Prospective cohort study by InspECT on safety and efficacy of electrochemotherapy for cutaneous tumors and metastases depending on ulceration.
Journal
Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG
ISSN: 1610-0387
Titre abrégé: J Dtsch Dermatol Ges
Pays: Germany
ID NLM: 101164708
Informations de publication
Date de publication:
04 2022
04 2022
Historique:
received:
29
03
2021
accepted:
17
11
2021
pubmed:
7
4
2022
medline:
26
4
2022
entrez:
6
4
2022
Statut:
ppublish
Résumé
Electrochemotherapy (ECT) is an effective local treatment for cutaneous tumors. The aim of this study was to compare the effectiveness of ECT in ulcerated vs. non-ulcerated tumors and investigate the effect on tumor-associated symptoms. Twenty cancer centers in the International Network for Sharing Practices on Electrochemotherapy (InspECT) prospectively collected data. ECT was performed following ESOPE protocol. Response was evaluated by lesion size development. Pain, symptoms, performance status (ECOG-Index) and health status (EQ-5D questionnaire) were evaluated. 716 patients with ulcerated (n = 302) and non-ulcerated (n = 414) cutaneous tumors and metastases were included (minimum follow-up of 45 days). Non-ulcerated lesions responded to ECT better than ulcerated lesions (complete response 65 % vs. 51 %, p = 0.0061). Only 38 % (115/302) with ulcerated lesions before ECT presented with ulcerated lesions at final follow-up. Patients with ulcerated lesions reported higher pain and more severe symptoms compared to non-ulcerated lesions, which significantly and continuously improved following ECT. In non-ulcerated lesions however, pain spiked during the treatment. No serious adverse events were reported. ECT is a safe and effective local treatment for cutaneous tumors. While ECT improves symptoms especially in patients with ulcerated lesions, data suggest the implementation of a perioperative pain management in non-ulcerated lesions during ECT.
Sections du résumé
BACKGROUND
Electrochemotherapy (ECT) is an effective local treatment for cutaneous tumors. The aim of this study was to compare the effectiveness of ECT in ulcerated vs. non-ulcerated tumors and investigate the effect on tumor-associated symptoms.
METHODS
Twenty cancer centers in the International Network for Sharing Practices on Electrochemotherapy (InspECT) prospectively collected data. ECT was performed following ESOPE protocol. Response was evaluated by lesion size development. Pain, symptoms, performance status (ECOG-Index) and health status (EQ-5D questionnaire) were evaluated.
RESULTS
716 patients with ulcerated (n = 302) and non-ulcerated (n = 414) cutaneous tumors and metastases were included (minimum follow-up of 45 days). Non-ulcerated lesions responded to ECT better than ulcerated lesions (complete response 65 % vs. 51 %, p = 0.0061). Only 38 % (115/302) with ulcerated lesions before ECT presented with ulcerated lesions at final follow-up. Patients with ulcerated lesions reported higher pain and more severe symptoms compared to non-ulcerated lesions, which significantly and continuously improved following ECT. In non-ulcerated lesions however, pain spiked during the treatment. No serious adverse events were reported.
CONCLUSIONS
ECT is a safe and effective local treatment for cutaneous tumors. While ECT improves symptoms especially in patients with ulcerated lesions, data suggest the implementation of a perioperative pain management in non-ulcerated lesions during ECT.
Substances chimiques
Bleomycin
11056-06-7
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
470-481Informations de copyright
© 2022 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd.
Références
Sampogna F, Paradisi A, Iemboli ML et al. Comparison of quality of life between melanoma and non-melanoma skin cancer patients. Eur J Dermatol 2019; 29(2): 185-91.
Weitman ES, Perez M, Thompson JF et al. Quality of life patient-reported outcomes for locally advanced cutaneous melanoma. Melanoma Res 2018; 28(2): 134-42.
Probst U, Fuhrmann I, Beyer L et al. Electrochemotherapy as a new modality in interventional oncology: a review. Technol Cancer Res Treat 2018; 17: 1533033818785329.
Spratt DE, Gordon Spratt EA, Wu S. et al. Efficacy of skin-directed therapy for cutaneous metastases from advanced cancer: a meta-analysis. J Clin Oncol 2014. 32(28): 3144-55.
Marty M, Sersa G, Garbay JR et al. Electrochemotherapy - An easy, highly effective and safe treatment of cutaneous and subcutaneous metastases: Results of ESOPE (European Standard Operating Procedures of Electrochemotherapy) study. EJC Suppl 2006; 4(11): 3-13.
Gehl J, Geertsen PF. Efficient palliation of haemorrhaging malignant melanoma skin metastases by electrochemotherapy. Melanoma Res 2000; 10(6): 585-9.
Osagiede O, Colibaseanu DT, Spaulding AC et al. Palliative care use among patients with solid cancer tumors: a national cancer data base study. J Palliat Care 2018; 33(3): 149-58.
Kunte C, Letule V, Gehl J et al. Electrochemotherapy in the treatment of metastatic malignant melanoma: a prospective cohort study by InspECT. Br J Dermatol 2017; 176(6): 1475-85.
Campana LG, Kis E, Bottyán K et al. Electrochemotherapy for advanced cutaneous angiosarcoma: A European register-based cohort study from the International Network for Sharing Practices of electrochemotherapy (InspECT). Int J Surg 2019; 72: 34-42.
Clover AJP, Salwa SP, Bourke MG et al. Electrochemotherapy for the treatment of primary basal cell carcinoma; A randomised control trial comparing electrochemotherapy and surgery with five year follow up. Eur J Surg Oncol 2020; 46(5): 847-54.
Quaglino P, Mortera C, Osella-Abate S et al. Electrochemotherapy with intravenous bleomycin in the local treatment of skin melanoma metastases. Ann Surg Oncol 2008. 15(8): 2215-22.
Mir LM, Gehl J, Sersae G et al. Standard operating procedures of the electrochemotherapy: Instructions for the use of bleomycin or cisplatin administered either systemically or locally and electric pulses delivered by the CliniporatorTM by means of invasive or non-invasive electrodes. EJC Suppl 2006; 4(11): 14-25.
Gothelf A, Mir LM, Gehl J. Electrochemotherapy: results of cancer treatment using enhanced delivery of bleomycin by electroporation. Cancer Treat Rev 2003; 29(5): 371-87.
Campana LG, Mocellin S, Basso M et al. Bleomycin-based electrochemotherapy: clinical outcome from a single institution’s experience with 52 patients. Ann Surg Oncol 2009; 16(1): 191-9.
Sersa G. The state-of-the-art of electrochemotherapy before the ESOPE study; advantages and clinical uses. European Journal of Cancer Supplements 2006; 4(11): 52-9.
Mir LM, Gehl J, Sersa G et al. Standard operating procedures of the electrochemotherapy: Instructions for the use of bleomycin or cisplatin administered either systemically or locally and electric pulses delivered by the CliniporatorTM by means of invasive or non-invasive electrodes. EJC Suppl 2006: 14-25.
Matthiessen LW, Chalmers RL, Sainsbury DC et al. Management of cutaneous metastases using electrochemotherapy. Acta Oncol 2011; 50(5): 621-9.
Curatolo P, Quaglino P, Marenco F et al. Electrochemotherapy in the treatment of Kaposi sarcoma cutaneous lesions: a two-center prospective phase II trial. Ann Surg Oncol 2012; 19(1): 192-8.
Di Gennaro P, Gerlini G, Urso C et al. CD4(+)FOXP3(+) T regulatory cells decrease and CD3(+)CD8(+) T cells recruitment in TILs from melanoma metastases after electrochemotherapy. Clin Exp Metastasis 2016; 33(8): 787-98.
Gerlini G, Sestini S, Di Gennaro P et al. Dendritic cells recruitment in melanoma metastasis treated by electrochemotherapy. Clin Exp Metastasis 2013; 30(1): 37-45.
Bertino G, Sersa G, De Terlizzi F et al. European Research on Electrochemotherapy in Head and Neck Cancer (EURECA) project: Results of the treatment of skin cancer. Eur J Cancer 2016; 63: 41-52.
Cadossi R, Ronchetti M, Cadossi M. Locally enhanced chemotherapy by electroporation: clinical experiences and perspective of use of electrochemotherapy. Future Oncol 2014; 10(5): 877-90.
Quaglino P, Matthiessen LW, Curatolo P et al. Predicting patients at risk for pain associated with electrochemotherapy. Acta Oncol 2015; 54(3): 298-306.
Matthiessen LW, Keshtgar M, Curatolo P et al. Electrochemotherapy for Breast Cancer-Results From the INSPECT Database. Clin Breast Cancer 2018; 18(5): e909-e917.
(NICE), N.I.f.H.a.C.E. Electrochemotherapy for metastases in the skin from tumours of non-skin origin and melanoma. 2013, accessed 01.02.2021; Available from: https://www.nice.org.uk/guidance/ipg446 [Last accessed January 24, 2022].
Therasse P, Arbuck SG, Eisenhauer EA et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000; 92(3): 205-16.
Matthiessen LW, Keshtgar M, Curatolo P et al. Electrochemotherapy for breast cancer-results from the INSPECT Database. Clin Breast Cancer 2018; 18(5): e909-e917.
Hintze J. ASS 12. Kaysville, Utah: NCSS, LLC. 2013.
Gualdi G, Panarese F, Meogrossi G et al. Speed rate (SR) as a new dynamic index of melanoma behavior. Pigment Cell Melanoma Res 2020; 33(5): 709-18.
O’Byrne KJ, Dalgleish AG, Browning MJ et al. The relationship between angiogenesis and the immune response in carcinogenesis and the progression of malignant disease. Eur J Cancer 2000; 36(2): 151-69.
Callender GG, McMasters KM. What does ulceration of a melanoma mean for prognosis? Adv Surg 2011; 45: 225-36.
Greten FR, Grivennikov SI. Inflammation and cancer: triggers, mechanisms, and consequences. Immunity 2019; 51(1): 27-41.
Jain RK. Normalization of tumor vasculature: an emerging concept in antiangiogenic therapy. Science 2005; 307(5706): 58-62.
Gargiulo M, Papa A, Capasso P et al. Electrochemotherapy for non-melanoma head and neck cancers: clinical outcomes in 25 patients. Ann Surg 2012; 255(6): 1158-64.
Mevio N, Bertino G, Occhini A et al. Electrochemotherapy for the treatment of recurrent head and neck cancers: preliminary results. Tumori 2012; 98(3): 308-13.
Campana LG, Valpione S, Falci C et al. The activity and safety of electrochemotherapy in persistent chest wall recurrence from breast cancer after mastectomy: a phase-II study. Breast Cancer Res Treat 2012; 134(3): 1169-78.
Wurschmidt F, Dahle J, Petersen C et al. Reirradiation of recurrent breast cancer with and without concurrent chemotherapy. Radiat Oncol 2008; 3: 28.
Domenge C, Orlowski S, Luboinski B et al. Antitumor electrochemotherapy: new advances in the clinical protocol. Cancer 1996; 77(5): 956-63.
Plaschke CC, Bertino G, McCaul JA et al. European Research on Electrochemotherapy in Head and Neck Cancer (EURECA) project: Results from the treatment of mucosal cancers. Eur J Cancer, 2017. 87: 172-181.
Rotunno R, Campana LG, Quaglino P et al. Electrochemotherapy of unresectable cutaneous tumours with reduced dosages of intravenous bleomycin: analysis of 57 patients from the International Network for Sharing Practices of Electrochemotherapy registry. J Eur Acad Dermatol Venereol 2018; 32(7): 1147-54.
Matthiessen LW, Johannesen HH, Hendel HW et al. Electrochemotherapy for large cutaneous recurrence of breast cancer: a phase II clinical trial. Acta Oncol 2012; 51(6): 713-21.
Benevento R, Santoriello A, Perna G et al. Electrochemotherapy of cutaneous metastastes from breast cancer in elderly patients: a preliminary report. BMC Surg 2012; 12 (Suppl 1): S6.
Larkin JO, Collins CG, Aarons S et al. Electrochemotherapy: aspects of preclinical development and early clinical experience. Ann Surg 2007; 245(3): 469-79.
Cabula C, Campana LG, Grilz G et al. Electrochemotherapy in the treatment of cutaneous metastases from breast cancer: a multicenter cohort analysis. Ann Surg Oncol 2015; 22 (Suppl 3): S442-50.
Ágoston D, Baltás E, Ócsai H et al. Evaluation of calcium electroporation for the treatment of cutaneous metastases: a double blinded randomised controlled phase II trial. Cancers (Basel) 2020; 12(1).
Markelc B, Sersa G, Cemazar M. Differential mechanisms associated with vascular disrupting action of electrochemotherapy: intravital microscopy on the level of single normal and tumor blood vessels. PLoS One 2013; 8(3): e59557.
Jarm T, Cemazar M, Miklavcic D et al. Antivascular effects of electrochemotherapy: implications in treatment of bleeding metastases. Expert Rev Anticancer Ther 2010; 10(5): 729-46.
Campana LG, Miklavcˇicˇ D, Bertino G et al. Electrochemotherapy of superficial tumors - Current status: Basic principles, operating procedures, shared indications, and emerging applications. Semin Oncol 2019; 46(2): 173-91.