World journal of surgery · 2025
Does Adjuvant Therapy in Invasive Intraductal Papillary Mucinous Neoplasm of the Pancreas Improve Survival? A Systematic Review and Meta-Analysis Using Trial Sequential Analysis.
СтатьяМетаанализСистематический обзорНазвание и аннотация: Перевод пока не подготовлен
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Ingaldi Carlo, D'Ambra Vincenzo, Ricci Claudio, Alberici Laura, Migliori Marina, Di Marco Mariacristina, Palloni Andrea, Mosconi Cristina, Serra Carla, Casadei Riccardo
Аннотация
OBJECTIVE: This meta-analysis aims to evaluate the efficacy of adjuvant therapy (ADJ) in patients with resected invasive IPMNs, compared with follow-up (FUP).
METHODS: A random effects meta-analysis was performed. Meta-regression analysis was used to clarify heterogeneity. The trial sequential analysis was used to test Type I and Type II errors, defining the required information size (RIS). The primary endpoint was OS, and the secondary endpoint was DFS.
RESULTS: The accrued sample size (AIS) was 2422 patients for OS and 493 patients for DFS. OS and DFS in the ADJ arm were similar to the FUP arm (HR 1.21; 95% CI 0.81-1.79, p = 0.349 and HR 0.98; 95% CI 0.64-1.51, p = 0.936). The RIS were 2422 for OS and 254 for DFS, allowing the exclusion of Type II errors. For the primary endpoint, heterogeneity was high (I2 = 98%). Meta-regression analysis showed that, although considering two groups equal for confounding covariates, OS in the ADJ and FUP arms remains similar. A subgroup analysis showed that node-positive patients have improved OS after adjuvant therapy administration (HR 1.86; 95% CI 1.39; 2.47, p < 0.001).
CONCLUSION: Adjuvant therapy should not be administered indiscriminately to all patients. Node-positive invasive IPMN seems to have an improved OS.
TRIAL REGISTRATION: PROSPERO 2024 CRD42024561326.
METHODS: A random effects meta-analysis was performed. Meta-regression analysis was used to clarify heterogeneity. The trial sequential analysis was used to test Type I and Type II errors, defining the required information size (RIS). The primary endpoint was OS, and the secondary endpoint was DFS.
RESULTS: The accrued sample size (AIS) was 2422 patients for OS and 493 patients for DFS. OS and DFS in the ADJ arm were similar to the FUP arm (HR 1.21; 95% CI 0.81-1.79, p = 0.349 and HR 0.98; 95% CI 0.64-1.51, p = 0.936). The RIS were 2422 for OS and 254 for DFS, allowing the exclusion of Type II errors. For the primary endpoint, heterogeneity was high (I2 = 98%). Meta-regression analysis showed that, although considering two groups equal for confounding covariates, OS in the ADJ and FUP arms remains similar. A subgroup analysis showed that node-positive patients have improved OS after adjuvant therapy administration (HR 1.86; 95% CI 1.39; 2.47, p < 0.001).
CONCLUSION: Adjuvant therapy should not be administered indiscriminately to all patients. Node-positive invasive IPMN seems to have an improved OS.
TRIAL REGISTRATION: PROSPERO 2024 CRD42024561326.