

Section: Single Agent Fulvestrantmentioning

confidence: 94%

“…40 At 42 months, the estimated OS was 57.8% (95% CI, 52.0-63.2) in the ribociclib group and 45.9% (95% CI, 36.9-54.5) in the placebo group. 40 Comparison across multiple trials, including those in the second-line settings, studying the combination of fulvestrant with palbociclib or abemaciclib have shown statistically significant improvement in PFS. Based on the results of the Monaleesa-3 trial and extrapolation results from the second-line setting, the NCCN panel has included fulvestrant in combination with CDK 4/6 inhibitors as a category 1 first-line option for postmenopausal women and premenopausal women with ovarian ablation/ suppression with HR-positive, HER2-negative recurrent/ stage IV breast cancer.…”

Section: Single Agent Fulvestrantmentioning

confidence: 94%

See 1 more Smart Citation

Breast Cancer, Version 3.2020, NCCN Clinical Practice Guidelines in Oncology

Gradishar

Anderson

Abraham

et al. 2020

Journal of the National Comprehensive Cancer Network

957

586

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Several new systemic therapy options have become available for patients with metastatic breast cancer, which have led to improvements in survival. In addition to patient and clinical factors, the treatment selection primarily depends on the tumor biology (hormone-receptor status and HER2-status). The NCCN Guidelines specific to the workup and treatment of patients with recurrent/stage IV breast cancer are discussed in this article.

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Section: Single Agent Fulvestrantmentioning

confidence: 94%

Section: Single Agent Fulvestrantmentioning

confidence: 94%

Breast Cancer, Version 3.2020, NCCN Clinical Practice Guidelines in Oncology

Gradishar

Anderson

Abraham

et al. 2020

Journal of the National Comprehensive Cancer Network

957

586

View full text Add to dashboard Cite

show abstract

“…Palbociclib combined with fulvestrant improved the median PFS compared to fulvestrant alone, from 4.6 months to 9.5 months. Based on these results, the FDA approved palbociclib (Ibrance) for use in combination with fulvestrant for the treatment of women with ER+/HER2− ABC/MBC on February 19, 2016 [132][133][134][135]. Additionally, many ongoing studies are exploring palbociclib in ER+/HER2− early BC patients, including adjuvant and neoadjuvant studies, such as the randomized phase III study of PALLAS (NCT02513394) and PENELOPE-B (NCT01864746); primary results are expected in 2020 [6].…”

Section: The Clinical Success Of Cdk4/6-selective Inhibitors In Bcmentioning

confidence: 99%

The Roles of Cyclin-Dependent Kinases in Cell-Cycle Progression and Therapeutic Strategies in Human Breast Cancer

Ding

Cao

Lin

et al. 2020

IJMS

293

197

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Cyclin-dependent kinases (CDKs) are serine/threonine kinases whose catalytic activities are regulated by interactions with cyclins and CDK inhibitors (CKIs). CDKs are key regulatory enzymes involved in cell proliferation through regulating cell-cycle checkpoints and transcriptional events in response to extracellular and intracellular signals. Not surprisingly, the dysregulation of CDKs is a hallmark of cancers, and inhibition of specific members is considered an attractive target in cancer therapy. In breast cancer (BC), dual CDK4/6 inhibitors, palbociclib, ribociclib, and abemaciclib, combined with other agents, were approved by the Food and Drug Administration (FDA) recently for the treatment of hormone receptor positive (HR+) advanced or metastatic breast cancer (A/MBC), as well as other sub-types of breast cancer. Furthermore, ongoing studies identified more selective CDK inhibitors as promising clinical targets. In this review, we focus on the roles of CDKs in driving cell-cycle progression, cell-cycle checkpoints, and transcriptional regulation, a highlight of dysregulated CDK activation in BC. We also discuss the most relevant CDK inhibitors currently in clinical BC trials, with special emphasis on CDK4/6 inhibitors used for the treatment of estrogen receptor-positive (ER+)/human epidermal growth factor 2-negative (HER2−) M/ABC patients, as well as more emerging precise therapeutic strategies, such as combination therapies and microRNA (miRNA) therapy.

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“…A recent double-blinded trial of 726 women with advanced, postmenopausal breast cancer published by his group in The New England Journal of Medicine demonstrated that the addition of another CDK4/6 inhibitor known as ribociclib resulted in a 28% reduction in the risk of death. 1 At 42 months, the estimated rates of survival were 58% for women receiving the drug combination treatment and 46% for women who were treated with the hormone therapy alone. It was the first demonstration of an overall survival advantage for this drug in postmenopausal women.…”

Section: The Promise Of Cdk4/6 Inhibitorsmentioning

confidence: 99%

First person profile: Dennis J. Slamon, MD, PhD

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2020

Cancer

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Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer

Cited by 533 publications

References 20 publications

Breast Cancer, Version 3.2020, NCCN Clinical Practice Guidelines in Oncology

Breast Cancer, Version 3.2020, NCCN Clinical Practice Guidelines in Oncology

The Roles of Cyclin-Dependent Kinases in Cell-Cycle Progression and Therapeutic Strategies in Human Breast Cancer

First person profile: Dennis J. Slamon, MD, PhD

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