Ablation of soft tissue tumours by long needle variable electrode-geometry electrochemotherapy: final report from a single-arm, single-centre phase-2 study.
Administration, Intravenous
Adult
Aged
Aged, 80 and over
Bleomycin
/ administration & dosage
Electrochemotherapy
/ adverse effects
Electrodes
Feasibility Studies
Female
Follow-Up Studies
Humans
Male
Middle Aged
Needles
Neoplasms, Connective and Soft Tissue
/ drug therapy
Patient Reported Outcome Measures
Progression-Free Survival
Prospective Studies
Response Evaluation Criteria in Solid Tumors
Treatment Outcome
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
10 02 2020
10 02 2020
Historique:
received:
10
11
2019
accepted:
24
01
2020
entrez:
12
2
2020
pubmed:
12
2
2020
medline:
21
11
2020
Statut:
epublish
Résumé
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/m
Identifiants
pubmed: 32042142
doi: 10.1038/s41598-020-59230-w
pii: 10.1038/s41598-020-59230-w
pmc: PMC7010705
doi:
Substances chimiques
Bleomycin
11056-06-7
Types de publication
Clinical Trial, Phase II
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2291Références
Damron, T. A. & Heiner, J. Distant soft tissue metastases: a series of 30 new patients and 91 cases from the literature. Ann. Surg. Oncol. 7, 526–534 (2000).
doi: 10.1007/s10434-000-0526-7
Plaza, J. A., Perez-Montiel, D., Mayerson, J., Morrison, C. & Suster, S. Metastases to soft tissue: a review of 118 cases over a 30-year period. Cancer. 112, 193–203 (2008).
doi: 10.1002/cncr.23151
Abdalla, E. K. & Pisters, P. W. T. Metastasectomy for limited metastases from soft tissue sarcoma. Curr. Treat. Options Oncol. 3, 497–505 (2002).
doi: 10.1007/s11864-002-0069-1
Nicholas Kurup, A. & Callstrom, M. R. Ablation of musculoskeletal metastases: pain palliation, fracture risk reduction, and oligometastatic disease. Tech. Vasc. Interv. Radiol. 16, 253–261 (2013).
doi: 10.1053/j.tvir.2013.08.007
Gronchi, A., Guadagnolo, B. A. & Erinjeri, J. P. Local ablative therapies to metastatic soft tissue sarcoma. Am. Soc. Clin. Oncol. Educ. B. 35, e566–575 (2016).
doi: 10.14694/EDBK_157450
Theurich, S. et al. Local tumor treatment in combination with systemic ipilimumab immunotherapy prolongs overall survival in patients with advanced malignant melanoma. Cancer Immunol. Res. 4, 744–754 (2016).
doi: 10.1158/2326-6066.CIR-15-0156
Valpione, S., Campana, L. G., Pigozzo, J. & Chiarion-Sileni, V. Consolidation electrochemotherapy with bleomycin in metastatic melanoma during treatment with dabrafenib. Radiol. Oncol. 49, 71–74 (2015).
doi: 10.2478/raon-2014-0035
Campana, L. G. et al. Electrochemotherapy of superficial tumors – Current status: basic principles, operating procedures, shared indications, and emerging applications. Semin. Oncol. 46, 173–191 (2019).
doi: 10.1053/j.seminoncol.2019.04.002
Jarm, T., Cemazar, M., Miklavcic, D. & Sersa, G. Antivascular effects of electrochemotherapy: implications in treatment of bleeding metastases. Expert Rev. Anticancer Ther. 10, 729–746 (2010).
doi: 10.1586/era.10.43
Solari, N. et al. Electrochemotherapy for the management of cutaneous and subcutaneous metastasis: a series of 39 patients treated with palliative intent. J. Surg. Oncol. 109, 270–274 (2014).
doi: 10.1002/jso.23481
Mali, B. et al. Tumor size and effectiveness of electrochemotherapy. Radiol. Oncol. 47, 32–41 (2013).
doi: 10.2478/raon-2013-0002
Campana, L. G. et al. Electrochemotherapy treatment of locally advanced and metastatic soft tissue sarcomas: results of a non-comparative phase II study. World J. Surg. 38, 813–822 (2014).
doi: 10.1007/s00268-013-2321-1
Edhemovic, I. et al. Intraoperative electrochemotherapy of colorectal liver metastases. J. Surg. Oncol. 110, 320–327 (2014).
doi: 10.1002/jso.23625
Campana, L. G. et al. Electrochemotherapy – Emerging applications technical advances, new indications, combined approaches, and multi-institutional collaboration. Eur. J. Surg. Oncol. 45, 92–102 (2019).
doi: 10.1016/j.ejso.2018.11.023
Miklavcic, D. et al. Towards treatment planning and treatment of deep-seated solid tumors by electrochemotherapy. Biomed. Eng. Online. 9, 10 (2010).
doi: 10.1186/1475-925X-9-10
Bianchi, G., Campanacci, L., Ronchetti, M. & Donati, D. Electrochemotherapy in the treatment of bone metastases: a phase II trial. World J. Surg. 40, 3088–3094 (2016).
doi: 10.1007/s00268-016-3627-6
Kosjek, T. et al. Identification and quantification of bleomycin in serum and tumor tissue by liquid chromatography coupled to high-resolution mass spectrometry. Talanta. 160, 164–171 (2016).
doi: 10.1016/j.talanta.2016.06.062
A’Hern, R. P. Sample size tables for exact single-stage phase II designs. Stat. Med. 20, 859–866 (2001).
doi: 10.1002/sim.721
Abed, R., Grimer, R. J., Carter, S. R., Tillman, R. M. & Abudu, A. J. L. Soft-tissue metastases: their presentation and origin. J. Bone Jt. Surg Br. 91, 1083–1085 (2009).
doi: 10.1302/0301-620X.91B8.21680
Rao, U. N. M., Hanan, S. H., Lotze, M. T. & Karakousis, C. P. Distant skin and soft tissue metastases from sarcomas. J. Surg. Oncol. 69, 94–98 (1998).
doi: 10.1002/(SICI)1096-9098(199810)69:2<94::AID-JSO9>3.0.CO;2-4
Martinez, S. R. & Young, S. E. A rational surgical approach to the treatment of distant melanoma metastases. Cancer Treat. Rev. 34, 14–20 (2008).
doi: 10.1016/j.ctrv.2008.05.003
Essner, R. et al. Contemporary surgical treatment of advanced-stage melanoma. Arch. Surg. 139, 961–966 (2004).
doi: 10.1001/archsurg.139.9.961
Gómez-León, N. et al. Skeletal muscle and solitary bone metastases from malignant melanoma: multimodality imaging and oncological outcome. Melanoma Res. 28, 562–570 (2018).
doi: 10.1097/CMR.0000000000000466
Nguyen, N. C., Chaar, B. T. & Osman, M. M. Prevalence and patterns of soft tissue metastasis: detection with true whole-body F-18 FDG PET/CT. BMC Med. Imaging. 7, 8 (2007).
doi: 10.1186/1471-2342-7-8
Casali, P. G. et al. Soft tissue and visceral sarcomas: ESMO-EURACAN clinical practice guidelines for diagnosis, treatment and follow-up. Ann. Oncol. 29, iv51–67 (2018).
doi: 10.1093/annonc/mdy096
Soyfer, V. et al. Radiation therapy for palliation of sarcoma metastases: a unique and uniform hypofractionation experience. Sarcoma. 2010, 927972 (2010).
Takkenberg, R. B. et al. Palliative isolated limb perfusion for advanced limb disease in stage IV melanoma patients. J. Surg. Oncol. 91, 107–111 (2005).
doi: 10.1002/jso.20297
Kroon, H. M., Lin, D. Y., Kam, P. C. A. & Thompson, J. F. Isolated limb infusion as palliative treatment for advanced limb disease in patients with AJCC stage IV melanoma. Ann. Surg. Oncol. 16, 1193–1201 (2009).
doi: 10.1245/s10434-009-0326-7
Datta, N. R. et al. Local hyperthermia combined with radiotherapy and-/or chemotherapy: recent advances and promises for the future. Cancer Treat. Rev. 41, 742–753 (2015).
doi: 10.1016/j.ctrv.2015.05.009
Radny, P. et al. Phase II trial of intralesional therapy with interleukin-2 in soft-tissue melanoma metastases. Br. J. Cancer. 89, 1620–1626 (2003).
doi: 10.1038/sj.bjc.6601320
Neal, R. E. et al. Successful treatment of a large soft tissue sarcoma with irreversible electroporation. J. Clin. Oncol. 29, e372–377 (2011).
doi: 10.1200/JCO.2010.33.0902
Philips, P., Hays, D. & Martin, R. C. G. Irreversible electroporation ablation (IRE) of unresectable soft tissue tumors: learning curve evaluation in the first 150 patients treated. PLoS One. 8, e76260 (2013).
doi: 10.1371/journal.pone.0076260
Grilley-Olson, J. E., Webber, N. P., Demos, D. S., Christensen, J. D. & Kirsch, D. G. Multidisciplinary management of oligometastatic soft tissue sarcoma. Am. Soc. Clin. Oncol. Educ. B. 38, 939–948 (2018).
doi: 10.1200/EDBK_200573
Fini, M. et al. Electrochemotherapy is effective in the treatment of rat bone metastases. Clin. Exp. Metastasis. 30, 1033–1045 (2013).
doi: 10.1007/s10585-013-9601-x
Zmuc, J. et al. Large liver blood vessels and bile ducts are not damaged by electrochemotherapy with bleomycin in pigs. Sci. Rep. 9, 3649 (2019).
doi: 10.1038/s41598-019-40395-y
Miklavčič, D. et al. The importance of electric field distribution for effective in vivo electroporation of tissues. Biophys. J. 74, 2152–2158 (1998).
doi: 10.1016/S0006-3495(98)77924-X
Campana, L. G. et al. Electrical resistance of human soft tissue sarcomas: an ex vivo study on surgical specimens. Med. Biol. Eng. Comput. 54, 773–787 (2016).
doi: 10.1007/s11517-015-1368-6
Boc, N. et al. Ultrasonographic changes in the liver tumors as indicators of adequate tumor coverage with electric field for effective electrochemotherapy. Radiol. Oncol. 52, 383–391 (2018).
doi: 10.2478/raon-2018-0041
Kranjc, M. et al. Predicting irreversible electroporation-induced tissue damage by means of magnetic resonance electrical impedance tomography. Sci. Rep. 7, 10323 (2017).
doi: 10.1038/s41598-017-10846-5
Sebio, A., Wilky, B. A., Keedy, V. L. & Jones, R. L. The current landscape of early drug development for patients with sarcoma in the immunotherapy era. Future Oncol. 14, 1197–1211 (2018).
doi: 10.2217/fon-2017-0565
Weide, B. et al. Survival after intratumoral interleukin-2 treatment of 72 melanoma patients and response upon the first chemotherapy during follow-up. Cancer Immunol. Immunother. 60, 487–493 (2011).
doi: 10.1007/s00262-010-0957-3