HPB O03 - Snapshot Audit of RELEVANCE: REal worLd outcomEs of adjuVant therapy in pANcreatic CancEr

Abstract Background Evidence-based medicine plays a critical role in shaping clinical practices and setting patient expectations. While randomized controlled trials (RCTs) of adjuvant chemotherapy in pancreatic cancer have demonstrated improved survival rates with newer regimens, their selective inclusion criteria often favor patients with better prognoses. This study aims to compare real-world outcomes with those from RCTs to evaluate the effectiveness of adjuvant therapies in typical clinical settings. Method In this retrospective study, we examined overall survival (OS) among patients who received adjuvant chemotherapy (gemcitabine, gemcitabine-capecitabine, or FOLFIRINOX) following the resection of pancreatic ductal adenocarcinoma. We compared survival curves from RCTs (ESPAC 4, PRODIGE-24) with those from real-world cohorts selected based on RCT criteria. Data were collected retrospectively from medical records and institutional databases, covering OS, disease-free survival (DFS), and adverse events. Results From July 2014 to December 2019, 303 pancreatic ductal adenocarcinoma patients underwent resections, with 209 (69%) receiving adjuvant chemotherapy: 91 (44%) received gemcitabine, 69 (34%) gemcitabine-capecitabine, and 37 (18%) FOLFIRINOX. The median OS for gemcitabine was 21.6 months, close to ESPAC 4’s 25.5 months. Gemcitabine-capecitabine had a median OS of 25.2 months versus ESPAC 4’s 28 months. FOLFIRINOX had a lower median OS in our cohort (19.9 months) compared to PRODIGE 24’s 54.4 months. Additionally, gemcitabine OS in PRODIGE 24 was higher (35 months) than in our data. FOLFIRINOX had a 17% completion rate. Conclusion The real-world outcomes for gemcitabine-based adjuvant therapy align closely with RCT results, while FOLFIRINOX appears less effective in typical clinical settings, possibly due to tolerance issues. These findings highlight the importance of incorporating real-world data in clinical decision-making to better predict patient outcomes and improve treatment strategies for pancreatic cancer. Further research is needed to bridge the gap between RCTs and real-world practices, especially concerning patient selection and treatment tolerability.