A multicenter prospective observational study for health assessment questionnaires EQ-5D-5L and G8 in unresectable advanced pancreatic cancer treated with first-line gemcitabine plus nab-paclitaxel therapy.

Background: In chemotherapy for unresectable advanced pancreatic cancer (UPC), the clinical utility of pre-treatment health assessment questionnaires, EuroQoL 5-Dimension 5-Level (EQ-5D-5L) and G8, is unknown. This study aimed to fill this gap.

Methods: This multicenter, prospective, observational study investigated the association of EQ-5D-5L and G8 with the clinical outcomes of first-line gemcitabine plus nab-paclitaxel (GnP) for UPC. Differences in survival were analyzed using the log-rank test, and multivariate analyses were performed using the Cox proportional hazards model.

Results: Between April 2022 and September 2023, 60 patients were enrolled, and their data were analyzed. When patients were classified into two groups using the median EQ-5D-5L utility value (0.824), progression-free survival (PFS) and overall survival (OS) were significantly longer in patients with high EQ-5D-5L utility values than in those with low utility values (median PFS 7.0 vs. 4.7 months, P < 0.01; median OS 12 vs. 8.0 months, P = 0.023). Such differences were not observed in the EQ-5D-5L Visual Analog Scale or G8 scores. There was no association between the occurrence of severe adverse events and EQ-5D-5L or G8 scores. Multivariate analyses showed that high EQ-5D-5L utility value (≥ 0.824), high albumin (≥ 3.8 g/dl), and low carcinoembryonic antigen (CEA) (< 5.4 ng/mL) were preferable independent efficacy predictors for PFS and also independent prognostic factors for OS.

Conclusion: Pre-treatment EQ-5D-5L utility value, along with albumin and CEA, was an independent efficacy predictor and prognostic factor in patients with UPC treated with first-line GnP. Their usefulness should be validated in future studies.