276O Pooled analysis of patient (pt)-reported quality of life (QOL) in the MONALEESA (ML)-2, -3, and -7 trials of ribociclib (RIB) plus endocrine therapy (ET) to treat hormone receptor–positive, HER2-negative (HR+/HER2−) advanced breast cancer (ABC)

Fasching, Peter A.; Bardia, Aditya; Nusch, Arndt; Jérusalem, Guy; Chan, Arlene; Saghir, N. El; Alba, Emilio; Im, Sungbin; Janni, Wolfgang; Chandiwana, David; Lanoue, Brad; Thuerigen, A.; Gaur, Anil; Harbeck, Nadia

doi:10.1016/j.annonc.2020.08.378

Cited by 10 publications

(11 citation statements)

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“…Subsequently, ribociclib and abemaciclib exhibited remarkably similar outcomes when used in combination with endocrine therapy (ET) [ 5 , 6 , 7 , 8 , 9 ]. CDK4/6 inhibitors are oral medications, well-tolerated, and do not negatively impact quality of life [ 10 , 11 , 12 ].…”

Section: Introductionmentioning

confidence: 99%

First-Line Treatment with a Cyclin-Dependent Kinase 4/6 Inhibitor Plus an Aromatase Inhibitor for Metastatic Breast Cancer in Alberta

2021

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In this analysis, we describe population-based outcomes for first-line treatment with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) combined with an aromatase inhibitor (AI). All patients who were prescribed CDK4/6i + AI from January 2016 through June 2019 were included. Patient demographics, tumour and treatment characteristics were collected and described. Survival distributions were estimated using the Kaplan–Meier method. Multivariate analysis (MVA) was constructed to examine associations between potentially prognostic clinical variables and progression-free survival (PFS). In total, 316 patients were included. The median age was 61 years. After a median follow-up of 28.1 months, the median PFS was 37.9 months (95% CI, 26.7–NR). In the MVA, PR-negative tumour (HR, 2.37; 95% CI, 1.45–3.88; p = 0.001) and CDK4/6i dose reduction (HR, 1.51; 95% CI, 1.06–2.16; p = 0.022) predicted worse PFS. Median overall survival (OS) was not reached. The 30-month and 36-month OS rates were 74% and 68%, respectively. Of patients who progressed, 89% received second-line treatment. Median time to progression on second-line chemotherapy was 9.0 (5.8–17.6) months, and median time to progression on second-line hormonal therapy +/− targeted agent was 4.0 (3.4–8.6) months (p = 0.012). CDK4/6i + AI as first-line treatment for HR-positive, HER2-negative MBC in Alberta is justified based on favourable PFS and early OS outcomes.

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Section: Introductionmentioning

confidence: 99%

First-Line Treatment with a Cyclin-Dependent Kinase 4/6 Inhibitor Plus an Aromatase Inhibitor for Metastatic Breast Cancer in Alberta

2021

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“…Most such analyses revealed combination therapy and endocrine monotherapy were associated with similar quality-of-life scores 45 , 46 , 47 , while one study revealed a benefit for combination therapy 48 . Recently, a pooled analysis of all ribociclib studies was performed 49 . Reviewing all studies, this analysis showed that combination therapy can significantly delay deterioration in quality of life.…”

Section: Treatment Of Patients With Metastatic Breast Cancermentioning

confidence: 99%

“…Reviewing all studies, this analysis showed that combination therapy can significantly delay deterioration in quality of life. In subgroup analyses, which generate hypotheses, the effect was greatest in patients between 45 and 60 years of age and in patients with visceral metastases 49 .…”

Section: Treatment Of Patients With Metastatic Breast Cancermentioning

confidence: 99%

“…Die meisten Analysen zeigten ähnliche Lebensqualitätswerte bei der Kombinationstherapie verglichen mit einer endokrinen Monotherapie 45 , 46 , 47 , während eine Studie einen Vorteil zeigte 48 . Kürzlich wurde nun eine gepoolte Analyse aller Ribociclib-Studien vorgestellt 49 . Hier zeigte sich in der Zusammenschau aller Studien, dass eine signifikante Verzögerung der Verschlechterung der Lebensqualität mit der Kombinationstherapie erreicht werden kann.…”

Section: Lebensqualität Im Fokusunclassified

“…Hier zeigte sich in der Zusammenschau aller Studien, dass eine signifikante Verzögerung der Verschlechterung der Lebensqualität mit der Kombinationstherapie erreicht werden kann. In Subgruppenanalysen, die Hypothesen generieren, war der Effekt bei Patientinnen zwischen 45 und 60 Jahren und bei Patientinnen mit viszeralen Metastasen am größten 49 .…”

Section: Lebensqualität Im Fokusunclassified

See 2 more Smart Citations

Update Breast Cancer 2020 Part 5 – Moving Therapies From Advanced to Early Breast Cancer Patients

Lux

Schneeweiß

Hartkopf

et al. 2021

Geburtshilfe Frauenheilkd

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In recent years, significant progress has been made in new therapeutic approaches to breast cancer, particularly in patients with HER2-positive and HER2-negative/hormone receptor-positive (HR+) breast cancer. In the case of HER2-positive tumours, these approaches have included, in particular, treatment with pertuzumab, T-DM1, neratinib and, soon, also tucatinib and trastuzumab deruxtecan (neither of which has yet been authorised in Europe). In patients with HER2−/HR+ breast cancer, CDK4/6 inhibitors and the PIK3CA inhibitor alpelisib are of particular importance. Further novel therapies, such as Akt kinase inhibitors and oral SERDs (selective estrogen receptor down regulators), are already being investigated in ongoing clinical trials. These therapeutic agents are not only being introduced into curative, (neo-)adjuvant therapeutic settings for HER2-positive tumours; a first favourable study on abemaciclib as an adjuvant therapy has now also been published. In patients with triple-negative breast cancer, after many years of negative study results with the Trop-2 antibody drug conjugate (ADC) sacituzumab govitecan, a randomised study has been published that may represent a significant therapeutic advance. This review describes the latest developments in breast cancer subsequent to the ESMO Congress 2020.

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Health-related quality of life in breast cancer patients treated with CDK4/6 inhibitors: a systematic review

Lauro¹,

Barchiesi²,

Martorana³

et al. 2022

ESMO Open

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276O Pooled analysis of patient (pt)-reported quality of life (QOL) in the MONALEESA (ML)-2, -3, and -7 trials of ribociclib (RIB) plus endocrine therapy (ET) to treat hormone receptor–positive, HER2-negative (HR+/HER2−) advanced breast cancer (ABC)

Cited by 10 publications

References 0 publications

First-Line Treatment with a Cyclin-Dependent Kinase 4/6 Inhibitor Plus an Aromatase Inhibitor for Metastatic Breast Cancer in Alberta

First-Line Treatment with a Cyclin-Dependent Kinase 4/6 Inhibitor Plus an Aromatase Inhibitor for Metastatic Breast Cancer in Alberta

Update Breast Cancer 2020 Part 5 – Moving Therapies From Advanced to Early Breast Cancer Patients

Health-related quality of life in breast cancer patients treated with CDK4/6 inhibitors: a systematic review

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