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Background Electrochemotherapy (ECT) is a novel modality for the treatment of skin nodules and cutaneous or subcutaneous tumors that allows delivery of low and non-permeant drug into cells. The aim of this prospective single-center study was to evaluate ECT efficacy in the local treatment of Classic Kaposi's sarcoma (CKS) skin localization stage I-II sec. Brambilla et al. Methods Nineteen consecutive patients affected by classic KS were included in this study. All patients underwent blood sampling and concurrent incisional biopsy for histological diagnosis and Kaposi's sarcoma related herpes virus 8 (HHV-8) molecular analysis. ECT treatment of KS cutaneous lesions were performed according to the European Standard Operating Procedures of Electrochemotherapy (ESOPE). The primary endpoint of the study was the evaluation of ECT efficacy in the treatment of KS skin nodules and the assessment of HHV-8 viral load in the peripheral blood following the ECT therapy. Results Complete response (CR) was observed in 14 (73.6%) patients after first ECT session, while 3 (15.7%) and 2 (10.5%) out of 19 patients received a second and a third ECT treatment, respectively. Clinical response dragged out the whole follow-up period that ranged between 6 and 31 months with a median of 16 months. Conclusions Clinical management of CKS skin localizations still represents a challenging task for surgeons and oncologists. Therefore, according to this and other author's recent experiences, ECT is claimed to become the "new standard of care" as first line treatment strategy for stage I-II CKS patients. © 2013 Elsevier Ltd. All rights reserved.

Aims The aim of this study was to evaluate the incidence of lymph node metastases in patients with atypical Spitz nevi (ASN) after sentinel lymph node biopsy (SLNB) and during follow-up, and to assess the diagnostic value of the surgical procedure. Methods At the National Cancer Institute of Naples, Italy, 40 patients with ASN underwent SLNB between 2003 and 2011. Medical records were reviewed and all slides of the primary tumours were retrieved, rendered separately, and assessed by four experienced dermatopathologists from two different academic institutions. Each member of the review panel assessed slides separately without recourse to medical notes and blinded to each others' diagnosis. All patients were treated with wide local excision and SLN biopsy according to the standard procedure. All cases were followed up to assess outcomes. Results The original diagnosis of ASN was confirmed in all 40 cases. No sentinel node positivity was recorded, and no patients developed nodal involvement during a median follow-up of 46 months (range 16–103). All patients were alive and without evidence of locoregional or distant relapse at time of review. Conclusions In our experience, ASN were not associated with metastatic potential. Surgical staging procedures are not justified and careful clinical surveillance is adequate.

Purpose BMS-936558 is a monoclonal antibody that blocks the PD-1 co-inhibitory receptor expressed by activated T cells. This study describes its activity and safety in pts with previously treated advanced MEL. Methods BMS-936558 was administered IV q2wk to pts with various tumors at 0.1 - 10 mg/kg during dose-escalation and/or cohort expansion. Pts received up to 12 cycles (4 doses/cycle) of treatment or until unacceptable toxicity, confirmed progressive disease, or complete response. Clinical activity was assessed by RECIST v1.0. Results As of Feb 24, 2012, 104 MEL pts had received BMS-936558 at 0.1 (n = 17), 0.3 (n = 19), 1 (n = 31), 3 (n = 17), or 10 mg/kg (n = 20). ECOG performance status was 0/1/2 in 63/38/3 pts, respectively. Most pts (67/104) had received prior immunotherapy (IT); prior anti-CTLA-4, -PD-1, or -PD-L1 was not permitted. The number of prior therapies was 1 (39%), 2 (35%), or ≥3 (26%). Median therapy duration was 20 wks (range 2.0 - 121.7 wks). The incidence of grade 3 - 4 related AEs was 20% and included gastrointestinal (4%), endocrine (2%), and hepatobiliary disorders (1%). There were no drug-related deaths in MEL pts. Clinical activity (responses or prolonged stable disease) was observed at all doses (Table). Of the 26/94 (28%) evaluable responders, 19 (73%) are ongoing ranging from 1.9+ to 24.9+ months. For the 23 responders followed ≥6 months from first dose on study, 16 (70%) are progression free. ORs occurred in pts with visceral or bone metastases. Six pts (6%; 95% CI 2 - 13%) had prolonged SD (≥24 wk); 3 pts had a persistent decrease in target lesion tumor burden in the presence of new lesions and were not categorized as responders. Conclusions BMS-936558 had durable clinical benefit in pts with advanced MEL, including those who had received prior IT. Additional long-term follow-up data will be reported. Dose, (mg/kg) No. ptsa ORR, No. pts (%) [95% CI] PFSR at 24 wk (%) [95% CI] 0.1 14 4 (29) [8 - 58] 40 [13 - 66] 0.3 16 3 (19) [4 - 46] 31 [9 - 54] 1 27 8 (30) [14 - 50] 45 [26 - 65] 3 17 7 (41) [18 - 67] * 55 [30 - 80] 10 20 4 (20) [6 - 44] 30 [9 - 51] * 1 CR aResponse-evaluable pts dosed by 7/01/2011 ORR = objective response rate ([{CR + PR} ÷ n] × 100); PFSR = progression-free survival rate. Disclosure J. Sosman: Research Funding: Bristol-Myers Squibb (myself). M. Sznol: Consultant or Advisory Role: Bristol-Myers Squibb (myself, compensated). Research Funding: Bristol-Myers Squibb (myself, clinical trials funding). D.F. McDermott: Advisory Board Role: Bristol-Myers Squibb (myself). R. Carvajal: Research Funding: Bristol-Myers Squibb (myself). S.L. Topalian: Consultant or Advisory Role: Bristol-Myers Squibb (myself, immediate family member, uncompensated). Research Funding: Bristol-Myers Squibb (myself). J.M. Wigginton: Employment or Leadership Position: Bristol-Myers Squibb (myself, employment, compensated). Stock Ownership: Bristol-Myers Squibb (myself). G. Kollia: Employment or Leadership Role: Bristol-Myers Squibb (employment, myself, compensated). Stock Ownership: Bristol-Myers Squibb/BMY stocks (myself). A. Gupta: Employment or Leadership Role: Bristol-Myers Squibb (employment, myself, compensated). Stock Ownership: Bristol-Myers Squibb (myself). F.S. Hodi: Consultant or Advisory Role: Bristol-Myers Squibb (myself, uncompensated). Research Funding: Bristol-Myers Squibb (myself). All other authors have declared no conflicts of interest.

Backgroud Electrochemotherapy (ECT) has shown to be effective as local treatment of disseminated superficial melanoma, but there is a lack of evidence of its potential systemic effect. Potential immunologic changes due to ECT could have an impact on metastatic lesions but this hasn't been demonstrated yet. Combining ECT with new drugs, like ipilimumab (ipi), could be a new therapeutic strategy. T-regulatory cells (T-Reg) are immunosuppressive lymphocytes whose role during ipi therapy has still to be clarified. Our previous experience showed a reduction of T-reg cells in patients responder to ipi. Patients and methods 20 patients with advanced melanoma (8 at stage IIIc and 12 IV M1c) underwent ECT with bleomycine. 5 patients were treated with ECT and no further therapies, while 15 pts were treated with ECT first and then, after progression, with ipi at 3 mg/kg for 4 cycles. We collected PBMC of these patients. Blood draw was performed at ECT day 0-1-15-30 and during follow-up, while during ipi therapy, at each cycle (week 4-7-10) and at every tumor evaluation (every 12 weeks). Results 5/20 (25%) patients, all at stage IIIc, had performed only ECT and showed a good local response (2 CR and 3 PR). No variation of T-Reg was detected after ECT treatment with median value of 0.40 % (range 0.40-2.6 %). 15/20 (75%) patients had a low local response and developed visceral progression after ECT without significant reduction of T-Reg levels. The median T-reg value was of 0.7 (range 0.50-2.6%) During ipi treatment, we found a decrease of T-Reg of 0.10% per cycle. This result was consistent with our previous evidence in patients treated with ipi in Italian EAP. Moreover, 3/15 patients (20%) showed local CR and 2 of them also systemic PR lasting at 12.1 months of follow- up, with a median T-Reg value of 0.10%. 8/15 (53%) had both local and systemic SD with a median TTP of 7.9 months and a median T-Reg of 0.30%. 4/15 (27%) developed a local and distant progression and we found a small decrease with median T-Reg of 1.8%. Conclusion ECT followed by ipi in patients with metastatic melanoma, may be more effective than ECT and ipi alone. This combination may represent a new option. Anyway, further studies are necessary to verify these data. Disclosure All authors have declared no conflicts of interest.