Antitumor response and quality of life: is there a need to sacrifice? Clinical observation: long-term and safe control of the disease using a combination of ribociclib with letrozole. Case report

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Abstract

Metastatic luminal B HER2-negative breast cancer (HR+/HER2- mBC) occupies a leading place in the global structure of morbidity and mortality among women. The current gold standard of first-line treatment is the combination of CDK4/6 inhibitors with aromatase inhibitors, among which ribociclib with letrozole is distinguished. According to the MONALEESA-2 study, the addition of ribociclib to letrozole significantly increased the median overall survival to 63.9 months, reducing the risk of death by 24%. The safety profile of the combination is manageable, and the development of adverse events led to the interruption of therapy only in 7.5% of cases. A study of the actual clinical practice of CompLEEment-1 also confirmed the safety and effectiveness of the combination. Maintaining and improving the quality of life is one of the main tasks in the treatment of patients with HR+/HER2- mBC. According to the MONALEESA-2 study, the addition of ribociclib significantly affects the maintenance of quality of life and leads to a decrease in the intensity of pain syndrome. The published data allowed us to assign a combination of ribociclib and letrozole 4 points on the ESMO-MCBS scale. The safety of long-term use of the combination in the first line of treatment illustrated by clinical observation. The patient's progression-free survival during therapy was 40 months, which significantly exceeds the data of the MONALEESA-2 and CompLEEment-1 studies. The maximum effect (partial response according to RECIST 1.1 -40%) achieved after 24 weeks and persisted for 24 months. Clinically, the patient noted a decrease in the severity of the pain syndrome after 8 weeks of therapy. Against the background of therapy, it was possible to maintain the quality of life without sacrificing antitumor efficacy.

About the authors

Katerina S. Grechukhina

Loginov Moscow Clinical Scientific Center

Author for correspondence.
Email: dr.grechukhina@gmail.com
ORCID iD: 0000-0002-0616-5477

Department Head

Russian Federation, Moscow

Karina A. Vorontsova

Loginov Moscow Clinical Scientific Center

Email: dr.grechukhina@gmail.com
ORCID iD: 0000-0003-2739-8875

Cand. Sci. (Med.)

Russian Federation, Moscow

Daria A. Filonenko

Loginov Moscow Clinical Scientific Center

Email: dr.grechukhina@gmail.com
ORCID iD: 0000-0002-7224-3111

Cand. Sci. (Med.)

Russian Federation, Moscow

Pavel S. Tyutyunnik

Loginov Moscow Clinical Scientific Center

Email: dr.grechukhina@gmail.com
ORCID iD: 0000-0002-6410-7355

Cand. Sci. (Med.)

Russian Federation, Moscow

Victoria V. Shchadrova

Loginov Moscow Clinical Scientific Center

Email: dr.grechukhina@gmail.com
ORCID iD: 0000-0003-3451-0896

radiologist

Russian Federation, Moscow

Liudmila G. Zhukova

Loginov Moscow Clinical Scientific Center

Email: dr.grechukhina@gmail.com
ORCID iD: 0000-0003-4848-6938

D. Sci. (Med.), Corr. Memb. RAS

Russian Federation, Moscow

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Supplementary files

Supplementary Files
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1. JATS XML
2. Fig. 1. Median progression-free survival (PFS) in the MONALEESA-2 study [22].

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3. Fig. 2. Median overall survival (OS) in the MONALEESA-2 study [19].

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4. Fig. 3. Fragments of forest-plot subgroup analysis of PFS (a) and OS (b) in the MONALEESA-2 study [19, 23].

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5. Fig. 4. Kaplan–Meier curve for PFS locally estimated by researchers [28].

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6. Fig. 5. CT scans before treatment and after 30 cycles. Red arrows indicate tumor foci: a – metastasis in the lung, b – primary tumor in the breast, c – metastatic lymph node.

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7. Fig. 6: a – change in the EORTC QLQ-C30 quality of life questionnaire score. A clinically significant change was rated as >5 points (indicated by dashed lines); b – change in pain intensity assessed by the EORTC QLQ-C30 questionnaire. A clinically significant change was rated as >-5 points (indicated by a dashed line) [45].

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8. Fig. 7. Exploratory AUC analysis of the mean change in pain intensity between the two groups assessed by the EORTC QLQ-C30 questionnaire. A greater negative value means a more significant decrease in pain intensity [45].

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