A Study of Real-World Outcomes of Ribociclib in First-Line Treatment for Metastatic HR+/HER2- Breast Cancer

Novartis Pharmaceuticals350 enrolled

Overview

The main aim of this study was to describe the profile of hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (mBC) patients who received first-line (1L) current treatment options with ribociclib in the United States (US) clinical practice. This study used administrative claims data. De-identified patient-level data of adult patients with HR+/HER2- mBC who initiated 1L treatment with a cyclin dependant kinase 4/6 inhibitor (CDK4/6i) i.e., ribociclib from the Komodo Health Solutions Research Database (KRD; data from 1 January 2016 to 30 June 2023) was used. Data included medical and pharmacy claims for insured patients, which had already been collected (i.e., secondary use of data).

Study Type

OBSERVATIONAL

Enrollment

350

Conditions

Metastatic HR+/HER2- Breast Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: * Had 1 or more paid pharmacy claims for ribociclib with the first claim for the CDK4/6i observed between 26 February 2018 and 31 December 2022 (i.e., during the index period) * With the index CDK4/6i used in combination with an endocrine-based therapy, that is an aromatase inhibitor (i.e., letrozole, anastrozole, or exemestane), or fulvestrant, as 1L treatment for mBC * With the endocrine therapy (ET) initiated within 60 days of the first paid pharmacy claim of the index CDK4/6i; ET may have been initiated no earlier than 60 days prior to the index date (expected window for insurance approval of the CDK4/6i as 1L treatment for mBC in a real-world setting) * Adult who was 18 years of age or older as of the index date * Had 2 or more medical service claims with a code for breast cancer (BC) separated by 30 days or more, and 1 or more claims with a code for BC prior to the index date * Had 2 or more medical service claims with a code for a secondary neoplasm separated by 30 days or more, with the first code for a secondary neoplasm occurring not earlier than 30 days from the first diagnosis for BC, and 1 or more claims with a code for a secondary neoplasm prior to the index date * Had continuous health plan enrollment for 12 months or more prior to and 1 month or more after the index date Exclusion criteria: * Patients who did not meet the inclusion criteria * Had a diagnosis for other primary cancers (other than BC) before the first diagnosis for secondary neoplasm * Had prior treatments for BC (i.e., chemotherapy, targeted therapy, ET \[except ≤60 days prior to index date\], or immunotherapy) during the 12-month washout period (relapsed/progressed ≤12 months prior to index date) * Had prior surgical procedure for BC during the 12-month washout period (relapsed/progressed ≤12 months prior to index date) * Had evidence of participation in a clinical trial prior to or at the index date (International Classification of Disease, 10th Edition, Clinical Modification \[ICD-10-CM\]: Z00.6)

Outcomes

Primary Outcomes

Number Patients by Demographic Category

Demographics included: * Age (≥ 65 years, ≥ 75 years) * Gender * Race * Index year (year of the first paid pharmacy claim for ribociclib)

Time frame: Baseline

Number of Patients by Clinical Characteristic Category

Clinical characteristic categories included: * Menopausal status * Comorbidity * Metastatic site * Eastern Cooperative Oncology Group (ECOG) performance score less than 2 ECOG performance score measures a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability. Scores range from 0 (fully active, able to carry out all pre-disease performance without restriction) to 5 (deceased).

Time frame: Baseline

Clinical Characteristic: National Cancer Institute (NCI) Comorbidity Index Score

The NCI comorbidity index is a tool used to measure the risk of non-cancer deaths for cancer patients based on the presence and severity of other health conditions. It includes 14 conditions identified using administrative data diagnosis and procedure codes. The index excludes solid tumors, leukemias, and lymphomas as comorbid conditions. Each condition is assigned a score based on how serious it is and patient scores are summed to give a final overall score. A high score indicates a higher burden of comorbid conditions and possible higher risk of death.

Time frame: Baseline

Clinical Characteristic: Number of Metastatic Sites

Time frame: Baseline

Treatment Characteristic: Number of Patients by Type of Treatment Received While on 1L mBC Treatment

Treatments included: * Endocrine therapy partner (AI, Fulvestrant, or AI and Fulvestrant) * Gonadotropin-releasing hormone (GNRH) * Cytochrome P450, family 3, subfamily A (CYP3A) inhibitors and inducers * P-inhibitors and inducers * Medications potentially associated with an increased risk of torsade de pointes