Division of Pancreatic Surgery, Pancreas Translational and Clinical Research Center, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.
Unit of Pancreatic Surgery, Pancreas Institute, University of Verona Hospital Trust, GB Rossi Hospital, Verona, Italy.
JAMA Surg. 2024 Oct 1;159(10):1139-1147. doi: 10.1001/jamasurg.2024.2485.
There are currently no clinically relevant criteria to predict a futile up-front pancreatectomy in patients with anatomically resectable pancreatic ductal adenocarcinoma.
To 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 PARTICIPANTS: This 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.
Standard management, per existing guidelines.
The 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.
This 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.
In 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.
目前尚无临床相关标准可预测解剖可切除的胰腺导管腺癌患者的无效 upfront 胰切除术。
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、地点和参与者：这项回顾性研究于 2010 年 1 月至 2021 年 12 月在意大利的 5 个高或极高容量中心进行。数据分析于 2024 年 4 月进行。参与者包括在参与机构接受 upfront 胰切除术的连续患者。
标准管理，根据现有指南。
主要结局是无效胰切除术的发生率，定义为术后 6 个月内导致患者死亡或疾病复发的手术。构建了二项式标准，以将无效可能性保持在 20%以下，对应于从现有汇总数据中接受新辅助切除的机会。
这项研究纳入了 1426 名患者。中位年龄为 69（四分位距，62-75）岁，759 名男性（53.2%），1076 名患有头癌（75.4%）。接受辅助治疗的比例为 73.7%。为了构建模型，研究样本被分为一个推导（n=885）和验证队列（n=541）。无效胰切除术的发生率为 18.9%（发展组为 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（ASA）分级（系数的 95%置信区间为 0.68-0.87）、癌抗原（CA）19.9 血清水平（系数的 95%置信区间为 0.05-0.75）和肿瘤大小（系数的 95%置信区间为 0.28-0.46）。确定了三个与无效切除风险增加、病理特征恶化和预后恶化相关的风险组。确定了四个离散条件（定义为 CA 19.9 水平调整后的大小标准：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 水平小于 150 U/mL；肿瘤大小小于 5 cm，CA 19.9 水平小于 50 U/mL）与无效可能性低于 20%相关。符合标准的患者无病生存率和总生存率均显著延长。
在这项研究中，开发了一个术前模型（MetroPancreas）和二项式标准来确定无效胰切除术的风险。这可能有助于选择 upfront 切除或新辅助治疗的患者。
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