Reference values for EORTC QLQ-C30, for metastatic pancreatic cancer (mPC): Enhancing the interpretation of HRQoL scores in the POLO trial.

393 Background: Metastatic pancreatic cancer (mPC) and its treatments significantly impact patients’ (pts) health-related quality of life (HRQoL). POLO, a randomized, double-blind, placebo-controlled phase 3 trial evaluated the efficacy of olaparib as maintenance therapy in mPC pts who had not progressed during ≥16 weeks of first-line platinum-based chemo. HRQoL was assessed in POLO using EORTC QLQ-C30. To enhance the interpretation of HRQoL scores in POLO, we derived EORTC QLQ-C30 reference (ref) values for mPC from the literature, as these had not been previously established. Methods: A systematic literature review was conducted to identify existing baseline values in published data. EORTC QLQ-C30 ref values were calculated by deriving mean scores based on studies meeting all inclusion criteria. EORTC QLQ-C30 mean values were calculated for POLO using pooled baseline data from both study arms (olaparib; placebo). Results: Out of 186 studies identified, 4 met all inclusion criteria. Depending on respective EORTC QLQ-C30 subscale, the final sample sizes ranged from n=466 to n=639. Compared to the newly derived EORTC QLQ-C30 ref values based on the literature, POLO pts reported markedly better HRQoL scores at baseline across most subscales, with eight subscales showing differences of >15 points (table). Conclusions: This is the first study to systematically derive EORTC QLQ-C30 ref values for mPC. We found that mPC pts enrolled in POLO had better HRQoL scores compared with those reported in the literature and often close to or better than general population norm data, possibly due to positive effects of prior platinum-based first-line treatment, resolution of chemotherapy-related symptoms, response shift, or a combination. These newly derived ref values enhance the interpretation of patients’ HRQoL trajectory within a maintenance treatment setting. [Table: see text]