Thomas Jefferson University Hospital and The Jefferson Pancreas, Biliary and Related Cancer Center, Philadelphia, Pennsylvania.
Cedars Sinai Medical Center, Los Angeles, California.
Ann Surg. 2022 Jan 1;275(1):45-53. doi: 10.1097/SLA.0000000000004669.
To compare the efficacy and safety of algenpantucel-L [HyperAcute-Pancreas algenpantucel-L (HAPa); IND# 12311] immunotherapy combined with standard of care (SOC) chemotherapy and chemoradiation to SOC chemotherapy and chemoradiation therapy alone in patients with borderline resectable or locally advanced pancreatic ductal adenocarcinoma (PDAC).
To date, immunotherapy has not been shown to benefit patients with borderline resectable or locally advanced unresectable PDAC. HAPa is a cancer vaccine consisting of allogeneic pancreatic cancer cells engineered to express the murine α(1,3)GT gene.
A multicenter, phase 3, open label, randomized (1:1) trial of patients with borderline resectable or locally advanced unresectable PDAC. Patients received neoadjuvant SOC chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel) followed by chemoradiation (standard group) or the same standard neoadjuvant regimen combined with HAPa immunotherapy (experimental group). The primary outcome was overall survival.
Between May 2013 and December 2015, 303 patients were randomized from 32 sites. Median (interquartile range) overall survival was 14.9 (12.2-17.8) months in the standard group (N = 158) and 14.3 (12.6-16.3) months in the experimental group (N = 145) [hazard ratio (HR) 1.02, 95% confidence intervals 0.66-1.58; P = 0.98]. Median progression-free survival was 13.4 months in the standard group and 12.4 months in the experimental group (HR 1.33, 95% confidence intervals 0.72-1.78; P = 0.59). Grade 3 or higher adverse events occurred in 105 of 140 patients (75%) in the standard group and in 115 of 142 patients (81%) in the experimental group (P > 0.05).
Algenpantucel-L immunotherapy did not improve survival in patients with borderline resectable or locally advanced unresectable PDAC receiving SOC neoadjuvant chemotherapy and chemoradiation.
ClinicalTrials.gov Identifier: NCT01836432.
比较 algenpantucel-L [HyperAcute-Pancreas algenpantucel-L（HAPa）；IND#12311]免疫疗法联合标准治疗（SOC）化疗和放化疗与 SOC 化疗和放化疗联合治疗在边界可切除或局部晚期胰腺导管腺癌（PDAC）患者中的疗效和安全性。
迄今为止，免疫疗法并未显示对边界可切除或局部晚期不可切除的 PDAC 患者有益。HAPa 是一种癌症疫苗，由经过基因工程改造以表达鼠 α（1,3）GT 基因的同种异体胰腺癌细胞组成。
一项多中心、3 期、开放性、随机（1:1）试验，纳入了边界可切除或局部晚期不可切除的 PDAC 患者。患者接受新辅助 SOC 化疗（FOLFIRINOX 或吉西他滨/ nab-紫杉醇），然后进行放化疗（标准组）或相同的标准新辅助方案联合 HAPa 免疫疗法（实验组）。主要终点是总生存期。
2013 年 5 月至 2015 年 12 月，从 32 个地点随机分配了 303 名患者。标准组（n=158）和实验组（n=145）的中位（四分位距）总生存期分别为 14.9（12.2-17.8）个月和 14.3（12.6-16.3）个月[风险比（HR）1.02，95%置信区间 0.66-1.58；P=0.98]。标准组的中位无进展生存期为 13.4 个月，实验组为 12.4 个月（HR 1.33，95%置信区间 0.72-1.78；P=0.59）。标准组有 105 名（75%）患者和实验组有 115 名（81%）患者发生 3 级或以上不良事件（P>0.05）。
在接受 SOC 新辅助化疗和放化疗的边界可切除或局部晚期不可切除 PDAC 患者中，algenpantucel-L 免疫疗法并未改善生存。
ClinicalTrials.gov 标识符：NCT01836432。
