Background <p>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.</p> Methods <p>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.</p> Results <p>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&#xa0;months, <i>P</i> &lt; 0.01; median OS 12 vs. 8.0&#xa0;months, <i>P</i> = 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&#xa0;g/dl), and low carcinoembryonic antigen (CEA) (&lt; 5.4&#xa0;ng/mL) were preferable independent efficacy predictors for PFS and also independent prognostic factors for OS.</p> Conclusion <p>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.</p>

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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

  • Kaori Hino,
  • Tomohiro Nishina,
  • Mitsuhito Koizumi,
  • Kaori Marui,
  • Masahito Kokubu,
  • Yuki Numata,
  • Yoshiki Imamura,
  • Kozue Kanemitsu-Okada,
  • Toru Otsuru,
  • Taira Kuroda,
  • Yoshinori Ohno,
  • Akinori Asagi,
  • Hideki Miyata,
  • Tomoyuki Yokota,
  • Teru Kumagi,
  • Ichinosuke Hyodo,
  • Yoshio Ikeda,
  • Yoichi Hiasa

摘要

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.