Open versus laparoscopic gastrectomy for advanced gastric cancer: a propensity score matching analysis of survival in a western population-on behalf of the Italian Research Group for Gastric Cancer.

BACKGROUND: Oncologic outcomes after laparoscopic gastrectomy for advanced gastric cancer in the West have been poorly investigated. The aim of the present study was to compare survival outcomes in patients undergoing curative-intent laparoscopic and open gastrectomy for advanced gastric cancer in several centres belonging to the Italian Research Group for Gastric Cancer. METHODS: Data of patients operated between 2015 and 2018 were retrospectively analysed. Propensity Score Matching was performed to balance baseline characteristics of patients undergoing laparoscopic and open gastrectomy. The primary endpoint was 3-year overall survival. Secondary endpoints were 3-year disease-free survival and short-term outcomes. Multivariable regression analyses for survival were conducted. RESULTS: Data were retrieved from 20 centres. Of the 717 patients included, 438 patients were correctly matched, 219 per group. The 3-year overall survival was 73.6% and 68.7% in the laparoscopic and open group, respectively (p = 0.40). When compared with open gastrectomy, laparoscopic gastrectomy showed comparable 3-year disease-free survival (62.8%, vs 58.9%, p = 0.40), higher rate of return to intended oncologic treatment (56.9% vs 40.2%, p = 0.001), similar 30-day morbidity/mortality. Prognostic factors for survival were ASA Score ≥ 3, age-adjusted Charlson Comorbidity Index ≥ 5, lymph node ratio ≥ 0.15, p/ypTNM Stage III and return to intended oncologic treatment. CONCLUSIONS: Laparoscopic gastrectomy for advanced gastric cancer offers similar rates of survival when compared to open gastrectomy, with higher rates of return to intended oncologic treatment. ASA score, age-adjusted Charlson Comorbidity Index, lymph node ratio, return to intended oncologic treatment and p/ypTNM Stage, but not surgical approach, are prognostic factors for survival.

Core outcome set for surgical trials in gastric cancer (GASTROS study): international patient and healthcare professional consensus.

BACKGROUND: Surgery is the primary treatment that can offer potential cure for gastric cancer, but is associated with significant risks. Identifying optimal surgical approaches should be based on comparing outcomes from well designed trials. Currently, trials report different outcomes, making synthesis of evidence difficult. To address this, the aim of this study was to develop a core outcome set (COS)-a standardized group of outcomes important to key international stakeholders-that should be reported by future trials in this field. METHODS: Stage 1 of the study involved identifying potentially important outcomes from previous trials and a series of patient interviews. Stage 2 involved patients and healthcare professionals prioritizing outcomes using a multilanguage international Delphi survey that informed an international consensus meeting at which the COS was finalized. RESULTS: Some 498 outcomes were identified from previously reported trials and patient interviews, and rationalized into 56 items presented in the Delphi survey. A total of 952 patients, surgeons, and nurses enrolled in round 1 of the survey, and 662 (70 per cent) completed round 2. Following the consensus meeting, eight outcomes were included in the COS: disease-free survival, disease-specific survival, surgery-related death, recurrence, completeness of tumour removal, overall quality of life, nutritional effects, and 'serious' adverse events. CONCLUSION: A COS for surgical trials in gastric cancer has been developed with international patients and healthcare professionals. This is a minimum set of outcomes that is recommended to be used in all future trials in this field to improve trial design and synthesis of evidence.

Utility of Abdominal Drain in Gastrectomy (ADiGe) Trial: study protocol for a multicenter non-inferiority randomized trial.

BACKGROUND: Prophylactic use of abdominal drain in gastrectomy has been questioned in the last 15 years, and a 2015 Cochrane meta-analysis on four RCTs concluded that there was no convincing evidence to the routine drain placement in gastrectomy. Nevertheless, the authors evidenced the moderate/low quality of the included studies and highlighted how 3 out of 4 came from Eastern countries. After 2015, only retrospective studies have been published, all with inconsistent results. METHODS: ADiGe (Abdominal Drain in Gastrectomy) Trial is a multicenter prospective randomized non-inferiority trial with a parallel design. It aimed to verify whether avoiding routine use of abdominal drain is burdened with complications, particularly an increase in postoperative invasive procedures. Patients with gastric cancer, scheduled for subtotal or total gastrectomy with curative intent, are eligible for inclusion, irrespective of previous oncological treatment. The primary composite endpoint is reoperation or percutaneous drainage procedures within 30 postoperative days. The primary analysis will verify whether the incidence of the primary composite endpoint is higher in the experimental arm, avoiding routine drain placement, than control arm, undergoing prophylactic drain placement, in order to falsify or support the null hypothesis of inferiority. Secondary endpoints assessed for superiority are overall morbidity and mortality, Comprehensive Complications Index, incidence and time for diagnosis of anastomotic and duodenal leaks, length of hospital stay, and readmission rate. Assuming one-sided alpha of 5%, and cumulative incidence of the primary composite endpoint of 6.4% in the control arm and 4.2% in the experimental one, 364 patients allow to achieve 80% power to detect a non-inferiority margin difference between the arm proportions of 3.6%. Considering a 10% drop-out rate, 404 patients are needed. In order to have a balanced percentage between total and subtotal gastrectomy, recruitment will end at 202 patients for each type of gastrectomy. The surgeon and the patient are blinded until the end of the operation, while postoperative course is not blinded to the patient and caregivers. DISCUSSION: ADiGe Trial could contribute to critically re-evaluate the role of prophylactic drain in gastrectomy, a still widely used procedure. TRIAL REGISTRATION: Prospectively registered (last updated on 29 October 2020) at ClinicalTrials.gov with the identifier NCT04227951 .

Sexual function after vaginal erbium laser: the results of a large, multicentric, prospective study.

The aim of this multicentric, prospective study was to evaluate the effects of vaginal erbium laser (VEL-SMOOTH®) on sexual function in postmenopausal women suffering from the genitourinary syndrome of menopause (GSM). This study was performed on an outpatient basis without anesthesia or drug use before or after the intervention, using an erbium laser (XS Fotona Smooth®, Fotona, Ljubljana, Slovenia) in 1081 postmenopausal women (age 54.3 ± 3.9 years) treated with up to three laser applications every 30 days. Patients were assessed using the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale-Revised (FSDS-R). No adverse events were recorded during the study. The FSDS-R scores (n = 554), from basal values of 25.5 ± 3.5, were 11.5 ± 3.0, 10.5 ± 3.5 and 11.5 ± 3.5 at the 4-, 12- and 24-week follow-ups, respectively (p < 0.01 vs. corresponding basal values). Individual FSFI domain scores (n = 569) significantly (p < 0.001) increased after VEL-SMOOTH® treatment and remained significantly higher up to the 24th week after the end of treatment. The total scores, from basal values of 15.5 ± 1.5, were 27.5 ± 2.5, 27.6 ± 2.7and 27.0 ± 3.5 at the 4-, 12- and 24-week follow-ups, respectively (p < 0.01 vs. corresponding basal values). Albeit not randomized, this large, prospective study shows that VEL-SMOOTH® treatment may improve sexual function in postmenopausal women suffering from GSM.

Could fluorescence-guided surgery be an efficient and sustainable option? A SICE (Italian Society of Endoscopic Surgery) health technology assessment summary.

BACKGROUND: Indocyanine green fluorescence vision is an upcoming technology in surgery. It can be used in three ways: angiographic and biliary tree visualization and lymphatic spreading studies. The present paper shows the most outstanding results from an health technology assessment study design, conducted on fluorescence-guided compared with standard vision surgery. METHODS: A health technology assessment approach was implemented to investigate the economic, social, ethical, and organizational implications related to the adoption of the innovative fluorescence-guided view, with a focus on minimally invasive approach. With the support of a multidisciplinary team, qualitative and quantitative data were collected, by means of literature evidence, validated questionnaires and self-reported interviews, considering the dimensions resulting from the EUnetHTA Core Model. RESULTS: From a systematic search of literature, we retrieved the following studies: 6 on hepatic, 1 on pancreatic, 4 on biliary, 2 on bariatric, 4 on endocrine, 2 on thoracic, 11 on colorectal, 7 on urology, 11 on gynecology, 2 on gastric surgery. Fluorescence guide has shown advantages on the length of hospitalization particularly in colorectal surgery, with a reduction of the rate of leakages and re-do anastomoses, in spite of a slight increase in operating time, and is confirmed to be a safe, efficacious, and sustainable vision technology. Clinical applications are still presenting a low evidence in the literature. CONCLUSION: The present paper, under the patronage of Italian Society of Endoscopic Surgery, based on an HTA approach, sustains the use of fluorescence-guided vision in minimally invasive surgery, in the fields of general, gynecologic, urologic, and thoracic surgery, as an efficient and economically sustainable technology.

Early diagnosis of anastomotic leakage after colorectal surgery by the Dutch leakage score, serum procalcitonin and serum C-reactive protein: study protocol of a prospective multicentre observational study by the Italian ColoRectal Anastomotic Leakage (iC.

BACKGROUND: Anastomotic leakage (AL) is a dreaded major complication after colorectal surgery. There is no uniform definition of anastomotic dehiscence and leak. Over the years many risk factors have been identified (distance of anastomosis from anal verge, gender, BMI, ASA score) but none of these allows an early diagnosis of AL. The DUtch LeaKage (DULK) score, C reactive protein (CRP) and procalcitonin (PCT) have been identified as early predictors for anastomotic leakage starting from postoperative day (POD) 2-3. The study was designed to prospectively evaluate AL rates after colorectal resections, in order to give a definite answer to the need for clear risk factors, and testing the diagnostic yeld of DULK score and of laboratory markers. Methods and analysis. A prospective enrollment for all patients undergoing elective colorectal surgery with anastomosis carried out from September 2017 to September 2018 in 19 Italian surgical centers. OUTCOME MEASURES: preoperative risk factors of anastomotic leakage; operative parameters; leukocyte count, serum CRP, serum PCT and DULK score assessment on POD 2 and 3. Primary endpoint is AL; secondary endpoints are minor and major complications according to Clavien-Dindo classification; morbidity and mortality rates; readmission and reoperation rates, length of postoperative hospital stay (Retrospectively registered at ClinicalTrials.gov Identifier: NCT03560180, on June 18, 2018). Ethics. The ethics committee of the "Comitato Etico Regionale delle Marche - C.E.R.M." reviewed and approved this study protocol on September 7, 2017 (protocol no. 2017-0244-AS). All the participating centers submitted the protocol and obtained authorization from the local Institutional Review Board.

Surgery in ovarian cancer - Brazilian Society of Surgical Oncology consensus.

Surgical management in epithelial ovarian cancer (EOC) has a significant impact in overall survival and progression-free survival. The Brazilian Society of Surgical Oncology (BSSO) supported a taskforce of experts to reach a consensus: experienced and specialised trained surgeons, in cancer centres, provide the best EOC surgery. Laparoscopic and/or radiological staging prognosticates the possibility of complete cytoreduction (CC0) and helps to reduce unnecessary laparotomies. Surgical techniques were reviewed. Multidisciplinary input is essential for treatment planning. Quality assurance criteria are proposed and require national consensus. Genetic testing is mandatory. This consensus states the final recommendations from BSSO for management of EOC. TWEETABLE ABSTRACT: Brazilian Society of Surgical Oncology consensus for surgery in epithelial ovarian cancer patients.

Preoperative biliary drainage in hilar cholangiocarcinoma: Systematic review and meta-analysis.

BACKGROUND: The role of preoperative biliary drainage (PBD) for hilar cholangiocarcinoma (HCC) remains unclear. The aim of this meta-analysis is to investigate the role of PBD in the treatment of potentially resectable HCC. METHODS: All studies reporting outcomes on patients with PBD vs without PBD were included. A systematic literature search was performed in PubMed, Embase, and the Cochrane Library for studies published between 1980 and 2016. RESULTS: Initial search identified 667 articles. Only 9 studies met the inclusion criteria and were included in this analysis. No significant differences in mortality were observed between the two groups (RR = 0,935; 95% CI = 0,612 to 1429; p = 0,463). Overall morbidity was significantly higher in PBD group (RR = 1266; 95% CI = 1039 to 1543; p = 0,011). No significant differences in transfusion rate, hospital stay, anastomotic leaks, abdominal collections and operative time, were found. Wound infections were significantly higher in PBD group. CONCLUSIONS: PBD seems to be associated with higher postoperative morbidity and increases the risk of wound infections. Further prospective studies are needed to better define the impact of PBD in outcomes after surgery for hilar cholangiocarcinoma.

Evidence-based algorithm for diagnosis and assessment in psoriatic arthritis: results by Italian DElphi in psoriatic Arthritis (IDEA).

Psoriatic arthritis (PsA) is a chronic inflammatory disease involving skin, peripheral joints, entheses, and axial skeleton. The disease is frequently associated with extrarticular manifestations (EAMs) and comorbidities. In order to create a protocol for PsA diagnosis and global assessment of patients with an algorithm based on anamnestic, clinical, laboratory and imaging procedures, we established a DElphi study on a national scale, named Italian DElphi in psoriatic Arthritis (IDEA). After a literature search, a Delphi poll, involving 52 rheumatologists, was performed. On the basis of the literature search, 202 potential items were identified. The steering committee planned at least two Delphi rounds. In the first Delphi round, the experts judged each of the 202 items using a score ranging from 1 to 9 based on its increasing clinical relevance. The questions posed to experts were How relevant is this procedure/observation/sign/symptom for assessment of a psoriatic arthritis patient? Proposals of additional items, not included in the questionnaire, were also encouraged. The results of the poll were discussed by the Steering Committee, which evaluated the necessity for removing selected procedures or adding additional ones, according to criteria of clinical appropriateness and sustainability. A total of 43 recommended diagnosis and assessment procedures, recognized as items, were derived by combination of the Delphi survey and two National Expert Meetings, and grouped in different areas. Favourable opinion was reached in 100% of cases for several aspects covering the following areas: medical (familial and personal) history, physical evaluation, imaging tool, second level laboratory tests, disease activity measurement and extrarticular manifestations. After performing PsA diagnosis, identification of specific disease activity scores and clinimetric approaches were suggested for assessing the different clinical subsets. Further, results showed the need for investigation on the presence of several EAMs and risk factors. In the context of any area, a rank was assigned for each item by Expert Committee members, in order to create the logical sequence of the algorithm. The final list of recommended diagnosis and assessment procedures, by the Delphi survey and the two National Expert Meetings, was also reported as an algorithm. This study shows results obtained by the combination of a DElphi survey of a group of Italian rheumatologists and two National Expert Meetings, created with the aim of establishing a clinical procedure and algorithm for the diagnosis and the assessment of PsA patients. In order to find accurate and practical diagnostic and assessment items in clinical practice, we have focused our attention on evaluating the different PsA domains. Hence, we conceived the IDEA algorithm in order to address PsA diagnosis and assessment in the context of daily clinical practice. The IDEA algorithm might eventually lead to a multidimensional approach and could represent a useful and practical tool for addressing diagnosis and for assessing the disease appropriately. However, the elaborated algorithm needs to be further investigated in daily practice, for evidencing and proving its eventual efficacy in detecting and staging PsA and its heterogeneous spectrum appropriately.

Extended lymphadenectomy in elderly and/or highly co-morbid gastric cancer patients: A retrospective multicenter study.

BACKGROUND: Gastrectomy with extended lymphadenectomy is considered the gold standard treatment for advanced gastric cancer, with no age- or comorbidity-related limitations. We evaluated the safety and efficacy of curative gastrectomy with extended nodal dissection, verifying survival in elderly and highly co-morbid patients. METHODS: In a retrospective multicenter study, we examined 1322 non-metastatic gastric-cancer patients that underwent curative gastrectomy with D2 versus D1 lymphadenectomy from January 2000 to December 2009. Postoperative complications, overall survival (OS), and disease-specific survival (DSS) according to age and the Charlson Comorbidity Score were analyzed in relation to the extent of lymphadenectomy. RESULTS: Postoperative morbidity was 30.4%. Complications were more frequent in highly co-morbid elderly patients, and, although general morbidity rates after D2 and D1 lymphadenectomy were similar (29.9% and 33.2%, respectively), they increased following D2 in highly co-morbid elderly patients (39.6%). D2-lymphadenectomy significantly improved 5-year OS and DSS (48.0% vs. 37.6% in D1, p < 0.001 and 72.6% vs. 58.1% in D1, p < 0.001, respectively) in all patients. In elderly patients, this benefit was present only in 5-year DSS. D2 nodal dissection induced better 5-year OS and DSS rates in elderly patients with positive nodes (29.7% vs. 21.2% in D1, p = 0.008 and 47.5% vs. 30.6% in D1, p = 0.001, respectively), although it was present only in DSS when highly co-morbid elderly patients were considered. CONCLUSION: Extended lymphadenectomy confirmed better survival rates in gastric cancer patients. Due to high postoperative complication rate and no significant improvement of the OS, D1 lymphadenectomy should be considered in elderly and/or highly co-morbid gastric cancer patients.

Factors influencing survival after hepatectomy for metastases from gastric cancer.

PURPOSE: To investigate clinical factors influencing the prognosis of patients submitted to hepatectomy for metastases from gastric cancer and their clinical role. METHODS: Retrospective multi-center chart review. We evaluated how survival from surgery was influenced by patient-related, gastric cancer-related, metastasis-related and treatment-related candidate prognostic factors. RESULTS: One hundred and five patients submitted to hepatectomy for metastases from gastric cancer, in the synchronous and metachronous setting of the disease. In 89 cases a R0 resection was achieved, while in 16 a R+ hepatic resection was performed. Adjuvant chemotherapy was administered to 29 patients. Surgical mortality was 1% and morbidity 13.3%. Median disease-free survival was 10 months, median overall survival was 14.6 months. Overall 1, 3, and 5-year survival rates were 58.2%, 20.3%, and 13.1%, respectively. Survival was influenced independently by the factor T of the gastric primary (p < 0.001), by the curativity of surgical procedure (p = 0.001), by the timing of hepatic involvement (p < 0.001) and by adjuvant chemotherapy (p < 0.001). T4 gastric cancer, R+ resection, synchronous metastases, and abstention from adjuvant chemotherapy were associated with a worse prognosis; T4 gastric cancer and R+ resections displayed a cumulative effect (p < 0.001). CONCLUSIONS: Our data show that R0 resection must be pursued whenever possible. Furthermore, in the synchronous setting, the coexistence of T4 gastric primaries and R+ resections suggests prudence and probably abstention from hepatectomy. Finally, a multimodal treatment associating surgery and chemotherapy offers the best survival results.

Antibiotics alone for uncomplicated acute appendicitis in high operative risk adult patients: Analytical review of RCTs and proposal of evidence based treatment decision.

BACKGROUND: Clinical trials have so far shown controversial results as regards the standard of care for treating uncomplicated acute appendicitis (uC-AA). High operational risk adult patients (HORAP) could represent selected patients where primary antibiotic conservative therapy (pACT or A) could be indicated. METHODS: We carried a comprehensive search of the PubMed searching engine in the English language scientific literature from 1995 to 2015, using medical subject headings "antibiotics", "uncomplicated appendicitis", "appendicectomy", "conservative treatment", "surgery" and "randomized clinical trial". All RCTs comparing the outcomes of pACT versus primary surgical open or laparoscopic appendectomy (pSOLA or S) as primary treatment options for uC-AA were identified. Inclusion criteria for our analytical review were RCTs evaluating outcomes in terms of or related to all of the following four parameters: treatment efficacy, post therapeutic/operative complications, in hospital length of stay (LOS) and recurrence. RESULTS: The conclusion of all five RCTs considered antibiotics alone in the treatment of AA as an efficient and non inferior therapeutic option respect to surgery. Primary ACT was characterised by a higher LOS, a higher rate of recurrence and a lower rate of postoperative complication than pSOLA. CONCLUSIONS: Based on the current body of evidence, an appropriate pACT could be a rational tailored primary treatment option for CT proven uC-AA in HORAP. Accurate diagnoses and surgical risk stratification in patients with uC-AA could aid decision making for target therapy. However, results of large sample prospective multicenter RCTs are required to routinely recommend pACT for uC-AA in the clinical practice.

How important is the pathological margin distance in vulvar cancer?

PURPOSE: The ideal pathological margin in vulvar squamous cell carcinoma (VSCC) is still debated. Our aim was to analyze the value of tumor-free pathological margin distance with regard to local recurrence in VSCC. METHODS: We analyzed a series of 205 patients who were treated for VSCC from January 1980 to November 2007. Patients were categorized into 3 groups, based on pathological free margin (PFM): <3 mm (n = 18); ≥3 and <8 mm (n = 61); and ≥8 mm (n = 126). RESULTS: The median age was 69 years. The median PFM was 10 mm (range: 1-65). Of 168 patients who underwent lymphadenectomy, 64 (38.1%) developed LN metastasis. After a median follow-up of 36.2 months, 78 (38%) cases recurred-47 (60.2%) experienced a local recurrence (LR). LR occurred in 16.7% of patients with a PFM of <3 mm, 24.6% with a PFM ≥3 and <8 mm, and 22.2% of those with a PFM ≥8 mm (p = 0.77). PFM did not correlate with LR when analyzed continuously (p = 0.98). The 5-year disease-free survival (DFS) for LR was 79.6%. Margin distance did not negatively impact DFS (p = 0.94); the presence of perineural invasion was the only variable that negatively influenced DFS (p = 0.009). CONCLUSIONS: Although our results suggest no correlation between LR and pathological margin distance, the tumor-free resection margin remains significant with regard to locoregional control in vulvar cancer. A more conservative surgical approach may be considered in certain situations, such as margins near the clitoris, urethra, and anus.

Can FDG-PET/CT predict early response to neoadjuvant chemotherapy in breast cancer?

PURPOSE: Neoadjuvant chemotherapy (NAC) in breast cancer is currently used not only for locally advanced tumors, but also for large operable tumors when breast preservation is considered. It also provides the opportunity to evaluate chemotherapy tumor response. Our aim was to correlate the relative change in the standardized uptake value (SUV) of (18)F-2-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET/CT) with pathologic response after NAC. METHODS: We prospectively evaluated 40 patients with invasive ductal breast carcinomas from February 2010 to December 2011. FDG-PET/CT was performed at baseline and after the second cycle of NAC. All patients underwent surgery after NAC. Pathologic response was evaluated according to Residual Cancer Burden (RCB) index. RESULTS: The mean age was 41.9 years. Median primary tumor size was 6 cm. Pathologic complete response (pCR) was obtained in 12 (30%) patients. The tumor baseline mean maximum SUV (SUV(max)), and after second cycle were: 8.97 (sd.4.3) and 4.07 (sd.3.2), respectively. The relative change (ΔSUV) after the second course of NAC was significantly higher for patients with pCR (-81.58%) when compared to the non-pCR patients (-40.18%) (p = 0.001). The optimal ΔSUV threshold that discriminates between pCR and non-pCR was -71.8% (83.3% sensitivity; 78.5% specificity). Moreover, the optimal ΔSUV threshold to discriminate between NAC responders and non-responders was -59.1% (68% sensitivity; 75.0% specificity). CONCLUSIONS: Our data suggest that the FDG-PET/CT ΔSUV after the second course of NAC can predict pathological response in ductal breast carcinomas, and potentially identify a subgroup of non-responding patients for whom ineffective chemotherapy should be avoided. SYNOPSIS: Breast cancer is the most frequently diagnosed cancer in women. The indications for neoadjuvant chemotherapy are increasing. Early information on chemotherapy response is crucial and methods that predict the therapeutic effectiveness might avoid potentially ineffective chemotherapies in non-responding patients.

Epithelial-mesenchymal transition-like events in vulvar cancer and its relation with HPV.

BACKGROUND: Epithelial-to-mesenchymal transition (EMT) still remains an obscure event in vulvar squamous cell carcinoma (VSCC). METHODS: Immunohistochemistry (IHC) expression of E-cadherin, ß-catenin, Snail, Slug, Twist and Vimentin was analysed in 87 VSCC, controlled for human papillomavirus (HPV) positivity, considering tumour front and central tumour as different morphological categories from the same tumour. RESULTS: Lower ß-catenin and higher Vimentin expression was associated with invasive front when compared with the central tumour (P=0.013 and P≤0.001, respectively). Higher expression of E-cadherin in central tumour was significantly related to absence of vascular and perineural invasion, lower invasion depth and ≥2 lymph node involvement. Loss of ß-catenin and high Slug, Snail and Twist expression was associated with HPV-negative tumours. Moreover, ß-catenin lower expression associated with gain in Slug expression predicts a subgroup with worst outcome (P=0.001). Lower expression of ß-catenin in both central tumour and invasive front correlated with lower overall survival (P=0.021 and P=0.011, respectively). Also, multivariate analysis showed that lower ß-catenin expression was independently associated with poorer outcome (P=0.044). CONCLUSION: Human papillomavirus-related tumours show better prognosis and outcome; besides, they do not progress through EMT phenomenon. Immunohistochemical analysis of ß-catenin in invasive tumour front is a key issue for establishing prognosis of vulva cancer.

Prognostic value of the number and laterality of metastatic inguinal lymph nodes in vulvar cancer: revisiting the FIGO staging system.

OBJECTIVE: Inguinal lymph node (LN) metastasis is an important prognostic factor in vulvar cancer. Our aims were to analyze the prognostic value of LN metastasis with regard to the number of LNs that were involved and their laterality and compare these results with the current FIGO staging system. METHODS: A retrospective analysis was performed in a series of 234 individuals who underwent inguinal lymphadenectomy for vulvar squamous cell carcinoma from January 1980 to February 2010. RESULTS: The mean age was 68 years. One hundred seven (45.7%) patients had LN metastasis. Despite the FIGO staging, we did not observe any significant difference in the risk of recurrence or death between patients with 1 positive LN and ≥ 2 positive LNs. Moreover, there was no difference in outcome between the presence of 1 and 2 positive LNs. On categorizing patients into 3 groups-absence of LN involvement, 1-2 positive LNs, and ≥ 3 positive LNs-we achieved a significantly better prognostic correlation for progression-free survival, disease-specific survival, and overall survival. Extracapsular spread retained a prognostic role for the risk of recurrence in multivariate analysis. Further, for patients with ≥ 2 positive LNs, the presence of bilateral positive LNs did not negatively impact the risk of recurrence or death compared with those with unilateral positive LNs. CONCLUSIONS: Our data suggest that the prognostic effect of bilateral LNs reflects the worse prognosis of multiple positive LNs. Regarding prognosis, LN involvement should be categorized into 2 groups-1-2 positive LNs and ≥ 3 positive LNs.

Does the count after inguinofemoral lymphadenectomy in vulvar cancer correlate with outcome?

BACKGROUND: Inguinal lymph node (LN) metastasis is an important prognostic factor in vulvar cancer. Our aim was to determine the prognostic value of the number of resected LNs in inguinofemoral lymphadenectomy. METHODS: A retrospective analysis was performed in a series of 158 individuals who underwent bilateral inguinofemoral lymphadenectomy for vulvar squamous cell carcinoma from January 1980 to February 2010. RESULTS: The mean age was 67 years (range: 15-90). Median tumor size was 5 cm (range: 1-18). A median of 22.5 inguinal LNs (range: 2-57) was resected. Thirteen (8.2%) patients had <12 LNs resected, and 145 (91.8%) had ≥ 12 LNs resected. Eighty (50.6%) patients had LN metastasis, with a median of 2 positive LNs (range: 1-16). Of those with positive LNs, 19 (23.8%), 23 (28.8%), and 38 (47.5%) patients had 1, 2, and 3 or more positive LNs, respectively. Thirty-three (41.2%) patients had bilateral LN metastasis. For patients without LN involvement, we failed to observe any significant difference between patients with <12 LNs and ≥ 12 LNs that were resected with regard to risk of recurrence (p=0.97) and death from cancer (p=0.43) in 5 years. However, resection of <12 LNs in patients with positive LNs negatively impacted the risk of recurrence (p=0.003) and death from cancer (p=0.043). CONCLUSIONS: Resection of fewer than 12 LNs in vulvar cancer has a negative impact on outcome for patients with positive inguinal LNs.

Prognostic factors in pelvic exenteration for gynecological malignancies.

OBJECTIVES: Analyze morbidity, mortality and prognostic factors after pelvic exenteration (PE) for gynecological malignancies. METHODS: We reviewed a series of 107 individuals who underwent PE at A.C. Camargo Cancer Hospital from August 1982 to September 2010. RESULTS: Median age was 56.4 years. Primary tumor sites were uterine cervix in 73 cases (68.2%); vaginal, 10 (9.3%); endometrial, 14 (13.1%); vulvar, 7 (6.5%); and uterine sarcomas, 3 (2.8%). Median tumor size was 5.5 cm. Total PE was performed in 56 cases (52.3%), anterior in 31 (29.9%), posterior in 10 (9.3%) and lateral extended in 10. Median operation time, blood transfusion and hospital stay length were 420 min (range: 180-780), 900 ml (range: 300-4500) and 13 days (range: 4-79), respectively. There was no intra-operative death. Fifty-seven (53.3%) and 48 (44.8%) patients had early and late complications, respectively. Five-year progression free survival (PFS), overall survival (OS) and cancer specific survival (CSS) were 35.8%, 27.4% and 41.1%, respectively. Endometrial cancer had better 5-year OS (64.3%) than cervical cancer (23.1%). Lymph node metastasis negatively impacted PFS, CSS and OS. Presence of perineural invasion negatively impacted PFS and CSS. No variable retained the risk of recurrence or death in the multivariate analysis. CONCLUSIONS: PE has acceptable morbidity and mortality and may be the only method that can offer long-term survival in highly selected patients.