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Efficacy of neoadjuvant therapy in gallbladder cancer: a meta-analysis using reconstructed time-to-event data
Sean Loke1, Chen Ee Low1, Benedict Ding Chao Ong1
1Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
Background:
Gallbladder cancer (GBC) is an aggressive malignancy with poor prognosis due to its late-stage diagnosis and high recurrence rates after surgery. Neoadjuvant chemotherapy (NAC) has been explored as a strategy to improve resectability, downstage tumors, and target micrometastatic disease. However, the efficacy of NAC remains inconclusive due to heterogeneous study designs. This meta-analysis aimed to evaluate the effect between NAC and upfront surgery on overall survival (OS) and disease-free survival (DFS) in patients with GBC.
Methods:
A systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (International Prospective Register of Systematic Reviews reference number: CRD42024621395). PubMed, Embase, and Cochrane databases were searched for studies reporting on patients with GBC who received NAC followed by surgery or upfront surgery. Kaplan-Meier curves from studies were digitized and reconstructed, and a 1-stage meta-analysis was performed. The primary objective was evaluating OS, and the secondary objectives were evaluating DFS, postoperative complications, and surgical futility.
Results:
A total of 13 studies (N = 6059) were included, with 4 studies comparing NAC with upfront surgery and 9 single-arm studies evaluating NAC outcomes alone. NAC was associated with significantly improved OS (hazard ratio [HR], 0.54 [95% CI, 0.47-0.62]) compared with upfront surgery. DFS analysis showed a median of 42.9 months (95% CI, 33.9-56.0) in patients treated with NAC. The postoperative complication rates were similar between the groups. However, the proportion of patients unable to proceed to surgery due to disease progression was lower in the NAC group (0.16 [95% CI, 0.05-0.38]) than in the upfront surgery group (0.27 [95% CI, 0.05-0.73]).
Conclusion:
NAC in GBC is associated with improved OS and reduced surgical futility without an increase in postoperative morbidity. Our findings highlight the need for randomized controlled trials to validate NAC's role in treatment algorithms for resectable GBC.
