Ribociclib efficacy in special populations and analysis of patient-reported outcomes in the MONALEESA trials

Sanò, Maria V.; Martorana, Federica; Lavenia, G.; Rossello, Rosalba; Prestifilippo, Angela; Sava, Serena; Ricciardi, Giuseppina Rosaria Rita; Vigneri, Paolo

doi:10.1080/14737140.2022.2052277

Cited by 8 publications

(4 citation statements)

References 68 publications

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“…Медиана ВБП на фоне терапии рибоциклибом в группе пациенток люминального В-подтипа РМЖ составила 20,0 ± 3,07 мес. от начала лечения (95% доверительный интервал (ДИ) 13,[9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26]. Среднее время до прогрессирования в группе люминального А-подтипа составило 40,4 ± 3,9 мес.…”

Section: выживаемость без прогрессирования в зависимости от гистологи...unclassified

“…В РКП при одинаковых фенотипических характеристиках опухоли отмечаются разные ответы на противоопухолевые препараты. Несмотря на значимые результаты высокой эффективности комбинированной терапии с CDK4/6-ингибиторами при мРМЖ, пациенты в дальнейшем имеют прогрессирование опухолевого процесса, что актуализирует поиск механизмов развития гормонорезистентности как важной онкологической задачи [21][22][23][24][25][26][27]. Первичная и вторичная резистентность, обусловленная обходными сигналами для стимуляции пролиферации опухолевых клеток и способностью к устойчивому формированию комплекса «циклин D -CDK4/6», ограничивает эффективность ингибиторов CDK4/6 [20,21,28].…”

Section: оригинальные исследованияunclassified

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The use of ribociclib in real clinical practice: results of a single-center observational retrospective study

Sultanbaev,

Kolyadina,

Musin

et al. 2024

Medicinskij sovet

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Introduction. The standard initial treatment for patients with hormone receptor positive, HER2 negative, metastatic breast cancer (HR+/HER2– mBC) involves the use of CDK4/6 inhibitors (CDK4/6i) in combination with endocrine therapy. The combination therapy has proven effectiveness in numerous Phase II and III randomized controlled trials (RCTs). Nonetheless, RCTs may not fully represent real-world clinical situations due to their stringent inclusion criteria, resulting in a specific patient population.Aim. Analyze of ribociclib using for treating patients with HR+/HER2– advanced breast cancer (mBC) at the Republican Clinical Oncology Dispensary.Materials and methods. Patients diagnosed with HR+/HER2– mBC who were treated in clinical routine with ribociclib in combination with different endocrine agents between 2016 and 2020 were identified and enrolled in this retrospective study. Clinicopathological characteristics and clinical outcomes were recorded with particular emphasis on ribociclib therapy course (progression-free survival (PFS), toxicity, dose reduction).Results. Data from n = 101 patients were evaluated. The mean patient age was 61 years. The study included 67 (66.3%) patients with progression after radical treatment and 34 (33.7%) patients with primary disseminated breast cancer. Dose reduction due to adverse events was performed in n = 14 cases (13.9%). Presence of prior therapy lines and lower ECOG status were associated with shorter PFS, whereas estrogen positivity and the choice of fulvestrant over aromatase inhibitor were positively associated with PFS. Metastatic pattern, progesterone positivity and dose reduction due to toxicity did not significantly impact on PFS.Conclusion. Our real-world data analysis on ribociclib treatment in Russian regional hospital supports data from RCTs regarding both treatment efficacy and safety of CDK4/6i for treatment of patients with HR+/HER2– mBC. Currently, by expanding our experience with CDK4/6 inhibitors in different groups of patients with mBC, we will be able to provide patients with optimal treatment options.

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Section: выживаемость без прогрессирования в зависимости от гистологи...unclassified

Section: оригинальные исследованияunclassified

The use of ribociclib in real clinical practice: results of a single-center observational retrospective study

Sultanbaev,

Kolyadina,

Musin

et al. 2024

Medicinskij sovet

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“…The potentially fatal long QT syndrome (LQTS) is one of the main cardiotoxic side effects of cancer drugs [1], including arsenic trioxide [2][3][4][5][6], selective cyclin-dependent kinase 4 and 6 inhibitors such as ribociclib [7][8][9][10][11][12], tyrosine kinase inhibitors such as vandetanib [13][14][15][16][17][18], or histone deacetylase inhibitors such as depsipeptide [19,20]. This syndrome is characterized by a prolongation of the corrected QT interval (QTc), which may induce life-threatening arrhythmias, including torsade de pointes (TdP), and can lead to sudden cardiac death [21].…”

Section: Introductionmentioning

confidence: 99%

Corrected QT Interval (QTc) Diagnostic App for the Oncological Routine: Development Study

Klier,

Patel,

Schinköthe

et al. 2023

JMIR Cardio

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Background Numerous antineoplastic drugs such as chemotherapeutics have cardiotoxic side effects and can lead to long QT syndrome (LQTS). When diagnosed and treated in time, the potentially fatal outcomes of LQTS can be prevented. Therefore, regular electrocardiogram (ECG) assessments are critical to ensure patient safety. However, these assessments are associated with patient discomfort and require timely support of the attending oncologist by a cardiologist. Objective This study aimed to examine whether this approach can be made more efficient and comfortable by a smartphone app (QTc Tracker), supporting single-lead ECG records on site and transferring to a tele-cardiologist for an immediate diagnosis. Methods To evaluate the QTc Tracker, it was implemented in 54 cancer centers in Germany. In total, 266 corrected QT interval (QTc) diagnoses of 122 patients were recorded. Moreover, a questionnaire on routine ECG workflow, turnaround time, and satisfaction (1=best, 6=worst) was answered by the centers before and after the implementation of the QTc Tracker. Results Compared to the routine ECG workflow, the QTc Tracker enabled a substantial turnaround time reduction of 98% (mean 2.67, 95% CI 1.72-2.67 h) and even further time efficiency in combination with a cardiologic on-call service (mean 12.10, 95% CI 5.67-18.67 min). Additionally, nurses and patients reported higher satisfaction when using the QTc Tracker. In particular, patients’ satisfaction sharply improved from 2.59 (95% CI 2.41-2.88) for the routine ECG workflow to 1.25 (95% CI 0.99-1.51) for the QTc Tracker workflow. Conclusions These results reveal a significant improvement regarding reduced turnaround time and increased user satisfaction. Best patient care might be guaranteed as the exposure of patients with an uncontrolled risk of QTc prolongations can be avoided by using the fast and easy QTc Tracker. In particular, as regular side-effect monitoring, the QTc Tracker app promises more convenience for patients and their physicians. Finally, future studies are needed to empirically test the usability and validity of such mobile ECG assessment methods. Trial Registration ClinicalTrials.gov NCT04055493; https://classic.clinicaltrials.gov/ct2/show/NCT04055493

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“…Частота объективного ответа в данных исследованиях колебалась от 42 до 49%, что говорит о возможности применения комбинации ИА с ингибиторами ЦЗК 4/6 у больных с симптомными метастазами. У больных с висцеральными метастазами выигрыш от добавления ингибиторов ЦЗК 4/6 к гормонотерапии был пропорционален выигрышу во всей группе больных [9][10][11]. Во всех исследованиях показано также поддержание удовлетворительного качества жизни при добавлении ингибиторов ЦЗК 4/6 к ИА [12][13][14], что позволяет пациентам вести привычный, полноценный образ жизни, находясь на удобной таблетированной терапии, позволяющей длительно контролировать болезнь.…”

Section: Introductionunclassified

Real clinical practice patterns of palbociclib usage in Russian Federation

Фролова

Стенина

2022

Medicinskij sovet

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Introduction. Current treatment of metastatic luminal Her2-negative breast cancer includes combination of endocrine therapy (ET) with CDK4/6 inhibitors. This type of therapy demonstrated impressive efficacy over mono ET in early lines of treatment in phase III randomized clinical trials. Treatment patterns in real clinical practice (RCP) are of great interest. We represent the first available local data for all CDK 4/6 inhibitors in RCP in Russian Federation in accordance with the number of patients (pts).Aim. Analysis of the patterns of palbociclib administration in RCP.Materials and methods. One hundred and 5 pts from 12 regions of Russian Federation were included in this analysis and received palbociclib in combination with ET from 2017 to 2020. Median age was 57 years (29-75), 31/105 (29.5%) of pts were < 50. De novo metastatic disease was observed in 16 (15.2%) pts, 89 pts progressed after radical treatment. Visceral metastases (mts) at palbociclib initiation had 61/105 (58.1%) of pts.Results. Only 22/105 (21%) of pts received palbociclib as 1st line treatment of metastatic disease. The majority of pts was treated with palbociclib in 2nd and 3rd lines (28.5% and 30.5% respectively). In 26/105 (24.8%) pts palbociclib was combined with aromatase inhibitors, in other cases - with fulvestrant. Median follow-up time was 6.5 (1.1-31.9) months, median progression free survival - 6.0 (1.0-28.0) months. Most common adverse events (AE) were leukopenia, neutropenia and thrombocytopenia. Only in 3 cases palbociclib was completely stopped due to toxicity.Conclusions. Our data indicates that there is a need to move palbociclib initiation in first two lines of treatment to get maximal improvement in survival and to increase its usage in young women.

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Ribociclib efficacy in special populations and analysis of patient-reported outcomes in the MONALEESA trials

Cited by 8 publications

References 68 publications

The use of ribociclib in real clinical practice: results of a single-center observational retrospective study

The use of ribociclib in real clinical practice: results of a single-center observational retrospective study

Corrected QT Interval (QTc) Diagnostic App for the Oncological Routine: Development Study

Real clinical practice patterns of palbociclib usage in Russian Federation

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