T-DM1 versus pertuzumab, trastuzumab and a taxane as first-line therapy of early-relapsed HER2-positive metastatic breast cancer: an Italian multicenter observational study.

BACKGROUND: The current standard first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive (+) metastatic breast cancer is the combination of pertuzumab, trastuzumab and a taxane (P + T + taxane), while standard second-line is ado-trastuzumab-emtansine (T-DM1). The registration trial of pertuzumab, however, did not include early-relapsing patients, defined as patients experiencing tumor relapse ≤12 months from the end of (neo)adjuvant anti-HER2 therapy. Conversely, the pivotal trial of T-DM1 included some patients relapsing ≤6 months after the end of (neo)adjuvant trastuzumab. Thus, a proportion of early-relapsing patients are currently eligible to receive T-DM1 as first-line treatment. Nevertheless, no direct comparison exists between the two regimens in this clinical setting. PATIENTS AND METHODS: We retrospectively compared T-DM1 versus P + T + taxane as first-line treatment in two cohorts of early-relapsing patients in an Italian 'real-world' setting, involving 14 public health care institutions. The primary endpoint was progression-free survival. Secondary endpoints included patients' characterization, overall survival and post-progression survival. Univariate and multivariate analyses were carried out. All tests were two-sided and a P ≤ 0.05 was considered statistically significant. RESULTS: Among 1252 screened patients, 75 met the inclusion criteria. Forty-four (58.7%) received P + T + taxane and 31 (41.3%) received T-DM1. The two cohorts showed similar characteristics of aggressiveness and no significant differences in treatment history. T-DM1, compared with P + T + taxane was associated with worse progression-free survival (adjusted hazard ratio: 2.26, 95% confidence interval: 1.13-4.52, P = 0.021) and overall survival (adjusted hazard ratio: 3.95, 95% confidence interval: 1.38-11.32, P = 0.010), irrespective of previous (neo)adjuvant treatment, age, hormone receptors status, time-to-relapse (≤6 months or within 6-12 months) and presence of visceral/brain metastases. No differences were observed in post-progression survival (P = 0.095). CONCLUSIONS: Our study suggests superiority for P + T + taxane over T-DM1 as up-front treatment of early-relapsing HER2+ metastatic breast cancer, which merits further assessment in larger and prospective trials.

Laparoscopic management of cholecystocolonic fistula: A case report and a brief literature review.

INTRODUCTION: Cholecystoenteric fistula is a rare and late complication of cholelithiasis. The clinical presentation is mostly chronic and is not distinguishable from the dyspeptic symptoms of non-complicated cholelithiasis. For this reason, the preoperative diagnosis is difficult and uncertain, and it is often made up primarily intraoperatively and incidentally during cholecystectomy. In this article, we report a case of cholecystocolonic fistula management by laparoscopic approach. PRESENTATION OF CASE: We studied a 64 years old male patient with fever of an unknown origin for two months and abdominal pain. He underwent a contrast enhanced CT abdominal scan that showed a sclerotic gallbladder with a disorganized fluid collection. The colonoscopy identified a cholecystocolonic fistula with hepatic flexure. A laparoscopic cholecystectomy was performed to repair the colonic wall with intra-corporeal sutures. DISCUSSION: Thanks to the advancements in CT scan's resolution and the application of endoscopic technology such as ERCP or colonscopy, preoperative diagnosis of cholecystoenteric fistula has been greatly improved. In addition, cholecystoenteric fistula has been successfully managed laparoscopically with laparoscopic cholecystectomy and closure of the fistula tract. CONCLUSION: The laparoscopic management of cholecystoeneteric fistula is a feasible and safe procedure but the operative strategy should be individualized on diagnosis, patient characteristics, availability of resources and experience of surgical team.

Double-Microcatheter Technique through Tortuous Anatomy for Coil Embolization of a Saccular $plenic Aneurysm: a Technical Report.

We report on a case of an asymptomatic splenic artery aneurysm (SAA) with a large neck in a 53-year-old female with an extreme vessel tortuosity which was treated with a Double Microcatheter Technique. This endovascular procedure consists of embolization of the aneurysm using detachable coils with no application of any glue, stent or balloon. At the end of procedure, no complications occurred. At the three-month follow-up an MRI showed the aneurysm's complete exclusion and patency of the splenic artery.

Androgen receptor in triple negative breast cancer: A potential target for the targetless subtype.

Triple negative breast cancer (TNBC) represents the 15-20% of all breast cancers (BC) and is characterized by a very aggressive behavior. Recent data suggest that TNBC is not a single disease, but it is rather an umbrella for different ontology-profiles such as basal like 1 and 2, mesenchymal, and the luminal androgen receptor (LAR). The LAR subtype is characterized by the expression of the Androgen Receptor (AR) and its downstream effects. Notwithstanding the role of the AR in several signaling pathways, its impact on a biological and clinical standpoint is still controversial. The LAR subtype has been associated with better prognosis, less chemotherapy responsiveness and lower pathologic complete response after neoadjuvant treatment. Clinical evidence suggests a role for anti-androgen therapies such as bicalutamide, enzalutamide and abiraterone, offering an interesting chemo-free alternative for chemo-unresponsive patients, and therefore potentially shifting current treatment strategies.

Renal endometriosis mimicking complicated cysts of kidney: report of two cases.

Endometriosis is a common gynecologic disorder characterized by ectopic endometrial tissue growth outside the uterine cavity. Although usually occurring in pelvic organs, endometrial lesions may involve urinary tract. Renal endometriosis is extremely rare and it has only occasionally been reported in the past. We report two cases of patients with renal cystic lesions, incidentally found at imaging techniques during oncologic follow-up for gastric sarcoma and melanoma, initially misinterpreted as complicated haemorrhagic cysts and then histologically characterized as renal localizations of extragenital endometriosis.

Caecal leiomyoma detected by whole-body MRI in a patient with Hodgkin lymphoma: first case report.

INTRODUCTION: Hodgkin Lymphoma (HL) is one of the most curable malignant diseases. Modern treatments, like the combined radiochemotherapy and stem cell transplantation, have increased the number of malignant disease survivors. However, HL survivors are at risk of long-term effects, including the development of solid tumors. Secondary neoplasms are a major cause of late morbidity and mortality following treatment for HL. CASE REPORT: We report the case of a male patient, treated for HL by chemotherapy, who developed a large leiomyoma of the cecum one year after the treatment. A whole-body Magnetic Resonance (WBMRI) scan performed during the follow-up allowed the detection of this incidental caecal mass that was absent in a Computed Tomography (CT) scan performed immediately after the treatment. After a CT-guided biopsy, the lesion was surgically removed and the diagnosis of caecal leiomyoma was obtained. DISCUSSION: To our knowledge, this is the first case report, according to the scientific literature, of caecal leiomyoma developing after chemotherapy in a HL survivor. Leiomyoma is a rare benign tumor that usually appears as a solitary small mass with a nodular growth and a benign course. CONCLUSION: This case shows that WB-MRI allows detecting relevant incidental findings during the oncologic follow-up, avoiding both radiation exposure and contrast agent administration. Furthermore, leiomyoma should be considered in the differential diagnosis between the caecal masses with high growth rate.

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.

Body weight and risk of molecular breast cancer subtypes among postmenopausal Mediterranean women.

Breast cancer (BC) is the most common malignant tumor in women, obesity is associated with increased BC incidence and mortality and high levels of circulating insulin may negatively impact on cancer incidence. In the present study, we investigated whether the strength of several anthropometric and metabolic parameters varies between BC molecular subtypes. Eligible cases were 991 non-metastatic BC patients recruited between January 2009 and December 2013. Anthropometric, clinical and immunohistochemical features were measured. Multivariate logistic regression models were built to assess HER2 positive BC risk, comparing (a) triple positive (TP) with luminal A, luminal B and triple negative (TN) and (b) HER2-enriched group with luminal A, luminal B and TN. We stratified patients in pre- and post-menopause: significant differences emerged for luminal A in relation to age: they were more likely to be older compared to other groups. Among postmenopausal patients, the adjusted multivariate analysis showed that high BMI and high waist circumference were inversely correlated to TP subtype when compared to luminal B (OR=0.48 and OR=0.49, respectively). Conversely, HOMA-IR was a risk factor for TP when compared to luminal A and TN (OR=2.47 and OR=3.15, respectively). Our findings suggest a potential role of higher abdominal fat in the development of specific BC molecular subtypes in postmenopausal women. Moreover, they support a potential role of insulin resistance in the development of HER2 positive BC, although this role appears to be stronger when hormone receptors are co-expressed, suggesting a difference in the etiology of these two BC subtypes.

Terminal or truncal ligation of the inferior thyroid artery during thyroidectomy? A prospective randomized trial.

INTRODUCTION: Thyroidectomy is a common procedure in general and endocrine surgery. The technique of ligation of inferior thyroid artery (ITA) has been invoked as a possible cause of appearance of postoperative hypocalcemia. METHODS: We performed a prospective randomized study involving 184 patients undergoing total thyroidectomy to evaluate the differences of truncal ligation versus distal ligation of ITA in terms of postoperative hypocalcemia, vocal fold palsy, voice and swallowing impairment. The patients were divided into group A (trunk ligation of ITA) and group B (terminal branches ligation of ITA). RESULTS: We evaluated postoperative PTH and calcemia (immediate, 6 and 12 months after thyroidectomy), postoperative day of discontinuation of calcium and vitamin D supplementation, voice and swallowing complaints, evaluated by mean of two specific tests available in literature, day of hospital discharge. CONCLUSION: The only significant differences between the two groups were a higher immediate postoperative calcemia and a greater number of patients discharged without calcium and vitamin-D supplementation in the group B. In conclusion, no substantial differences were found between the two groups. The choice depends on the experience of the surgeon.

Large cavernous hemangioma of the adrenal gland: Laparoscopic treatment. Report of a case.

INTRODUCTION: Cavernous hemangioma of the adrenal gland is a rare benign tumor. The diagnosis is often postoperative on histological exam with the presence of blood-filled, dilated vascular spaces. PRESENTATION OF CASE: We report the clinical case of a 49 years-old woman who came to our observation with aspecific abdominal pain. A computed tomography (CT) abdominal scan revealed a 11cm right adrenal mass. This lesion was well circumscribed, round, encapsulated. After iodinated-contrast we observed a progressive, inhomogeneous enhancement without evidence of active bleeding and with pre-operative diagnosis of adrenal hemangioma. Laparoscopic adrenalectomy was performed by a transperitoneal flank approach. Pathological examination revealed a 11cm adrenal mass with extensive central necrotic areas mixed to sinusoidal dilation and fibrotic septa. Postoperative diagnosis was adrenal hemangioma. DISCUSSION: Adrenal hemangiomas occur infrequently. Generally these adrenal masses are non-functioning and there is no specific symptoms. Recent records demonstrate that laparoscopic adrenalectomy is technically safe and feasible for large adrenal tumors, but controversy exists in cases of suspected malignancy. We choose laparoscopic approach to adrenal gland on the basis of preoperative CT abdominal scan that excludes radiological signs of adrenocortical carcinoma (ACC) such as peri-adrenal infiltration and vascular invasion. CONCLUSION: Laparoscopic adrenalectomy is considered the standard treatment in case of diagnosis of benign lesions. In this case report we discussed a large adrenal cavernous hemangioma treated with laparoscopic approach. Fundamental is the study of preoperative endocrine disorders and radiologic findings to exclude signs of malignancy.

Inorganic contaminants from diffuse pollution in shallow groundwater of the Campanian Plain (Southern Italy). Implications for geochemical survey.

The Campanian Plain (CP) shallow aquifer (Southern Italy) represents a natural laboratory to validate geochemical methods for differentiating diffuse anthropogenic pollution from natural water-rock interaction processes. The CP is an appropriate study area because of numerous potential anthropogenic pollution vectors including agriculture, animal husbandry, septic/drainage sewage systems, and industry. In order to evaluate the potential for geochemical methods to differentiate various contamination vectors, 538 groundwater wells from the shallow aquifer in Campanian Plain (CP) were sampled. The dataset includes both major and trace elements. Natural water-rock interactions, which primarily depend on local lithology, control the majority of geochemical parameters, including most of the major and trace elements. Using prospective statistical methods in combination with the traditional geochemical techniques, we determined the chemical variables that are enriched by anthropogenic contamination (i.e. NO3, SO4 and U) by using NO3 as the diagnostic variable for detecting polluted groundwater. Synthetic agricultural fertilizers are responsible for the majority of SO4 and U pollution throughout the CP area. Both SO4 and U are present in the groundmass of synthetic fertilizers; the uranium concentration is specifically applicable as a tracer for non-point source agricultural fertilizer contamination. The recognition of non-geological (anthropogenic) inputs of these elements has to be considered in the geochemical investigations of contaminated aquifers.

Laparoscopic adrenalectomy for large adrenal masses: single team experience.

INTRODUCTION: Laparoscopic adrenalectomy is today considered the standard treatment for benign small adrenal tumors. An open question is the use of laparoscopy for large adrenal masses because of technical limitations and increased risk of malignancy. In this study we report our experience in laparoscopic adrenalectomy for adrenal masses larger than 6 cm. METHODS: Between January 2010 and December 2013 we performed 41 laparoscopic adrenalectomy. Fourteen of 41 patients (34,1%) were submitted to laparoscopic adrenalectomy for lesion >6 cm in size. All patients were submitted routinely to radiological and hormonal tests to indentify tumors characteristics. RESULTS: The patients treated were 9 male and 5 female, the mean age was 55.6 years (range 38-74). The mean tumor size was 8.2 cm (range 6-14 cm) and the lesion were localized on right side in 8 patients and on the left side in 6 patients. The mean operative time was 181 min (range 145-240 min). Mean blood loss was 90 ml. No conversion to open surgery was required. CONCLUSION: Laparoscopic adrenalectomy offers better surgical outcomes than open adrenalectomy. Size criteria are, at the moment, the main subject discussed for the laparoscopic approach to adrenal tumors. In fact, size is an important variable in predicting malignancy. This experience and the results of literature suggest that laparoscopic approach is safe and feasible for adrenal masses larger than 6 cm with a longer operative time. In presence of local invasion or vascular infiltration laparoscopy is contraindicated.

Endoscopic sclerotherapy for hemostasis of acute esophageal variceal bleeding.

INTRODUCTION: Currently the most widely used methods for endoscopic control of esophageal varices bleeding are sclerotherapy and rubber band ligation. Although the superiority of band ligation (BL) over endoscopic sclerotherapy (SCL) for the secondary prophylaxis of variceal hemorrhage has been proven, the best approach for acute bleeding remains controversial. PATIENTS AND METHODS: We performed a retrospective study between January 2005 and May 2013. We selected 104 patients with gastrointestinal hemorrhage from rupture of esophageal varices treated with endoscopic sclerotherapy. The sclerosing agent used was 1% polidocanol in 89 cases, butyl-cyanoacrylate in 8 cases and sodium tetradecylsulfate in 4 cases. In 3 cases had not been carried sclerosis because it was not possible to identify the bleeding site. RESULTS: Among the 101 patients who underwent endoscopic sclerotherapy 4 presented re-bleeding within 12 hours from first treatment. Other 10 patients (9.9%) presented re-bleeding within a 5-days period. The most frequent complication was ulceration, observed in 4 cases (3.8%). There was only one case of perforation treated conservatively. CONCLUSIONS: The general improvement in the results of the treatment of variceal acute bleeding might be attributed to better clinical management of these patients. In literature no consensus exists regarding the preferred endoscopic treatment. To date, there is no single method applicable to all patients with bleeding esophageal varices, but sclerotherapy is considered effective, safe and repeatable in experienced hands.

Modified fixation free plug technique using a new 3D multilamellar implant for inguinal hernia repair: a retrospective study of a single operator case series.

AIM: Implant fixation, mesh shrinkage and poor quality of tissue ingrowth are unresolved issues in modern hernia repair. Many complications reported in the literature such as bleeding, nerve entrapment, hematoma, pain, discomfort, and testicular complications, are considered to be a direct results of implant fixation. This article describes the outcomes of a procedure carried out using a handcrafted implant that addresses the issues consequent to point fixation. METHODS: This was a retrospective study on the short, medium and long-term results of placing a-modified, fixation free three-dimensional polypropylene implant in 61 patients who underwent inguinal hernia repair using a novel delivery technique. The follow up length was at least 36 months postop. RESULTS: Only minor adverse events and a low complication rate of the procedure were observed in this patient sample. There were no long- term complications. Postoperative pain was very low in both the short and long term. No chronic pain was reported. No recurrences occurred. CONCLUSION: The results of this retrospective study on a new method of inguinal hernia repair using a three dimensional handcrafted multilamellar implant delivered with a modified placement technique are promising. The short-, medium- and long-term complications were notably low. No recurrences were noticed but, more importantly, no chronic pain and extremely low discomfort rates were observed even in the long term.

Laparoscopic drainage of liver abscess: case report and literature review.

AIM: To evaluate the safety and efficacy of the minimally invasive surgical approach (laparoscopic drainage) of liver abscesses in selected cases. CASE REPORT: Male, 58 years old, from a rural area, presented with epigastric abdominal pain, fever, weight loss, loss of appetite, a palpable mass in the epigastrium and neutrophilic leukocytosis. CT revealed a complex multiloculated liver abscess in segments 2-3. Systemic antibiotic therapy alone was ineffective; percutaneous drainage was excluded due to the characteristics of the lesion. RESULT: Given the complexity of the lesion, a laparoscopic approach was chosen involving complete drainage of the abscess, debridement and irrigation; the cavity was unroofed using electrocautery and samples were obtained for bacterial culture and drug testing. Two drains were left in the cavity for seven days. No complications were observed. DISCUSSION: In accordance with the scientific literature, after thorough imaging we performed laparoscopic drainage of a large, complex liver abscess as a safe, effective alternative to open surgery when antibiotic therapy alone failed and percutaneous drainage was uncertain. CONCLUSION: Not all liver abscesses can be treated with antibiotic therapy or percutaneous drainage. Laparoscopic drainage in association with systemic antibiotic therapy is a safe and effective minimally invasive approach that should be considered in selected patients.

Laparoscopic, three-port and SILS cholecystectomy: a retrospective study.

INTRODUCTION: The aim of this study was to compare the results of classic laparoscopic, three-port and SILS cholecystectomy. MATERIALS AND METHODS: We conducted a retrospective study of data collected between January 2010 and December 2012 pertaining to 159 selected patients with symptomatic gallstones. 57 underwent laparoscopic cholecystectomy, 51 three-port cholecystectomy and 48 SILS cholecystectomy. We then compared the groups with respect to mean operating time, intraoperative complications, postoperative pain, duration of hospitalization and final aesthetic result. RESULTS: The mean operating time was significantly higher in the SILS cholecystectomy group (93 minutes) than in the other two groups. There were no intraoperative complications. There were no significant differences in the duration of hospitalization among the three groups. Patients in the SILS cholecystectomy group reported significantly less pain 3, 6 and 12 hours after surgery. The aesthetic results at 1 and 6 months' follow-up were also decidedly better. CONCLUSIONS: On the basis of this study, SILS cholecystectomy is a feasible, safe procedure. In any case, it should be used in selected patients only and carried out by a dedicated team with strong experience in laparoscopy. The main advantages of this technique are a reduction in post-operative pain and improved aesthetic result, at the price, however, of its greater technical difficulty and longer operating times. Future studies are in any case necessary to evaluate any other benefits of this method.

Laparoscopic approach in abdominal emergencies: a 5-year experience at a single center.

BACKGROUND: Laparoscopy is ever more common in both elective and emergency surgery. In fact, in abdominal emergencies it enables the resolution of preoperative diagnostic doubts as well as treatment of the underlying disease. We present a retrospective study of the results of a 5-year experience at a single center. PATIENTS AND METHODS: Between September 2006 and August 2011, 961 patients were treated via laparoscopy, including 486 emergency cases (15 gastroduodenal perforation; 165 acute cholecystitis; 255 acute appendicitis; 15 pelvic inflammatory disease and non-specific abdominal pain [NSAP]; 36 small bowel obstruction). All procedures were conducted by a team trained in laparoscopic surgery. RESULTS: The conversion rate was 22/486 patients (4.53%). A definitive laparoscopic diagnosis was possible in over 96% of cases, and definitive treatment via laparoscopy was possible in most of these. CONCLUSIONS: Our own experience confirms the literature evidence that laparoscopy is a valid option in the surgical treatment of abdominal emergencies. In any case, it must be performed by a dedicated and highly experienced team. Correct patient selection is also important, to enable the most suitable approach for each given situation.