Ribociclib for the treatment of hormone-positive HER2-negative breast cancer

Ganshina, Inna; Филоненко, Д. А.; Гордеева, О. О.; Lubennikova, E. V.; Колядина, И. В.; Мещеряков, А. А.

doi:10.21518/2079-701x-2019-10-72-80

Cited by 3 publications

(1 citation statement)

References 13 publications

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“…В настоящее время активно изучаются молекулярно-генетические механизмы, лежащие в основе резистентности к эндокринной терапии; некоторые исследования уже выявили потенциально новые терапевтические стратегии для преодоления эндокринной резистентности при РМЖ [11][12][13][14]. Поиск новых маркеров, позволяющих наиболее полно и в ранние сроки выявить особенности развития опухолевого процесса с возможностью в дальнейшем подобрать персонализированные подходы к терапии, является одной из актуальных задач современной онкологии [15].…”

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Prognostic role of clinical and biological factors and parameters of hormonal profile in patients with primary inoperable HER2-negative breast cancer

Samaneva¹,

Юрьевна²,

Vladimirova³

et al. 2021

J. Mod. Onco.

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Relevance. Breast cancer (BC) is among the most common cancers and the leading causes of cancer death in women worldwide. Much attention is paid to the problem of its hormoneresistance; however, the issues of using prognostic markers and predictors in routine cancer clinical practice remain unresolved. Aim. Study and analysis of prognostic significance of clinical and biological factors and parameters of the hormonal profile in patients with primary inoperable HER2-negative breast cancer receiving neoadjuvant chemotherapy. Materials and methods. The study included 162 patients with locally advanced primary inoperable HER2-negative breast cancer. Patients were divided into 2 groups. Group 1 included 58 patients with early disease progression within 6 to 12 months after radical surgical treatment. Group 2 included 104 patients with no disease progression within 2 years after radical surgical treatment. In all cases, diagnosis was verified histologically and immunohistochemically. Levels of prolactine, progesterone, estradiol, luteinizing hormone (LH), follicle-stimulating hormone, testosterone and cortisol were measured by RIA. The blood plasma values in 20 healthy donors were used as reference one. The data were processed using the Statistica 7.0 and MedCalc (version 9.3.5.0) programs. All patients received combination antitumor treatment according to clinical guidance. Results. An analysis of the overall (OS) and event-free (EFS) survival in group 1 showed that the median EFS in patients with luminal B BC was 9 months, with triple-negative BC (TNBC) 8 months. 6-month EFS in luminal B subtype was 87.5%, in TNBC 79.4%, p=0.37985. 1-year EFS was 1.721.7% regardless of the biological subtype. The median OS in luminal B BC was 25 months, in TNBC 26 months. 1-year OS in luminal B BC 100%, in TNBC 93.9%, p=0.138. 2-year OS in luminal B BC 54.2%, in TNBC 55.9%, p=0.697. 3-year survival in luminal B BC 37.5%, in TNBC 41.2%, p=0.639. An analysis of OS and EFS in group 2 showed that the median EFS was not reached for all biological subtypes. 3-year survival in the group was 100% regardless of the biological subtype. The median OS was not reached for all biological subtypes. 3-year OS in the group was 100%. An analysis of the hormonal profile in the treatment dynamics showed decreased levels of estradiol in all groups of patients (by 1.6 times). In group 1, progesterone was decreased by 2.1 times, testosterone by 2.4 times and LH by 2.1 times in all BC subtypes (p0.05). Patients of group 2 showed 2 times reduced cortisol and 3 times reduced prolactin in all BC subtypes, while LH levels were elevated by 1.6 times in luminal A and B BC. Conclusion. Aggressive course was observed similarly in triple-negative cancer as well as in luminal cancer with primary hormone resistance. Studying of pituitary and sex hormones and cortisol have a great clinical significance in patients with all biological subtypes of BC. This should be taken into account when predicting the course of the disease and developing further treatment options.

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Section: Introductionunclassified

Prognostic role of clinical and biological factors and parameters of hormonal profile in patients with primary inoperable HER2-negative breast cancer

Samaneva¹,

Юрьевна²,

Vladimirova³

et al. 2021

J. Mod. Onco.

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Alpelisib therapy: from theory to practice

2022

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Before the development and implementation of the first PI3K inhibitor (alpelisib), the presence of a mutation in the PIK3CA gene had only prognostic value: it determined the unfavorable course of luminal HER2-negative metastatic breast cancer (testing for mutations was not part of routine screening methods). Achievements in the treatment of HR+HER2- mBC are primarily associated with the use of CDK4/6 inhibitors, which allowed not only a significant increase in the median progression-free survival while maintaining high quality of life, but also significantly increased overall survival of patients with luminal HER2-negative metastatic breast cancer. However, subgroup analyses demonstrate that the presence of the PIK3CA mutation is an independent factor in decreasing progression-free time and overall survival, even in patients treated with CDK4/6 inhibitors. Mutations of the PIK3CA gene are diagnosed in 30-40% of luminal metastatic breast cancer patients, they are associated with an increased risk of relapse and disease progression, are associated with a significant reduction in survival rates and treatment effectiveness, and determine the development of primary and secondary resistance to endocrine therapy. Standard endocrine therapy with fulvestrant combined with alpelisib has significantly improved treatment outcomes in patients with HR+HER2-metastatic breast cancer with the PIK3CA mutation who previously received treatment for advanced disease or had progression during adjuvant therapy. This combination is now included in all major international guidelines and is a priority therapy option. Testing for PIK3CA mutations is the current diagnostic standard in luminal HER2-negative mBC. The review presents an update of the main clinical trials with alpelisib, treatment results from real clinical practice, and also considers aspects of use in pretreated patients with different medical history. The article outlines the main recommendations for the prevention and correction of adverse events, and presents our own experience of using alpelisib in a patient with a classic course of breast cancer with a PIK3CA mutation.

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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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Ribociclib for the treatment of hormone-positive HER2-negative breast cancer

Cited by 3 publications

References 13 publications

Prognostic role of clinical and biological factors and parameters of hormonal profile in patients with primary inoperable HER2-negative breast cancer

Prognostic role of clinical and biological factors and parameters of hormonal profile in patients with primary inoperable HER2-negative breast cancer

Alpelisib therapy: from theory to practice

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

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