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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解剖学上可切除的胰腺癌前期切除术无效


重要性目前尚无临床相关标准来预测解剖学上可切除的胰腺导管腺癌患者徒劳的前期胰腺切除术。目标使用多机构数据库开发无效风险模型，并提供与低于 20% 安全阈值的无效可能性相关的统一标准。设计、设置和参与者这项回顾性研究于 2010 年 1 月至 2021 年 12 月在意大利的 5 个高容量或超高容量中心进行。数据是在 2024 年 4 月期间分析的。参与者包括在参与机构接受前期胰腺切除术的连续患者。ExposureStandard 管理，根据现有指南。主要结局和测量主要结局指标是胰腺切除术无效率，定义为 6 个月内导致患者死亡或疾病复发的手术。构建二分类标准以将无效可能性保持在 20% 以下，对应于从现有汇总数据中不接受新辅助切除的机会。结果本研究包括 1426 例患者。中位年龄为 69 岁 （四分位距，62-75） 岁，男性 759 例 （53.2%），头癌 1076 例 （75.4%）。辅助治疗接受率为 73.7%。对于模型构建，研究样本分为派生 （n = 885） 和验证队列 （n = 541）。胰腺切除术无效率为 18.9% （开发队列中为 19.2%，验证队列中为 18.6%）。与无效切除相关的术前变量是美国麻醉医师协会分级 （系数 95% CI，0.68-0.87）、癌症抗原 （CA） 19.9 血清水平 （95% CI，系数 0.05-0.75）和肿瘤大小 （系数 95% CI，0.28-0.46）。 确定了与无效切除可能性增加、病理特征恶化和结局恶化相关的 3 个风险组。四种离散情况（定义为 CA 19.9 水平调整至大小标准：肿瘤大小小于 2 cm，CA 19.9 水平低于 1000 U/mL;肿瘤大小小于 3 cm，CA 19.9 水平低于 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）与无效相关可能性低于 20%。在符合标准的患者中，无病生存期和总生存期均显著延长。结论和相关性在本研究中，开发了确定徒劳性胰腺切除术风险的术前模型 （MetroPancreas） 和二分类标准。这可能有助于选择进行前期切除或新辅助治疗的患者。