Real-world Evaluation of Patient Outcomes and Experiences With Ribociclib Early Adopters.

iDFS is defined as time to first invasive breast cancer recurrence (ipsilateral, contralateral, local/regional, distant), new primary invasive cancer, or death from breast cancer, non-breast cancer or unknown cause.

Distant disease-free survival (DDFS) is defined as time to first distant recurrence, second primary invasive cancer, or death from breast cancer, non-breast cancer or unknown cause.

This will be assessed based on STEEP criteria version 2.0 (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials) and collected retrospectively from patient chart.

The MARS-5 (Medication Adherence Report Scale) is a 5 item questionnaire designed to assess patient adherence to treatment. Score is ranging from 1 (always) to 5 (never) for each item. The total score ranges from 5 to 25, where a higher MARS-5 score indicates higher adherence. One item assesses unintentional non-adherence, and four items assess intentional non-adherence.

6 bespoke questions as to adherence have been added to capture key behavior patterns (ie, use of other products, cost, schedule, time, access to medication and convenience). Score is ranging from 1 (always) to 5 (never) for each item.

Treatment satisfaction will be assessed using 8 bespoke questions, focusing on key domains such as expectations, feelings about side effects, management of side effects, and overall satisfaction. Responses are scored on a 5-point Likert scale ranging 1 (always) to 5 (never) depending on satisfaction level.

Health related quality of life will be assessed with the EORTC QLQ c30, which was designed to measure psychical, social, emotional, cognitive functions, symptom and health status in individuals with cancer.

Item 1-28 are scored on a 4 point Liker t scale (1 + not at all, to 4 + very much). Item 29 and 30 are scored on a 7 point numerical rating scale (from 1 + very poor to 7 + Excellent).

Raw scored are transformed and standardized with scores ranging from 0 to 100. A higher score represents either a better functioning, a higher level of Quality of life or a worse (higher) level of symptomatology.

The EORTC QLQ BR42 is a specific breast cancer questionnaire to be used in conjunction with the EORTC QLQ c30. Items were designed to measure treatment side effect, symptoms, body image sexual functioning, breast satisfaction, future perspective, sexual enjoyment and weight gain.

All items are scored on a 4-point Likert scale (from 1 = Not at all, to 4 = Very much). Items and domains are transformed and scores range between 0-100. Higher scores represent higher (better) functioning or higher levels (worse) symptomatology .

Health related quality of life assessed using bespoke questions to evaluate long term quality of life.

Three bespoke questions were designed to measure long term QoL. The questions will be scored individually from 1 (Always) to 5 (Never), scores will be reversed as needed.

There are also 2 bespoke questions to assess the impact on cognitive functions, both are scored individually from 1 (Always) to 5 (Never) with higher score indicating better cognitive functions.

This is assessed using the WPAI tool, focusing on key aspects such as absenteeism, presenteeism, work productivity loss, activity impairment, and long-term impact of side effects on work activity.

This questionnaire has 6 questions, which are used to calculate 4 types of scores, which are absenteeism (work time missed), presenteeism (impairment at work/reduced on the job effectiveness), work productivity loss (overall work impairment), and activity impairment. The scores are expressed in percentage with higher numbers indicating greater impairment and less productivity.

Patients' experience of treatment assessed using qualitative interviews conducted in the sub-cohort of ribociclib + ET in the US only.

One bespoke question is used to evaluate impact of side effect on work productivity. The question is rated from 1 (always) to 5 (never) with higher score indicating better situation (reduced impact on work).

Proportion of patients who continue (persist) and discontinue ribociclib + ET.

Distant disease-free survival (DDFS) is defined as the time to first distant recurrence, second primary invasive cancer, or death from breast cancer, non-breast cancer or unknown cause.

Overall survival (OS) is defined as time to death from breast cancer, non-breast cancer or unknown cause.

Distant recurrence-free survival (DRFS) is defined as the time to first distant recurrence or death from breast cancer, non-breast cancer or unknown cause.

Invasive disease-free survival (iDFS) is defined as the time to first invasive breast cancer recurrence (ipsilateral, contralateral, local/regional, distant), new primary invasive cancer, or death from breast cancer, non-breast cancer or unknown cause.

Invasive breast cancer-free survival (iBCFS) is defined as time to first invasive breast cancer recurrence (ipsilateral, local/regional, contralateral or distant) or death from breast cancer, non-breast cancer or unknown cause.

Patient characteristics and tumor characteristics at/around recurrence, as available from chart.

AEs will be collected retrospectively from chart with their grading.

• Adjuvant setting: neoadjuvant, adjuvant, and any chemotherapy, type of primary site surgery, neoadjuvant ET, neoadjuvant chemotherapy and/or ET, type of ET, and TTD from adjuvant ribociclib initiation.
• Metastatic setting: number of patients who receive 1L, most common treatment regimens at 1L, and TTD from the start of 1L following the first metastatic recurrence