Treatment strategies with electrochemotherapy for limb in-transit melanoma: Real-world outcomes from a European, retrospective, cohort study.

BACKGROUND: This study analysed treatment strategies with electrochemotherapy (ECT) in melanoma with limb in-transit metastases (ITM). METHODS: We audited AJCC v.8 stage IIIB-IIID patients treated across 22 centres (2006-2020) within the International Network for Sharing Practices of ECT (InspECT). RESULTS: 452 patients were included, 58 % pre-treated (93 % had lower limb ITM, 44 % had ≤10 metastases [median size 1.5 cm]. Treatment strategies included first-line ECT (n = 145, 32 %), ECT with concurrent locoregional/systemic treatment (n = 163, 36 %), and salvage ECT (n = 144, 32 %). The objective response rate was 63 % (complete response [CR], 24 %), increasing to 74 % (CR, 39 %) following retreatment (median two ECT, range 1-8). CR rate in treatment-naïve and pre-treated patients was 50 % vs 32 % (p < 0.001). Bleomycin de-escalation was associated with lower CR (p = 0.004). Small tumour number and size, hexagonal electrode, retreatment, and post-ECT skin ulceration predicted response in multivariable analysis. At a median follow-up of 61 months, local and locoregional recurrence occurred in 55 % and 81 % of patients. Median local progression-free, new lesions-free, and regional recurrence-free survival were 32.9, 6.9, and 7.7 months. Grade-3 toxicity was 15 %. Concurrent treatment and CR correlated with improved regional control and survival. Concomitant checkpoint inhibition did not impact toxicity or survival outcomes. The median overall survival was 5.7 years. CONCLUSIONS: Among patients with low-burden limb-only ITM, standard-dose bleomycin ECT results in durable local response. Treatment naivety, low tumour volume, hexagonal electrode application, retreatment, and post-ECT ulceration predict response. CR and concurrent treatment correlate with improved regional control and survival outcomes. Combination with checkpoint inhibitors is safe but lacks conclusive support.

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

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.

Electrochemotherapy is an effective locoregional therapy for skin metastases from melanoma, a problem faced by almost half of patients with metastatic disease. The lack of comparative studies and the heterogeneity of its clinical application among centres make it challenging to support consistent, evidence-based recommendations. To address this unmet need, a three-round online survey was conducted to establish a consensus on treatment indications, standard operating procedures, and quality indicators. In the survey, a panel of 100 European melanoma experts agreed on 56 statements that can be used to improve patient selection, homogenize treatment application, and monitor outcomes.

The role of sentinel node tumor burden in modeling the prognosis of melanoma patients with positive sentinel node biopsy: an Italian melanoma intergroup study (N = 2,086).

BACKGROUND: The management of melanoma patients with metastatic melanoma in the sentinel nodes (SN) is evolving based on the results of trials questioning the impact of completion lymph node dissection (CLND) and demonstrating the efficacy of new adjuvant treatments. In this landscape, new prognostic tools for fine risk stratification are eagerly sought to optimize the therapeutic path of these patients. METHODS: A retrospective cohort of 2,086 patients treated with CLND after a positive SN biopsy in thirteen Italian Melanoma Centers was reviewed. Overall survival (OS) was the outcome of interest; included independent variables were the following: age, gender, primary melanoma site, Breslow thickness, ulceration, sentinel node tumor burden (SNTB), number of positive SN, non-sentinel lymph nodes (NSN) status. Univariate and multivariate survival analyses were performed using the Cox proportional hazard regression model. RESULTS: The 3-year, 5-year and 10-year OS rates were 79%, 70% and 54%, respectively. At univariate analysis, all variables, except for primary melanoma body site, were found to be statistically significant prognostic factors. Multivariate Cox regression analysis indicated that older age (P < 0.0001), male gender (P = 0.04), increasing Breslow thickness (P < 0.0001), presence of ulceration (P = 0.004), SNTB size (P < 0.0001) and metastatic NSN (P < 0.0001) were independent negative predictors of OS. CONCLUSION: The above results were utilized to build a nomogram in order to ease the practical implementation of our prognostic model, which might improve treatment personalization.

Timing of sentinel node biopsy independently predicts disease-free and overall survival in clinical stage I-II melanoma patients: A multicentre study of the Italian Melanoma Intergroup (IMI).

BACKGROUND: Sentinel lymph node biopsy (SNB) still remains a key procedure to appropriately stage melanoma patients and to select those who are candidate to novel treatments with immunotherapy and targeted therapy in the adjuvant setting. The impact of timing of SNB on disease-free survival (DFS) and overall survival (OS) is still unclear. MATERIAL AND METHODS: The study was conducted at 6 Italian Melanoma Intergroup (IMI) centres and included 8953 consecutive clinical stage I-II melanoma patients who were diagnosed, treated, and followed up between November 1997 and March 2018. All patients were prospectively included in dedicated IMI database. Multivariable Cox regression analyses were performed to investigate how baseline characteristics and time interval until SNB are related to DFS and OS. RESULTS: Considering the whole population, at multivariable analysis, after adjusting for age, gender, Breslow thickness, site, ulceration, and the SNB status, a delay in the timing of SNB was associated with a better DFS (adjusted hazard ratio [aHR, delayed versus early SNB] 0.98, 95% confidence interval [CI] 0.97-0.99, p < 0.001) and OS (aHR 0.98, 95% CI 0.97-0.99, p = 0.001). Specifically, in patients with a negative SNB status, a beneficial impact of delayed SNB (i.e. at least 32 days after primary excision) was confirmed for DFS (aHR 0.70, 95%CI 0.63-0.79, p < 0.001) and OS (aHR 0.69, 95%CI 0.61-0.78, p < 0.001), whereas in those with a positive SNB status, DFS (aHR 0.96, 95%CI 0.84-1.09, p = 0.534) and OS (aHR 0.94 95%CI 0.81-1.08, p = 0.374) were not significantly different in patients with early or delayed SNB. CONCLUSIONS: Our study does not support a strict time interval for SNB. These results may be useful for national guidelines, for counselling patients and reducing the number of high urgency referrals.

Suicidal fall from heights trauma: difficult management and poor results.

BACKGROUND: Self-inflicted injuries represent a consistent cause of trauma and falls from heights (FFH) represent a common dynamic used for suicidal attempts. The aim of the current report is to compare, among FFH patients, unintentional fallers and intentional jumpers in terms of demographical characteristics, clinical-pathological parameters and mortality, describing the population at risk for suicide by jumping and the particular patterns of injury of FFH patients. MATERIALS AND METHODS: The present study is a retrospective analysis of prospectively collected data regarding FFH patients, extracted from the Trauma Registry of the Papa Giovanni XXIII Hospital in Bergamo, Italy. Demographic characteristics, clinical-pathological parameters, patterns of injury, outcomes including mortality rates of jumpers and fallers were analyzed and compared. RESULTS: The FFH trauma group included 299 patients between April 2014 and July 2016: 259 of them (86.6%) were fallers and 40 (13.4%) were jumpers. At multivariate analysis both young age (p = 0.01) and female sex (p < 0.001) were statistical significant risk factors for suicidal attempt with FFH. Systolic blood pressure (SBP) at the arrival was lower and ISS was higher in the self-inflicted injury group (SBP 133.35 ± 23.46 in fallers vs 109.89 ± 29.93 in jumpers, p < 0.001; ISS in fallers 12.61 ± 10.65 vs 18.88 ± 11.80 in jumpers, p = 0.001). Jumpers reported higher AIS score than fallers for injuries to: face (p = 0.023), abdomen (p < 0.001) and extremities (p = 0.004). The global percentage of patients who required advanced or definitive airway control was significantly higher in the jumper group (35.0% vs 16.2%, p = 0.005). In total, 75% of jumpers and the 34% of fallers received surgical intervention (p < 0.001). A higher number of jumpers needed ICU admission, as compared to fallers (57.5% vs 23.6%, p < 0.001); jumpers showed longer total length of stay (26.00 ± 24.34 vs 14.89 ± 13.04, p = 0.007) and higher early mortality than fallers (7.5% vs 1.2%, p = 0.008). CONCLUSIONS: In Northern Italy, the population at highest risk of suicide by jumping and requiring Trauma Team activation is greatly composed by middle-aged women. Furthermore, FFH is the most common suicidal method. Jumpers show tendency to "feet-first landing" and seem to have more severe injuries, worse outcome and a higher early mortality rate, as compared to fallers. The Trauma Registry can be a useful tool to describe clusters of patients at high risk for suicidal attempts and to plan preventive and clinical actions, with the aim of optimizing hospital care for FFH trauma patients.

The need for red blood cell transfusions in the emergency department as a risk factor for failure of non-operative management of splenic trauma: a multicenter prospective study.

INTRODUCTION: The majority of patients with splenic trauma undergo non-operative management (NOM); around 15% of these cases fail NOM and require surgery. The aim of the current study is to assess whether the hemodynamic status of the patient represents a risk factor for failure of NOM (fNOM) and if this may be considered a relevant factor in the decision-making process, especially in Centers where AE (angioembolization), intensive monitoring and 24-h-operating room are not available. Furthermore, the presence of additional risk factors for fNOM was investigated. MATERIALS AND METHODS: This is a multicentre prospective observational study, including patients presenting with blunt splenic trauma older than 17 years, managed between 2014 and 2016 in two Italian trauma centres (ASST Papa Giovanni XXIII in Bergamo and Sant'Anna University Hospital in Ferrara-Italy). The risk factors for fNOM were analyzed with univariate and multivariate analyses. RESULTS: In total, 124 patients were included in the study. In univariate analysis, the risk factors for fNOM were AAST grade > 3 (fNOM 37.5% vs 9.1%, p = 0.024), and the need of red blood cell (RBC) transfusion in the emergency department (ED) (fNOM 42.9% vs 8.9%, p = 0.011). Multivariate analysis showed that the only significant risk factor for fNOM was the need for RBC transfusion in the ED (p = 0.049). CONCLUSIONS: The current study confirms the contraindication to NOM in case of hemodynamically instability in case of splenic trauma, as indicated by the most recent guidelines; attention should be paid to patients with transient hemodynamic stability, including patients who require transfusion of RBC in the ED. These patients could benefit from AE; in centers where AE, intensive monitoring and an 24-h-operating room are not available, this particular subgroup of patients should probably be treated with operative management.

Can sentinel node biopsy be safely omitted in thin melanoma? Risk factor analysis of 1272 multicenter prospective cases.

BACKGROUND: The indication to sentinel node biopsy (SNB) for thin melanomas (Breslow <1 mm) is still subject to controversies. The aim of this paper is to review all SNB performed for thin melanoma and to analyze factors related to lymphatic metastasis. Moreover, the diagnostic performance of the 5th, 6th, 7th and 8th AJCC classifications for cutaneous melanoma were investigated. METHODS: All sentinel node biopsies performed for thin melanomas were selected from a multicentre prospectively-collected database. For each patient the following was collected: age, sex, date of treatment, site of primary melanoma, histopathologic features (Breslow, Clark, number of mitoses/mm2, presence of ulceration) and the results of the sentinel node biopsy. RESULTS: From 1998 to 2017 were performed a total of 1272 SNB for thin melanoma. Mean age was 51years with 48.7% of male patients. Overall, 5.6% positive SNB were found. At univariate and multivariate analyses, Breslow thickness and ulceration were related to the presence of lymphatic metastasis. We compared the four versions of the AJCC classification: among pT1a patients there were respectively 5.32%, 5.63%, 3.72% and 3.49% of positive SNB. CONCLUSIONS: in thin melanoma Breslow thickness and ulceration were the only factors related to a positive SNB. Although convincing improvements resulted from the implementation of AJCC classifications with a reduction of positive biopsies among pT1a, a 10.71% rate among all positive nodes remains in the low-risk group. No recommendations can be drawn from this research and adjunctive evidences are needed to better identify patients at risk of nodal metastasis.

Prediction of Non-sentinel Node Status in Patients with Melanoma and Positive Sentinel Node Biopsy: An Italian Melanoma Intergroup (IMI) Study.

BACKGROUND AND PURPOSE: Approximately 20% of melanoma patients harbor metastases in non-sentinel nodes (NSNs) after a positive sentinel node biopsy (SNB), and recent evidence questions the therapeutic benefit of completion lymph node dissection (CLND). We built a nomogram for prediction of NSN status in melanoma patients with positive SNB. METHODS: Data on anthropometric and clinicopathological features of patients with cutaneous melanoma who underwent CLND after a positive SNB were collected from nine Italian centers. Multivariate logistic regression was utilized to identify predictors of NSN status in a training set, while model efficiency was validated in a validation set. RESULTS: Data were available for 1220 patients treated from 2000 through 2016. In the training set (n = 810), the risk of NSN involvement was higher when (1) the primary melanoma is thicker or (2) sited in the trunk/head and neck; (3) fewer nodes are excised and (4) more nodes are involved; and (5) the lymph node metastasis is larger or (6) is deeply located. The model showed high discrimination (area under the receiver operating characteristic curve 0.74, 95% confidence interval [CI] 0.70-0.79) and calibration (Brier score 0.16, 95% CI 0.15-0.17) performance in the validation set (n = 410). The nomogram including these six clinicopathological variables performed significantly better than five other previously published models in terms of both discrimination and calibration. CONCLUSIONS: Our nomogram could be useful for follow-up personalization in clinical practice, and for patient risk stratification while conducting clinical trials or analyzing their results.

Multiple Lymph Node Basin Drainage in Trunk Melanoma Is Not Associated with Survival of Sentinel Lymph Node-Positive Patients.

OBJECTIVES: This study was aimed at investigating the prognostic role of multiple lymph node basin drainage (MLBD) in patients with positive sentinel lymph node (SLN) biopsy. BACKGROUND: MLBD is frequently observed in patients with trunk melanoma undergoing SLN. The prognostic value of MLBD in SLN-positive patients is still debated. METHODS: Retrospective data from 312 trunk melanoma patients with positive SLN biopsy (1991-2012) at 6 Italian referral centres were gathered in a multicentre database. MLBD was defined at preoperative lymphoscintigraphy. Clinical and pathological data were analysed for their association with disease-free interval (DFI) and disease-specific (DSS) survival. RESULTS: MLBD was identified in 34.6% of patients (108/312) and was significantly associated with >1 positive SLN (37 vs. 15.2%; p < 0.001) and with >1 positive lymph node (LN) after complete lymph node dissection (CLND) (50.9 vs. 34.8%; p = 0.033). No differences were observed according to drainage pattern in patients who had negative and positive non-SLN at CLND. MLBD was not associated with either DFI or DSS. Multivariate analyses showed that tumour thickness, ulceration, and number of metastatic LNs were associated with worse DFI and DSS, while regression confirmed its protective role in survival. CONCLUSION: In positive SLN patients, MLBD has no association with survival, which is mainly related to American Joint Committee on Cancer (AJCC) prognostic factors. Since the overall number of positive LNs drives the prognosis, the importance of a CLND in all the positive basins is confirmed.

Mitotic rate correlates with sentinel lymph node status and outcome in cutaneous melanoma greater than 1 millimeter in thickness: A multi-institutional study of 1524 cases.

BACKGROUND: The 7th edition of the TNM American Joint Committee on Cancer classification incorporates mitotic rate (MR) only for primary cutaneous melanoma (PCM) with Breslow thickness (BT) ≤1 mm. OBJECTIVE: To investigate whether and to what extent MR is able to predict sentinel lymph node (SLN) status and clinical outcome of PCM patients with BT >1 mm. METHODS: The study included consecutive patients with PCM. Logistic regression and Cox regression model were used to analyze the impact of MR on SLN status, disease-free survival (DFS), and overall survival. RESULTS: From 1998 to 2015, 1524 PCM (median age 57.8 years) cases were diagnosed with a BT >1 mm in six centers of the Italian Melanoma Intergroup. Median follow-up was 5.0 years. By multivariate analysis, MR was associated with SLN positivity (odds ratio 1.98, 95% confidence interval [CI] 1.12-3.50, P = .018). After adjusting for BT, ulceration, age, sex, and SLN status, MR correlated with a poor DFS (hazard ratio 1.52, 95% CI 1.18-1.97, P = .002) and overall survival (hazard ratio 1.63, 95% CI 1.17-2.29, P = .004). LIMITATIONS: Retrospective analysis. CONCLUSION: MR is an independent prognostic factor for PCM patients with BT >1 mm. Incorporating this tissue biomarker could provide a better stratification of patients entering clinical trials in the adjuvant setting.

Impact of ATLS guidelines, trauma team introduction, and 24-hour mortality due to severe trauma in a busy, metropolitan Italian hospital: A case control study.

BACKGROUND: Advanced Trauma Life Support (ATLS) guidelines are widely accepted for use in initial management of trauma patients. The application of ATLS guidelines and introduction of management by means of trauma team (TT) both took place in April 2011. The aim of the present study was to evaluate related effects on mortality in the shock room (SR) and at 24 hours after admission. METHODS: Data were retrieved by administrative software based on patient admission for trauma of at least 48 hours. Study period was from April 2011 to December 2012, and control period was from January 2007 to March 2011. All admitted patients were identified by first diagnosis (ICD 9-CM), excluding traumatic brain injuries, and only patients admitted to the general intensive care, general surgery, and orthopedics units were included. RESULTS: The control group (CG) included 198 patients; the study group (SG) included 141. Differences were determined in patient age, which was mean 45.2 years (SD: 19.2) in the CG and mean 49.3 years (SD±18.3) in the SG (p=0.03). Differences were not found regarding gender, length of hospital stay, or Injury Severity Score (ISS). Among the patients who died, no differences were found in terms of systolic blood pressure, metabolic acidosis, or packed red blood cell consumption. Mortality was significantly higher in the CG, compared to the SG (14.1% vs 7.1%, respectively; p=0.033; confidence interval [CI]: 0.21-0.95). Mortality in the shock room was significantly lower in the SG, compared to the CG (0.7% vs 7.1%, respectively; p=0.002; CI: 0.004-0.592). CONCLUSION: The introduction of ATLS guidelines and TT had a positive impact on mortality in the first 24 hours, both in the SR and after admission.

Laparoscopic HIPEC: A bridge between open and closed-techniques.

Hyperthermic intraperitoneal chemotherapy (HIPEC) is currently delivered after cytoreductive surgery in patients with several kinds of peritoneal surface malignancies. Different methods for delivering HIPEC have been proposed all of them being variations between two modalities: the open technique and the closed technique. The open technique assures optimal distribution of heat and cytotoxic solution, with the disadvantage of heat loss and leakage of cytotoxic drugs. The closed technique prevents heat loss and drug spillage, increases drug penetration, but does not warrant homogeneous distribution of the perfusion fluid. A novel procedure that combines the advantages of the two techniques by means of laparoscopy is herein presented.

Prognostic Role of Multiple Lymphatic Basin Drainage in Sentinel Lymph Node-Negative Trunk Melanoma Patients: A Multicenter Study from the Italian Melanoma Intergroup.

BACKGROUND: Multiple lymphatic basin drainage (MLBD) is frequently observed in patients with trunk melanoma undergoing sentinel lymph node (SLN) biopsy. Conflicting data regarding the prognostic association of MLBD in SLN-negative patients have been reported. This study aimed to investigate the prognostic role of MLBD in patients with negative SLN biopsy. METHODS: Retrospective data from 656 melanoma patients who underwent a SLN biopsy (1991-2012) at six Italian centers were gathered in a multicenter database. MLBD was defined as lymphoscintigraphic and intraoperative identification of an SLN in more than one nodal basin. Clinical and pathologic variables were recorded and analyzed for their impact on survival. RESULTS: SLN-negative patients with MLBD were at lower risk of melanoma recurrence [hazard ratio (HR) 0.73, P = 0.05) and melanoma-related death (HR 0.68, P = 0.001) independent of common staging features. Multivariable Cox analyses of disease-free interval (DFI) and disease-specific survival (DSS) showed that MLBD maintained a favorable role and ulceration an unfavorable role. Histologic regression was independently associated only with DFI. When survival was stratified according to presence of MLBD, histologic regression and Breslow thickness <2 mm were associated with improved DFI (5-year DFI: 96.9 vs. 66,1 %, respectively; HR 0.48, P < 0.001) and DSS (5-year DSS: 96.7 vs. 71.8 %, respectively; HR 0.52, P = 0.005) compared to patients without these three favorable parameters. CONCLUSIONS: Patients with negative SLN biopsy results have better prognosis when two or more lymphatic basins are identified and analyzed. Further research is required to investigate the mechanisms behind this evidence.

Epidemiology of acute cholecystitis and its treatment in Bergamo District, Northern Italy.

BACKGROUND: Acute calcolous cholecystitis (ACC) is a very common pathology in western countries. The aim of our work was to assess the epidemiology of ACC and its treatment in Bergamo, a northern Italy province, during the last seventeen years. METHODS: A restrospective analysis, covering 1997 to 2013, was performed based on the administrative register of the province Health System. Only patients admitted for ACC were selected. From 1997 to 2013 were collected 8959 cases of ACC, mean age was 61.28, 51.5% were male. RESULTS: The incidence of ACC was 48/100.000 per year; the operation rate was 66%. Overall mortality was 0.7%, mean hospitalization time was 9.7 days. The treatment of ACC in Bergamo Province seemed to be acceptable and comparable to literature results. Over the last years, laparoscopy has become the standard treatment. CONCLUSIONS: This study outlined some criticisms on the selection's methodology sourcing data from administrative registers, raising questions about truthfulness of results and usefulness for health policy issues.

Single center retrospective analysis of early vs. delayed treatment in acute calculous cholecystitis: application of a clinical pathway and an economic analysis.

BACKGROUND: Treatment option and timing for surgery in case of acute calculous cholecystitis (ACC) is still a matter of discussion. Tokyo Guidelines (TG13) offers some rules but they don't reflect entirely the information of Evidence Based Medicine (EBM). This study aimed to draw some consideration from our practice in the application of the guidelines and put forward the clinical, economic and organizational effect of it. METHODS: The study is a single center retrospective study based on administrative database formed by gathering information from clinical registry. Data were collected between January 1st, 2008 and April 30th, 2013. A cutoff point was established on May 15th, 2010 when we moved from a single surgeon method to a shared EBM method to treat ACC. The economic aspect was developed considering health service reimburse and hospital costs. RESULTS: Five hundred and two patients were selected, 203 patients before the organizational change (Group 0) and 299 after (Group 1). In Group 0, 24.63% of the patients were treated with early laparoscopic cholecystectomy (ELC) and 39.4% received surgery delayed in second admission (DLC). After the change, 57.5% of the patients were treated with ELC while 13% were treated with DLC. Median length of stay (LOS) was significantly lower after the change (9.5 vs. 7.3, p<0.0001), and no difference in terms of complication was noticed. CONCLUSION: Application of evidence based medicine in clinical practice resulted in better results. Economically, the clinical change resulted in a proper use of resources with a positive gap between the costs and refund to the hospital.

Abracadabra.

A voluminous radiopaque foreign body (7 cm in diameter bowl) in the rectum of a 45-year-old male patient was removed uneventfully by a transanal approach with an obstetric forceps.

Number of excised lymph nodes as a quality assurance measure for lymphadenectomy in melanoma.

IMPORTANCE: Although the number of excised lymph nodes (LNs) represents a quality assurance measure in lymphadenectomy for many solid tumors, the minimum number of LNs to be dissected has not been established for melanoma. OBJECTIVE: To investigate the distribution of the number of excised LNs in a large patient series (N = 2526) to identify values that may serve as benchmarks for monitoring the quality of lymphadenectomy in patients with melanoma. DESIGN, SETTING, AND PARTICIPANTS: A retrospective multicenter study was conducted (1992-2010) in tertiary referral centers for treatment of cutaneous melanoma. Medical records on 2526 patients who underwent lymphadenectomy for regional LN metastasis associated with cutaneous melanoma were examined. EXPOSURE: Patients had undergone lymphadenectomy for regional LN metastasis. MAIN OUTCOMES AND MEASURES: The mean, median, and 10th percentile of the number of excised LNs were calculated for the axilla (3 levels), neck (≤3 or ≥4 dissected levels), inguinal, and ilioinguinal LN fields. RESULTS: After 3-level axillary (n = 1150), 3-level or less neck (n = 77), 4-level or more neck (n = 135), inguinal (n = 209), and ilioinguinal (n = 955) dissections, the median (interquartile range [IQR]) and mean (SD) number of excised LNs were as follows: 3-level axillary dissection, 20 (15-27) and 22 (8); 3-level or less neck, 21 (14-33) and 24 (15); 4-level or more neck, 29 (21-41) and 31 (14); inguinal, 11 ( 9-14) and 12 (5); and ilioinguinal, 21 (16-26) and 22 (4). A total of 90% of the patients had 12, 7, 14, 6, and 13 excised LNs (10th percentile of the distribution) after 3-level axillary, 3-level or less neck, 4-level or more neck, inguinal, and ilioinguinal dissections, respectively. More excised LNs were detected in younger (21 for those <54 years of age and 19 for ≥54 years, P < .001) and male (21 for male sex and 19 for female sex, P < .001) patients from high-volume institutions (21 for volume of ≥300 vs 18 for volume <300, P < .001) with a more recent year of diagnosis (21 for years 2002-2010 vs 18 for years 1992-2001, P < .001), LN micrometastasis vs macrometastasis (20 vs 19, P = .005), and more positive LNs (R² = 0.03, P < .001); however, the differences between median values were small. CONCLUSIONS AND RELEVANCE: These minimum numbers of excised LNs are reproducible across the institution, patient, and tumor factors evaluated. They can be taken into consideration when monitoring the quality of lymphadenectomy in melanoma and can represent entry criteria for randomized trials investigating adjuvant therapies.

Management of hemodynamically unstable pelvic trauma: results of the first Italian consensus conference (cooperative guidelines of the Italian Society of Surgery, the Italian Association of Hospital Surgeons, the Multi-specialist Italian Society of Young Surgeons, the Italian Society of Emergency Surgery and Trauma, the Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care, the Italian Society of Orthopaedics and Traumatology, the Italian Society of Emergency Medicine, the Italian Society of Medical Radiology -Section of Vascular and Interventional Radiology- and the World Society of Emergency Surgery).

Hemodynamically Unstable Pelvic Trauma is a major problem in blunt traumatic injury. No cosensus has been reached in literature on the optimal treatment of this condition. We present the results of the First Italian Consensus Conference on Pelvic Trauma which took place in Bergamo on April 13 2013. An extensive review of the literature has been undertaken by the Organizing Committee (OC) and forwarded to the Scientific Committee (SC) and the Panel (JP). Members of them were appointed by surgery, critical care, radiology, emergency medicine and orthopedics Italian and International societies: the Italian Society of Surgery, the Italian Association of Hospital Surgeons, the Multi-specialist Italian Society of Young Surgeons, the Italian Society of Emergency Surgery and Trauma, the Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care, the Italian Society of Orthopaedics and Traumatology, the Italian Society of Emergency Medicine, the Italian Society of Medical Radiology, Section of Vascular and Interventional Radiology and the World Society of Emergency Surgery. From November 2012 to January 2013 the SC undertook the critical revision and prepared the presentation to the audience and the Panel on the day of the Conference. Then 3 recommendations were presented according to the 3 submitted questions. The Panel voted the recommendations after discussion and amendments with the audience. Later on a email debate took place until December 2013 to reach a unanimous consent. We present results on the 3 following questions: which hemodynamically unstable patient needs an extraperitoneal pelvic packing? Which hemodynamically unstable patient needs an external fixation? Which hemodynamically unstable patient needs emergent angiography? No longer angiography is considered the first therapeutic maneuver in such a patient. Preperitoneal pelvic packing and external fixation, preceded by pelvic binder have a pivotal role in the management of these patients.Hemodynamically Unstable Pelvic Trauma is a frequent death cause among people who sustain blunt trauma. We present the results of the First Italian Consensus Conference.

Nonsentinel lymph node status in patients with cutaneous melanoma: results from a multi-institution prognostic study.

PURPOSE: We investigated whether the nonsentinel lymph node (NSLN) status in patients with melanoma improves the prognostic accuracy of common staging features; then we formulated a proposal for including the NSLN status in the current melanoma staging system. PATIENTS AND METHODS: We retrospectively collected the clinicopathologic data of 1,538 patients with positive SLN status who underwent completion lymph node dissection (CLND) at nine Italian centers. Multivariable Cox regression survival analysis was used to identify independent prognostic factors. Literature meta-analysis was used to summarize the available evidence on the prognostic value of the NSLN status in patients with positive SLN. RESULTS: NSLN metastasis was observed in 353 patients (23%). After a median follow-up of 45 months, NSLN status was an independent prognostic factor for melanoma-specific survival (hazard ratio [HR] = 1.34; 95% CI, 1.18 to 1.52; P < .001). NSLN status efficiently stratified the prognosis of patients with two to three positive lymph nodes (n = 387; HR = 1.39; 95% CI, 1.07 to 1.81; P = .013), independently of other staging features. Searching the literature, this patient subgroup was investigated in other two studies. Pooling the results (n = 620 patients; 284 NSLN negative and 336 NSLN positive), we found that NSLN status is a highly significant prognostic factor (summary HR = 1.59; 95% CI, 1.27 to 1.98; P < .001) in patients with two to three positive lymph nodes. CONCLUSION: These findings support the independent prognostic value of the NSLN status in patients with two to three positive lymph nodes, suggesting that this information should be considered for the routine staging in patients with melanoma.