ImportanceThere are currently no clinically relevant criteria to predict a futile up-front pancreatectomy in patients with anatomically resectable pancreatic ductal adenocarcinoma.ObjectivesTo develop a futility risk model using a multi-institutional database and provide unified criteria associated with a futility likelihood below a safety threshold of 20%.Design, Setting, and ParticipantsThis retrospective study took place from January 2010 through December 2021 at 5 high- or very high-volume centers in Italy. Data were analyzed during April 2024. Participants included consecutive patients undergoing up-front pancreatectomy at the participating institutions.ExposureStandard management, per existing guidelines.Main Outcomes and MeasuresThe main outcome measure was the rate of futile pancreatectomy, defined as an operation resulting in patient death or disease recurrence within 6 months. Dichotomous criteria were constructed to maintain the futility likelihood below 20%, corresponding to the chance of not receiving postneoadjuvant resection from existing pooled data.ResultsThis study included 1426 patients. The median age was 69 (interquartile range, 62-75) years, 759 patients were male (53.2%), and 1076 had head cancer (75.4%). The rate of adjuvant treatment receipt was 73.7%. For the model construction, the study sample was split into a derivation (n = 885) and a validation cohort (n = 541). The rate of futile pancreatectomy was 18.9% (19.2% in the development and 18.6% in the validation cohort). Preoperative variables associated with futile resection were American Society of Anesthesiologists class (95% CI for coefficients, 0.68-0.87), cancer antigen (CA) 19.9 serum levels (95% CI, for coefficients 0.05-0.75), and tumor size (95% CI for coefficients, 0.28-0.46). Three risk groups associated with an escalating likelihood of futile resection, worse pathological features, and worse outcomes were identified. Four discrete conditions (defined as CA 19.9 levels-adjusted-to-size criteria: tumor size less than 2 cm with CA 19.9 levels less than 1000 U/mL; tumor size less than 3 cm with CA 19.9 levels less than 500 U/mL; tumor size less than 4 cm with CA 19.9 levels less than 150 U/mL; and tumor size less than 5 cm with CA 19.9 levels less than 50 U/mL) were associated with a futility likelihood below 20%. Both disease-free survival and overall survival were significantly longer in patients fulfilling the criteria.Conclusions and relevanceIn this study, a preoperative model (MetroPancreas) and dichotomous criteria to determine the risk of futile pancreatectomy were developed. This might help in selecting patients for up-front resection or neoadjuvant therapy.

中文翻译：

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预先切除解剖学上可切除的胰腺癌是徒劳的


重要性目前尚无临床相关标准来预测解剖上可切除的胰腺导管腺癌患者进行无效的前期胰腺切除术。 目的使用多机构数据库开发无效风险模型，并提供与低于安全阈值的无效可能性相关的统一标准20%。设计、设置和参与者这项回顾性研究于 2010 年 1 月至 2021 年 12 月在意大利 5 个高容量或超高容量中心进行。数据于 2024 年 4 月进行分析。参与者包括在参与机构接受前期胰腺切除术的连续患者。暴露标准管理，根据现有指南。主要结果和测量主要结果测量是无效胰腺切除术的发生率，定义为导致患者死亡的手术或6个月内疾病复发。构建二分标准以将无效可能性维持在 20% 以下，对应于现有汇总数据中未接受新辅助切除术后的可能性。结果本研究包括 1426 名患者。中位年龄为 69 岁（四分位距，62-75）岁，759 名患者为男性（53.2%），1076 名患者患有头部癌症（75.4%）。辅助治疗接受率为73.7%。为了构建模型，研究样本分为推导样本 (n = 885) 和验证样本 (n = 541)。胰腺切除术无效率为 18.9%（开发组为 19.2%，验证组为 18.6%）。与无效切除相关的术前变量包括美国麻醉医师协会等级（95% CI，系数为 0.68-0.87）、癌抗原 (CA) 19.9 血清水平（95% CI，系数为 0.05-0.75）和肿瘤大小（95% CI，系数为 0.05-0.75）。系数 CI，0.28-0.46）。 确定了与徒劳切除的可能性不断增加、更糟糕的病理特征和更糟糕的结果相关的三个风险组。四种离散条件（定义为 CA 19.9 水平调整大小标准：肿瘤大小小于 2 cm，CA 19.9 水平小于 1000 U/mL；肿瘤大小小于 3 cm，CA 19.9 水平小于 500 U/mL ；肿瘤大小小于 4 cm，CA 19.9 水平低于 150 U/mL；肿瘤大小小于 5 cm，CA 19.9 水平低于 50 U/mL）与低于 20% 的无效可能性相关。满足标准的患者的无病生存期和总生存期均显着延长。结论和相关性在本研究中，开发了术前模型（MetroPancreas）和二分标准来确定无效胰腺切除术的风险。这可能有助于选择接受前期切除或新辅助治疗的患者。