Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial

Tripathy, Debu; Im, Seock Ah; Colleoni, Marco; Franke, Fábio; Bardia, Aditya; Harbeck, Nadia; Hurvitz, Sara A.; Chow, Louis W.C.; Sohn, Joohyuk; Lee, Keun Seok; Campos-Gomez, Saúl; Vázquez, Rafael; Jung, Kyung Hae; Babu, K Govind; Wheatley‐Price, Paul; Laurentiis, Michelino De; Im, Young Hyuck; Küemmel, Sherko; El-Saghir, Nagi S.; Liu, Mei Ching; Carlson, Gary P.; Hughes, G.; Díaz-Padilla, Iván; Germa, Caroline; Hirawat, Samit; Lu, Yen‐Shen

doi:10.1016/s1470-2045(18)30292-4

Cited by 723 publications

(831 citation statements)

References 29 publications

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“…The pronounced efficacy of CDK4/6 inhibitors is not limited to postmenopausal patients: In the MONALEESA-7 study, only pre- and perimenopausal patients were randomized to receive endocrine-based therapy alone versus in combination with ribociclib. With a prolongation of the median progression-free survival (PFS) from 13.0 to 23.8 months and a hazard ratio of 0.55, the MONALEESA-7 study results align seamlessly with the results of all other trials [2]. …”

Section: Efficacy Data Of Endocrine-based Therapy With Cdk4/6 Inhibitmentioning

confidence: 79%

Management of Adverse Events Due to Cyclin-Dependent Kinase 4/6 Inhibitors

Ettl¹

2019

Breast Care

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Cyclin-dependent kinase (CDK) 4/6 inhibitors have become standard of care in the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer. They have been shown to double the efficacy of endocrine-based treatment. Three oral agents are available to date: palbociclib, ribociclib, and abemaciclib. The aim of this article is to give a short overview of the existing efficacy data, to summarize the recommended clinical monitoring procedures for patients under CDK4/6 inhibitors, and to shed light on the clinical management of the most common treatment-emergent adverse events. The hematological class side effect neutropenia as well as non-hematological toxicities (e.g., impaired liver function, prolonged QTc interval, and diarrhea) are discussed. In addition, the current knowledge about relevant drug interactions is reviewed.

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Section: Efficacy Data Of Endocrine-based Therapy With Cdk4/6 Inhibitmentioning

confidence: 79%

Management of Adverse Events Due to Cyclin-Dependent Kinase 4/6 Inhibitors

Ettl¹

2019

Breast Care

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“…Patients were randomized to either tamoxifen/goserelin or NSAI/goserelin plus ribociclib or placebo. Overall, the addition of ribociclib improved PFS from 13 to 23.8 months (HR0.55; P < .001) [23]. …”

Section: Reviewmentioning

confidence: 99%

CDK 4/6 Inhibitors in Breast Cancer: Current Controversies and Future Directions

et al. 2019

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Purpose of Review: To describe the clinical role of CDK 4/6 inhibitors in hormone receptor-positive (HR+) metastatic breast cancer (HR+ MBC) as well as current controversies and evolving areas of research. Recent Findings: Palbociclib, ribociclib, and abemaciclib are each approved in combination with an aromatase inhibitor or fulvestrant for HR+ MBC. Abemaciclib is also approved as monotherapy for pre-treated patients. Key questions in the field include whether all patients with HR+ MBC should receive a CDK 4/6 inhibitor up front versus later line, impact on overall survival, role of continued CDK 4/6 blockade, mechanism of clinical resistance, and treatment sequencing. Summary: The development of CDK 4/6 inhibitors has changed the therapeutic management of HR+ MBC. Additional research is needed to determine optimal treatment sequencing, understand mechanisms governing resistance, and develop novel therapeutic strategies to circumvent or overcome clinical resistance and further improve the outcomes of patients with MBC.

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“…Although this phenomenon of creatinine rise has been underreported in the large phase III studies, it was a recognised AE in early phase studies. In a phase I study of ribociclib in advanced solid tumours and lymphomas, rise in blood creatinine was found in 14 (11%), and none was grade 3 or 4 .…”

Section: Discussionmentioning

confidence: 99%

Association between ribociclib and changes in creatinine in patients with hormone receptor positive metastatic breast cancer

Wilson

Mok

Kiely

et al. 2019

Internal Medicine Journal

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Combination ribociclib and aromatase inhibitors are currently the preferred treatment in Australia for newly diagnosed hormone receptor positive metastatic breast cancer in the absence of visceral crisis. In our case series of 32 patients, 28% experienced grade 1 elevations in creatinine, a toxicity that was under‐recognised in large phase III studies. Creatinine rise appears to be due to a reversible inhibition of renal efflux transporters rather than an acute kidney injury in the majority of cases.

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Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial

Cited by 723 publications

References 29 publications

Management of Adverse Events Due to Cyclin-Dependent Kinase 4/6 Inhibitors

Management of Adverse Events Due to Cyclin-Dependent Kinase 4/6 Inhibitors

CDK 4/6 Inhibitors in Breast Cancer: Current Controversies and Future Directions

Association between ribociclib and changes in creatinine in patients with hormone receptor positive metastatic breast cancer

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