TY - JOUR
T1 - Ablation of soft tissue tumours by long needle variable electrode-geometry electrochemotherapy: final report from a single-arm, single-centre phase-2 study
AU - Simioni, Andrea
AU - Valpione, Sara
AU - Granziera, Elisa
AU - Rossi, Carlo Riccardo
AU - Cavallin, Francesco
AU - Spina, Romina
AU - Sieni, Elisabetta
AU - Aliberti, Camillo
AU - Stramare, Roberto
AU - Campana, Luca Giovanni
N1 - Funding Information:
The authors would like to thank the participating patients, Matteo Pedretti, Mattia Ronchetti and Rodolfo Spina for technical support, the nursing staff for patient care, Elisabetta Bezzon for intraoperative radiologic assistance, and Michele Gregianin for the evaluation of PET-CT scans. The preliminary results of this study have been presented at the European Society of Medical Oncology (ESMO) Congress 2014 (Madrid, September 26–30), at the 3rd World Congress of Electroporation (Toulouse, September 3–6 2019) and the XLII Congress of the Italian Society of Surgical Oncology (SICO), Cagliari, September 9, 2019. During the preparation of this manuscript, the authors printed 4/40 papers of the reference list, in compliance with the Sustainable Paperless Reference Initiative Nourishes Trees (S-PRINT) recommendation. https://t.co/SStD2ZeGNN. The S-PRINT score of this paper is 10%. (https://twitter.com/LucaCampana_611/status/1140741813277483008?s=09). There were no external funding sources. AS was supported by a charity grant from “Piccoli Punti Onlus”, Padova; LGC was partly supported by an institutional grant (SID-2017) from the Department of Surgical Oncological and Gastroenterological Sciences DISCOG of the University of Padova.
Publisher Copyright:
© 2020, The Author(s).
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/12/1
Y1 - 2020/12/1
N2 - Standard electrochemotherapy (ECT) is effective in many tumour types but is confined to the treatment of small superficial lesions. Variable electrode-geometry ECT (VEG-ECT) may overcome these limitations by using long freely-placeable electrodes. Patients with bulky or deep-seated soft-tissue malignancies not amenable to resection participated in a single-arm phase-2 study (ISRCTN.11667954) and received a single course of VEG-ECT with intravenous bleomycin (15,000 IU/m2) and concomitant electric pulses applied through an adjustable electrode array. The primary outcome was radiologic complete response rate (CRR) per RECIST; secondary endpoints included feasibility, metabolic response, toxicity (CTCAE), local progression-free survival (LPFS) and patient perception (EQ-5D). During 2009–2014, we enrolled 30 patients with trunk/limb sarcomas, melanoma, Merkel-cell carcinoma, and colorectal/lung cancer. Median tumour size was 4.7 cm. Electrode probes were placed under US/TC guidance (28 and 2 patients, respectively). Median procedure duration was 80 minutes. Tumour coverage rate was 97% (29 of 30 patients). Perioperative side-effects were negligible; one patient experienced grade-3 ulceration and infection. One-month 18F-FDG-SUV decreased by 86%; CRR was 63% (95% CI 44–79%). Local control was durable in 24 of 30 patients (two-year LPFS, 62%). Patients reported an improvement in “usual activities”, “anxiety/depression”, and “overall health” scores. VEG-ECT demonstrated encouraging antitumour activity in soft-tissue malignancies; a single course of treatment produced high and durable responses, with low complications.
AB - Standard electrochemotherapy (ECT) is effective in many tumour types but is confined to the treatment of small superficial lesions. Variable electrode-geometry ECT (VEG-ECT) may overcome these limitations by using long freely-placeable electrodes. Patients with bulky or deep-seated soft-tissue malignancies not amenable to resection participated in a single-arm phase-2 study (ISRCTN.11667954) and received a single course of VEG-ECT with intravenous bleomycin (15,000 IU/m2) and concomitant electric pulses applied through an adjustable electrode array. The primary outcome was radiologic complete response rate (CRR) per RECIST; secondary endpoints included feasibility, metabolic response, toxicity (CTCAE), local progression-free survival (LPFS) and patient perception (EQ-5D). During 2009–2014, we enrolled 30 patients with trunk/limb sarcomas, melanoma, Merkel-cell carcinoma, and colorectal/lung cancer. Median tumour size was 4.7 cm. Electrode probes were placed under US/TC guidance (28 and 2 patients, respectively). Median procedure duration was 80 minutes. Tumour coverage rate was 97% (29 of 30 patients). Perioperative side-effects were negligible; one patient experienced grade-3 ulceration and infection. One-month 18F-FDG-SUV decreased by 86%; CRR was 63% (95% CI 44–79%). Local control was durable in 24 of 30 patients (two-year LPFS, 62%). Patients reported an improvement in “usual activities”, “anxiety/depression”, and “overall health” scores. VEG-ECT demonstrated encouraging antitumour activity in soft-tissue malignancies; a single course of treatment produced high and durable responses, with low complications.
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U2 - 10.1038/s41598-020-59230-w
DO - 10.1038/s41598-020-59230-w
M3 - Article
C2 - 32042142
AN - SCOPUS:85079245013
VL - 10
SP - 1
EP - 13
JO - Scientific Reports
JF - Scientific Reports
SN - 2045-2322
IS - 1
M1 - 2291
ER -