Ribociclib (RIBO) + letrozole (LET) in patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC) with no prior endocrine therapy (ET) for ABC: Preliminary results from the phase 3b CompLEEment-1 trial.

DeLaurentiis, Michelino; Neven, Patrick; Jérusalem, Guy; Bachelot, Thomas; Jacot, William; Dent, Susan; Colleoni, Marco; Prat, Aleix; Martı́n, Miguel; Ring, Alistair; Cottu, Paul; Lu, Janice; Azim, Hamdy A.; Zhou, Katie; Wu, Jiwen; Zarate, Juan Pablo; Zamagni, Claudio

doi:10.1200/jco.2018.36.15_suppl.1056

Cited by 5 publications

(11 citation statements)

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“…Following induction chemotherapy, maintenance endocrine therapy plus CDK4/6 inhibition may be appropriate and this approach is currently under investigation in the CompLEEment-1 study, in which 22% of patients are aged 70+ and 19% received first-line chemotherapy. 101 Less fit patients may be better suited to receive endocrine treatment alone, particularly if their life expectancy is thought to be short owing to competing causes of mortality. Vulnerabilities in CGA domains, such as functional status, cognition, polypharmacy, mood, nutrition and geriatric syndromes, may impact on the decision to use of CDK4/6 inhibitors in frail adults due to the risk of potential toxicities and increased burden of medications, required hospital visits, and blood tests.…”

Section: Discussionmentioning

confidence: 99%

Use of cyclin-dependent kinase 4/6 (CDK4/6) inhibitors in older patients with ER-positive HER2-negative breast cancer: Young International Society of Geriatric Oncology review paper

et al. 2018

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The current standard of care for the management of estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer has been redefined by the introduction of cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Although adults aged 65 years and older account for the majority of patients with breast cancer, limited data are available about the age-specific dosing, tolerability, and benefit of CDK4/6 inhibitors in this growing population. Older adults are under-represented in clinical trials and as a result, clinicians are forced to extrapolate from findings in younger and healthier patients when making treatment decisions for older patients. In this article, we review the limited age-specific evidence on the efficacy, toxicity, and quality of life (QoL) outcomes associated with the use of CDK4/6 inhibitors in older adults. We also describe ongoing trials evaluating CDK4/6 inhibitors in the older population and highlight that only a minority of adjuvant and metastatic trials of CDK4/6 inhibitors in the general breast cancer population includes geriatric assessments. Finally, we propose potential strategies to help guide decision making for fit and unfit older patients based on disease endocrine sensitivity, the need for rapid response and geriatric assessment.

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Section: Discussionmentioning

confidence: 99%

Use of cyclin-dependent kinase 4/6 (CDK4/6) inhibitors in older patients with ER-positive HER2-negative breast cancer: Young International Society of Geriatric Oncology review paper

et al. 2018

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“…As for the last main study conducted, the CompLEEment phase IIIb trial, a low incidence of QTcF prolongation ⩾ 3 (0.5%) has been preliminarily observed among the 1008 patients analysed. 65 This lower incidence in comparison with prior ribociclib trials might be due to an enhanced awareness of this toxicity among the investigators, leading to a better management of concomitant risk factors for QTc prolongation. However, this interpretation is flawed by the short follow up in this study and the lack of a control arm.…”

Section: Educational Modulementioning

confidence: 98%

“…The concomitant use of drugs with risk of QTc prolongation should be checked at any time, including the use of medicinal or herbal products. 64…”

Section: Educational Modulementioning

confidence: 99%

“…For the workshop, a comprehensive review of liver enzyme abnormalities during treatment with ribociclib and palbociclib was performed. As in “Digging for neutropenia, QTc and infections: What actually matters?” section, the results from the main published studies, 3–6,48,49,52,53,55–57,65–67 together with data available at clinicaltrials.gov, FDA/EMA documents and Pfizer/Novartis reports were considered. 50,51,68–72 The US National Institutes of Health LiverTox database was also taken into account.…”

Section: Educational Modulementioning

confidence: 99%

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Palbociclib and ribociclib in breast cancer: consensus workshop on the management of concomitant medication

et al. 2019

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Drug–drug interactions are of significant concern in clinical practice in oncology, particularly in patients receiving Cyclin-dependent kinase (CDK) 4/6 inhibitors, which are typically exposed to long-term regimens. This article presents the highlights from the ‘First Workshop on Pharmacology and Management of CDK4/6 Inhibitors: Consensus about Concomitant Medications’. The article is structured into two modules. The educational module includes background information regarding drug metabolism, corrected QT (QTc) interval abnormalities, management of psychotropic drugs and a comprehensive review of selected adverse effects of palbociclib and ribociclib. The collaborative module presents the conclusions of the five working groups, each of which comprised five experts from different fields. From these conclusions positive lists of drugs for treating common comorbid conditions that can be safely administered concomitantly with palbociclib and/or ribociclib were developed.

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“…Besides palbociclib, two other CDK4/6 inhibitors (ribociclib and abemaciclib) are currently approved for the treatment of HR+/HER2− advanced or metastatic breast cancer. 27,28 A clinical trial of ribociclib has enrolled men, 29 and abemaciclib is indicated for women and men with MBC as monotherapy for disease progression following ET and before chemotherapy. 27 The findings from the present analysis further support palbociclib as a treatment for HR+/HER2-MBC in men in the real-world setting.…”

Section: Articlementioning

confidence: 99%

Real‐World Data of Palbociclib in Combination With Endocrine Therapy for the Treatment of Metastatic Breast Cancer in Men

Kraus

Yu-Kite

Mardekian

et al. 2021

Clin Pharma and Therapeutics

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This report examined the benefits and risks of palbociclib plus endocrine therapy (ET) in men with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2−negative (HER2−) metastatic breast cancer (MBC). Palbociclib was evaluated using three independent data sources: real-world data from pharmacy and medical claims, a de-identified real-world data source derived from electronic health records (EHRs), and a global safety database. From medical and pharmacy records, 1,139 men with MBC were identified; in the first-line setting, median duration of treatment was longer with palbociclib plus ET (n = 37, 8.5 months, 95% confidence interval (CI), 4.4-13.0) than ET alone (n = 214, 4.3 months, 95% CI, 3.0-5.7) and specifically, was longer with palbociclib plus letrozole (n = 26, 9.4 months, 95% CI, 4.4-14.0) than letrozole alone (n = 63, 3.0 months, 95% CI, 1.8-4.8). In the EHR-derived database, 59 men received treatment for MBC; real-world response across all lines of therapy in the metastatic setting was reported in 4 of 12 patients (33.3%) in the palbociclib plus ET group vs. 1 of 8 (12.5%) patients in the ET group. Review of the global safety database did not identify any new safety signals in palbociclibtreated men. Real-world data indicated that men with MBC benefit from palbociclib plus ET, with a safety profile consistent with previous observations in women with MBC. Collective data on palbociclib in women and men in this report, including clinical trial data, real-world data, and a well-established risk/benefit profile, led to US approval of an expansion of the palbociclib indication to include men with MBC.An estimated 2,620 new cases of invasive breast cancer and 520 deaths due to breast cancer will occur in men in the United States in 2020. 1 The 5-year survival rate for men with metastatic breast cancer (MBC) is only 16%. 2 Breast tumor subtype and hormone receptor status can vary between men and women (Table S1), 2 but >80% of men present with hormone receptor−positive (HR+)/

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Ribociclib (RIBO) + letrozole (LET) in patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC) with no prior endocrine therapy (ET) for ABC: Preliminary results from the phase 3b CompLEEment-1 trial.

Cited by 5 publications

References 0 publications

Use of cyclin-dependent kinase 4/6 (CDK4/6) inhibitors in older patients with ER-positive HER2-negative breast cancer: Young International Society of Geriatric Oncology review paper

Use of cyclin-dependent kinase 4/6 (CDK4/6) inhibitors in older patients with ER-positive HER2-negative breast cancer: Young International Society of Geriatric Oncology review paper

Palbociclib and ribociclib in breast cancer: consensus workshop on the management of concomitant medication

Real‐World Data of Palbociclib in Combination With Endocrine Therapy for the Treatment of Metastatic Breast Cancer in Men

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