Inflammation‑based prognostic markers of metastatic pancreatic cancer using real‑world data in Japan: The Tokushukai REAl‑world Data (TREAD) project.

"Competing interests The authors declare that they have no competing interests."

"Funding: No funding was received."

"The Tokushukai Real-world Data (TREAD) project is a retrospective cohort study conducted at Tokushukai Medical Group hospitals. Tokushukai Medical Group is a leading medical group in Japan, encompassing 71 general hospitals nationwide. The study utilizes a shared medical record system across these hospitals. (e-Karte and Newtons2; Software Service Inc., Osaka, Japan) and chemotherapy protocol system (srvApmDrop; Software Service Inc., Osaka, Japan), the details of which can be found in a separate article (). The project adhered to the ethical guidelines for medical and biological research involving human subjects in Japan () and followed the principles of the Declaration of Helsinki. Approval for the study was obtained from the Ethics Committee of the Tokushukai Group in April 2020 (approval no. TGE01427-024). Patients were informed about the opt-out method, and the study was registered in the UMIN Clinical Trial Registry under the number UMIN000050590. Inflammation-based prognostic markers based on a combination of blood-based parameters, including the modified Glasgow prognostic score (mGPS), have been associated with clinical outcomes in patients with various types of cancer. The present study aimed to evaluate and compare the accuracy of these previously reported markers in patients with metastatic pancreatic cancer receiving first-line chemotherapy. A total of 846 patients were identified between April 2010 and March 2020 as part of a nationwide real-world study from 46 Tokushukai medical group hospitals in Japan. Blood laboratory data collected within 14 days of starting first-line chemotherapy assessed 17 inflammation-based prognostic markers. Information from patients with no missing data was used to compare the accuracy and performance of the inflammation-based prognostic markers. A total of 487 patients were eligible for this supplemental analysis. The 17 inflammation-based markers demonstrated significant prognostic value. Among them, the concordance rate with overall survival (OS) was highest for mGPS. The median OS time of patients with mGPS 0, 1 and 2 was 8.2, 6.0 and 2.9 months, respectively. Compared with mGPS 0, mGPS 1 and 2 showed hazard ratios of 1.39 (95% confidence interval, 1.07–1.81) and 2.63 (2.00–3.45), respectively. The present real-world data analysis showed that various previously reported inflammation-based markers had significant prognostic value in patients with metastatic pancreatic cancer. Among these markers, the mGPS demonstrated the highest level of accuracy. This trial has been registered in the University Hospital Medical Information Network Clinical Trials Registry as UMIN000050590 on April 1, 2023. Ethics approval and consent to participate: The project adhered to the ethical guidelines for medical and biological research involving human subjects in Japan and followed the principles of The Declaration of Helsinki. Approval for the study was obtained from the Ethics Committee of the Tokushukai Group in April 2020 (approval no. TGE01427-024), and the study was registered in the UMIN Clinical Trial Registry under the number UMIN000050590. Patients were provided with information using opt-out methods and no patient declared not to participate."