SynthesisAnnals of surgery2024
Surrogacy of Recurrence-free Survival for Overall Survival as an Endpoint of Clinical Trials of Perioperative Adjuvant Therapy in Hepatobiliary-pancreatic Cancers: A Retrospective Study and Meta-analysis.
Synthesis in Annals of surgery, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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Who cites it
7 citing papers in PubMed, 5 citations in OpenAlex.
- Effects of an intensive pulmonary rehabilitation program on postoperative pulmonary complications in frail elderly patients undergoing hepatobiliary and pancreatic surgery: a randomized controlled trial.Frontiers in oncology · 2026Trial
- ASO Author Reflections: Redefining Prognostic Endpoints in Intrahepatic Cholangiocarcinoma-The Role of Recurrence-Free Survival.Annals of surgical oncology · 2025Article
- Recurrence-Free Survival as a Surrogate for Overall Survival Among Patients with Intrahepatic Cholangiocarcinoma Following Upfront Surgery: An International Multi-institutional Analysis.Annals of surgical oncology · 2025Article
- Histologic- and Genomic-Directed Adjuvant Therapy for Ampullary Adenocarcinoma: A Hidden Genome-Derived Analysis.Journal of the National Comprehensive Cancer Network : JNCCN · 2025Article
- Comparison of initial treatments for resectable hepatocellular carcinoma within Milan criteria: an observational study based on a nationwide survey.Annals of surgical treatment and research · 2025Article
- Recurrence-free or progression-free survival as a surrogate endpoint for overall survival in hepatobiliary-pancreatic cancers: would be associated with time change.Hepatobiliary surgery and nutrition · 2024Article
- Surrogate endpoints in clinical trials: when is good...good enough?Hepatobiliary surgery and nutrition · 2024Article
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8 authors at 1 institution in 1 country.
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No grant is acknowledged in the PubMed record.
Abstract
objectiveTo assess the correlation between recurrence-free survival (RFS) and overall survival (OS) in the hepatobiliary-pancreatic (HBP) surgical setting to validate RFS as a surrogate endpoint.
backgroundReliable surrogate endpoints for OS are still limited in the field of HBP surgery.
methodsWe analyzed patients who underwent curative resection for HBP disease [986 patients with pancreatic ductal adenocarcinoma (PDAC), 1168 with biliary tract cancer (BTC), 1043 with hepatocellular carcinoma, and 1071 with colorectal liver metastasis] from September 2002 to June 2022. We also conducted meta-analyses of randomized controlled trials of neoadjuvant or adjuvant therapy to validate the surrogacy in PDAC and BTC.
resultsCorrelation coefficients between RFS and OS were low for hepatocellular carcinoma ( p = 0.67) and colorectal liver metastasis ( p = 0.53) but strong for PDAC ( p = 0.80) and BTC ( p = 0.75). In a landmark analysis, the concordance rates between survival or death at 5 years postoperatively and the presence or absence of recurrence at each time point (1, 2, 3, and 4 years) were 50%, 70%, 74%, and 77% for PDAC and 54%, 67%, 73%, and 78% for BTC, respectively, both increasing and reaching a plateau at 3 years. In a meta-analysis, the correlation coefficients for the RFS hazard ratio and OS hazard ratio in PDAC and BTC were p = 0.88 ( P < 0.001) and p = 0.87 ( P < 0.001), respectively.
conclusionsThree-year RFS can be a reliable surrogate endpoint for OS in clinical trials of neoadjuvant or adjuvant therapy for PDAC and BTC.
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