A Real-world Study of Effectiveness and Safety in HR+/HER2- Breast Cancer Patients Treated With Ribociclib or Alpelisib

rwPFS was defined as the time from the index date to the date of the first documented progression or death due to any cause. If a patient did not have an event, rwPFS was censored at the date of the last adequate tumor assessment. The index date was defined as the date of the first treatment with ribociclib or alpelisib.

Age groups:

• Younger than 65 years
• 65 years or older

The index date was defined as the date of the first treatment with ribociclib or alpelisib.

Comorbidities included:

• Diabetes mellitus
• Cardiovascular disease
• Cerebrovascular disease
• Chronic obstructive pulmonary disease (COPD)
• Dementia
• Depression
• Heart Failure
• Hypertension
• Hypothyroidism
• Ischemic heart disease
• Liver disease
• Myocardial infarction
• Osteoporosis
• Peripheral vascular disease
• Renal Disease
• Rheumatological disease
• Ulcer disease
• Other

BMI Categories:

• Underweight: below 18.5 kilograms per meter squared (kg/m^2)
• Healthy/normal weight: 18.5 to 24.9 kg/m^2
• Pre-obesity: 25 to 29.9 kg/m^2
• Obesity: 30 kg/m^2 and higher

Menopausal status:

• Pre- or peri-menopausal
• Post-menopausal

CCI predicts the ten-year mortality for a patient who may have a range of comorbid conditions. Comorbidity was assessed using the CCI, categorized as low (0-1) and high (≥2).

Disease recurrence categories:

• 12 months or less
• More than 12 months

Smoking status:

• Current smoker
• Former smoker
• Never smoked

Tumor types:

• Invasive ductal
• Lobular carcinoma
• Other

Disease site categories:

• Non-visceral
• Visceral
• Multiple

Categories for number of metastatic sites: 0, 1, 2, 3, 4 or more.

Metastases:

• Local/breast metastases
• Bone metastases
• Lung metastases
• Liver metastases
• Central nervous system metastases
• Lymph node metastases
• Other metastases

Categories:

• 24 months or less
• More than 24 months
• Metastatic BC at diagnosis

Tumor Grades:

• Grade 1
• Grade 2
• Grade 3

Cancer Stages: I, IIA, IIB, IIIA, IIIB, IIIC, and IV.

ECOG performance score describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Scores ranged from a lower value of 0 (fully active, able to carry out all pre-disease performance without restriction) up to 4 (completely disabled; cannot carry out any selfcare; totally confined to bed or chair).

Treatment categories:

• Chemotherapy
• Surgery
• Radiotherapy
• Adjuvant endocrine therapy
• Everolimus treatment

Categories for number of lines of ET: 0, 1, 2, and 3 or more.

CDK4/6i lines of treatment:

• Adjuvant
• 1st metastatic line
• 2nd metastatic line
• 3rd metastatic line or later

Categories for number of lines of treatment: 0, 1, 2, and 3 or more.