在国家合作小组中接受新辅助治疗和胰腺切除术治疗的临界可切除胰腺导管腺癌（BR-PC）患者的术后不良事件（AE）此前尚未被描述。我们对参加联盟 A021501 临床试验的患者进行了预先计划的二次分析，以量化围手术期 AE 发生率。A021501 2 期试验将 BR-PC 患者随机分配接受 8 剂 mFOLFIRINOX（第 1 组）或 7 剂 mFOLFIRINOX 和大分割放疗（第2臂），随后进行胰腺切除术（2016年12月31日至2019年5月31日）。胰腺切除术后 90 天评估不良事件。在 126 名入组患者中，51 名 (40%) 在 28 个机构接受了胰腺切除术（n = 32，第 1 组；n = 19，第 2 组）。 5 名（10%）患者需要在 90 天内再次手术； 56% 的患者 (n = 27/48) 经历至少一种 3 级或以上 AE（50% vs. 67%，p = 0.37）。 90 天死亡率为 2.0%。第 1 组的再入院频率较低（16% vs. 42%，p = 0.05），但研究组之间在再次手术率（13% vs. 5%）、胰瘘或需要引流的腹内脓肿发生率方面没有差异（9% vs. 16%），或伤口感染（6% vs. 16%）。需要引流的胰瘘或腹内脓肿与接受辅助治疗相关（p = 0.012）。根据术后 AE 的发生率，总体生存率没有差异（风险比 = 1.1；95% 置信区间 0.5-2.6）。在这项多中心研究中，术后 AE 发生率与之前报道的一致。 BR-PC 术前治疗的多模式试验可以在合作小组中进行，并进行仔细的质量保证和安全监测。Clinicaltrials.gov 标识符：NCT02839343。© 2024。外科肿瘤学会。

Postoperative adverse events (AEs) in patients with borderline resectable pancreatic ductal adenocarcinoma (BR-PC) treated with neoadjuvant therapy and pancreatectomy in the national cooperative group setting have not been previously characterized. We conducted a preplanned secondary analysis of patients enrolled on the Alliance A021501 clinical trial to quantify perioperative AE rates.The A021501 phase 2 trial randomized patients with BR-PC to receive 8 doses of mFOLFIRINOX (Arm 1) or 7 doses of mFOLFIRINOX and hypofractionated radiotherapy (Arm 2), followed by pancreatectomy (December 31, 2016 to May 31, 2019). Adverse events were assessed 90 days after pancreatectomy.Of 126 enrolled patients, 51 (40%) underwent pancreatectomy (n = 32, Arm 1; n = 19, Arm 2) at 28 institutions. Five (10%) patients required reoperation within 90 days; 56% of patients (n = 27/48) experienced at least one grade 3 or higher AE (50% vs. 67%, p = 0.37). Ninety-day mortality was 2.0%. Readmission was less frequent in Arm 1 (16% vs. 42%, p = 0.05), but there were no differences between study arms in rates of reoperation (13% vs. 5%), pancreatic fistula or intra-abdominal abscess requiring drainage (9% vs. 16%), or wound infection (6% vs. 16%). Pancreatic fistula or intra-abdominal abscess requiring drainage was associated with receipt of adjuvant therapy (p = 0.012). No difference in overall survival was observed based on occurrence of postoperative AEs (hazard ratio = 1.1; 95% confidence interval 0.5-2.6).In this multicenter study, rates of postoperative AEs were consistent with those previously reported. Multimodality trials of preoperative therapy for BR-PC may be performed in the cooperative group setting with careful quality assurance and safety monitoring.Clinicaltrials.gov identifier: NCT02839343.© 2024. Society of Surgical Oncology.