Background:This study aimed to assess the safety and efficacy of gemcitabine plus S-1-based chemoradiotherapy (GS-CRT) among patients with locally advanced pancreatic ductal adenocarcinoma (PDAC), especially among those with unresectable locally advanced (UR-LA) cases.Methods: A total of 351 consecutive PDAC patients were enrolled and prognostic predictors of disease-specific survival (DSS) were identified.Results:The treatment completion rate was 98.9% and Grade 3 or higher adverse events occurred in 181 cases (51.6%). Among 319 re-evaluated patients, pancreatectomy was performed in 184 (57.7%). Based on resectability, the 5-year DSS rates for the entire cohort were 39.6% (R), 43.8% (BR-PV), 21.2% (BR-A) and 13.3% (UR-LA), while the predictors of DSS were performance status (PS), hemoglobin (Hb) level, celiac artery (CA) involvement of ≥180 degrees and JPS 8th T category. In the resected cases, the predictors of DSS were preoperative PS, preoperative CA19-9 level, preoperative JPS-T factor, degree of histological response and adjuvant chemotherapy. In UR-LA resected patients, preoperative prognostic nutritional index (PNI), absence of pathological venous invasion and adjuvant chemotherapy were predictors of DSS.Conclusions:Even though Grade 3 or higher adverse events were encountered in about half of the cases, they were uneventfully managed. Therefore, GS-CRT is safe and highly tolerable with potential to improve patients‘ prognosis. Preoperative PS, CA19-9 levels and histological response are important prognostic factors, as well as adjuvant therapy. In UR-LA patients, prognostic nutritional index (PNI) and adjuvant chemotherapy were important for curative intent surgery.
背景：本研究旨在评估吉西他滨联合S-1为基础的放化疗（GS-CRT）在局部进展期胰腺导管腺癌（PDAC）患者中的安全性与疗效，尤其针对不可切除局部进展期（UR-LA）病例。方法：连续纳入351例PDAC患者，分析其疾病特异性生存期（DSS）的预后预测因素。结果：治疗完成率达98.9%，181例（51.6%）发生3级及以上不良事件。在319例接受再评估的患者中，184例（57.7%）接受了胰腺切除术。根据可切除性分层，全队列5年DSS率分别为：可切除组39.6%、门静脉临界可切除组43.8%、动脉临界可切除组21.2%、UR-LA组13.3%。DSS的独立预测因素包括体能状态（PS）、血红蛋白（Hb）水平、腹腔动脉受累≥180度及日本胰腺学会第8版T分期。在手术切除病例中，DSS预测因素为术前PS、术前CA19-9水平、术前JPS-T分期、组织学反应程度及辅助化疗。UR-LA切除患者的DSS预测因素包括术前预后营养指数（PNI）、无病理静脉侵犯及辅助化疗。结论：尽管约半数病例出现3级及以上不良事件，但均得到有效控制。GS-CRT方案安全性良好且耐受性高，具有改善患者预后的潜力。术前PS、CA19-9水平及组织学反应是重要预后因素，辅助治疗亦发挥关键作用。对于UR-LA患者，预后营养指数（PNI）与辅助化疗是实现根治性手术的重要影响因素。
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