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. 2020 Oct;8(10):E1511-E1519.
doi: 10.1055/a-1221-9879. Epub 2020 Oct 7.

Necrosis volume and Choi criteria predict the response to endoscopic ultrasonography-guided HybridTherm ablation of locally advanced pancreatic cancer

Sabrina Gloria Giulia Testoni  1 , Gabriele Capurso  1 , Maria Chiara Petrone  1 , Maurizio Barbera  2 , Walter Linzenbold  3 , Markus Enderle  3 , Simone Gusmini  2 , Roberto Nicoletti  2 , Emanuel Della Torre  4 , Alberto Mariani  1 , Gemma Rossi  1 , Livia Archibugi  1 , Francesco De Cobelli  2 , Michele Reni  5 , Massimo Falconi  6 , Paolo Giorgio Arcidiacono  1
Affiliations

Necrosis volume and Choi criteria predict the response to endoscopic ultrasonography-guided HybridTherm ablation of locally advanced pancreatic cancer

Sabrina Gloria Giulia Testoni et al. Endosc Int Open. 2020 Oct.

Abstract

Background and study aims Endoscopic ultrasound (EUS)-guided ablation of pancreatic ductal adenocarcinoma (PDAC) with HybridTherm-Probe (EUS-HTP) is feasible and safe, but the radiological response and ideal tool to measure it have not been investigated yet. The aims of this study were to: 1) assess the radiological response to EUS-HTP evaluating the vital tumor volume reduction rate, Response Evaluation Criteria in Solid Tumors (RECIST1.1) and Choi criteria; 2) determine the prognostic predictive yield of these criteria. Patients and methods A retrospective analysis was performed of patients with locally advanced PDAC after primary treatment or unfit for chemotherapy prospectively treated by EUS-HTP. Computed tomography scan was performed 1 month after EUS-HTP to evaluate: 1) vital tumor volume reduction rate (VTVRR) by measuring necrosis and tumor volumes through a computer-aided detection system; and 2) RECIST1.1 and Choi criteria. Results EUS-HTP was feasible in 22 of 31 patients (71 %), with no severe adverse events. Median post-HTP survival was 7 months (1 - 35). Compared to pre-HTP tumor volume, a significant 1-month VTVRR (mean 21.4 %) was observed after EUS-HTP ( P = 0.005). We identified through ROC analysis a VTVRR > 11.46 % as the best cut-off to determine post-HTP 6-month survival outcome (AUC = 0.733; sensitivity = 70.0 %, specificity = 83.3 %). This cut-off was significantly associated with longer overall survival (HR = 0.372; P = 0.039). According to RECIST1.1 and Choi criteria, good responders to EUS-HTP were 60 % and 46.7 %, respectively. Good responders according to Choi, but not to RECIST1.1, had longer survival (HR = 0.407; P = 0.04). Conclusions EUS-HTP induces a significant 1-month VTVRR. This effect is assessed accurately by evaluation of necrosis and tumor volumes. Use of VTVRR and Choi criteria, but not RECIST 1.1 criteria, might identify patients who could benefit clinically from EUS-HTP.

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Conflict of interest statement

Competing interests Prof. M. Enderle and Dr. W. Linzenbold are employees of the research department of Erbe Elektromedizin GmbH, Tubingen, Germany.

Figures

Fig. 1
Fig. 1
Study patient flowchart.
Fig. 2a
Fig. 2a
ROC curve for the 1-month post-ablation of the vital tumor volume reduction rate (VTVRR) in 16 patients related to the post-ablation 6-month overall survival: AUC = 0.733 (95 % CI 0.4590 – 0.9178), associated criterion > 11.46 %, sensitivity = 70.00 % (95 % CI 34.8 – 93.3), specificity = 83.33 % (95 % CI 35.9 – 99.6) ( P  = 0.115). b Kaplan-Meier survival curve for post-ablation overall survival (months) using the VTVRR cut-off > 11.46 %: median overall survival 10 vs. 6 months, Log-rank test = 5.5 ( P  = 0.039), HR = 0.3723 (95 % CI 0.1237 – 1.1207).
Fig. 3
Fig. 3
Kaplan-Meier survival curves of patients classified as Good Responders (partial responder + stable disease) and Poor Responders (progressive disease) according to a Choi criteria: median 9 vs. 6 months (Log-rank = 4.2; p  = 0.04), with HR = 0.4066 (95 % CI 0.1370 to 1.2060 ) and b RECIST1.1: median 8 vs. 6 months (Log-rank = 2.1; p  = 0.15), with HR = 0.5088 (95 % CI 0.1589 to 1.6290).
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