OBJECTIVES: Hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2−) breast cancer (BC) accounts for ~70% of early-stage cases. Given the high unmet need and emerging new therapies for early-stage HR+/HER2- BC, it is important to understand the humanistic and economic burden in this setting.

METHODS: Systematic literature reviews of Embase^®, MEDLINE^®, Tufts CEA, EconLit, CRD York databases were conducted (database inception to May 10, 2023). Relevant conference proceedings were also searched (2020­-2023). Study selection was in accordance with NICE recommendations. PICOTS criteria included adult patients with early-stage HR+/HER2- BC (localized invasive breast ductal adenocarcinoma stage T1c-T2, clinical node (cN) stage cN1-cN2, or T3-T4, cN0-cN2).

RESULTS: N=10 studies were identified for economic burden, from North America (n=6), Europe (n=2), Oceania and international (n=1 each). Studies were heterogeneous in terms of methodologies used and timeframe reported. Total healthcare costs per patient were reported for Canada (CAN$22,662), US (US$10­,391-31,458), Portugal (€11,516), UK (£4,765-5,987), and New Zealand (NZ$28,481). Costs were higher among patients receiving chemotherapy-based regimens vs. endocrine therapy, driven by hematopoietic growth factor use. Healthcare resource utilization (HCRU) was characterised by hospitalizations including inpatient (19-45%), outpatient (25-96%), and emergency room visits (62%). Significantly higher hospitalization rates were reported among patients with stage II-III HR+/HER2- BC receiving chemotherapy vs. endocrine therapy (54% vs. 9%). N=8 studies reported humanistic burden. EORTC-QLQ-C30 scores showed clinically meaningful deterioration from baseline among patients who received neoadjuvant ribociclib+letrozole (36% patients) or chemotherapy (68% patients). Chemotherapy was associated with significant deterioration in cognitive/sexual functioning and symptom burden. Meanwhile, EQ-5D utility values were comparable during active adjuvant therapy (during treatment) vs. post-adjuvant surveillance (0.836-0.868 vs. 0.851-0.869, respectively).

CONCLUSIONS: Existing treatment options in early-stage HR+/HER2- BC were associated with substantial healthcare resource use, economic burden and decrement in quality of life suggesting an unmet need for novel treatment approaches in this setting.