Real-world treatment outcomes in HR+ HER2- metastatic breast cancer patients treated with CDK4/6 inhibitors: Results from a reference center in Brazil

Queiroz, Marcello Moro; Sacardo, Karina Perez; Ribeiro, Mauricio Fernando; Gadotti, Luiza Lara; Saddi, Rodrigo; Oliveira, Leandro Jonata de Carvalho; Linck, Rudinei Diogo Marques; Cruz, Marcelo; Barroso‐Sousa, Romualdo; Sahade, Marina; Correa, Tatiana; Mano, Max Senna; Suzuki, Daniele Assad; Shimada, Andrea Kazumi; Katz, Artur

doi:10.1016/j.ctarc.2023.100683

Cited by 5 publications

(4 citation statements)

References 37 publications

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“…To the best of our knowledge, there is currently only one published real-world study on CDK 4/6 inhibitors in Brazil. Recently, Queiroz et al 26 retrospectively analyzed data from patients with confirmed HR+/HER2 metastatic breast cancer in a single institution who were treated with endocrine therapy in combination with ribociclib, palbociclib, or abemaciclib. In an analysis restricted to patients in first-line treatment, ribociclib was superior in PFS length.…”

Section: Discussionmentioning

confidence: 99%

Real-World Evidence of Ribociclib Plus Aromatase Inhibitors as First-Line Treatment in Advanced Breast Cancer: The BrasiLEEira Study

Suzuki,

Morelle,

de Brito

et al. 2024

JCO Glob Oncol

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PURPOSE Cyclin inhibitors plus endocrine therapy represent the reference standard for hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2–) locally advanced or metastatic breast cancer (ABC). Efficacy results on hard end points such as overall survival come from well-designed randomized clinical trials (RCTs). However, a limitation of RCTs is the low external results validity, and their extrapolation to a broader population may not be appropriate. Real-world studies can overcome these limitations, also increasing the reliability of RCTs. MATERIALS AND METHODS The BrasiLEEira was an observational, longitudinal, retrospective, multicenter study to evaluate the effectiveness and safety of ribociclib plus nonsteroidal aromatase inhibitors in Brazilian women age 18 years or older with HR+/HER2– ABC. The study was approved by the institutional review boards of all 11 hospitals. Data were collected anonymously from medical records using an electronic case report form designed by an independent academic research organization, which conducted the study considering all recommendations of international guidelines. The primary end point was 1-year progression-free survival (PFS) rate. Secondary end points included mortality, dose reduction, and safety. RESULTS The mean age of 76 patients was 57 years, and 28.9% were Black/Brown. The most prevalent comorbidity was arterial hypertension (34.7%). About 26.0% had endocrine-resistant disease, and 54.1% had more than three metastatic sites. The PFS rate was 77.6%. Three patients died (3.9%). Dose reductions occurred in 37.7% of patients. The most common adverse event was neutropenia (68.4%). CONCLUSION The high-quality evidence from the BrasiLEEira study corroborates the RCTs' findings, expanding its validity to a broader spectrum and underrepresented population who may benefit from ribociclib treatment.

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Section: Discussionmentioning

confidence: 99%

Real-World Evidence of Ribociclib Plus Aromatase Inhibitors as First-Line Treatment in Advanced Breast Cancer: The BrasiLEEira Study

Suzuki,

Morelle,

de Brito

et al. 2024

JCO Glob Oncol

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“…Рибоциклиб + ГТ (n = 54, в том числе 34 в комбинации с ИА) Абемациклиб + ГТ (n = 56, в том числе 29 в комбинации с ИА) Palbociclib + HT (n = 96, including 53 in combination with AI) Ribociclib + HT (n = 54, including 34 in combination with AI) Abemaciclib + HT (n = 56, including 29 in combination with AI) Палбоциклиб + ГТ (n = 79, в том числе 37 -в составе 1-й линии, 34 -в комбинации с ИА) Рибоциклиб + ГТ (n = 42, в том числе 33 -в составе 1-й линии, 31 -в комбинации с ИА) Абемациклиб + ГТ (n = 21, в том числе 9 -в составе 1-й линии, 9 -в комбинации с ИА) Palbociclib + HT (n = 79, including 37 as first-line therapy, 34 in combination with AI) Ribociclib + HT (n = 42 including 33 as first-line therapy, 31 in combination with AI) Abemaciclib + HT (n = 21, including 9 as first-line therapy, 9 in combination with AI) Палбоциклиб + ГТ (n = 33, в том числе 6 -в составе 1-й линии, 8 -в комбинации с ИА) Рибоциклиб + ГТ (n = 28, в том числе 19 -в составе 1-й линии, 25 -в комбинации с ИА) Palbociclib + HT (n = 33, including 6 as first-line therapy, 8 in combination with AI) Ribociclib + HT (n = 28, including 19 as first-line therapy, 25 in combination with AI)No Таблица 1. Общая характеристика отобранных исследований[15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33] …”

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“…General characteristics of the studies included[15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33] …”

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Effectiveness of cyclin-dependent kinase 4 and 6 inhibitors for the treatment of hormonesensitive HER2-negative metastatic breast cancer in first-line therapy: A systematic literature review

Avxentyev,

Andreyashkina,

Artamonova

et al. 2024

Opuholi ženskoj reproduktivnoj sistemy

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At present, cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors such as palbociclib, ribociclib, and abemaciclib are widely used for the first-line treatment of locally advanced or metastatic breast cancer. However, direct comparisons of these treatment options in randomized studies have not been conducted.Aim of the work is to gather and analyze published data on the comparative effectiveness of CDK4/6 inhibitors in combination with aromatase inhibitors in postmenopausal patients with HR+/HER2– locally advanced or metastatic breast cancer. A systematic review of publications presenting results from original studies on the impact of CDK4/6 inhibitor therapy in combination with aromatase inhibitors on the survival of patients was performed. Nineteen studies with original data on progression-free survival and overall survival were identified. None of the studies found significant differences between different CDK4/6 inhibitors and aromatase inhibitors in terms of progression-free survival. A statistically significant superiority of ribociclib over palbociclib in terms of overall survival was observed in a single matching-adjusted indirect comparison, while seven other studies of various types (real-world data studies, matching-adjusted indirect comparisons, and meta-analyses) did not find significant differences between the investigated drugs in terms of overall survival.Currently, there is no compelling evidence of the superiority of one CDK4/6 inhibitor over others. The decision on the preference for a specific drug within the class can only be made after conducting direct randomized comparison trials, or accumulating sufficient real-world data on the use of palbociclib, ribociclib, and abemaciclib.

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Palbociclib in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer: A Systematic Scoping Review of Real-World Evidence from Countries Outside of Western Regions that Are Underrepresented in Clinical Trials

Rauthan,

Jain,

Singh

et al. 2024

Oncol Ther

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Introduction Limited awareness exists regarding real-world data (RWD) for palbociclib in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced/metastatic breast cancer in populations from certain countries outside of Western regions. Methods A systematic scoping review was conducted using PubMed and Embase to evaluate RWD for palbociclib from countries outside of Western regions that are underrepresented in clinical trials. Search criteria were aligned with our research question for relevant English-language publications, without restrictions on publication date, followed by Phase 1 (title and abstract) and Phase 2 (full-text) screening of retrieved citations as per Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Data analyses of eligible studies were done separately for abstracts and full-text publications to enhance the precision and reliability of the results. Results Database search yielded 1485 non-duplicate records, 46 qualified for inclusion, of which 47.8% were published as full text. The analysis of outcomes, based exclusively on full-text publications that collectively included 2048 patients treated with palbociclib, revealed the median progression-free survival (PFS) of 20.2–36.7 months, overall survival (OS) of 39.9 months (reported in one publication) and objective response rate (ORR) of 45.3–80.0% with first-line treatment. In ≥ second line, the median PFS, OS and ORR ranged from 7.0 to 24.2 months, 11 to 19.6 months, and 13.9% to 47.9%, respectively. The safety profile of palbociclib was similar to that reported in pivotal clinical studies, and no new safety concerns were identified. Conclusions A comprehensive volume of evidence demonstrates that palbociclib’s effectiveness and safety profile in real-world settings align with those observed in clinical trials, offering valuable insights for clinical decision-making in countries outside of Western regions underrepresented in clinical trials. Supplementary Information The online version contains supplementary material available at 10.1007/s40487-024-00295-2.

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Real-world treatment outcomes in HR+ HER2- metastatic breast cancer patients treated with CDK4/6 inhibitors: Results from a reference center in Brazil

Cited by 5 publications

References 37 publications

Real-World Evidence of Ribociclib Plus Aromatase Inhibitors as First-Line Treatment in Advanced Breast Cancer: The BrasiLEEira Study

Real-World Evidence of Ribociclib Plus Aromatase Inhibitors as First-Line Treatment in Advanced Breast Cancer: The BrasiLEEira Study

Effectiveness of cyclin-dependent kinase 4 and 6 inhibitors for the treatment of hormonesensitive HER2-negative metastatic breast cancer in first-line therapy: A systematic literature review

Palbociclib in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer: A Systematic Scoping Review of Real-World Evidence from Countries Outside of Western Regions that Are Underrepresented in Clinical Trials

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