Martin Robert C G, White Rebekah Ruth, Bilimoria Malcolm M, Kluger Michael D, Iannitti David A, Polanco Patricio M, Hammil Chet W, Cleary Sean P, Heithaus Robert Evans, Welling Theodore, Chan Carlos H F
Division of Surgical Oncology, Department of Surgery, University of Louisville, Louisville, KY 40202, USA.
San Diego Moores Cancer Center, University of California, La Jolla, CA 92037, USA.
Cancers (Basel). 2024 Nov 21;16(23):3894. doi: 10.3390/cancers16233894.
BACKGROUND/OBJECTIVES: Overall survival for patients with Stage 3 pancreatic ductal adenocarcinoma (PDAC) remains limited, with a median survival of 12 to 15 months. Irreversible electroporation (IRE) is a local tumor ablation method that induces cancerous cell death by disrupting cell membrane homeostasis. The DIRECT Registry study was designed to assess the effectiveness and safety of IRE when combined with standard of care (SOC) treatment for Stage 3 PDAC versus SOC alone in a real-world setting after at least 3 months of induction chemotherapy; Methods: Patients with Stage 3 PDAC treated with IRE plus SOC or SOC alone were prospectively enrolled in a multicenter registry study. Enrollment required 3 months of active multi-agent chemotherapy with no progression before enrollment. Endpoints were 30- and 90-day mortality and adverse events (AEs).
Eighty-seven IRE and 27 SOC subjects were enrolled in the registry. Mean ages were 64.0 ± 8.4 and 66.4 ± 9.9 years, and mean anterior/posterior tumor diameters were 2.2 ± 0.7 cm and 3.2 ± 1.3 for the IRE and SOC groups respectively ( = 0.0066). All IRE procedures were performed using an open approach. The 90-day all-cause mortality was 5/83 (6.0%) and 2/27 (7.4%) for the IRE and SOC groups, respectively. Two subjects in the IRE group died from treatment-related complications, and one patient in the SOC group died due to chemotherapy-related complications.
Initial results from the DIRECT registry study indicate the use of IRE for curative intent tumor ablation in combination with induction chemotherapy has equivalent morbidity and mortality rates when compared to standard-of-care chemotherapy alone.
背景/目的：3期胰腺导管腺癌（PDAC）患者的总生存期仍然有限，中位生存期为12至15个月。不可逆电穿孔（IRE）是一种局部肿瘤消融方法，通过破坏细胞膜稳态诱导癌细胞死亡。DIRECT注册研究旨在评估在诱导化疗至少3个月后的真实世界环境中，IRE联合3期PDAC的标准治疗（SOC）与单纯SOC治疗相比的有效性和安全性。方法：接受IRE联合SOC或单纯SOC治疗的3期PDAC患者前瞻性纳入一项多中心注册研究。入组要求在入组前进行3个月的积极多药化疗且无进展。终点为30天和90天死亡率及不良事件（AE）。
87名接受IRE治疗和27名接受SOC治疗的受试者纳入注册研究。IRE组和SOC组的平均年龄分别为64.0±8.4岁和66.4±9.9岁，肿瘤前后径平均分别为2.2±0.7 cm和3.2±1.3 cm（P = 0.0066）。所有IRE操作均采用开放入路。IRE组和SOC组的90天全因死亡率分别为5/83（6.0%）和2/27（7.4%）。IRE组有2名受试者死于治疗相关并发症，SOC组有1名患者死于化疗相关并发症。
DIRECT注册研究的初步结果表明，与单纯标准治疗化疗相比，IRE联合诱导化疗用于根治性肿瘤消融的发病率和死亡率相当。
