18 Tolerability of First-Line Treatment With Ribociclib for Metastatic Breast Cancer Using 2 Large US Data Sources

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Article
Miami Breast Cancer Conference® Abstracts Supplement42nd Annual Miami Breast Cancer Conference® - Abstracts
Volume 39
Issue 4
Pages: 11

18 Tolerability of First-Line Treatment With Ribociclib for Metastatic Breast Cancer Using 2 Large US Data Sources

18 Tolerability of First-Line Treatment With Ribociclib for Metastatic Breast Cancer Using 2 Large US Data Sources

Background

In addition to progression-free survival (PFS) and overall survival (OS) benefits, first-line (1L) ribociclib plus endocrine therapy (ET) showed tolerable and manageable safety across the MONALEESA (ML) trials. Ribociclib plus ET is recommended by the NCCN as a category 1 preferred CDK4/6 inhibitor as a 1L treatment option for hormone receptor–positive/HER2-negative (HR+/HER2–) metastatic breast cancer with no visceral crisis in patients who are postmenopausal patients or premenopausal with ovarian ablation/suppression. We describe real-world adverse effects (AEs) of interest with ribociclib in 2 large US datasets.

Materials and Methods

Two cohort analyses were conducted in the Flatiron Health electronic health record (HER)-derived deidentified database and the deidentified Komodo Research Database (KRD; commercially insured, managed-Medicare [excluding fee for service] and Medicaid-insured administrative claims). Adult patients with HR+/HER2− MBC who initiated 1L RIB + ET were included. New onset of medical conditions of interest are presented.

Results

Overall, 373 (EHR) and 350 (KRD) patients who received 1L ribociclib plus ET were included. In EHR, the mean age was 62.6 years, 49.1% were aged 65 years or older, and 17.4% were 75 years or older. In KRD, the mean age was 56.5 years, 16.3% were aged 65 years or older, and 4.6% were 75 years or older. The majority of patients received an aromatase inhibitor. The data suggest an increase in 1L use of ribociclib in 2022, as observed in KRD.

New onset any-grade AEs were: neutropenia (53.4%, EHR; 21.3%, KRD), elevated liver enzymes (9.0%, EHR; 4.6%, KRD), and QTc prolongation (4.0%, EHR; 2.0%, KRD). Evidence of newly diagnosed or suspected CV medical conditions, available only in KRD, was relatively low. The incidence of AEs for patients 65 years or older was consistent with the overall cohort.

Conclusion

Data from 2 US databases reaffirm the safety of 1L ribociclib seen across the ML trials, with no new real-world safety signals among medical conditions of interest. In the real world, 1L ribociclib plus ET is well tolerated for patients with HR+/HER2− MBC, including patients who are older.

Articles in this issue

18 Tolerability of First-Line Treatment With Ribociclib for Metastatic Breast Cancer Using 2 Large US Data Sources
18 Tolerability of First-Line Treatment With Ribociclib for Metastatic Breast Cancer Using 2 Large US Data Sources
20 Impact of Ribociclib Dose Reduction on Efficacy in Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast
20 Impact of Ribociclib Dose Reduction on Efficacy in Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast
21 Distant Disease-Free Survival Across Key Subgroups From the Phase 3 NATALEE Trial of Ribociclib Plus a Nonsteroidal Aromatase Inhibitor in Patients With HR+/HER2− Early Breast Cancer
21 Distant Disease-Free Survival Across Key Subgroups From the Phase 3 NATALEE Trial of Ribociclib Plus a Nonsteroidal Aromatase Inhibitor in Patients With HR+/HER2− Early Breast Cancer
22 Efficacy and Safety of Ribociclib + Nonsteroidal Aromatase Inhibitor in Younger Patients With HR+/HER2− Early Breast Cancer in NATALEE
22 Efficacy and Safety of Ribociclib + Nonsteroidal Aromatase Inhibitor in Younger Patients With HR+/HER2− Early Breast Cancer in NATALEE
23 Clinical Outcomes in Patients With HR+/HER2− Early Breast Cancer By Prior Systemic Treatment: A Subgroup Analysis of the NATALEE Trial
23 Clinical Outcomes in Patients With HR+/HER2− Early Breast Cancer By Prior Systemic Treatment: A Subgroup Analysis of the NATALEE Trial
TPS 24 Phase Ib Dose-Finding Study of [177Lu]Lu-NeoB + Ribociclib + Fulvestrant in Patients With ER+/HER2− Advanced Breast Cancer With GRPR Expression With Early Relapse FromAdjuvant Endocrine Therapy or Progression on ET + CDK4/6i for ABC
TPS 24 Phase Ib Dose-Finding Study of [177Lu]Lu-NeoB + Ribociclib + Fulvestrant in Patients With ER+/HER2− Advanced Breast Cancer With GRPR Expression With Early Relapse FromAdjuvant Endocrine Therapy or Progression on ET + CDK4/6i for ABC
TPS 25 Phase 1/2 Study of the Novel Radioligand Therapy [177Lu]Lu-NeoB Plus Capecitabine in Patients With ER+/HER2− Advanced Breast Cancer (ABC) With GRPR Expression After Progression on Prior Endocrine Therapy Plus a CDK4/6 Inhibitor for ABC
TPS 25 Phase 1/2 Study of the Novel Radioligand Therapy [177Lu]Lu-NeoB Plus Capecitabine in Patients With ER+/HER2− Advanced Breast Cancer (ABC) With GRPR Expression After Progression on Prior Endocrine Therapy Plus a CDK4/6 Inhibitor for ABC
26 Risk of Recurrence in Real-World NATALEE- and monarchE-Eligible Populations of Patients With HR+/HER2− Early Breast Cancer in an Electronic Health Record-Derived Database
26 Risk of Recurrence in Real-World NATALEE- and monarchE-Eligible Populations of Patients With HR+/HER2− Early Breast Cancer in an Electronic Health Record-Derived Database
27 Elacestrant vs Standard of Care in ER+, HER2- Advanced or Metastatic Breast Cancer With ESR1-Mutated Tumors: ESR1 Allelic Frequencies and Clinical Activity From the Phase 3 EMERALD Trial
27 Elacestrant vs Standard of Care in ER+, HER2- Advanced or Metastatic Breast Cancer With ESR1-Mutated Tumors: ESR1 Allelic Frequencies and Clinical Activity From the Phase 3 EMERALD Trial
TPS 28 ELEGANT: Elacestrant VS Standard Endocrine Therapy in Women and Men With Node-Positive, Estrogen Receptor-Positive, HER2-Negative, Early Breast Cancer With High Risk of Recurrence in a Global, Multicenter, Randomized, Open-Label Phase 3 Study
TPS 28 ELEGANT: Elacestrant VS Standard Endocrine Therapy in Women and Men With Node-Positive, Estrogen Receptor-Positive, HER2-Negative, Early Breast Cancer With High Risk of Recurrence in a Global, Multicenter, Randomized, Open-Label Phase 3 Study
29 A Real-World Exploratory Analysis to Identify Disparities in Breast Cancer Tumor Biopsy Practice at Community Oncology Clinics in the United States
29 A Real-World Exploratory Analysis to Identify Disparities in Breast Cancer Tumor Biopsy Practice at Community Oncology Clinics in the United States
30 Imlunestrant, an Oral Selective Estrogen Receptor Degrader, as Monotherapy and Combined With Abemaciclib, for Patients with ER+, HER2– Advanced Breast Cancer, Pretreated With Endocrine Therapy: Results of the Phase 3 EMBER-3 Trial
30 Imlunestrant, an Oral Selective Estrogen Receptor Degrader, as Monotherapy and Combined With Abemaciclib, for Patients with ER+, HER2– Advanced Breast Cancer, Pretreated With Endocrine Therapy: Results of the Phase 3 EMBER-3 Trial
TPS 31 Real-World Sacituzumab Govitecan Treatment Patterns and Outcomes in Second-Line or Later Metastatic Triple-Negative Breast Cancer: Leveraging Electronic Health Records and Manual Curation of a US Database
TPS 31 Real-World Sacituzumab Govitecan Treatment Patterns and Outcomes in Second-Line or Later Metastatic Triple-Negative Breast Cancer: Leveraging Electronic Health Records and Manual Curation of a US Database
36 Expert Perspectives in the Management of Breast Cancer Brain Metastases: A Survey of 32 International Specialists
36 Expert Perspectives in the Management of Breast Cancer Brain Metastases: A Survey of 32 International Specialists
TPS 38 ELCIN: Elacestrant in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer: An Open-Label, Multicenter, Phase 2 Study
TPS 38 ELCIN: Elacestrant in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer: An Open-Label, Multicenter, Phase 2 Study
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