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

Wilson, Brooke E; Mok, Kelly; Kiely, Belinda E; Nguyen, Rebecca; Moylan, Eugene

doi:10.1111/imj.14629

Cited by 12 publications

(12 citation statements)

References 14 publications

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“…The authors hypothesized that like abemaciclib, ribociclib also appears to reversibly inhibit these secretory transporters, causing pseudo-AKI. 9…”

Section: Discussionmentioning

confidence: 99%

“…7 Like many other drugs, CDK 4/6 inhibitors, that is, abemaciclib, have been shown to cause a transient and mostly reversible elevation in serum creatinine (SCr) and a corresponding reduction in estimated glomerular filtration rate (eGFR) without affecting kidney function. [8][9][10][11] Herein, we report the first case of pseudo-acute kidney injury (pseudo-AKI) in a patient on ribociclib-verified using both cystatin-based eGFR and measured GFR by urinary iothalamate clearance.…”

Section: Introductionmentioning

confidence: 99%

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Ribociclib-Induced Pseudo-Acute Kidney Injury

Sy-Go

Yarandi

Schwartz

et al. 2022

Journal of Onco-Nephrology

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The combination of endocrine therapy and cyclin-dependent kinase (CDK) 4/6 inhibitors is currently one of the preferred first-line regimens for patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. CDK 4/6 inhibitors can cause serum creatinine (SCr) elevation and corresponding estimated glomerular filtration rate (eGFR) reduction without affecting kidney function by inhibiting tubular secretory transporters in the kidneys—a phenomenon called pseudo-acute kidney injury (pseudo-AKI). We report a case of a 69-year old woman found to have elevated SCr while on ribociclib for treatment of metastatic breast cancer. Further evaluation with cystatin C-based eGFR and measured GFR by urinary iothalamate clearance revealed values close to her baseline Cr-based eGFR prior to initiation of treatment with ribociclib. She was therefore diagnosed with ribociclib-induced pseudo-AKI. Treatment with ribociclib was continued with steady favorable response. This case highlights that, in addition to true AKI, ribociclib can cause pseudo-AKI. Alternative methods of kidney function assessment may be necessary in patients who develop elevated SCr while on this medication to help discriminate between artifactual and true kidney function impairment. Doing so can help avoid unnecessary work-up and/or premature discontinuation of the treatment.

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“…The authors hypothesized that like abemaciclib, ribociclib also appears to reversibly inhibit these secretory transporters, causing pseudo-AKI. 9…”

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Ribociclib-Induced Pseudo-Acute Kidney Injury

Sy-Go

Yarandi

Schwartz

et al. 2022

Journal of Onco-Nephrology

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“…9 (%28) patients had grade 1 creatinine elevation and none discontinued therapy or had dose reductions for this reason. 14 In our case; Naranjo algorithm for adverse drug reaction is calculated as 9, which is classified as definitive adverse drug reaction and our patient was evaluated as grade 3 AKI due to Common Terminology Criteria for Adverse Events version 4.0. The detection of grade >2 acute AKI may lead clinicians to perform further examinations or even invasive tests.…”

Section: Discussionmentioning

confidence: 99%

“…In a study by Wilson et al; if grade 3 AKI occurs, restarting at reduced dose ribociclib is recommended. 14 Based on this study, ribociclib treatment was re-initiated with lower dose(400 mg daily). However, grade 3 AKI recurred despite dose reduction (creatinine: 2.5 mg/dl).…”

Section: Discussionmentioning

confidence: 99%

Ribociclib induced acute kidney injury: A case report

Gültürk

Yılmaz

Özmen

et al. 2021

J Oncol Pharm Pract

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Introduction Among females, breast cancer is the most common type of cancer. Hormon receptor positive (HR+) subtype constitutes 75% of the diagnosed breast cancers. Combination of the cyclin D-cyclin-dependent kinase 4/6 (CDK4/6) inhibitor and endocrine therapy significantly improves overall survival and progression-free survival. Ribociclib is an oral CDK 4/6 inhibitor and some adverse effects are identified. According to MONALEESA 2-3-7 studies, no adverse effect (AE) were reported due to grade 3 or 4 acute kidney injury (AKI) that caused treatment discontinuation. Case report We report a ribociclib-induced grade 3 AKI in an elderly woman who was treated for metastatic breast cancer. During first cycle of therapy, she was admitted to the oncology clinic with diagnosis of AKI. Management and outcome: Ribociclib treatment was discontinued and secondary causes of AKI were excluded. During the follow-up, kidney function values returned to the normal range spontaneously. Ribociclib treatment was re-initiated by reducing the dose (400 mg daily). Despite dose reduction; grade 3 AKI recurred when ribociclib was re-initiated and the drug was permanently discontinued. Discussion According to MONALEESA 2-3-7 studies; no AE were reported due to grade 3 or 4 AKI. Despite these studies, the FDA reported that 20% of patients with ribociclib + letrozole combination therapy may have any stage elevation of creatinine. Ribociclib induced creatinine elevations are generally mild (grade 1–2) and can be managed by dose reduction or close monitoring of creatinine levels. We report the first case of grade 3 AKI that caused treatment discontinuation following administration of ribociclib.

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“…Moreover, at clinically relevant concentrations it also inhibited BCRP, OCT2, multidrug and toxin extrusion protein (MATE) 1, and bile salt export pump (BSEP) [15,29,56,68]. In a retrospective study in patients treated with ribociclib, creatinine levels increased 37% compared to baseline, probably due to OCT2 inhibition [69].…”

Section: Drug Transportersmentioning

confidence: 99%

Cyclin-dependent kinase inhibitors in cancer: bioanalysis and pharmacokinetics

Chávez¹,

Alejandra²

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

Cited by 12 publications

References 14 publications

Ribociclib-Induced Pseudo-Acute Kidney Injury

Ribociclib-Induced Pseudo-Acute Kidney Injury

Ribociclib induced acute kidney injury: A case report

Cyclin-dependent kinase inhibitors in cancer: bioanalysis and pharmacokinetics

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