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可切除胰腺癌术前切除后的辅助治疗:省略和使用的模式-一项前瞻性真实世界研究。

Adjuvant Therapy After Upfront Resection of Resectable Pancreatic Cancer: Patterns of Omission and Use-A Prospective Real-Life Study.

机构信息

General and Pancreatic Surgery Unit, Pancreas Institute, University of Verona, Verona, Italy.

Department of Surgical Sciences, University of Verona, Verona, Italy.

出版信息

Ann Surg Oncol. 2024 May;31(5):2892-2901. doi: 10.1245/s10434-024-14951-4. Epub 2024 Jan 29.

Abstract

BACKGROUND

Little is known about adjuvant therapy (AT) omission and use outside of randomized trials. We aimed to assess the patterns of AT omission and use in a cohort of upfront resected pancreatic cancer patients in a real-life scenario.

METHODS

From January 2019 to July 2022, 317 patients with resected pancreatic cancer and operated upfront were prospectively enrolled in this prospective observational trial according to the previously calculated sample size. The association between perioperative variables and the risk of AT omission and AT delay was analyzed using multivariable logistic regression.

RESULTS

Eighty patients (25.2%) did not receive AT. The main reasons for AT omission were postoperative complications (38.8%), oncologist's choice (21.2%), baseline comorbidities (20%), patient's choice (10%), and early recurrence (10%). At the multivariable analysis, the odds of not receiving AT increased significantly for older patients (odds ratio [OR] 1.1, p < 0.001), those having an American Society of Anesthesiologists score ≥II (OR 2.03, p = 0.015), or developing postoperative pancreatic fistula (OR 2.5, p = 0.019). The likelihood of not receiving FOLFIRINOX as AT increased for older patients (OR 1.1, p < 0.001), in the presence of early-stage disease (stage I-IIa vs. IIb-III, OR 2.82, p =0.031; N0 vs. N+, OR 3, p = 0.03), and for patients who experienced postoperative major complications (OR 4.7, p = 0.009). A twofold increased likelihood of delay in AT was found in patients experiencing postoperative complications (OR 3.86, p = 0.011).

CONCLUSIONS

AT is not delivered in about one-quarter of upfront resected pancreatic cancer patients. Age, comorbidities, and postoperative complications are the main drivers of AT omission and mFOLFIRINOX non-use.

CLINICALTRIALS REGISTRATION

NCT03788382.

摘要

背景

关于辅助治疗(AT)在随机试验之外的省略和使用情况知之甚少。我们旨在评估在真实环境中接受 upfront 切除术的胰腺癌患者队列中省略和使用 AT 的模式。

方法

从 2019 年 1 月至 2022 年 7 月,根据之前计算的样本量,前瞻性纳入了 317 名接受 upfront 切除术的胰腺癌患者进行前瞻性观察性试验。使用多变量逻辑回归分析围手术期变量与 AT 省略和 AT 延迟风险之间的关系。

结果

80 名患者(25.2%)未接受 AT。省略 AT 的主要原因是术后并发症(38.8%)、肿瘤医生的选择(21.2%)、基线合并症(20%)、患者的选择(10%)和早期复发(10%)。多变量分析显示,年龄较大(优势比 [OR] 1.1,p<0.001)、美国麻醉医师协会评分≥II 级(OR 2.03,p=0.015)或发生术后胰瘘(OR 2.5,p=0.019)的患者接受 AT 的可能性显著增加。对于年龄较大的患者(OR 1.1,p<0.001)、早期疾病(I 期-IIa 期与 IIb-III 期,OR 2.82,p=0.031;N0 与 N+,OR 3,p=0.03)和经历术后重大并发症的患者(OR 4.7,p=0.009),接受 FOLFIRINOX 作为 AT 的可能性增加。术后并发症患者接受 AT 延迟的可能性增加两倍(OR 3.86,p=0.011)。

结论

大约四分之一的 upfront 切除术胰腺癌患者未接受 AT。年龄、合并症和术后并发症是省略 AT 和不使用 mFOLFIRINOX 的主要驱动因素。

临床试验注册

NCT03788382。

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