European e-Delphi process to define expert consensus on electrochemotherapy treatment indications, procedural aspects, and quality indicators in melanoma

Abstract

Background Skin metastases are an important co-morbidity in melanoma. Despite broad adoption, electrochemotherapy implementation is hindered by a lack of treatment indications, uncertainty regarding procedural aspects, and the absence of quality indicators. An expert consensus may harmonize the approach among centres and facilitate comparison with other therapies. Methods An interdisciplinary panel was recruited for a three-round e-Delphi survey. A literature-based 113-item questionnaire was proposed to 160 professionals from 53 European centres. Participants rated each item for relevance and degree of agreement on a five-point Likert scale, and received anonymous controlled feedback to allow revision. The items that reached concordant agreement in two successive iterations were included in the final consensus list. In the third round, quality indicator benchmarks were defined using a real-time Delphi method. Results The initial working group included 122 respondents, of whom 100 (82 per cent) completed the first round, thus qualifying for inclusion in the expert panel (49 surgeons, 29 dermatologists, 15 medical oncologists, three radiotherapists, two nurse specialists, two clinician scientists). The completion rate was 97 per cent (97 of 100) and 93 per cent (90 of 97) in the second and third rounds respectively. The final consensus list included 54 statements with benchmarks (treatment indications, (37); procedural aspects, (1); quality indicators, (16)). Conclusion An expert panel achieved consensus on the use of electrochemotherapy in melanoma, with a core set of statements providing general direction to electrochemotherapy users to refine indications, align clinical practices, and promote quality assurance programmes and local audits. The residual controversial topics set future research priorities to improve patient care.

Pulsed Electric Fields in Oncology: A Snapshot of Current Clinical Practices and Research Directions from the 4th World Congress of Electroporation

“…Despite the development of electric protocols and the availability of standard operating procedures for some PEF-based therapies (e.g., the ESOPE guidelines [ 150 ]), some variation remains across centres in treatment delivery. For instance, bleomycin dose and electrode application (i.e., the inclusion of a safety margin) is a matter of debate among ECT users [ 268 ], whereas the standardisation of energy delivery is a controversial aspect in IRE [ 267 ]. At the same time, improving treatment precision, particularly for deep-seated lesions, can potentially ensure patient safety and improve treatment results.…”

The Diagnosis and Management of Cutaneous Metastases from Melanoma

“…Both these drugs represent the best choices for ECT, since they both disperse scantily throughout the cell membrane and are highly cytotoxic inside cells [93]. ECT was first approved for head and neck squamous cell carcinomas following a clinical trial in 1993, but nowadays, it finds its main applications in melanoma and Kaposi sarcoma [94,95]. Kunte et al, demonstrated that, in 151 patients with metastatic melanoma, among the 394 lesions treated, 306 (78%) showed OR, while 229 (58%) showed a complete response [96].…”

“…Kunte et al, demonstrated that, in 151 patients with metastatic melanoma, among the 394 lesions treated, 306 (78%) showed OR, while 229 (58%) showed a complete response [96]. According to the European expert consensus, the ideal patient with in-transit melanoma metastases that could benefit from ECT should have fewer than 10 tumors smaller than 3 cm, or fewer than 20 smaller than 1 cm, and they should involve the same limb segment over an area not exceeding 10 cm [94]. ECT can induce immunogenic cell death (ICD), stimulating the immune system, mainly dendritic cells (DCs) and macrophages, through damageassociated molecular patterns (DAMPs) such as calreticulin (CRT), heat shock proteins, high-mobility group box 1 (HMGB1), type I IFN, and ATP [97,98].…”