Thromboembolic Events During Perioperative Therapy for Resectable and Borderline Resectable Pancreatic Cancer in the PREOPANC-2 Trial.

This study evaluated VTE incidenceduring (neo)adjuvant therapy for resectable and borderline resectable PDAC and its relation to survival.

本研究评估了在可切除和边缘可切除PDAC的（新）辅助治疗期间VTE的发生率及其与生存率的关系。

Methods

This study included patients from the investigator-initiated, multicenter, randomized controlled phase III PREOPANC-2 trial. Patients were randomly assigned to neoadjuvant 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin followed by surgery (FFX arm) or neoadjuvant gemcitabine-based chemoradiotherapy (CRT), followed by surgery and adjuvant gemcitabine (CRT arm).

本研究纳入了研究者发起的、多中心的、随机对照的III期PREOPANC-2试验的患者。患者被随机分配到新辅助5-氟尿嘧啶、亚叶酸、伊立替康和奥沙利铂治疗后进行手术（FFX组）或新辅助吉西他滨为基础的放化疗（CRT），随后进行手术和辅助吉西他滨治疗（CRT组）。

VTE was defined as both incidental and symptomatic lower- or upper-extremity deep vein thrombosis, pulmonary embolism (PE), splanchnic vein thrombosis, and catheter-related thrombosis.

VTE被定义为包括偶然发现的和有症状的下肢或上肢深静脉血栓形成、肺栓塞（PE）、内脏静脉血栓形成和导管相关血栓形成。

VTE occurrence was retrospectively evaluated from random assignment to 12 months after random assignment.

从随机分组开始至随机分组后12个月内，回顾性评估了静脉血栓栓塞症（VTE）的发生情况。

The association with overall survival(OS) was analyzed using Cox regression analysis.

使用Cox回归分析方法分析了与总生存（OS）的关联。

Results

VTE was diagnosed in 28 of 325 patients (9%): nine (3%) preoperatively and 19 (8%) postoperatively.

在325名患者中有28名（9%）被诊断为静脉血栓栓塞症（VTE）：其中9名（3%）为术前诊断，19名（8%）为术后诊断。

Most VTEs were symptomatic (54%).

大多数VTE是有症状的（54%）。

Although a higher proportion of patients developed postoperative VTE in the CRT arm (FFX 3% v CRT 12%, P = .02), the 12-month cumulative incidencedid not differ between arms (6% v 11%, P = .06).

尽管接受放化疗组（FFX 3% v CRT 12%，P = .02）的患者术后发展为静脉血栓栓塞症（VTE）的比例更高，但两组间12个月累积发生率并无差异（6% v 11%，P = .06）。

Two patients died from PE-related causes in the CRT arm.

在放化疗组中有两名患者因肺栓塞（PE）相关原因死亡。

VTE was independently associated with reduced OS (adjusted time-varying hazard ratio, 2.13, P = .002).

VTE 与降低的总生存率独立相关（调整后的时间变化风险比为2.13，P = .002）。

Conclusions

VTE occurred in 9% of patients with (borderline) resectable PDAC undergoing (neo)adjuvant treatment in the year after random assignment and was associated with decreased OS.

在随机分配后的一年内，接受（新）辅助治疗的（边缘）可切除PDAC患者中有9%发生了VTE，并且与总生存率降低相关。

These results underscore the need for standardized reporting of thromboembolic events in clinical trials and future studies assessing the potential benefits of thromboprophylaxis during neoadjuvant therapy.

这些结果强调了在临床试验和未来评估新辅助治疗期间血栓预防潜在益处的研究中，标准化报告血栓栓塞事件的必要性。