Randomized open-label controlled study of cancer vaccine OSE2101 versus chemotherapy in HLA-A2-positive patients with advanced non-small-cell lung cancer with resistance to immunotherapy: ATALANTE-1.

BACKGROUND: Patients with advanced non-small-cell lung cancer (NSCLC) treated with immune checkpoint blockers (ICBs) ultimately progress either rapidly (primary resistance) or after durable benefit (secondary resistance). The cancer vaccine OSE2101 may invigorate antitumor-specific immune responses after ICB failure. The objective of ATALANTE-1 was to evaluate its efficacy and safety in these patients. PATIENTS AND METHODS: ATALANTE-1 was a two-step open-label study to evaluate the efficacy and safety of OSE2101 compared to standard-of-care (SoC) chemotherapy (CT). Patients with human leukocyte antigen (HLA)-A2-positive advanced NSCLC without actionable alterations, failing sequential or concurrent CT and ICB were randomized (2 : 1) to OSE2101 or SoC (docetaxel or pemetrexed). Primary endpoint was overall survival (OS). Interim OS futility analysis was planned as per Fleming design. In April 2020 at the time of interim analysis, a decision was taken to prematurely stop the accrual due to coronavirus disease 2019 (COVID-19). Final analysis was carried out in all patients and in the subgroup of patients with ICB secondary resistance defined as failure after ICB monotherapy second line ≥12 weeks. RESULTS: Two hundred and nineteen patients were randomized (139 OSE2101, 80 SoC); 118 had secondary resistance to sequential ICB. Overall, median OS non-significantly favored OSE2101 over SoC {hazard ratio (HR) [95% confidence interval (CI)] 0.86 [0.62-1.19], P = 0.36}. In the secondary resistance subgroup, OSE2101 significantly improved median OS versus SoC [11.1 versus 7.5 months; HR (95% CI) 0.59 (0.38-0.91), P = 0.017], and significantly improved post-progression survival (HR 0.46, P = 0.004), time to Eastern Cooperative Oncology Group (ECOG) performance status deterioration (HR 0.43, P = 0.006) and Quality of Life Questionnaire Core 30 (QLQ-C30) global health status compared to SoC (P = 0.045). Six-month disease control rates and progression-free survival were similar between groups. Grade ≥3 adverse effects occurred in 11.4% of patients with OSE2101 and 35.1% in SoC (P = 0.002). CONCLUSIONS: In HLA-A2-positive patients with advanced NSCLC and secondary resistance to immunotherapy, OSE2101 increased survival with better safety compared to CT. Further evaluation in this population is warranted.

Influence of stomach mucosa tissue on the efficacy of intragastric antibacterial PDT.

In the field of photodynamic therapy (PDT), optimization of the in vivo therapeutic efficacy needs a comprehensive study of the photo-killing action spectrum that depends on both the photosensitizer (PS) absorption and the tissue optical properties. This is especially true in the case of gastric infections by Helicobacter pylori: PS absorption has been largely investigated in vitro, while the contribution of tissue optical properties and illumination geometry has been poorly studied, despite being parameters that reflect the specific in vivo conditions. To investigate their influence, we focussed on the case of a point-like light source positioned in the antrum. This models a therapeutic device developed by our team which consists of a LED-based ingestible pill. By a simple 3D illumination model, our approach mediates light-tissue interaction over the illuminated stomach wall surface, then calculates its average transmittance T by means of a 1D model representative of the mean gastric mucosa structure. Finally, by merging T(λ) with the photosensitizers' absorption we obtained the in vivo action spectrum. This shows two peaks at about 500 and 630 nm, indicating a noticeable influence of the tissue with respect to in vitro studies, where the action spectrum reflects PS absorption only. Our approach defines one average action spectrum for this specific therapeutic context, which reflects the need to choose one emission spectrum for the light source used. The proposed methodology could be applied to any other illumination geometry of cave organs, provided appropriate model modifications for the light source and tissue characteristics are made.

Estimate of choline nutritional requirements for chicks from 1 to 21 days of age.

Choline is an essential nutrient in poultry diets because it performs various important metabolic functions. The objective of this study was to re-evaluate the choline requirements of male broiler chickens from 1 to 21 days of age at two levels of methionine. Two assays using 2,160 Cobb® chickens (1,080 in each assay) were conducted. The study design was completely randomized and consisted of six treatments and six replicates, with 30 animals per experimental unit. The semipurified basal diet was formulated with corn, soya bean meal, soya protein concentrate, starch and sugar, providing 390 mg/kg choline and 0.593% digestible methionine (requirement level) in Assay 1 and a reduction of about one-quarter in the requirement level of digestible methionine (0.440%) in Assay 2. Choline chloride (62.5%) was added by a supplementation technique to both basal diets to compose crescent levels of choline supplementation (715, 1,040, 1,365, 1,690 and 2,015 mg/kg). The weight gain responses were fitted using quadratic polynomial (QP) and broken-line (BL) models. The ideal intake of choline (mg/bird.day) was estimated from the first intercept of the QP with the BL plateau (BL + QP). The results showed that the diet with the 25% reduction in digestible methionine limited the maximum weight gain by approximately 10%. The choline requirements of broilers from 1 to 7, 1 to 14 and 1 to 21 days of age were 27,013, 44,458 and 62,535 mg/bird.day, respectively, for the requirement level of digestible methionine and 26,796, 41,820 and 56,578 mg/bird.day for the broilers receiving the diet with the 25% reduction in digestible methionine.

Clinical and angiographic outcome of a single center, real world population treated with a dedicated technique of implantation for bioresorbable vascular scaffolds. The FAtebenefratelli Bioresorbable Vascular Scaffold (FABS) registry.

OBJECTIVES: With this prospective study we aim at investigating the long-term outcome of a consecutive cohort of patients successfully treated with bioresorbable scaffold (BVS) implantation. BACKGROUND: It is not clearly understood if there is a relation between the technique of BVS implantation and the outcome. METHODS: Between December 2012 and December 2014, all consecutive patients treated with BVS were included in this registry and received an angiographic follow-up. After a run-in phase, all BVS were implanted using a specific technique consisting of aggressive predilation, correct scaffold sizing, visually determined, and high-pressure post-dilation with a noncompliance balloon. Primary endpoint was late lumen loss (LLL) at 1-year angiographic follow-up and ischemia-driven target-lesion revascularization (ID-TLR) at 2-year clinical follow-up. Secondary endpoints were the occurrence of binary restenosis, major adverse cardiac events (MACE), and every single component of MACE (cardiac death, myocardial infarction, TLR) at 2 years. RESULTS: A total of 144 lesions in 122 patients treated consecutively with BVS, were enrolled. Diabetics were 29.5% and acute coronary syndrome at presentation occurred in 29.5% of patients. At the angiographic follow-up LLL was 0.38 ± 0.9. At 2-year clinical follow-up, ID-TLR occurred in eight patients (5.6%). We observed two cases of scaffold thrombosis (1.38%, one early and one very late). At multivariate statistical analysis, STEMI presentation remained a significant predictor for TLR. CONCLUSIONS: In a complex, all-comers real world population, BVS implantation with a specific, and standardized technique showed to be feasible, with acceptable mid-term angiographic and long-term clinical outcome.

Extralevator with vs nonextralevator abdominoperineal excision for rectal cancer: the RELAPe randomized controlled trial.

AIM: A randomized controlled trial was conducted to test the null hypothesis that there is no difference in circumferential resection margin (CRM) between extralevator abdominoperineal excision (ELAPE) and non-ELAPE for rectal cancer. METHOD: This was a multicentre, randomized controlled trial registered as NCT01702116. Patients with rectal cancer involving the external anal sphincter were randomized to ELAPE or non-ELAPE following neoadjuvant chemoradiation. Randomization was performed according to Consolidated Standards of Reporting Trials (CONSORT) guidelines. The primary end-point was CRM (in mm), defined as the shortest distance between the tumour and the cut edge of the specimen. Pathologists and centralized pathology were blinded to the patients' study arm. Interrater reliability (IRR) was assessed using Kendall's coefficient. Intra-operative perforation (IOP) was any rectal defect determined at pathology. Complications were classified using the Clavien-Dindo classification. Participating surgeons were retrained and credentialed. A sample size calculation showed that 34 subjects would provide sufficient power to reject the null hypothesis. RESULTS: Thirty-four patients underwent the allocated intervention. Seventeen patients treated with ELAPE were comparable with 17 patients treated with non-ELAPE regarding age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) class and pre-existing comorbidities. CRM depth (7.14 ± 5.76 mm vs 2.98 ± 3.28 mm, P = 0.016) and involvement rates (5.8% vs 41.0%, P = 0.04) were significantly increased in patients treated with ELAPE. The IRR for CRM was 0.78. There were no significant differences in IOP (5.8% vs 11.7%, P = 0.77) and complication rates (29% vs 29%, P = 0.97). CONCLUSIONS: ELAPE was associated with statistically improved CRM with no difference in IOP and complication rates compared with non-ELAPE for rectal cancer involving the external anal sphincter.

T1 colon cancer in the era of screening: risk factors and treatment.

BACKGROUND: The aim of this study was to identify risk factors for lymph node positivity in T1 colon cancer and to carry out a surgical quality assurance audit. METHODS: The sample consisted of consecutive patients treated for early-stage colon lesions in 15 colorectal referral centres between 2011 and 2014. The study investigated 38 factors grouped into four categories: demographic information, preoperative data, indications for surgery and post-operative data. A univariate and multivariate logistic regression analysis was performed to analyze the significance of each factor both in terms of lymph node (LN) harvesting and LN metastases. RESULTS: Out of 507 patients enrolled, 394 patients were considered for analysis. Thirty-five (8.91%) patients had positive LN. Statistically significant differences related to total LN harvesting were found in relation to central vessel ligation and segmental resections. Cumulative distribution demonstrated that the rate of positive LN increased starting at 12 LN harvested and reached a plateau at 25 LN. CONCLUSIONS: Some factors associated with an increase in detection of positive LN were identified. However, further studies are needed to identify more sensitive markers and avoid surgical overtreatment. There is a need to raise the minimum LN count and to use the LN count as an indicator of surgical quality.

Metronomic temozolomide as second line treatment for metastatic poorly differentiated pancreatic neuroendocrine carcinoma.

Neuroendocrine Neoplasms (NEN) are a group of heterogeneous malignancies derived from neuroendocrine cell compartment, with different roles in both endocrine and nervous system. Most NETs have gastroentero-pancreatic (GEP) origin, arising in the foregut, midgut, or hindgut. The 2010 WHO classification divides GEP-NETs into two main subgroups, neuroendocrine tumors (NET) and neuroendocrine carcinomas (NEC), according with Ki-67 levels. NET are tumors with low (<20 %) Ki-67 value, and NECs, including small cell lung carcinomas and Merkel Cell carcinomas, are all NETs with high Ki-67 levels (>20 %-G3). Poorly differentiated neuroendocrine carcinomas (NEC) are usually treated with cisplatin-based chemotherapy regimens. Here we present a case of a patient with pancreatic NEC progressing after cisplatin and etoposide, treated with temozolomide as palliative, second line treatment. According with the poor Performance Status (PS = 2) and to reduce the toxicity of the treatment was chosen an intermittent dosing regimen of metronomic temozolomide (75 mg/m(2)/day-one-week-on/on-week-off). MGMT resulted methylated. On July 2014 the patient started the treatment. On August 2014 the patient obtained a significant clinical benefit (PS = 0) and the total body CT scan performed on October 2014 showed a RECIST partial response on all the sites of disease. No drug-related side effects were reported by the patient. After 18 months of therapy the treatment continues without significant toxicity, and with further remission of the metastases. Treatment with metronomic "one-week-on/on-week-off" Temozolomide can be considered a good treatment option in patients with poor performance status, affected by pNEC with MGMT methylation.

Influence of dietary fat and carbohydrates proportions on plasma lipids, glucose control and low-grade inflammation in patients with type 2 diabetes-The TOSCA.IT Study.

PURPOSE: The optimal macronutrient composition of the diet for the management of type 2 diabetes is debated, particularly with regard to the ideal proportion of fat and carbohydrates. The aim of the study was to explore the association of different proportions of fat and carbohydrates of the diet-within the ranges recommended by different guidelines-with metabolic risk factors. METHODS: We studied 1785 people with type 2 diabetes, aged 50-75, enrolled in the TOSCA.IT Study. Dietary habits were assessed using a validated food-frequency questionnaire (EPIC). Anthropometry, fasting lipids, HbA1c and C-reactive protein (CRP) were measured. RESULTS: Increasing fat intake from <25 to ≥35 % is associated with a significant increase in LDL-cholesterol, triglycerides, HbA1c and CRP (p < 0.05). Increasing carbohydrates intake from <45 to ≥60 % is associated with significantly lower triglycerides, HbA1c and CRP (p < 0.05). A fiber intake ≥15 g/1000 kcal is associated with a better plasma lipids profile and lower HbA1c and CRP than lower fiber consumption. A consumption of added sugars of ≥10 % of the energy intake is associated with a more adverse plasma lipids profile and higher CRP than lower intake. CONCLUSIONS: In people with type 2 diabetes, variations in the proportion of fat and carbohydrates of the diet, within the relatively narrow ranges recommended by different nutritional guidelines, significantly impact on the metabolic profile and markers of low-grade inflammation. The data support the potential for reducing the intake of fat and added sugars, preferring complex, slowly absorbable, carbohydrates.

Robotic versus laparoscopic sacrocolpopexy for apical prolapse: a case-control study.

The apical prolapse has always been considered the most complex of the defects of the pelvic floor, for both the difficulty of the surgical corrective technique and for the high post-surgical recurrence rate. Today, the laparoscopic sacrocolpopexy can be considered the standard treatment for apical prolapse. In the last years, several author performed robotic sacrocolpopexy, obtaining positive results. So, we developed a casecontrol study in order to compare the surgical outcome of robotic group with a control group of laparoscopic approach in patients with symptomatic apical pro-lapsed between January 2015 and December 2015 at University Hospital Policlinico "P. Giaccone" and Ospedali Riuniti "Villa Sofia-Cervello", Palermo. Our experience shows that robotic sacrocolpopexy can be considered in positive way for clinical results obtained: all procedures were executed with no complications, we noted a lower intraoperative blood loss and a shorter hospital stay than in laparoscopic group. Although the mean operative time and the economic costs are higher in robotic surgery, this study demonstrates that the use of robotic platform for repairing of symptomatic apical vaginal prolapse is feasible, safe and associated with short-term satisfactory results, representing therefore a valid alternative to laparoscopic approach.

Appendiceal mucinous neoplasms: an uncertain nosological entity. Report of a case.

INTRODUCTION: Appendiceal mucocele is a relatively rare condition characterized by progressive dilation of the appendix caused by intraluminal accumulation of mucoid substance. Its incidence is 0.07 - 0,63% of all appendectomies performed. CASE REPORT: We report the case of a 70-year-old man who came to our observation with gravative pain in right lower abdominal region. A computed tomography abdominal scan revealed a cystic/tubular structure like an appendicular mass with wall enhancement but without calcifications suggestive of a mucocele. Into peritoneal cavity we found profuse mucinous material with a 1,5 cm size parietal nodule. We also identified a free perforation of the cecum with consensual spillage of gelatinous material mimicking a pseudomyxoma peritonei. We decided to perform a right hemicolectomy with excision of peritoneal lesion. DISCUSSION: The controversy in the pathologic terminology can give rise to a clinical dilemma in terms of the management and follow-up plans. For mucosal hyperplasia and cystadenoma simple appendectomy is curative. Only in case of large base of implantation it may be necessary the resection of the ileum and caecum or right hemicolectomy. In case of mucinous cystoadenocarcinoma authors perform a right hemicolectomy. CONCLUSION: Appendiceal mucinous neoplasms are different pathological entities. The correct surgical management depends on size and location of lesion. A preoperative diagnosis is obviously needed in order to perform the correct treatment. CT abdominal scan is the better diagnostic tool, but different authors show their inability to reach a preoperative diagnosis in the larger majority of cases.

Results of the validation study of the Psodisk instrument, and determination of the cut-off scores for varying degrees of impairment.

BACKGROUND: The Psodisk is a 10-item visual instrument, aimed at measuring the burden of psoriasis on patients. OBJECTIVES: To validate the Psodisk in a large sample of patients with psoriasis, and to define categories for the interpretation of the scores. METHODS: Data were collected in 21 dermatological centres. The Psodisk was administered at baseline (t0), after 2 or 3 days (t1) and about 3 months (t2) after baseline, and data were used to assess validity and reliability of the instrument. The cut-off scores were determined using the perception of the severity of the disease by the patient as anchor point. RESULTS: The evaluable population consisted of 320 patients at baseline, with a mean Psodisk score of 36.9. The concurrent validity of the instrument was confirmed by the high correlation with Skindex-29 and DLQI. Factor analyses selected a single factor, which alone explained almost 60% of the variance. Cronbach's coefficient alpha was 0.927, suggesting a good reliability. Test-retest reliability was verified by a Pearson's correlation coefficient between the Psodisk scores at baseline and t1 of 0.924. Five categories of disease burden were defined: 1. minimal (<9); 2. mild (9-15); 3. moderate (16-30); 4. marked (31-50); 5. severe (>50). CONCLUSION: The Psodisk showed good psychometric properties. The definition of the cut-off scores will be useful to evaluate the burden of psoriasis on patients.

Practice parameters for early colon cancer management: Italian Society of Colorectal Surgery (Società Italiana di Chirurgia Colo-Rettale; SICCR) guidelines.

Early colon cancer (ECC) has been defined as a carcinoma with invasion limited to the submucosa regardless of lymph node status and according to the Royal College of Pathologists as TNM stage T1 NX M0. As the potential risk of lymph node metastasis ranges from 6 to 17% and the preoperative assessment of lymph node metastasis is not reliable, the management of ECC is still controversial, varying from endoscopic to radical resection. A meeting on recent advances on the management of colorectal polyps endorsed by the Italian Society of Colorectal Surgery (SICCR) took place in April 2014, in Genoa (Italy). Based on this material the SICCR decided to issue guidelines updating the evidence and to write a position statement paper in order to define the diagnostic and therapeutic strategy for ECC treatment in context of the Italian healthcare system.

Practice parameters for early rectal cancer management: Italian Society of Colorectal Surgery (Società Italiana di Chirurgia Colo-Rettale; SICCR) guidelines.

The introduction of new technologies for diagnosis and screening programs led to an increasing rate of early detection of colorectal cancer. This, associated with the evolution of endoscopic techniques of local excision, led to the assessment of new strategies to reduce morbidity related to treatment, especially for early rectal cancer (ERC). Nevertheless, the definition of ERC and its staging and treatment algorithm are still under debate. The Italian Society of Colorectal Surgery developed practice guidelines to provide recommendations on the diagnosis, staging and treatment of ERC. A systematic review on the topic was performed by a multidisciplinary group of experts selected based on their clinical and scientific expertise in endoscopy, endoscopic ultrasound, magnetic resonance and surgery, with the aid of an external international audit.

Measuring the efficiency of wastewater services through Data Envelopment Analysis.

Efficient water management is a priority in the European Union, since the operational efficiency of many water utilities is very low compared to best practice. Several countries are restructuring the water industry to save costs. Larger-scale operations and vertical integration are promoted to achieve scale and scope economies; however, the literature is not unanimous that such economies exist. There is also little evidence of the effect of customer density on costs. This article offers some insights into this matter, analysing the Danish water industry by a two-stage Data Envelopment Analysis approach to investigate the effects of size, scope and density in the wastewater industry. The results show that the Danish wastewater industry is positively affected by vertical integration and higher population density: firms that serve more than 100 person per km of sewer and combine water and wastewater services achieve better efficiency. Size does not have any significant influence on global efficiency, although technical pure efficiency decreases statistically with firm size.

Single-Incision Laparoscopic Cholecystectomy: our experience and review of literature.

AIM: After the revolution in the surgery of gallbladder stones represented by the laparoscopic cholecystectomy, we tried a new technique that further maximize the aesthetic results and that at the same time is of easy learning for young surgeons. PATIENTS AND METHODS: From January 2011 to December 2012 we performed at our department 320 cholecystectomy: 27 in laparotomy and 293 in laparoscopy. Of these, 88 underwent to Single Incision Laparoscopic Surgery (SILS), namely the Single Incision Laparoscopic Cholecystectomy (SILC), in recruited patients aged between 19-65 years; 56 patients were females and 32 were males. RESULTS: The laparoscopic cholecystectomy with the SILS methodology is a safe technique. Respect to multi-port Laparoscopic Cholecystectomy (LC), we have cosmetic advances. The pain is less in extraumbilical sites, and the major umbilical pain can be prevented by local anaesthesia. The times are slightly longer, especially at the beginning of training, but after a few of operations it is reduced to about one hour. We didn't found any other difference in vantage and advantage between the two technics, only a case of postoperative umbilical hernia in SILS. CONCLUSION: We found the SILS a safe and effective technique for the cholecystectomy.

Management of immunosuppression and antiviral treatment before and after heart transplant for HIV-associated dilated cardiomyopathy.

Infection with HIV may lead to the development of cardiomyopathy as improved antiretroviral regimens continue to prolong patient life. However, advanced therapeutic options, such as heart transplant, have until recently been precluded to HIV-positive persons. A favorable long-term outcome has been obtained after kidney or liver transplant in HIV-positive recipients fulfilling strict virological and clinical criteria. We recently reported the first heart transplant in a HIV-infected patient carried out in our center. In this article, we detail the major challenges we faced with the management of antiretroviral and immunosuppressive treatments over the first 3 years post-transplant. The patient had developed dilated cardiomyopathy while on antiretroviral treatment with zidovudine, lamivudine and efavirenz. He was in WHO Stage 1 of HIV infection and had normal CD4+ count and persistently undetectable HIV-RNA. In spite of cardiac resynchronization therapy and maximal drug therapy, the patient progressed to end stage heart failure, requiring heart transplant. He was placed on a standard immune suppressive protocol including cyclosporine A and everolimus. Despite its potential pharmacokinetic interaction with efavirenz, everolimus was chosen to reduce the long-term risk of opportunistic neoplasia. Plasma levels of both drugs were monitored and remained within the target range, although high doses of everolimus were needed. There were no infectious, neoplastic or metabolic complications during a 3-year follow-up. In summary, our experience supports previous data showing that cardiac transplantation should not be denied to carefully selected HIV patients. Careful management of drug interactions and adverse events is mandatory.

Single incision laparoscopic right colectomy: a systematic review and meta-analysis.

AIM: A meta-analysis was performed to compare the outcome of single incision laparoscopic right hemicolectomy with standard multiport laparoscopic right hemicolectomy. METHOD: A systematic search of databases was carried out to extract comparative studies (randomized and non-randomized, prospective and retrospective). Data were analysed according to Cochrane Collaboration guidelines. A meta-analysis was performed when the data permitted this form of analysis. RESULTS: Nine comparative studies were retrieved comprising 241 patients with single incision and standard laparoscopy. None of these was randomized. There was no significant difference between the two methods for the primary end-points of mortality, morbidity and cancer-specific parameters and for the secondary end-points of operation time, blood loss, ileus, hospital stay and conversion. It was not possible to analyse pain and cosmetics data owing to insufficient information. CONCLUSION: Single incision laparoscopic right hemicolectomy is comparable with standard multiport laparoscopic right hemicolectomy in primary and secondary outcomes. Given current information it is justified to use single incision laparoscopic right hemicolectomy, but there is a need for a prospective randomized study.

International quality assurance project in colorectal cancer-unifying diagnostic and histopathological evaluation.

PURPOSE: Several European countries are undertaking quality control projects in colorectal cancer. These efforts have led to improvements in survival, but a comparison between different projects reveals questionable results. The aim of this study is the presentation of results from hospitals in three different European countries participating in the International Quality Assurance in Colorectal Cancer (IQACC) project. METHODS: For this publication, patients with cancer of the colon or rectum treated in 2009 and 2010 and recorded in the IQACC (Germany, Poland and Italy) were analysed. The comparison included number of patients, age, preoperative diagnostics (CT of the abdomen and thorax, MRI, colonoscopy, ultrasound, tumour markers), surgical approach, metastasis, height of rectal cancer and histopathological examination of a specimen (T stage, N stage and MERCURY classification for rectum resection). For short-term outcomes, general complications, wound dehiscence, tumour-free status at discharge, anastomotic leakage and in-hospital mortality were analysed. RESULTS: A total of 12,691 patients (6,756 with colon cancer, 5,935 with rectal cancer) were included in the analysis. Preoperative diagnostics differed significantly between countries. For pT and pN stages, several quality differences could be demonstrated, including missing stages (colon cancer: pT 5.7-12.5 %, pN 2.5-11.0 %; rectal cancer: pT 1.1-5.6 %, pN 1.1-15.5 %). The most relevant differences for short-term outcomes in colon cancer were found in general complications (4.2-22.8 %) and tumour-free status at discharge (74.5-91.7 %). In-hospital deaths ranged between 2.5 and 4.3 % and did not show significant differences. For rectal cancer, the country with the highest percentage of tumours localised less than 4 cm from the anal verge (16.0 %) showed the lowest frequency of amputation (8.5 %). Outcome differences were found for general complications (3.2-18.8 %), anastomotic leakage (0-4.3 %) and tumour-free status at discharge (72.9-87.6 %). In-hospital deaths ranged between 1.1 and 3.2 %. CONCLUSION: This study demonstrates the feasibility of an international quality assurance project in colorectal cancer. This concept ensures data analysis based on a comparable data input. Differences in preoperative diagnostics, completeness of histopathological evaluation and short-term outcomes for Germany, Poland and Italy might result from disparities in socioeconomic factors and implementation of existing guidelines. Further activities are necessary to warrant the use of common standards in outcome control.

The impact of psoriasis on work-related problems: a multicenter cross-sectional survey.

BACKGROUND: Psoriasis can have cumulative physical and psychosocial effects preventing sufferers from achieving their full-life potential. Few studies have addressed the impact of psoriasis on work-related characteristics. OBJECTIVE: To evaluate the impact of psoriasis on education prospects and work limitations in patients with moderate-to-severe psoriasis. METHODS: This study was conducted in 29 dermatology centres across Italy. Information was collected by questionnaire during office visits. RESULTS: A total of 787 patients (64% male, aged 50 years) completed the questionnaire. At the time of the survey, mean Psoriasis Area and Severity Index (PASI) score and disease duration were 10 and 19 years respectively. Current smokers had higher PASI scores compared to non-smokers (10.8 vs. 9.4, P = 0.02). Plaque psoriasis was the most frequently described (91.2%). Fifty-five percent of patients had limited expectations of career progression. Similarly, in 42% of cases, psoriasis reduced the prospects of improvement in employment status and 35% of patients reported having reduced earning potential. Approximately 60% of patients reported that psoriasis localized to their hands or feet caused work limitations, whilst in about 25%, it caused them to quit their job. Approximately 37% of patients reported having lost between 3-10 work days in the past 3 months due to clinical assessment or treatment. Logistic regression revealed that gender, low standard of education, number of localizations, shame, anger and self-esteem were predictors significantly associated with limitations in work. CONCLUSIONS: Moderate-to-severe psoriasis has a profound negative impact on the employment capacity of patients in Italy. Psoriasis also contributes to days lost from work, affects job opportunity, career prospects and revenue potential.