Department of General Surgery, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Shanghai Key Laboratory of Biliary Tract Disease Research, Shanghai, China.
Cancer Control. 2024 Jan-Dec;31:10732748241271682. doi: 10.1177/10732748241271682.
The effect of neoadjuvant chemotherapy (NACT) in gallbladder cancer (GBC) patients remains controversial. The aim of this study was to assess the impact of NACT on overall survival (OS) and cancer specific survival (CSS) in patients with localized or locoregionally advanced GBC, and to explore possible protective predictors for prognosis.
Data for patients with localized or locoregionally advanced GBC (i.e., categories cTx-cT4, cN0-2, and cM0) from 2004 to 2020 were collected from the Surveillance, Epidemiology, and End Results (SEER) database. Patients in the NACT and non-NACT groups were propensity score matched (PSM) 1:3, and the Kaplan-Meier method and log-rank test were performed to analyze the impact of NACT on OS and CSS. Univariable and multivariable Cox regression models were applied to identify the possible prognostic factors. Subgroup analysis was conducted to identify patients who would benefit from NACT.
Of the 2676 cases included, 78 NACT and 234 non-NACT patients remained after PSM. In localized or locoregionally advanced GBC patients, the median OS of the NACT and non-NACT was 31 and 16 months (log-rank < 0.01), and the median CSS of NACT and non-NACT was 32 and 17 months (log-rank < 0.01), respectively. Longer median OS (31 vs 17 months, log-rank < 0.01) and CSS (32 vs 20 months, log-rank < 0.01) was associated with NACT compared with surgery alone. Multivariable Cox regression analysis showed that NACT, stage, and surgery type were prognostic factors for OS and CSS in GBC patients. Subgroup analysis revealed that the survival hazard ratios (HRs) of NACT vs non-NACT for localized or locoregionally advanced GBC patients were significant in most subgroups.
NACT may provide therapeutic benefits for localized or locoregionally advanced GBC patients, especially for those with advanced stage, node-positive, poorly differentiated or undifferentiated disease. NACT combined with radical surgery was associated with a survival advantage. Therefore, NACT combined with surgery may provide a better treatment option for resectable GBC patients.
新辅助化疗（NACT）在胆囊癌（GBC）患者中的疗效仍存在争议。本研究旨在评估 NACT 对局限性或局部区域性进展期 GBC 患者总生存（OS）和癌症特异性生存（CSS）的影响，并探讨可能的预后保护预测因素。
从 2004 年至 2020 年，从监测、流行病学和最终结果（SEER）数据库中收集了局限性或局部区域性进展期 GBC（即 cTx-cT4、cN0-2 和 cM0 期）患者的数据。NACT 和非 NACT 组患者进行倾向评分匹配（PSM）1:3，采用 Kaplan-Meier 法和对数秩检验分析 NACT 对 OS 和 CSS 的影响。采用单变量和多变量 Cox 回归模型确定可能的预后因素。进行亚组分析以确定可能从 NACT 中获益的患者。
在 2676 例患者中，PSM 后有 78 例 NACT 和 234 例非 NACT 患者。在局限性或局部区域性进展期 GBC 患者中，NACT 和非 NACT 的中位 OS 分别为 31 和 16 个月（对数秩 < 0.01），中位 CSS 分别为 32 和 17 个月（对数秩 < 0.01）。与单纯手术相比，NACT 可使中位 OS（31 个月 vs 17 个月，对数秩 < 0.01）和 CSS（32 个月 vs 20 个月，对数秩 < 0.01）更长。多变量 Cox 回归分析显示，NACT、分期和手术类型是 GBC 患者 OS 和 CSS 的预后因素。亚组分析显示，在大多数亚组中，NACT 与非 NACT 相比，对局限性或局部区域性进展期 GBC 患者的生存风险比（HR）有显著差异。
NACT 可能为局限性或局部区域性进展期 GBC 患者提供治疗益处，尤其是对于晚期、淋巴结阳性、低分化或未分化疾病的患者。NACT 联合根治性手术与生存获益相关。因此，NACT 联合手术可能为可切除的 GBC 患者提供更好的治疗选择。
