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Neuroendocrine tumors represent the most common small bowel malignancy. At the time of presentation, they often debut as metastatic disease. Consensus guidelines recommend a multimodal and multidisciplinary approach that includes punctual investigations, aggressive surgical resection of the primary tumor and the assessment of possible synchronous metastasis through surgical procedures or ablative techniques. This report details the case of a 77-year-old male with a multifocal mid-gut neuroendocrine tumor with nodal dissemination and synchronous hepatic metastasis. He underwent a laparoscopic procedure that included an ileal resection with intracorporeal side-to-side ileo-ileal anastomosis, a large mesenteric nodal dissection extended up to superior mesenteric vein, a laparoscopic dissection of hepatic metastasis and an ultra-soundguided thermal ablation of two hepatic metastasis. This case highlights the efficacy of laparoscopy, providing a mini-invasive radical treatment and the importance of an aggressive multimodal approach in facing a metastatic multifocal mid-gut neuroendocrine tumor.

Background and Objective: EUS-FNA sensitivity for malignancy in parenchymal masses of patients with concurrent chronic pancreatitis (CP) has been reported to be unsatisfactory. The aim of the present study was to directly compare the diagnostic accuracy of EUS-FNA and EUS-fine-needle biopsy (FNB) in differentiating between inflammatory masses and malignancies in the setting of CP. Methods: We performed a retrospective analysis of prospective, multicentric databases of all patients with pancreatic masses and clinico-radiological-endosonographic features of CP who underwent EUS-FNA or FNB. Results: Among 1124 patients with CP, 210 patients (60% males, mean age: 62.7 years) with CP and pancreatic masses met the inclusion criteria and were enrolled. In the FNA group (110 patients), a correct diagnosis was obtained in all but 18 cases (diagnostic accuracy 83.6%, sensitivity 69.5%, specificity 100%, positive predictive value [PPV] 100%, and negative predictive value [NPV] 73.9%); by contrast, among 100 patients undergoing FNB, a correct diagnosis was obtained in all but seven cases (diagnostic accuracy 93%, sensitivity 86.8%, specificity 100%, PPV 100%, and NPV 87%) (P = 0.03, 0.03, 1, 1, and 0.07, respectively). At binary logistic regression, focal pancreatitis (odds of event occurrence [OR]: 4.9; P < 0.001), higher Ca19-9 (OR: 2.3; P = 0.02), and FNB (OR: 2.5; P < 0.01) were the only independent factors associated with a correct diagnosis. Conclusion: EUS-FNB is effective in the differential diagnosis between pseudotumoral masses and solid neoplasms in CP, showing higher diagnostic accuracy and sensitivity than EUS-FNA. EUS-FNB should be considered the preferred diagnostic technique for diagnosing cancer in the setting of CP.

Background: The management of rectal cancer is multimodal and involves a multidisciplinary team of cancer specialists with expertise in medical oncology, surgical oncology, radiation oncology and radiology. It is crucial for highly specialized centers to collaborate via networks that aim to maintain uniformity in every aspect of treatment and rigorously gather patients’ data, from the first clinical evaluation to the last follow-up visit. The Advanced International Mini-Invasive Surgery (AIMS) academy clinical research network aims to create a rectal cancer registry. This will prospectively collect the data of patients operated on for non-metastatic rectal cancer in high volume colorectal surgical units through a well design pre-fashioned database for non-metastatic rectal cancer, in order to take all multidisciplinary aspects into consideration. Methods/Design: The protocol describes a multicenter prospective observational cohort study, investigating demographics, frailty, cancer-related features, surgical and radiological parameters, and oncological outcomes among patients with non-metastatic rectal cancer who are candidates for surgery with curative intent. Patients enrolled in the present registry will be followed up for 5 years after surgery. Discussion: Standardization and centralization of data collection for neoplastic diseases is a virtuous process for patient care. The creation of a register will allow the control of the quality of treatments provided and permit prospective and retrospective studies to be carried out on complete and reliable high quality data. Establishing data collection in a prospective and systematic fashion is the only possibility to preserve the enormous resource that each patient represents.

Purpose: Measurement and monitoring of the quality of care using a core set of quality measures are increasing in health service research. Although administrative databases include limited clinical data, they offer an attractive source for quality measurement. The purpose of this study, therefore, was to evaluate the completeness of different administrative data sources compared to a clinical survey in evaluating rectal cancer cases. Methods: Between May 2012 and November 2014, a clinical survey was done on 498 Lombardy patients who had rectal cancer and underwent surgical resection. These collected data were compared with the information extracted from administrative sources including Hospital Discharge Dataset, drug database, daycare activity data, fee-exemption database, and regional screening program database. The agreement evaluation was performed using a set of 12 quality indicators. Results: Patient complexity was a difficult indicator to measure for lack of clinical data. Preoperative staging was another suboptimal indicator due to the frequent missing administrative registration of tests performed. The agreement between the 2 data sources regarding chemoradiotherapy treatments was high. Screening detection, minimally invasive techniques, length of stay, and unpreventable readmissions were detected as reliable quality indicators. Postoperative morbidity could be a useful indicator but its agreement was lower, as expected. Conclusions: Healthcare administrative databases are large and real-time collected repositories of data useful in measuring quality in a healthcare system. Our investigation reveals that the reliability of indicators varies between them. Ideally, a combination of data from both sources could be used in order to improve usefulness of less reliable indicators.

Medullary carcinoma (MC) of the large intestine is a relatively new histological type of adenocarcinoma characterized by poor glandular differentiation and an intraepithelial lymphocytic infiltrate. MC can be associated to a defective mechanism for DNA mismatch repair, caused by the so-called microsatellite instability (MSI). We present the case of a 44 years old Caucasian woman, who referred to the Emergency Room with symptoms mimicking an acute appendicitis. Computed tomography and colonoscopy demonstrated an ulcerated and stenotic lesion of the caecum without signs of metastasis and peritoneal carcinosis. Patient underwent a laparoscopic right colectomy. The final pathologic findings provided the diagnosis of medullary carcinoma with MSI. Patient then underwent adjuvant chemotherapy according to the FOLFOX-4 protocol (association of 5-Fluorouracil, Leucovorin, and Oxaliplatin) for twelve cycles. At two-years follow-up, patient is disease free. MC in association with MSI is a non-frequent tumor of the colon characterized by a better prognosis compared to other types of poorly differentiated adenocarcinoma. In the observed case, 24 months after the surgical operation, the patient is in good health and there is no evidence of metastasis or relapse.

Introduction: Low colorectal and colo-anal anastomosis leakage after anterior resection of rectum occurs in up to 24% of cases. Leak is the main cause of morbidity and mortality in postoperative period and can result in a permanent stoma in up to 25% of cases. Loop ileostomy or colostomy does not reduce the percentage of fistulas, but reduces flow rate. Conservative management imply long times to heal. Endosponge® system (B. Braun Aesculap AG, Germany) was recently acquired in clinical practice. This system accelerates healing process through vacuum creation, removal of fluids and edema, infection control, local increase of blood flow and stimulation of granulation tissue formation. The device consists of a cylindrical polyurethane sponge, with 400 to 600 micron pores, standard dimension of 7 cm, which can be cut to fit the estimated size of the abscess cavity. The drain tube is connected to a Redyrob Trans Plus®bottle which exerts a constant suction during the therapy. Materials and Methods: From November 2012 and March 2014 four patients were treated with Endosponge® system, all of them underwent operation of anterior resection of rectum for cancer and developed anastomotic leakage during postoperative course. All patients had loop ileostomy, none presented signs of sepsis. The Endosponge® system was then placed endoscopically. In all cases, after the first placing, the authors utilized sterile foam dressing from negative pressure wound therapy kit, tailored to better fill the abscess cavity and connected with Redyrob Trans Plus?bottle. Device changes were performed every 5 - 7 days, according to the size of the cavity and the amount of secretions produced. The treatment was started during hospitalization first and then continued as outpatient. Results: There was no mortality. The amount of secretions was related to the initial size and the degree of contamination of the abscess cavity. Antibiotic therapy was discontinued after an average of 21 days, with a range between 14 and 32 days. Complete healing was achieved in a median of 82 days (30 to 148) in all patients with good functional results, no further surgery was required. Conclusions: The results of therapy with Endosponge® seem encouraging. Success of therapy is higher if initiated as soon possible after the intervention and is also related to the size of dehiscence and abscess cavity. In cases with large abscesses, it is not clear whether this new treatment leads to reduction in healing time, however, can prevent the packaging of a (often definitive) colostomy. Further studies will be able to select patients who will most benefit from the procedure.

We previously studied a dose-dense TCF (TCF-dd) regimen demonstrating its feasibility and an activity comparable to epirubicin-based chemotherapy and TCF q3w in terms of overall survival and time to progression (TTP). We report here the final results of a phase II study of chemotherapy with a modified TCF-dd regimen in locally advanced or metastatic gastric cancer (MGC).Patients with histologically confirmed measurable MGC, not previously treated for advanced disease, received docetaxel 70 mg/m(2) day 1, cisplatin 60 mg/m(2) day 1, l-folinic acid 100 mg/m(2) days 1 and 2, followed by 5-fluorouracil (5-FU) 400 mg/m(2) bolus days 1 and 2, and then 600 mg/m(2) as a 22-h continuous infusion days 1 and 2, every 14 days, plus pegfilgrastim 6 mg on day 3. Patients aged ≥65 years received the same schedule with a dose reduction of 30 %.Study duration: December 2007-November 2010. Forty-six consecutive patients were enrolled (78 % male, 22 % female; median age, 66 years, range, 38-76 years; ECOG PS: 0, 48 %, 1, 46 %). Primary endpoint was overall response rate (ORR). A median of four cycles (range, one to six) was administered. Forty-three patients were evaluated for response (93.5 %) and all for toxicity: 3 complete response (CR), 25 partial response (PR), 10 stable disease (SD), and 5 progressive disease (PD) were observed, for an ORR by intention to treat (ITT) of 61 % (95 % CI 47-75). Median overall survival (OS) was 17.63 months (95 % CI, 13.67-20.67); median progression-free survival was 8.9 months (95 % CI, 6.5-13.4). Twenty-one patients (46.0 %) were treated at full doses without any delay, thus respecting the dose-dense criterion. Most frequent grade 3-4 toxicities were neutropenia (20 %), leukopenia (4 %), thrombocytopenia (2 %), anemia (2 %), febrile neutropenia (6 %), asthenia (22 %), diarrhea (4 %), nausea/vomiting (11 %), and hypokalemia (6 %). Overall, TCF-dd was shown to be safe.The TCF-dd regimen in locally advanced or MGC is confirmed to be feasible and very active and needs to be further tested in randomized studies.

Introduction Fuzzy logic and Artificial Neural Networks (ANN) are complementary technologies that together generate neuro-fuzzy system. The aim of our study is to compare 2 models for predicting the presence of high-grade prostate cancer (Gleason score 7 or more). Methods We evaluated data from 1000 men with PSA less than 50 ng/mL, who underwent prostate biopsy. A prostate cancer was found in 313 (31%), and in 172 (17.2%) we detected high-grade prostate cancer. With those data, we developed 2 Co-Active Neuro-Fuzzy Inference Systems to predict the presence of high-grade prostate cancer. The first model had four input neurons (PSA, free PSA percentage [%freePSA], PSA density, and age) and the second model had three input neurons (PSA, %freePSA, and age). Results The model with four input neurons (PSA, %freePSA, PSA density, and age) showed better performances than the one with three input neurons (PSA, %freePSA, and age). In fact the average testing error was 0.42 for the model with four input neurons and 0.44 for the other model. Conclusions The addition of PSA density to the model has allowed to obtain better results for the diagnosis of high grade prostate cancer.

Background: The considerable increase in Obesity and especially the increase in super obese patients (Body Mass Index—BMI ≥ 50 Kg/m2) who require surgery lead doctors to search for surgery techniques which give good results in terms of a consistent and stable weight loss associated with low morbidity and good quality of life. The Long Magenstrasse (LM) intervention, born from combining two properly modified surgical procedures (Selective Vagotomy with pyloric divulsion and Mangestrasse & Mill by Johnston) seems to have these characteristics according to our experience after operating on 660 patients. Methods: From October 2003 to October 2008 we treated 186 patients with LM. One hundred and sixty-two patients were regularly present to the annual follow-up, but 24 patients didn’t turn up, therefore, they were contacted by phone. On average, surgery lasted approximately 80 minutes (range: 50 - 90 minutes). Thirty patients were super obese with an average BMI of 57.4 Kg/m2; 156 patients were grade II and III obese with an average BMI of 40.7 Kg/m2. Results: The average BMI of the 30 super obese patients decreased from 57.4 Kg/m2 to 35.9 Kg/m2 one year after surgery, to 35.6, 5 years after surgery and it has remained stable until now. In the 156 patients suffering from II and III grade obesity, the average BMI decreased from 40.7 Kg/m2 to 27.8 Kg/m2 one year after surgery and it has remained stable until now. Out of all super obese diabetic patients, only one has partially maintained his/her therapy. Patients have reported a decreased appetite since the very first days of post-operative period with an early sense of satiety which is unchanged until today. Conclusions: A consistent and stable weight loss over 5 years after surgery even in Super Obese patients, a decrease in appetite with an early sense of satiety, a re-equilibrium of the metabolic syndrome in particular of Diabetes Mellitus, allow to classify LM among those surgical treatments with a mixed mechanism of action: both restrictive and functional, in particular, entero-hormonal and gastric neurosecretory.

The widespread use of antibiotics, the progress of intensive care medicine and the better comprehension of the physio-pathology of trauma and Abdominal Compartment Syndrome (ACS) made the open abdomen (OA) a cornerstone step of damage control surgery (DCS). Given the indisputable advantages of OA, the exposure of the abdominal viscera to the outer environment brings itself an unavoidable load of morbidity, where the appearance of an enteroatmospheric fistula (EAF) is the most feared complication. In fact, the onset of an EAF is associated with significant morbidity and mortality, because of its extremely challenging critical care and nutritional management issues. For these reasons, the best way to deal with an EAF is to prevent it and the knowledge of the causes and risk factors for fistula formation is essential. EAF management is complex and demanding and should be tailored upon the specific characteristic of every single case; from the surgeon point of view the corner stone of the treatment is the complete diversion of fistula effluent. Prevention of malnutrition, dehidratation and electrolyte imbalance is of vital importance.

e16079Background: Surgical resection remains the only curative treatment option for non-metastatic gastric cancer (GC). A large cohort of GCs from a high-volume Italian center was analyzed to descr...

Aims and background Previous studies have reported that in early breast cancer, lymphomas and advanced bladder cancer, dose-dense chemotherapy may be more effective than conventional treatments. In metastatic gastric cancer, chemotherapy with docetaxel, cisplatin and 5-fluorouracil (TCF) q3w is very active, and, even though there is no international consensus on the subject, it is the regimen of choice of many European centers as first-line chemotherapy in this subset of patients. Based on these studies, we tested for the first time the feasibility and activity of an intensified dose-dense TCF regimen (q2w) modifying the 5-fluorouracil infusion with l-folinic acid/5-fluorouracil according to the “De Gramont regimen”. Methods and study design Patients with histologically confirmed measurable metastatic gastric cancer, ECOG performance status ≤1, and not previously treated for advanced disease received docetaxel, 85 mg/m2 (75 mg/m2 after the first 6 patients, 70 mg/m2 after the 19th patient) on day 1, cisplatin, 75 mg/m2 on day 1 (60 mg/m2 after the 19th patient), l-folinic acid, 100 mg/m2 on days 1 and 2, followed by 5-fluorouracil, 400 mg/m2 bolus on days 1 and 2 and then 600 mg/m2 as a 22-h continuous infusion on days 1 and 2, every 14 days, plus pegfilgrastim, 6 mg on day 3. Patients aged ≥65 years received the same schedule with a dose reduction of 30%. Results Thirty-two consecutive patients were enrolled (63% male, 37% female); median age, 64 years (range, 40–81). A median of 4 cycles (range, 1–7) per patient was administered. Eleven of 32 patients (34%) required a dose reduction, mostly for hematological grade III-IV toxicity and severe asthenia. Twelve patients (38%) completed the first 4 cycles of therapy within 7 weeks, thereby finishing without delay the initially planned dose-density schedule. Twenty-eight patients were evaluated for response (1 early suspension after the first cycle because of toxicity, 3 deaths before response evaluation due to progression of disease). There were 3 complete responses (9%), 15 partial responses (47%), 7 stable disease (22%) and 3 progression of disease (9%), for an overall response rate, by intention to treat, of 56% (95% CI, 39–73). The most frequent grade 3–4 toxicities were: neutropenia (53%), thrombocytopenia (34%), anemia (16%) febrile neutropenia (22%), asthenia (38%) and diarrhea (19%). Median time to progression was 9.1 months (95% CI, 6.0–12.2); median overall survival was 10.1 months (95% CI, 8.8–12.2). Conclusions A dose-dense TCF regimen in metastatic gastric cancer is feasible, with activity comparable to previous results achieved with epirubicin-based chemotherapy and TCF q3wk in terms of overall survival and time to progression, and deserves to be further tested in randomized phase III studies.

Breast cancer represents a heterogeneous group of diseases with varied biological features, behavior, and response to therapy; thus, management of breast cancer relies on the availability of robust predictive and prognostic factors to support therapy decision-making. Traditionally, neoadjuvant treatment for breast cancer was preserved for locally advanced, converting an inoperable to a surgical resectable cancer. Neoadjuvant trials, additionally, offer: 1) the opportunity to evaluate new treatment options in a faster way and with fewer patients than large adjuvant trials; 2) to identify and validate the prognostic and predictive value of a marker with its association with clinical outcome in relation to the administered treatment. In this setting, thanks to new, affordable technologies which help to detail the molecular profiles of tumors, new trial designs based on new target therapies, like window-of-opportunity, are also suggested, as they represent the chance to identify tumor sensitivity or to overcome tumor resistance to the treatment used, based on its interaction with tumor biology in early tumor stages. However, clinicians and researchers should pay particular attention: In this setting, the safety of patients is paramount, given the exposure of potentially curable patients to investigational agents with limited safety experience, the definition of the study population and the study design, such as adaptive strategies, should limit patient exposure to ineffective agents, and intensify safety monitoring in the course of the treatment. Here, issues related to outcome determination in breast cancer, including some critical points of view, are presented.

Gene expression profiling tests are used in an attempt to determine the right treatment for the right person with early-stage breast cancer that may have spread to nearby lymph nodes but not to distant parts of the body. These new diagnostic approaches are designed to spare people who do not need additional treatment (adjuvant therapy) the side effects of unnecessary treatment, and allow people who may benefit from adjuvant therapy to receive it. In the present review we discuss in detail the major diagnostic tests available such as MammaPrint dx, Oncotype dx, PAM50, Mammostrat, IHC4, MapQuant DX, Theros-Breast Cancer Gene Expression Ratio Assay, and their potential clinical applications.

Purpose: To assess whether the combination of letrozole, metronomic cyclophosphamide and sorafenib (LCS) is well tolerated and shows activity in primary breast cancer (BC). Methods: Thirteen oestrogen receptor-positive, postmenopausal, T2-4, N0-1 BC patients received the LCS combination for 6 months. In these patients we examined the pharmacokinetics of sorafenib and cyclophosphamide, toxicity of the regimen, the clinical response to therapy and changes in the levels of biologically relevant biomarkers. Results: Adequate plasma concentrations of sorafenib were achieved in patients when it was dosed in combination with L+C. The mean plasma concentrations of C were consistently lower following administration of LCS, compared with administration of L+C only. The most common drug-related grade 3/4 adverse events were skin rash (69.3%), hand-foot skin reaction (69.3%) and diarrhoea (46.1%). According to RECIST Criteria, a clinical complete response was observed in 6 of 13 patients. A significant reduction in tumour size, evaluated with MRI, was also observed between baseline and 14 days of treatment in all 13 patients (P=0.005). A significant reduction in SUV uptake, measured by 18FDG-PET/CT, was observed in all patients between baseline and 30 days of treatment (P=0.015) and between baseline and definitive surgery (P=0.0002). Using modified CT Criteria, a response was demonstrated in 8 out of 10 evaluable patients at 30 days and in 11 out of 13 evaluable patients at the definitive surgery. A significant reduction in Ki67 expression was observed in all patients at day 14 compared with baseline (P

e15588 Background: Chemotherapy (CT) and chemoradiotherapy (CTRT) both in neoadjuvant (neoadj) or adjuvant (adj) setting are associated with better overall survival (OS) over surgery alone in patients (pts) with resectable gastroesophageal (GE) adenocarcinoma (ADK). The best sequence and timing of treatments have still not been defined. A large cohort of GE ADKs derived from 2 high-volume Italian centers was analyzed to describe clinical outcomes and prognostic factors. Methods: 497 patients (pts) diagnosed with GE ADK who underwent surgery with curative intent from 2007 to 2016 were considered. Variables analyzed were: age, sex, tumor location, histology, T, N, M, R, G, HER-2, Helicobacter Pylori (HP) infection, (neo)adj CT, and adj CTRT. Analysis was performed according to ITT principle. Results: Median age at diagnosis was 71 years (range 35-92). At 26.7 months (mo) median follow-up, median OS was 27.6 mo (range 1-127) and median time to recurrence (TTR) 10.8 mo (range 7.8-13.1). Adj CT was administered in 203 cases (41%); 116 pts (23%) had adj CTRT and 47 (9%) neoadj CT. Statistically significant variables for OS and/or TTR at 12 months at univariate analysis were: age, T, N, M, R, G, adj CTRT, neoadj CT and adj CT. Results of multivariate analysis (MVA) are shown in Table 1. Conclusions: Despite a short follow-up, our analysis performed on a very large cohort of consecutive pts confirms the prognostic value of T and N for both OS and TTR. Adj CT and CTRT had a significant impact on 1 year OS, while neoadj CT gave only a 12 months TTR significant benefit. Based on these results, perioperative treatment strategies should always be considered in the management of resectable GE cancer. [Table: see text]

BACKGROUND: Although Trastuzumab has improved survival of HER2+ breast cancer patients, resistance to the agent pre-exists or develops through the course of therapy. Here we show that a specific metabolism and autophagy-related cancer cell phenotype relates to resistance of HER2+ breast cancer to Trastuzumab and chemotherapy. METHODS: Twenty-eight patients with locally advanced primary breast cancer were prospectively scheduled to received one cycle of Trastuzumab followed by a new biopsy on day 21, followed by taxol/Trastuzumab chemotherapy for four cycles before surgery. FDG PET/CT scan was used to monitor tumour response. Tissue samples were immunohistochemically analysed for metabolism and autophagy markers. RESULTS: In pre-Trastuzumab biopsies, the LC3A+/HER2+ cell population was correlated with HIF1α expression (P=0.01), while GLUT1 and LC3B expression were correlated with Ki67 proliferation index (P=0.01 and P=0.01, respectively). FDG PET tumour dimensions before therapy were correlated with LC3B expression (P=0.005). Administration of Trastuzumab significantly reduced clinical and PET-detected tumour dimensions (P

To the Editor: Community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) has been identified in livestock animals (particularly pigs), veterinarians, and animal farm workers (1,2). CA-MRSA strains from pigs have been classified most frequently within the multilocus sequence type (ST) 398 (1) and have been rarely identified as a cause of invasive infection in humans (1,3,4). We report a case of invasive infection in a pig-farm worker in Cremona, Italy, an intensive animal farming area; the infection was caused by MRSA of swine origin, ST398. The case-patient was a 58-year-old man admitted to a surgical department in Cremona, Italy, on July 30, 2007, because of a 1-week history of fever and intense pain in his right buttock. He worked on a pig farm, was obese, consumed high volumes of wine (1.5 L/day), was taking medication for hypertension, and had not had recent (

Fuzzy logic and Artificial Neural Networks (ANN) are complementary technologies that together generate neuro-fuzzy system. The aim of our study is to compare 2 models for predicting the presence of high-grade prostate cancer (Gleason score 7 or more).We evaluated data from 1000 men with PSA less than 50 ng/mL, who underwent prostate biopsy. A prostate cancer was found in 313 (31%), and in 172 (17.2%) we detected high-grade prostate cancer. With those data, we developed 2 Co-Active Neuro-Fuzzy Inference Systems to predict the presence of high-grade prostate cancer. The first model had four input neurons (PSA, free PSA percentage [%freePSA], PSA density, and age) and the second model had three input neurons (PSA, %freePSA, and age).The model with four input neurons (PSA, %freePSA, PSA density, and age) showed better performances than the one with three input neurons (PSA, %freePSA, and age). In fact the average testing error was 0.42 for the model with four input neurons and 0.44 for the other model.The addition of PSA density to the model has allowed to obtain better results for the diagnosis of high grade prostate cancer.

Background: The objective of this study was to determine the optimal scheduling of 2.5 mg daily letrozole in neoadjuvant breast cancer patients to obtain pathological complete response (pathCR) and assess Ki-67 expression as an early predictor of response.Patients and methods:This single institution study comprised 120 oestrogen receptor (ER)-positive postmenopausal women with primary breast cancer (clinical stage ≥T2, N0-1), from three sequential cohorts (cohort A of 40, cohort B of 40 and cohort C of 40 patients, respectively) based on different duration of the neoadjuvant letrozole. Biological markers such as ER, progesterone receptor, HER2 and Ki-67 expression were tested at diagnosis and at definitive surgery.Results:A total of 89 patients (75.4%) achieved an objective response with 44 (37.3%) clinical CRs and 45 (38.1%) partial responses. The clinical CRs were significantly observed in cohort C (23 out of 40 patients, 57.5%) and B (16 out of 38 patients, 42.1%) compared with cohort A (5 out of 40 patients, 12.5%) (P-value for trend

AIM To evaluate the safety and efficacy of a modified cyanoacrylate [N-butyl-2-cyanoacrylate associated with methacryloxysulfolane (NBCA + MS)] to treat non-variceal upper gastrointestinal bleeding (NV-UGIB). METHODS In our retrospective study we took into account 579 out of 1177 patients receiving endoscopic treatment for NV-UGIB admitted to our institution from 2008 to 2015; the remaining 598 patients were treated with other treatments. Initial hemostasis was not achieved in 45 of 579 patients; early rebleeding occurred in 12 of 579 patients. Thirty-three patients were treated with modified cyanoacrylate: 27 patients had duodenal, gastric or anastomotic ulcers, 3 had post-mucosectomy bleeding, 2 had Dieulafoy’s lesions, and 1 had duodenal diverticular bleeding. RESULTS Of the 45 patients treated endoscopically without initial hemostasis or with early rebleeding, 33 (76.7%) were treated with modified cyanoacrylate glue, 16 (37.2%) underwent surgery, and 3 (7.0%) were treated with selective transarterial embolization. The mean age of patients treated with NBCA + MS (23 males and 10 females) was 74.5 years. Modified cyanoacrylate was used in 24 patients during the first endoscopy and in 9 patients experiencing rebleeding. Overall, hemostasis was achieved in 26 of 33 patients (78.8%): 19 out of 24 (79.2%) during the first endoscopy and in 7 out of 9 (77.8%) among early rebleeders. Two patients (22.2%) not responding to cyanoacrylate treatment were treated with surgery or transarterial embolization. One patient had early rebleeding after treatment with cyanoacrylate. No late rebleeding during the follow-up or complications related to the glue injection were recorded. CONCLUSION Modified cyanoacrylate solved definitively NV-UGIB after failure of conventional treatment. Some reported life-threatening adverse events with other formulations, advise to use it as last option.

Introduction The aim of our study is to assess the incidence of the surgical approach in scrotal trauma. Materials and Methods We retrospectively assessed both penetrating and blunt cases of scrotal trauma observed from 2002 to 2012. For each case we considered various parameters such as the age of the patient, whether the type of trauma was penetrating or blunt, whether or not a surgical approach was taken, whether or not there were polytrauma, whether or not an orchiectomy was performed, and how many days had elapsed since the first urological observation of the trauma. Results 43 cases of scrotal trauma were assessed, of which 39 were blunt traumas (90%) and four penetrating traumas (10%). The median age of all patients was 29 years (range 4–88). Of these patients, eight underwent surgical procedures, of which three were cases of penetrating scrotal trauma and five were cases of blunt trauma, with an average age of 20. We only found it necessary to carry out an orchiectomy in two of these patients, of which one was after penetrating trauma and the other after blunt trauma. Most of the blunt traumas did not require surgery (8 versus 35, pConclusions In our case studies, in the majority of cases early exploratory intervention in scrotal trauma allows the testicle to be saved in its entirety or at least in part.

Merkel cell carcinoma (MCC) is a rare and aggressive neuroendocrine tumor of the skin. Fourty-eight patients with MCC were observed at the Rare Hormonal Tumors Group of Cremona Hospital, 15 of these with unknown primary site. Due to rarity of Merkel cell carcinoma, clinical experience is generally limited. Data from our series confirm the current recommendations. Wide surgical excision must be associated with radiotherapy also in early stages in order to avoid local relapse and the rapid progression of disease. In advanced stages chemotherapy is the standard despite the short duration of responses and poor quality of life. The data of our series, characterized by a high demand for second opinion, offer some insight about the real rarity of the tumor, the difficulty of managing of disease in our country secondary to a wrong cultural approach to the problem, the indiscriminate use of molecules unnecessary and often expensive, the lack of protocols, and the presence of guidelines often ignored. This results in very poor survival associated with a very low quality of life, requiring to find the right direction towards a correct management of disease.

Endometriosis is a non-cancerous disorder characterised by development of endometrial epithelium outside the uterus, in which involvement of the gastrointestinal tract is most common. The most frequent site is the rectosigmoid colon (72%), whereas the caecum is involved in 4% of cases. Endometriosis may present with abdominal pain, constipation, and sometimes intestinal bleeding. The treatment of the disease is surgical when medical therapy fails and in cases of surgical urgency. We report the case of a patient with bowel obstruction due endometriosis of the caecum and ileo-caecal valve in association with metrorrhagia. A segmentectomy of the right colon was performed. Since endometriosis is more frequent on the left side of the pelvis probably due to regurgitated endometrial cells, the case observed is not very frequent and is worth reporting.

146 Background: Gastric cancer is a highly aggressive disease. No established standard first-line regimens are currently available. Aim of this study is to evaluate efficacy of dose-dense chemotherapy with DCF combined with P in patients (pts) with locally advanced or metastatic cancer of the stomach or GEJ. Methods: HER2 negative, ECOG PS 0-1, not previously treated pts, received up to 4 cycles of therapy with Panitumumab 6 mg/kg d 1, Docetaxel 60 mg/m2 d 1, Cisplatin 50 mg/m2 d 1, L-Folinic acid 100 mg/m2 d 1 and 2, followed by 5-FU 400 mg/m2 bolus d 1 and 2, and then 600 mg/m2 as a 22 h c.i. on d 1 and 2, every 2 weeks, plus Pegfilgrastim 6 mg on d 3. Pts aged ≥ 65 years were treated with the same chemotherapy schedule with a dose reduction by 30%. Pts with disease control after 4 cycles, received P until progression. Results: From 05/2010 to 01/2014, 52 consecutive pts were enrolled (75% M, 25% F; median age: 64.5 y, range: 42-75; metastatic 90%, locally advanced inoperable 10%; 96% adenocarcinoma; 13 pts with GEJ cancer). Primary end point was overall response rate (ORR). At 31 Aug 2014 cut-off date, 1 pt is still on treatment, 2 lost at f-up, 11 alive and 39 dead. 50 pts evaluable for response and all for toxicity. A median of 4 cycles (range 0-6) was administered. 3 CR, 29 PR, 10 SD and 8 PD were observed, for an ORR (by ITT) of 62% (95% CI, 48%-75) and a DCR of 81%. 26 pts entered the maintenance phase with only P and received a median 7.3 cycles (range 1-46). Median TTP was 4.8 months (95% CI, 4.1-6.9) and median OS was 9.4 months (95% CI, 7.4- 11.6). Most frequent grade 3-4 toxicities were: leucopenia (29%), neutropenia (19%), febrile neutropenia (13%), anemia (10%), asthenia (27%), mucosytis (13%), anorexia (17%), nausea/vomiting (12%), diarrhea (15%), ipokalemia (12%), and skin rash (25%). Two toxic deaths were registered (pulmonary aspergyllosis due to febrile neutropenia and gastric hemorrhage). Conclusions: Dose-dense chemotherapy combined with P is a very active regimen in gastric cancer. Due to a not negligible toxicity profile, it may represent a treatment option in neoadjuvant setting. Clinical trial information: 2009-016962-10.

e15086 Background: Gastric cancer is more common in elderly pts with its highest incidence around the seventh decade of life. Most oncologists are reluctant to treat this population with the most active polichemotherapy combinations because of safety concerns. Subgroup analyses of elderly pts enrolled in European studies show limited and conflicting data.We previously reported on the feasibility and high activity of a dose-dense TCF regimen (Tomasello 2010). This is a retrospective analysis of efficacy and safety of this schema in the elderly pts subgroup (≥ 65 years). Methods: From Nov 2004 to Jan 2013, 119 consecutivepts with MGC, PS 0-2, not previously treated, received Docetaxel 70 mg/m2 d1, Cisplatin 60 mg/m2 d1, l-Folinic Acid 100 mg/m2 d1-2, followed by 5-FU 400 mg/m2 bolus d1-2, and then 600 mg/m222 h c.i. d1-2, every 2 weeks, plus Pegfilgrastim 6 mg on day 3. Pts aged ≥ 65 years (60) received the same schedule with doses reducted by 30%. Results: Overall pts characteristics: 76% male, 24% female; median age: 65, range 31-81. A median of 4 cycles was administered. 102 pts were evaluable for response (86%) and all for toxicity. In pts aged ≥ 65 y, we observed 5 CR (8%), 26 PR (43%), 10 SD (17%) and 7 PD (12%); in younger pts: 3 CR (5%), 32 PR (54%), 9 SD (15%) and 10 PD (17%); ORR by ITT was 56% (95% CI 45-64). Median OS was 11,2 months (95% CI 9,4-14,1); in elderly and younger pts was 11,2 (95% CI 7,3-15,1) and 11,8 (95% CI 9,2-16,2), respectively. Out of 48 evaluable pts aged ≥ 65 years, 24 (50%) were treated at full doses without any delay. In the elderly most frequent grade 3-4 toxicities were: neutropenia (13%, p

4570 Background: In the 2007 ASCO Annual Meeting we reported the high activity of TCF-DD in MGC. Previous phase II trials showed that regimens with O, I, FA, and 5-FU are very active in MGC. Based ...

Background The spread of the SARS-CoV2 virus, which causes COVID-19 disease, profoundly impacted the surgical community. Recommendations have been published to manage patients needing surgery during the COVID-19 pandemic. This survey, under the aegis of the Italian Society of Endoscopic Surgery, aims to analyze how Italian surgeons have changed their practice during the pandemic. Methods The authors designed an online survey that was circulated for completion to the Italian departments of general surgery registered in the Italian Ministry of Health database in December 2020. Questions were divided into three sections: hospital organization, screening policies, and safety profile of the surgical operation. The investigation periods were divided into the Italian pandemic phases I (March–May 2020), II (June–September 2020), and III (October–December 2020). Results Of 447 invited departments, 226 answered the survey. Most hospitals were treating both COVID-19-positive and -negative patients. The reduction in effective beds dedicated to surgical activity was significant, affecting 59% of the responding units. 12.4% of the respondents in phase I, 2.6% in phase II, and 7.7% in phase III reported that their surgical unit had been closed. 51.4%, 23.5%, and 47.8% of the respondents had at least one colleague reassigned to non-surgical COVID-19 activities during the three phases. There has been a reduction in elective (> 200 procedures: 2.1%, 20.6% and 9.9% in the three phases, respectively) and emergency ( Conclusion This survey offers three faithful snapshots of how the surgical community has reacted to the COVID-19 pandemic during its three phases. The significant reduction in surgical activity indicates that better health policies and more evidence-based guidelines are needed to make up for lost time and surgery not performed during the pandemic.