Background: Gallbladder cancer (GBC) is a rare but aggressive malignancy. Prognostic tools are essential for optimizing postoperative treatment strategies. We aim to develop and validate a prognostic nomogram to estimate 1-, 3-, and 5-year overall survival (OS) in GBC patients and explore the role of adjuvant chemotherapy across different subgroups. Methods: A total of 1848 postoperative GBC patients from the SEER database (2000–2020 17 regions) were analyzed, with an additional external validation cohort of 108 patients from China (2010–2020). Prognostic factors were identified using LASSO regression and multivariable Cox analysis. A nomogram was constructed and validated using the concordance index (C-index), time-dependent ROC curves, calibration curves, and decision curve analysis (DCA). Subgroup analyses were performed to evaluate the impact of adjuvant chemotherapy. Results: The nomogram demonstrated strong predictive performance, with C-indices of 0.767 (training), 0.798 (internal validation), and 0.750 (external validation). Time-dependent ROC curves in the training cohort showed AUCs of 0.777, 0.769, and 0.800 for 1-, 3-, and 5-year OS, respectively. In the internal validation cohort, the corresponding AUCs were 0.763, 0.743, and 0.803. External validation using the independent Chinese cohort of 108 patients showed consistent results, with AUCs of 0.771, 0.835, and 0.810 for 1-, 3-, and 5-year OS. Subgroup analysis revealed that adjuvant chemotherapy significantly improved survival in patients with TNM stage >IIB. In contrast, patients with early-stage disease (TNM ≤ IIB) showed no significant survival benefit from chemotherapy. Conclusions: This study developed a validated prognostic nomogram for postoperative GBC patients, demonstrating strong discrimination and calibration. Subgroup analysis suggests that adjuvant chemotherapy benefits select high-risk patients, aiding personalized decision-making in clinical practice.
背景:胆囊癌是一种罕见但侵袭性强的恶性肿瘤。预后评估工具对于优化术后治疗策略至关重要。本研究旨在开发并验证一种预测胆囊癌患者1年、3年和5年总生存期的预后列线图,并探讨辅助化疗在不同亚组中的作用。 方法:分析来自SEER数据库(2000-2020年,17个地区)的1848例术后胆囊癌患者,并使用来自中国(2010-2020年)的108例患者作为外部验证队列。通过LASSO回归和多变量Cox分析确定预后因素。构建列线图,并使用一致性指数、时间依赖性ROC曲线、校准曲线和决策曲线分析进行验证。通过亚组分析评估辅助化疗的影响。 结果:列线图显示出强大的预测性能,训练集、内部验证集和外部验证集的一致性指数分别为0.767、0.798和0.750。训练集中1年、3年和5年总生存期的时间依赖性ROC曲线下面积分别为0.777、0.769和0.800。在内部验证集中,相应的曲线下面积分别为0.763、0.743和0.803。使用独立的108例中国患者队列进行外部验证,结果一致,1年、3年和5年总生存期的曲线下面积分别为0.771、0.835和0.810。亚组分析显示,辅助化疗显著提高了TNM分期>IIB患者的生存率。相比之下,早期疾病(TNM ≤ IIB)患者未从化疗中获得显著的生存获益。 结论:本研究开发并验证了用于术后胆囊癌患者的预后列线图,显示出良好的区分度和校准度。亚组分析表明辅助化疗可使选定的高危患者获益,有助于临床实践中的个性化决策。