Background: Pancreatic cancer (PC) is a refractory malignancy with a dismal prognosis. For unresectable PC, gemcitabine plus nab-paclitaxel (GnP) is widely used as first-line chemotherapy. During treatment, patients may require unplanned hospitalization (UPH) due to tumor progression, biliary obstruction, or chemotherapy-related adverse events. Although UPH during chemotherapy may be linked to poorer survival, its prognostic impact as a time-dependent clinical event during active treatment has not been empirically evaluated in unresectable PC. We investigated the prognostic impact of UPH occurring during first-line GnP therapy. Objective: To clarify the association between UPH during first-line GnP and overall survival (OS). Methods: We retrospectively analyzed 189 patients with histologically confirmed unresectable PC who received first-line GnP at our institution between February 2016 and February 2023. The occurrence of UPH during GnP and the reason for the first UPH were categorized. Associations with OS were assessed using the Kaplan–Meier method and Cox proportional hazards models, including a time-varying covariate (TVC) analysis. Risk factors for UPH were examined with logistic regression. Results: UPH occurred in 76 patients (40.2%) during GnP. Pancreatic head tumors and pre-treatment biliary drainage were significantly more frequent in the UPH group. Median OS was 10.88 months in the UPH group versus 19.23 months in the non-UPH group; UPH was a significant adverse prognostic factor (hazard ratio [HR] 1.97,p< 0.01). In multivariable analysis incorporating a TVC, UPH remained an independent predictor of worse prognosis (HR 3.02,p< 0.01). Reasons for first UPH were progression (n= 28), recurrent biliary obstruction (RBO;n= 26), GnP-related adverse event (AE;n= 16), and other (n= 6). Hospitalization due to progression or RBO was associated with poorer survival. Pancreatic head location was identified as a risk factor for UPH. Conclusions: UPH during first-line GnP is an independent adverse prognostic factor in patients with unresectable PC, even after accounting for TVC. In pancreatic head cancer, closer monitoring for biliary and obstructive complications may be particularly important during treatment.
背景：胰腺癌是一种难治性恶性肿瘤，预后极差。对于不可切除的胰腺癌，吉西他滨联合白蛋白结合型紫杉醇（GnP）被广泛用作一线化疗方案。治疗期间，患者可能因肿瘤进展、胆道梗阻或化疗相关不良事件需要非计划住院。尽管化疗期间的非计划住院可能与较差的生存期相关，但其作为积极治疗期间随时间变化的临床事件对预后的影响，在不可切除胰腺癌中尚未得到实证评估。本研究探讨了在一线GnP治疗期间发生非计划住院的预后影响。
目的：阐明一线GnP治疗期间非计划住院与总生存期之间的关联。
方法：我们回顾性分析了2016年2月至2023年2月期间在本机构接受一线GnP治疗的189例经组织学确诊的不可切除胰腺癌患者。对GnP治疗期间非计划住院的发生情况及首次住院原因进行分类。采用Kaplan-Meier法和Cox比例风险模型（包括时依协变量分析）评估其与总生存期的关联。采用逻辑回归分析非计划住院的风险因素。
结果：76例患者（40.2%）在GnP治疗期间发生非计划住院。与非住院组相比，住院组中胰头肿瘤和治疗前胆道引流的发生率显著更高。住院组的中位总生存期为10.88个月，而非住院组为19.23个月；非计划住院是一个显著的不良预后因素（风险比 1.97, p<0.01）。在纳入时依协变量的多变量分析中，非计划住院仍是预后较差的独立预测因素（风险比 3.02, p<0.01）。首次非计划住院的原因为疾病进展（28例）、复发性胆道梗阻（26例）、GnP相关不良事件（16例）及其他原因（6例）。因疾病进展或复发性胆道梗阻导致的住院与较差的生存期相关。胰头肿瘤位置被确定为非计划住院的风险因素。
结论：在不可切除胰腺癌患者中，一线GnP治疗期间的非计划住院是一个独立的不良预后因素，即使在考虑时依协变量后亦然。对于胰头癌，在治疗期间加强对胆道和梗阻性并发症的监测可能尤为重要。
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