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Background: Electrochemotherapy (ECT) effectively controls skin metastases from cutaneous melanoma. Objectives: This study aimed to evaluate health‐related quality of life (HRQoL) in melanoma patients pre−/post‐ECT and its effect on treatment outcome. Methods: The analysis included prospective data from the International Network for Sharing Practices of ECT register. Following the Standard Operating Procedures, patients received intravenous or intratumoural bleomycin (15 000 IU/m2; 1000 IU mL/cm3) followed by 100‐microsecond, 1000‐V/cm electric pulses. Endpoints included response (RECIST v3.0), local progression‐free survival (LPFS), toxicity (CTCAE v5.0), and patient‐reported HRQoL at baseline, one, two, four, and 10 months (EuroQol [EQ‐5D‐3L], including 5‐item utility score [EQ‐5D] and visual analogue scale for self‐reported health state [EQ‐VAS]). Comparisons within/between subgroups were made for statistical and minimal important differences (MID). HRQoL scores and clinical covariates were analysed to identify predictors of response in multivariate analysis. Results: Median tumour size was 2 cm. Complete response rate, G3 toxicity, and one‐year LPFS in 378 patients (76% of the melanoma cohort) were 47%, 5%, and 78%, respectively. At baseline, age‐paired HRQoL did not differ from the general European population. Following ECT, both EQ‐5D and EQ‐VAS scores remained within MID boundaries, particularly among complete responders. A subanalysis of the EQ‐5D items revealed a statistically significant deterioration in pain/discomfort and mobility (restored within 4 months), and self‐care and usual activities (throughout the follow‐up) domains. Concomitant checkpoint inhibition correlated with better EQ‐5D and EQ‐VAS trajectories. Baseline EQ‐5D was the exclusive independent predictor for complete response (RR 14.76, P = 0.001). Conclusions: HRQoL of ECT melanoma patients parallels the general population and is preserved in complete responders. Transient deterioration in pain/discomfort and mobility and persistent decline in self‐care and usual activities may warrant targeted support interventions. Combination with checkpoint inhibitors is associated with better QoL outcomes. Baseline HRQoL provides predictive information, which can help identify patients most likely to respond. [ABSTRACT FROM AUTHOR]

Abstract: Background: Electrochemotherapy (ECT) is currently used to treat unresectable superficial tumours of different histotypes through the combination of cytotoxic chemotherapy and local application of electric pulses. In 2006, a collaborative project defined the ESOPE (European Standard Operating Procedures of Electrochemotherapy) guidelines to standardize the procedure. The International Network for Sharing Practices of Electrochemotherapy (InspECT) aims to refine the ESOPE and improve clinical practice. Limiting patient exposure to systemic chemotherapy would be advisable to ameliorate ECT safety profile. Objective: The aim of this study was to evaluate the efficacy and toxicity of ECT with reduced chemotherapy dosages. Methods: In a retrospective analysis of a prospectively maintained database (InspECT registry), we evaluated the outcome of patients who received ECT with reduced dosages of bleomycin (7500, 10 000 or 13 500 IU/m2, instead of the standard dose of 15 000 IU/m2). Tumour response in melanoma patients was compared with melanoma patients of the InspECT registry who received the standard dose of bleomycin. Results: We identified 57 patients with 147 tumours (melanoma, 38.6%; squamous cell carcinoma, 22.8%; basal cell carcinoma, 17.5%; breast cancer 7%; Kaposi sarcoma 7%; other histotypes, 7.1%). Per‐tumour complete response (CR) rate at 60 days was 70.1% (partial, 16.3%); per‐patient CR was 57.9% (partial, 21.1%). Local pain was the most frequently reported side‐effect (n = 22 patients [39%]), mostly mild; two patients experienced flu‐like symptoms, one patient nausea. We observed the same CR rate (55%) in patients with melanoma treated by reduced or conventional bleomycin dosages (P = 1.00). Conclusions: Electrochemotherapy performed with reduced bleomycin dosages could be as effective as with currently recommended dose. Patients with impaired renal function or candidate to multiple ECT cycles could benefit from a reduced dose protocol. Our findings need prospective confirmation before being adopted in clinical practice. [ABSTRACT FROM AUTHOR]

Background ( ECT) is an effective local treatment for cutaneous metastasis. Treatment involves the administration of chemotherapeutic drugs followed by delivery of electrical pulses to the tumour. Objectives To investigate the effectiveness of ECT in cutaneous metastases of melanoma and to identify factors that affect (beneficially or adversely) the outcome. Methods Thirteen cancer centres in the International Network for Sharing Practices on Electrochemotherapy consecutively and prospectively uploaded data to a common database. ECT consisted of intratumoral or intravenous injection of bleomycin, followed by application of electric pulses under local or general anaesthesia. Results In total, 151 patients with metastatic melanoma were identified from the database, 114 of whom had follow-up data of 60 days or more. Eighty-four of these patients (74%) experienced an overall response ( OR = complete response + partial response). Overall, 394 lesions were treated, of which 306 (78%) showed OR, with 229 showing complete response (58%). In multivariate analysis, factors positively associated with overall response were coverage of deep margins, absence of visceral metastases, presence of lymphoedema and treatment of nonirradiated areas. Factors significantly associated with complete response to ECT treatment were coverage of deep margins, previous irradiation of the treated area and tumour size (< 3 cm). One-year overall survival in this cohort of patients was 67% (95% confidence interval 57-77%), while melanoma-specific survival was 74% (95% confidence interval 64-84%). No serious adverse events were reported, and the treatment was in general very well tolerated. Conclusions ECT is a highly effective local treatment for melanoma metastases in the skin, with no severe adverse effects noted in this study. In the presence of certain clinical factors, ECT may be considered for local tumour control as an alternative to established local treatments, or as an adjunct to systemic treatments. [ABSTRACT FROM AUTHOR]

Background Sentinel lymph node dissection ( SLND) is considered a standard staging procedure providing important prognostic information on melanoma patients. It remains a matter of debate, whether SLND and hence, removal of potential lymph node micrometastasis will alter survival outcome. Objective The aim of this group-matched analysis was to compare survival data of a large cohort of melanoma patients who were treated by wide local excision only ( WLE) and nodal observation ( WLE group) to a group of patients treated with WLE plus SLND group to investigate the potential therapeutic benefit of SLND in the treatment of patients with melanoma. Methods and materials A total of 596 consecutive patients who had undergone WLE plus SLND between 1996 and 2003 were assessed. As a historical control group 596 patients treated with WLE and nodal observation but without SLND between 1986 and 1995 were selected. The groups were matched according to sex, age, Breslow tumour thickness and localization of primary tumour. The adjuvant treatment and follow-up examinations were performed according to protocols of the German Dermatologic Cooperative Oncology Group (De COG) and applicable study protocols that our clinic participated in; and hence, subject to change over time. Results Kaplan-Meier testing revealed significant differences in survival in favour of the SLND group. Mean overall tumour-specific survival ( OS) was 102.7 months in the SLND group vs. 97.0 months in the WLE group respectively ( P-value: 0.024). Disease-free survival (log-rank test: 0.003) and time to lymph node progression ( P-value: <0.01) also differed significantly between the two groups. Conclusion SLND is not only an important diagnostic procedure, but might also be of therapeutic benefit in terms of disease-free and overall tumour-specific survival of melanoma patients. [ABSTRACT FROM AUTHOR]