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临床I/II期研究:电化学疗法治疗局部晚期胰腺癌的局部疾病控制和生存情况

Clinical Phase I/II Study: Local Disease Control and Survival in Locally Advanced Pancreatic Cancer Treated with Electrochemotherapy.

作者信息

Izzo Francesco, Granata Vincenza, Fusco Roberta, D'Alessio Valeria, Petrillo Antonella, Lastoria Secondo, Piccirillo Mauro, Albino Vittorio, Belli Andrea, Tafuto Salvatore, Avallone Antonio, Patrone Renato, Palaia Raffaele

机构信息

Hepatobiliary Surgical Oncology Unit, "Istituto Nazionale Tumori IRCCS Fondazione Pascale-IRCCS di Napoli", 80131 Naples, Italy.

Radiodiodiagnostic Unit, "Istituto Nazionale Tumori IRCCS Fondazione Pascale-IRCCS di Napoli", 80131 Naples, Italy.

出版信息

J Clin Med. 2021 Mar 22;10(6):1305. doi: 10.3390/jcm10061305.

DOI:10.3390/jcm10061305
PMID:33810058
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8005134/
Abstract

OBJECTIVE

To assess local disease control rates (LDCR) and overall survival (OS) in locally advanced pancreatic cancer (LAPC) treated with electrochemotherapy (ECT).

METHODS

Electrochemotherapy with bleomycin was performed in 25 LAPC patients who underwent baseline Magnetic Resonance Imaging (MRI) and/or Computed Tomography (CT) and Position Emission Tomography (PET) scans before ECT and 1 and 6 months post ECT. LDCR were assessed using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Choi criteria. Needle electrodes with fixed linear (N-30-4B) or fixed hexagonal configurations (N-30-HG or I-40-HG or H-30-ST) or variable geometry (VGD1230 or VGD1240) (IGEA S.p.A., Carpi, Italy) were used to apply electric pulses. Pain evaluation was performed pre-ECT, after 1 month and after 6 months with ECT. Overall survival estimates were calculated by means of a Kaplan-Meier analysis.

RESULTS

At 1 month after ECT, 76% of patients were in partial response (PR) and 20% in stable disease (SD). Six months after ECT, 44.0% patients were still in PR and 12.0% in SD. A LDCR of 56.0% was reached six months after ECT: 13 patients treated with fixed geometry had a LDCR of 46.1%, while for the 12 patients treated with variable geometry, the LDCR was 66.7%. The overall survival median value was 11.5 months: for patients treated with fixed geometry the OS was 6 months, while for patients treated with variable geometry it was 12 months. Electrochemotherapy was well-tolerated and abdominal pain was rapidly resolved.

CONCLUSIONS

Electrochemotherapy obtained good results in terms of LDCR and OS in LAPC. Multiple needle insertion in a variable geometry configuration optimized by pre-treatment planning determined an increase in LDCR and OS compared to a fixed geometry configuration.

摘要

目的

评估接受电化学疗法(ECT)治疗的局部晚期胰腺癌(LAPC)的局部疾病控制率(LDCR)和总生存期(OS)。

方法

对25例LAPC患者进行博来霉素电化学疗法,这些患者在ECT前、ECT后1个月和6个月接受了基线磁共振成像(MRI)和/或计算机断层扫描(CT)以及正电子发射断层扫描(PET)。使用实体瘤疗效评价标准(RECIST 1.1)和Choi标准评估LDCR。使用具有固定线性(N-30-4B)或固定六边形配置(N-30-HG或I-40-HG或H-30-ST)或可变几何形状(VGD1230或VGD1240)的针电极(IGEA S.p.A.,意大利卡尔皮)施加电脉冲。在ECT前、ECT后1个月和6个月进行疼痛评估。通过Kaplan-Meier分析计算总生存期估计值。

结果

ECT后1个月,76%的患者部分缓解(PR),20%病情稳定(SD)。ECT后6个月,44.0%的患者仍处于PR,12.0%处于SD。ECT后6个月达到56.0%的LDCR:13例接受固定几何形状治疗的患者LDCR为46.1%,而12例接受可变几何形状治疗的患者LDCR为66.7%。总生存期的中位数为11.5个月:接受固定几何形状治疗的患者OS为6个月,而接受可变几何形状治疗的患者为12个月。电化学疗法耐受性良好,腹痛迅速缓解。

结论

电化学疗法在LAPC的LDCR和OS方面取得了良好效果。与固定几何形状配置相比,通过预处理计划优化的可变几何形状配置中的多针插入确定了LDCR和OS的增加。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a9a3/8005134/54f0f2b904b1/jcm-10-01305-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a9a3/8005134/80f4d24cdc86/jcm-10-01305-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a9a3/8005134/0a9326a494a1/jcm-10-01305-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a9a3/8005134/3cb7e845529d/jcm-10-01305-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a9a3/8005134/dc36b3465a28/jcm-10-01305-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a9a3/8005134/fadcb06f40c9/jcm-10-01305-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a9a3/8005134/291baabe169f/jcm-10-01305-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a9a3/8005134/54f0f2b904b1/jcm-10-01305-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a9a3/8005134/80f4d24cdc86/jcm-10-01305-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a9a3/8005134/0a9326a494a1/jcm-10-01305-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a9a3/8005134/3cb7e845529d/jcm-10-01305-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a9a3/8005134/dc36b3465a28/jcm-10-01305-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a9a3/8005134/fadcb06f40c9/jcm-10-01305-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a9a3/8005134/291baabe169f/jcm-10-01305-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a9a3/8005134/54f0f2b904b1/jcm-10-01305-g007.jpg

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