Department of Surgery, Wexner Medical Center and James Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.
Department of Surgery, University of Verona, Verona, Italy.
Ann Surg Oncol. 2023 Aug;30(8):4799-4808. doi: 10.1245/s10434-023-13429-z. Epub 2023 Apr 8.
Concordance between clinical and pathological staging, as well as the overall survival (OS) benefit associated with neoadjuvant therapy (NAT) remain ill-defined. We sought to determine the impact of staging accuracy and NAT downstaging on OS among patients with intrahepatic cholangiocarcinoma (ICC).
Patients treated for ICC between 2010 and 2018 were identified using the National Cancer Database. A Bayesian approach was applied to estimate NAT downstaging. OS was assessed relative to staging concordant/overstaged disease treated with upfront surgery, understaged disease treated with upfront surgery, no downstaging, and downstaging after NAT.
Among 3384 patients, 2904 (85.8%) underwent upfront surgery, whereas 480 (14.2%) received NAT and 85/480 (18.4%) were downstaged. Patients with cT3 (odds ratio [OR] 2.12, 95% confidence interval [CI] 1.34-3.34), cN1 (OR 2.47, 95% CI 1.71-3.58) disease, and patients treated at high-volume facilities (OR 1.63, 95% CI 1.13-2.36) were more likely to receive NAT (all p < 0.05). Median OS was 40.1 months (95% CI 38.6-43.4). Patients with cT1-2N1 (NAT: 31.5 months vs. upfront surgery: 22.4 months; p = 0.04) and cT3-4N1 (NAT: 27.8 months vs. upfront surgery: 14.4 months; p = 0.01) disease benefited most from NAT. NAT downstaging decreased the risk of death among patients with cT3-4N1 disease (hazard ratio [HR] 0.35, 95% CI 0.15-0.82). In contrast, understaged patients with cT1-2N0/X (HR 2.15, 95% CI 1.83-2.53) and cT3-4N0/X (HR 1.71, 95% CI 1.06-2.74) disease treated with upfront surgery had increased risk of death.
Patients with N1 ICC treated with NAT demonstrated improved OS compared with upfront surgery. Downstaging secondary to NAT conferred survival benefits among patients with cT3-4N1 versus upfront surgery. NAT should be considered in ICC patients with advanced T disease and/or nodal metastases.
临床病理分期的一致性以及新辅助治疗（NAT）带来的总生存（OS）获益仍不明确。我们旨在确定肝内胆管癌（ICC）患者中分期准确性和 NAT 降期对 OS 的影响。
使用国家癌症数据库确定了 2010 年至 2018 年间接受 ICC 治疗的患者。应用贝叶斯方法估计 NAT 降期。根据与初始手术治疗的分期一致/过度分期疾病、初始手术治疗的分期不足疾病、无降期和 NAT 后降期相关的 OS 进行评估。
在 3384 例患者中，2904 例（85.8%）接受了初始手术，480 例（14.2%）接受了 NAT，85/480 例（18.4%）降期。cT3（比值比[OR]2.12，95%置信区间[CI]1.34-3.34）、cN1（OR 2.47，95%CI 1.71-3.58）疾病和在高容量设施接受治疗的患者（OR 1.63，95%CI 1.13-2.36）更有可能接受 NAT（均 p<0.05）。中位 OS 为 40.1 个月（95%CI 38.6-43.4）。cT1-2N1（NAT：31.5 个月 vs. 初始手术：22.4 个月；p=0.04）和 cT3-4N1（NAT：27.8 个月 vs. 初始手术：14.4 个月；p=0.01）疾病患者从 NAT 中获益最多。NAT 降期降低了 cT3-4N1 疾病患者的死亡风险（风险比[HR]0.35，95%CI 0.15-0.82）。相比之下，接受初始手术治疗的 cT1-2N0/X（HR 2.15，95%CI 1.83-2.53）和 cT3-4N0/X（HR 1.71，95%CI 1.06-2.74）疾病的分期不足患者死亡风险增加。
接受 NAT 治疗的 N1 ICC 患者的 OS 较初始手术有所改善。与初始手术相比，NAT 导致的降期为 cT3-4N1 患者带来了生存获益。NAT 应考虑用于 T 期疾病和/或淋巴结转移的 ICC 患者。
