Real-World Burden of Illness in Patients With ER+/HER2- ABC Receiving Second-Line Treatment: Interim Results of Longitudinal Health Utility Data
Author(s)
Prabir Chakraborti, MD1, Christian Atkinson, MRes2, Veronique Lambert, PhD3, Anna Louise Barry, MSc4, Joseph C. Cappelleri, MPH, MS, PhD3, David Chandiwana, MSc5, Charley Cooper, MSc2, Liane Gillespie-Akar, MSc2, Katie Louise Mycock, MChem2, Chloe Grace Rose, MS, PharmD3.
1Buckinghamshire NHS Health Trust, Aylesbury, United Kingdom, 2Adelphi Real World, Bollington, United Kingdom, 3Pfizer Inc, New York, NY, USA, 4Pfizer Ltd, Surrey, United Kingdom, 5Arvinas Inc, Randolph, NJ, USA.
1Buckinghamshire NHS Health Trust, Aylesbury, United Kingdom, 2Adelphi Real World, Bollington, United Kingdom, 3Pfizer Inc, New York, NY, USA, 4Pfizer Ltd, Surrey, United Kingdom, 5Arvinas Inc, Randolph, NJ, USA.
OBJECTIVES: Estimate health utility for patients with estrogen receptor-positive (ER+) human epidermal growth factor receptor 2-negative (HER2-) advanced/metastatic breast cancer (aBC) receiving second-line (2L) treatment in a real-world setting.
METHODS: Data were prospectively collected (November 2023-April 2025) from patients with ER+/HER2- aBC, previously treated with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i), initiating 2L endocrine-therapy (ET) or targeted-therapies (TT)±ET at 9 sites in the UK and Canada. Health utility and health-related quality of life (HRQoL; EQ-5D-5L, Functional Assessment of Cancer Therapy Breast Symptom Index [FBSI-16]) data were collected at baseline (prior to 2L initiation) and months 1, 2, 4, and 6 following 2L initiation, and reported by collection timepoint (baseline and pre-progression observations) and as mean on-treatment score (pooled pre-progression observations). Patient demographic and clinical characteristics were extracted from medical records.
RESULTS: A descriptive longitudinal profile of interim data are reported for 22 patients (mean age: 62.2 years; White: 90%; mean time since mBC diagnosis: 3.4 years [n=21]) who received 2L ET (n=5) or TT±ET (n=17); the majority received mTOR or PI3K/AKT pathway inhibitors as TT. The mean on-treatment utility score, based on 73 longitudinal observations from 22 patients (mean [range] observations per patient: 3.32 [2-5]) was 0.64 (95% CI: 0.59-0.68). Mean (95% CI) utilities were 0.62 (0.53-0.72) at baseline (n=22), 0.61 (0.52-0.70) at month 1 (n=21), 0.71 (0.61-0.80) at month 2 (n=14), 0.63 (0.52-0.75) at month 4 (n=9), and 0.60 (0.37-0.82) at month 6 (n=7). The mean on-treatment FBSI-16 score (scale: 0-64) was 39.9 (95% CI: 37.3-42.6). Mean FBSI-16 GP5 (“I am bothered by side effects of treatment”; scale 0-4) was 2.4 (95% CI: 2.1-2.7).
CONCLUSIONS: This interim analysis demonstrates real-world health utility is lower for patients with ER+/HER2- aBC, receiving 2L TT±ET or ET, compared to prior published estimates and could suggest a negative impact on patient HRQoL associated with treatment side effects.
METHODS: Data were prospectively collected (November 2023-April 2025) from patients with ER+/HER2- aBC, previously treated with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i), initiating 2L endocrine-therapy (ET) or targeted-therapies (TT)±ET at 9 sites in the UK and Canada. Health utility and health-related quality of life (HRQoL; EQ-5D-5L, Functional Assessment of Cancer Therapy Breast Symptom Index [FBSI-16]) data were collected at baseline (prior to 2L initiation) and months 1, 2, 4, and 6 following 2L initiation, and reported by collection timepoint (baseline and pre-progression observations) and as mean on-treatment score (pooled pre-progression observations). Patient demographic and clinical characteristics were extracted from medical records.
RESULTS: A descriptive longitudinal profile of interim data are reported for 22 patients (mean age: 62.2 years; White: 90%; mean time since mBC diagnosis: 3.4 years [n=21]) who received 2L ET (n=5) or TT±ET (n=17); the majority received mTOR or PI3K/AKT pathway inhibitors as TT. The mean on-treatment utility score, based on 73 longitudinal observations from 22 patients (mean [range] observations per patient: 3.32 [2-5]) was 0.64 (95% CI: 0.59-0.68). Mean (95% CI) utilities were 0.62 (0.53-0.72) at baseline (n=22), 0.61 (0.52-0.70) at month 1 (n=21), 0.71 (0.61-0.80) at month 2 (n=14), 0.63 (0.52-0.75) at month 4 (n=9), and 0.60 (0.37-0.82) at month 6 (n=7). The mean on-treatment FBSI-16 score (scale: 0-64) was 39.9 (95% CI: 37.3-42.6). Mean FBSI-16 GP5 (“I am bothered by side effects of treatment”; scale 0-4) was 2.4 (95% CI: 2.1-2.7).
CONCLUSIONS: This interim analysis demonstrates real-world health utility is lower for patients with ER+/HER2- aBC, receiving 2L TT±ET or ET, compared to prior published estimates and could suggest a negative impact on patient HRQoL associated with treatment side effects.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
RWD149
Topic
Patient-Centered Research, Real World Data & Information Systems, Study Approaches
Disease
Oncology