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In a retrospective analysis, 21 acute myeloid leukemia patients receiving single-agent sorafenib maintenance therapy in complete remission (CR) after hematopoietic stem cell transplantation (HSCT) were compared with a control group of 22 patients without maintenance. Sorafenib was initiated a median of 3 months (IQR: 2.3–3.5) after allogeneic HSCT with a median daily dosage of 400 mg (range: 200–800) orally, and lasted a median of 11.3 months (IQR: 3.3–24.4). No significant increase in graft versus host disease or toxicity was observed. Adverse events were reversible with dose adjustment or temporary discontinuation in 19/19 cases. With a median follow-up of 34.7 months (IQR: 16.9–79.5), sorafenib maintenance significantly improved cumulative incidence of relapse (p = 0.028) as well as overall survival (OS) (p = 0.016), especially in patients undergoing allogeneic HSCT in CR1 (p

Purpose: To explore the role of artificial intelligence and machine learning (ML) techniques in oncological urology. In recent years, our group investigated the prostate cancer gene 3 (PCA3) score, prostate-specific antigen (PSA), and free-PSA predictive role for prostate cancer (PCa), using the classical binary logistic regression (LR) modeling. In this research, we approached the same clinical problem by several different ML algorithms, to evaluate their performances and feasibility in a real-world evidence PCa detection trial.Materials and Methods: The occurrence of a positive biopsy has been studied in a large cohort of 1,246 Italian men undergoing first or repeat biopsy. Seven supervised ML algorithms were selected to build biomarkers-based predictive models: generalized linear model, gradient boosting machine, eXtreme gradient boosting machine (XGBoost), distributed random forest/ extremely randomized forest, multilayer artificial Deep Neural Network, naïve Bayes classifier, and an automatic ML ensemble function.Results: All the ML models showed better performances in terms of area under curve (AUC) and accuracy, when compared to LR model. Among them, an XGBoost model tuned by the autoML function reached the best metrics (AUC, 0.830), well overtaking LR results (AUC, 0.738). In the variable importance ranking coming from this XGBoost model (accuracy, 0.824), the PCA3 score importance was 3-fold and 4-fold larger, when compared to that of free-PSA and PSA, respectively.Conclusions: The ML approach proved to be feasible and able to achieve good predictive performances with reproducible results: it may thus be recommended, when applied to PCa prediction based on biomarkers fluctuations.

Graft-versus-host disease (GVHD) is one of the most important complications of allogeneic hematopoietic stem cell transplantation. Rabbit antilymphocyte serum (ATG/ATLG) is recommended for GVHD prophylaxis, while its appropriate dosing is debated. We performed a retrospective single-center study to examine the outcome of patients receiving ATG at the dose of 5 mg/kg as GVHD prophylaxis for unrelated donor (URD) HSCT. We collected data from all consecutive adult patients with hematological malignancies who had undergone allogeneic HSCT from URDs at the Stem Cell Transplant Center of the Città della Salute e della Scienza Hospital of Torino between July 2008 and July 2021. The primary aim was to ascertain the cumulative incidence (CI) for acute GVHD (aGVHD) and chronic GVHD (cGVHD); the secondary aim was to ascertain the CI for NRM (Non-Relapse Mortality) and RI (Relapse Incidence), as well the overall survival (OS) and infection incidence within 30 days of transplantation. We included in the analysis 226 patients who collectively underwent 231 HSCTs. The CI of grade II–IV aGVHD was found to be 29.9%, while that of moderate to severe cGVHD was 29.8%. The CI of NRM recorded at 1, 2, and 3 years after transplant was 18.2%, 19.6%, and 20.2%, respectively. The CI of RI at 1, 2, and 3 years from transplant was recorded to be 17.8%, 21.0%, and 21.6%, respectively. The median follow-up was 56 months, while the median OS for the whole cohort was not established; the OS at 1, 3, and 5 years from transplant was 69.6%, 59.3%, and 57.2%, respectively. We registered 88 bacteremias in 82/231 patients (35.5%), while invasive fungal infections occurred in 12/231 patients (5.2%). Our study suggests that the use of ATG at 5 mg/kg is highly effective in limiting the occurrence of both aGVHD and cGVHD, ensuring a low NRM, RI, and infection incidence.

Prostate-specific-membrane-antigen/positron-emission-tomography (PSMA-PET) can accurately detect disease localizations in prostate cancer (PCa) patients with early biochemical recurrence/persistence (BCR/BCP), allowing for more personalized image-guided treatments in oligometastatic patients with major impact in the case of bone metastases (BM). Therefore, this study aimed to identify predictors of BM at PSMA-PET in early-BCR/BCP hormone-sensitive PCa (HSPC) patients, previously treated with radical intent (radiotherapy or radical prostatectomy ± salvage-radiotherapy (SRT)). A retrospective analysis was performed on 443

ObjectiveThe evidence base for home parenteral nutrition (HPN) in patients with advanced cancer is lacking. To compare the survival of malnourished patients with cancer undergoing palliative care who received HPN with a homogeneous group of patients, equally eligible for HPN, who did not receive HPN.DesignProspective, cohort study; tertiary university hospital, home care, hospice.MethodsPatients were assessed for HPN eligibility according to the guidelines. In the eligible population, who received both HPN and chemotherapy was excluded, while who received only HPN was included in the HPN+ group and who received neither HPN nor chemotherapy but artificial hydration (AH) was included in the HPN− group.Results301 patients were assessed for HPN eligibility and 86 patients (28.6%) were excluded for having severe organ dysfunction or Karnofsky performance status ConclusionsComparative survival associated with the use of HPN versus AH showed significantly longer survival in malnourished patients with advanced cancer receiving HPN. These data support the guideline recommendation that HPN should be considered when malnutrition represents the overriding threat for the survival of these patients.

Current international guidelines strongly advise endoscopic submucosal dissection (ESD) instead of endoscopic mucosal resection (EMR) for the endoscopic resection of sessile colorectal tumours20 mm.To compare the safety and efficacy of EMR and ESD for treating large non-invasive colorectal lesions.We performed a systematic review using electronic databases (MEDLINE/PubMed, EMBASE, and Cochrane Library) on February 21st, 2021 and a meta-analysis to assess en-bloc and R0 rates, and related adverse events.Twenty-four studies were included, comparing 3,424 ESD and 5,122 EMR procedures. The en-bloc resection rate was 90.8% in the ESD and 33.0% in the EMR group (ESD for large non-pedunculated colorectal lesions allows a higher rate of R0 resections than EMR, at the cost of a higher perforation rate and the need for additional surgery.

Background/aim Prostate-specific-membrane-antigen/positron emission tomography (PSMA-PET) detects with high accuracy disease-recurrence, leading to changes in the management of biochemically-recurrent (BCR) prostate cancer (PCa). However, data regarding the oncological outcomes of patients who performed PSMA-PET are needed. The aim of this study was to evaluate the incidence of clinically relevant events during follow-up in patients who performed PSMA-PET for BCR after radical treatment. Materials and methods This analysis included consecutive, hormone-sensitive, hormone-free, recurrent PCa patients (HSPC) enrolled through a prospective study. All patients were eligible for salvage therapy, having at least 24 months of follow-up after PSMA-PET. The primary endpoint was the Event-Free Survival (EFS), defined as the time between the PSMA-PET and the date of event/last follow-up. The Kaplan–Meier method was used to estimate the EFS curves. EFS was also investigated by Cox proportional hazards regression. Events were defined as death, radiological progression, or PSA recurrence after therapy. Results One-hundred and seventy-six (n = 176) patients were analyzed (median PSA 0.62 [IQR: 0.43–1.00] ng/mL; median follow-up of 35.4 [IQR: 26.5–40.3] months). The EFS was 78.8% at 1 year, 65.2% (2 years), and 52.2% (3 years). Patients experiencing events during study follow-up had a significantly higher median PSA (0.81 [IQR: 0.53–1.28] vs 0.51 [IQR: 0.36–0.80] ng/mL) and a lower PSA doubling time (PSAdt) (5.4 [IQR: 3.7–11.6] vs 12.7 [IQR: 6.6–24.3] months) (p 0.5 ng/mL, PSAdt ≤ 6 months, and a positive PSMA-PET result were associated with a higher event rate (p 0.5 ng/mL and PSAdt ≤ 6 months were statistically significant event-predictors in multivariate model (p Conclusion Low PSA and long PSAdt were significant predictors of longer EFS. A lower incidence of events was observed in patients having negative PSMA-PET, since longer EFS was significantly more probable in case of a negative scan.

Background Total mesorectal excision (TME) represents the “gold standard” of rectal cancer surgery. In locally advanced lesions neoadjuvant treatments (e.g. radiotherapy-nRT, radio chemotherapy-cnRT) have been shown to improve TME oncological results, reducing local recurrences rate. Nevertheless, these treatments have significant functional consequences impacting patients’ quality of life (QoL). The resulting syndrome is known as Low Anterior Resection Syndrome (LARS). The purpose of this work was to evaluate the association between risk factors and the development of LARS in a prospective series of laparoscopic sphincter-saving TME. Methods The study was conducted as a retrospective observational epidemiological study of a prospective database, including all patients undergoing laparoscopic anterior resection surgery for rectal cancer at our Unit from 1st January 2013 to 31st May 2018. The diagnosis of LARS was performed using the LARS Score. We classified risk factors in patient-related, pre-, intra- and post-operative factors. Results The sample included 153 consecutive patients. Forty-one were affected by “low” rectal cancer, 74 by “middle” rectal cancer, 38 by “high” rectal cancer. The prevalence of overall LARS (major LARS + minor LARS) in our series was 35.9% (55/153 cases). Association between nRT and overall/major LARS was significant (respectively p = 0.03 and 0.02). Distal localization of tumor was also significantly associated with LARS [overall LARS (p = 0.03), major LARS (p = 0.014)]. Conclusions In our study, neoadjuvant radiotherapy and tumor localization resulted independent risk factors for LARS after laparoscopic sphincter-saving TME. Tumor localization in the “middle” and “high” rectum resulted a protective factor compared to the localization in “low” rectum.

Kinase domain mutations in BCR-ABL1 are associated with resistance to tyrosine kinase inhibitors in patients with chronic myeloid leukaemia. Next-generation sequencing (NGS) allows detection of low-level kinase domain mutations, but its relevance in clinical practice remains debated. We aimed to examine the clinical effects of low-level kinase domain mutations identified using NGS in patients with chronic myeloid leukaemia.In this population-based study, we included consecutive patients newly diagnosed with chronic myeloid leukaemia treated with first-line tyrosine kinase inhibitors, and patients identified at the time of resistance to first-line treatment with imatinib at six institutions (teaching hospitals and district hospitals) in southeast England. We screened patients for BCR-ABL1 kinase domain mutations using NGS, irrespective of patient response to tyrosine kinase inhibitor therapy. When we detected a mutation with NGS, we retrospectively analysed all previous samples to establish the date of first occurrence and subsequent kinetics of the mutant subclone (or subclones). The primary endpoints of this study were progression-free and event-free survival at 5 years.Between Feb 1, 2007, and Dec 31, 2014, we screened 121 patients with chronic myeloid leukaemia for BCR-ABL1 kinase domain mutation. 99 consecutive patients were newly diagnosed, with available sequential RNA stored. The remaining 22 patients were diagnosed between June 1, 1999, and June 30, 2006, and were screened at the time of resistance to first-line treatment with imatinib. Imatinib was the first-line treatment for 111 patients, nilotinib for seven patients, and dasatinib for three patients. We detected a kinase domain mutation in 25 (21%) of 121 patients. Low-level kinase domain mutations were first identified in 17 (68%) of 25 patients with mutation. For patients with a complete cytogenetic response, 13 (14%) of 93 patients screened had a mutation. Five (71%) of the seven patients with a clinically relevant mutation lost complete cytogenetic response compared with 15 (17%) of 86 patients without a clinically relevant mutation (80 patients without mutation and six patients with a tyrosine kinase inhibitor-sensitive mutation, p=0·0031). Patients harbouring a mutant clone had poorer 5-year progression-free survival (65·3% [95% CI 40·5-81·8] vs 86·9% [75·8-93·2]; p=0·0161) and poorer 5-year event-free survival (22·2% [CI 5·6-45·9] vs 62·0% [50·4-71·6]; p0·0001) than did patients without a mutation. We identified a kinase domain mutation in four (10%) of 41 patients with samples available at 3 months after starting first-line tyrosine kinase inhibitor treatment; all four subsequently progressed to accelerated phase disease compared with only three (8%) of 37 without a mutation (p0·0001).NGS reliably and consistently detected early appearance of kinase domain mutations that would not otherwise be detected by Sanger sequencing. For the first time, to our knowledge, we report the presence of kinase domain mutations after only 3 months of therapy, which could have substantial clinical implications. NGS will allow early clinical intervention and our findings will contribute to the establishment of new recommendations on the frequency of kinase domain mutation analysis to improve patient clinical care.None.

Background To determine on a national basis the surgical activity regarding appendectomies during the first Italian wave of the COVID-19 pandemic. Major surgical societies advised using non-operative management of appendicitis and suggested against laparoscopy during the COVID-19 pandemic. Methods Multicenter, observational study investigating the outcomes of patients undergoing appendectomy in the two months of March-April 2019 vs. March-April 2020. The primary outcome was the number of appendectomies performed during each of the two months, classified according to the American Association for the Surgery of Trauma (AAST) score. Secondary outcomes were the type of surgical technique employed (laparoscopic vs. open), and the complication rates. Results 1541 patients with acute appendicitis underwent surgery during the two study periods. 1337 (86.8%) patients met the study inclusion criteria. 546 (40.8%) patients underwent surgery for acute appendicitis in 2020 and 791 (59.8%) in 2019. Patients with complicated appendicitis operated in 2019 were 76 (9.6%) vs. 87 (15.9%) in 2020 (p = 0.001). An increase in the number of post-operative complications was found in 2020 (15.9%) compared to 2019 (9.6%) (p 24 h (+ 58%), being the surgeon aged > 40 years (+ 47%), undergoing open surgery (+ 112%) and being converted to open surgery (+ 166%). Conclusions In Italian hospitals, in March and April 2020, the number of appendectomies has drastically dropped. Patients undergoing surgery during the first pandemic wave were more frequently affected by more severe appendicitis than the previous year's timeframe and a higher complication rate was reported. Trial registration: ResearchRegistry ID 5789.

Introduction This is a prospective, single-center trial in pediatric patients with sarcoma aiming to evaluate [18F]FDG PET/CT as a tool for early response assessment to neoadjuvant chemotherapy (neo-CTX). Methods Bone or soft tissue sarcoma patients with (1) baseline [18F]FDG PET/CT within 4 weeks prior to the start of neo-CTX (PET1), (2) early interim [18F]FDG PET/CT (6 weeks after the start of neo-CTX (PET2), (3) evaluation of neo-CTX response by histology or MRI, and (4) definitive therapy after neo-CTX (surgery or radiation) were included. Semiquantitative PET parameters (SUVmax, SUVmean, SUVpeak, MTV and TLG) and their changes from PET1 to PET2 (ΔPET) were obtained. The primary endpoint was to evaluate the predictive value of PET1, PET2 and ΔPET parameters for overall survival (OS) and time to progression (TTP). The secondary outcome was to evaluate if [18F]FDG PET/CT can predict the response to neo-CTX assessed by histopathology or MRI. Primary and secondary outcomes were also evaluated in a subpopulation of patients with bone involvement only. Results Thirty-four consecutive patients were enrolled (10 females; 24 males; median age 15.1 years). 17/34 patients (50%) had osteosarcoma, 13/34 (38%) Ewing's sarcoma, 2/34 (6%) synovial sarcoma and 2/34 (6%) embryonal liver sarcoma. Median follow-up was 39 months (range 16–84). Eight of 34 patients (24%) died, 9/34 (27%) were alive with disease, and 17/34 (50%) had no evidence of residual/recurrent disease. Fifteen of 34 (44%) and 19/34 (56%) were responders and non-responders, respectively. PET2-parameters were associated with longer TTP (p p = 0.047). None of the PET1, PET2 or ΔPET parameters were associated with OS. Conclusion [18F]FDG PET/CT performed 6 weeks after the start of neo-CTX can serve as an early interim biomarker for TTP and pathologic response but not for OS in pediatric patients with sarcoma.

Introduction: This is a prospective, single-center trial in pediatric patients with sarcoma aiming to evaluate [18F]FDG PET/CT as a tool for early response assessment to neoadjuvant chemotherapy (neo-CTX).Methods: Bone or soft tissue sarcoma patients with i) baseline [18F]FDG PET/CT within four weeks prior to the start of neo-CTX (PET1), ii) early interim [18F]FDG PET/CT (six weeks after the start of neo-CTX (PET2), iii) evaluation of neo-CTX response by histology or MRI, and iv) definitive therapy after neo-CTX (surgery or radiation) were included. Semi-quantitative PET parameters (SUVmax, SUVmean, SUVpeak, MTV and TLG) and their changes from PET1 to PET2 (ΔPET) were obtained. The primary endpoint was to evaluate the predictive value of PET1, PET2 and ΔPET parameters for overall survival (OS) and time to progression (TTP). The secondary outcome was to evaluate if [18F]FDG PET/CT can predict the response to neo-CTX assessed by histopathology or MRI. Primary and secondary outcomes were also evaluated in a sub-population of patients with bone involvement only.Results: Thirty-four consecutive patients were enrolled (10 females; 24 males; median age 15.1 years). 17/34 patients (50%) had Osteosarcoma, 13/34 (38%) Ewing Sarcoma, 2/34 (6%) synovial sarcoma and 2/34 (6%) embryonal liver sarcoma. Median follow-up was 39 months (range 16-84). Eight of 34 patients (24%) died, 9/34 (27%) were alive with disease and 17/34 (50%) had no evidence of residual/recurrent disease. Fifteen of 34 (44%) and 19/34 (56%) were responders and non-responders, respectively. PET2-parameters were associated with longer TTP (p Conclusion: [18F]FDG PET/CT performed six weeks after the start of neo-CTX can serve as an early interim biomarker for TTP and pathologic response but not for OS in pediatric patients with sarcoma.

Aim of our study was to search for variables associated with worse outcomes in patients treated with radioactive iodine (RAI) for hyperthyroidism by a dosimetric-based approach. Four hundred twenty-four patients with hyperthyroidism related to Toxic Multinodular Goiter (TMG; n = 213), Grave’s disease (GD; n = 150) and toxic adenoma (TA; n = 61) treated with RAI between 2000 and 2018 and with at least 12 months follow-up were retrospectively evaluated. Association between outcomes (response vs. no response) at 6 and 12 months and baseline TSH values, anti-thyroid drugs (ATD) duration and posology, RAI absorbed dose and dimensional reduction of target mass at ultrasound was evaluated by Mann–Whitney test. Risk factors for response vs. no-response were analysed by binary logistic regression model. Overall response rate was 78.7 and 83% at 6 and 12 months, respectively. Both at 6 and 12 months higher TSH baseline values (p

Objective To assess overall (OS), time to progression (TTP), and disease-free survival (DFS) at 3 years after treatment, comparing stenting as bridge-to-surgery (SBTS) versus emergency surgery (ES) in neoplastic left colon obstruction, secondary endpoints of the previously published randomized controlled trial. Background While SBTS in neoplastic colon obstruction may reduce morbidity and need for a stoma compared with ES, concern has been raised, about long-term survival. Methods Individuals affected by left-sided malignant large-bowel obstruction were enrolled from 5 European hospitals and randomly assigned (1:1 ratio) to receive SBTS or ES. The computer-generated randomization sequence was stratified by center on cT and concealed by the use of a web-based application. Investigators and participants were unmasked to treatment assignment. The secondary outcomes analyzed here were OS, TTP, and DFS. Analysis was by intention to treat. This study is registered, ID-code NCT00591695. Results Between March 2008 and November 2015, 144 patients were randomly assigned to undergo either SBTS or ES; 115 (SBTS n = 56, ES n = 59) were eligible for analysis, while 20 participants were excluded for a benign disease, 1 for unavailability of the endoscopist while 8 withdrew from the trial. With a median follow-up of 37 months (range 1-62), no difference was observed in the SBTS group compared with ES in terms of OS (HR 0.93 (95% CI 0.49-1.76), P = 0.822), TTP (HR 0.81 (95% CI 0.42-1.54), P = 0.512), and DFS (HR 1.01 (95% CI 0.56-1.81), P = 0.972). Planned subgroup analysis showed no difference in respect to age, sex, American Society for Anesthesiology score, body mass index, and pT between SBTS and ES groups. Those participants randomized for the SBTS group whose obstruction was located in the descending colon had a better TTP compared with ES group (HR 0.44 (95% CI 0.20-0.97), P = 0.042), but no difference was observed in terms of OS (HR 0.73 (95% CI 0.33-1.63), P = 0.442) and DFS (HR 0.68 (95% CI 0.34-1.34), P = 0.261) in the same individuals. Conclusions This randomized controlled trial shows that, although not powered for these seconday outcomes, OS, TTP, and DFS did not differ between groups at a minimum follow-up of 36 months.

The aim of this study is to evaluate if multiparametric magnetic resonance (mpMRI)-transrectal ultrasound (TRUS) fusion targeted biopsy (TBx) versus untargeted standard biopsy (SBx) may decrease the rate of pathological upgrading of Gleason Score (GS) 3+4 prostate cancer (PCa) at radical prostatectomy (RP). We also evaluated the impact of percent pattern 4 and cribriform glands at biopsy in the risk of GS 3+4=7 upgrading.A total of 301 patients with GS 3+4 PCa on biopsy (159 SBx and 142 TBx) who underwent laparoscopic robot-assisted RP were sequentially enrolled. Histological data from RP sections were used as reference standard. The concordance of biopsy with pathological GS, as well as the GS 3+4 upgrading at RP were evaluated in different univariate and multivariate binary logistic regression models, testing age, PSA, fPSA%, tumor volume, PI-RADS, clinical stage, percentage of Gleason pattern 4 (GP) and/or presence of cribriform sub-type at biopsy.Of the 301 biopsies, the median of GP 4 was 16% of the tissue. Minimal GP 4 (≤16%) cancers had a significant lower median volume (1.7 mL) than those with GP416% (2.9 mL), (P0.001). Pathological GS 3+4 was confirmed for 58.8% and 82.2% for SBx and TBx patients, respectively. The rate of upgraded and downgraded GS on SBx versus TBx was 38.8% vis. 16.7% and 1.8% and 2.1%, respectively. The rate of upgrading was significantly associated with the presence of GP416% versus ≤16% (OR 4.4, 95% CI 1.4-12.0; P=0.021) and with the presence of cribriform sub-type at biopsy specimens (OR 6.2, 95% CI 2.2-18.7; P0.001).We demonstrated that TBx technique significantly reduced the risk of GS 3+4 upgrading at RP, compared to SBx one. The rate of upgrading was significantly associated with GP416%, mostly when cribriform sub-type was present at biopsy specimens.

Background Robust data reporting the survival of cancer patients on home parenteral nutrition (HPN) are lacking. The aim of this prospective, cohort study was to investigate clinical characteristics, predictive factors, and overall survival (OS) of adult‐malnourished cancer patients eligible for HPN according to the European guideline recommendations. Methods During the study period, 1658 cancer patients were consecutively evaluated in a tertiary university hospital. Of these, 761 who received HPN were grouped into four cohorts according to the provision of supplemental PN (SPN) or total (TPN) and whether they received chemotherapy (CT+ or CT‐): SPN/CT+ (n = 376), TPN/CT+ (n = 99), SPN/CT‐ (n = 191), and TPN/CT‐ (n = 95). Patient demographics, nutritional status, cancer‐related characteristics, and prognostic scores assessed at HPN start. The primary outcome was OS. Results Median OS was 8.9, 4.3, 5.7, and 2.2 months for the SPN/CT+, TPN/CT+, SPN/CT‐, and TPN/CT‐ cohorts, respectively. In multivariable analysis, predictors showing significant association with decreased survival were patient cohorts, modified Glasgow Prognostic Score (1 and 2 scores), weight loss (>15%) in the 3 months before HPN start, and TNM IV stage while protective factors of survival were Karnofsky Performance Status (>50), albumin level (>3.5 g/dL), oral protein intake, BMI (>20.5), and weight at HPN start. Conclusion For the first time, in four different cohorts of cancer patients on HPN, clinical characteristics and survival were compared. This large study showed that survival is significantly correlated with patient characteristics at HPN start and that the presence of favorable factors may determine even a fourfold increase in survival. These data are expected to assist physicians in the appropriate prescription of HPN., This is the largest, prospective, clinical study investigating survival exclusively of adult malnourished cancer patients receiving home parenteral nutrition (HPN). This study showed that survival is significantly correlated with patient characteristics at HPN start and that the presence of favorable factors may determine even a 4‐fold increase in survival.

Background The use of 3D laparoscopic systems is expanding. The European Association of Endoscopic Surgery (EAES) initiated a consensus development conference with the aim of creating evidence-based statements and recommendations for the surgical community. Methods Systematic reviews of the PubMed and Embase libraries were performed to identify evidence on potential benefits of 3D on clinical practice and patient outcomes. Statements and recommendations were prepared and unanimously agreed by an international surgical and engineering expert panel which were presented and voted at the EAES annual congress, London, May 2018. Results 9967 abstracts were screened with 138 articles included. 18 statements and two recommendations were generated and approved. 3D significantly shortened operative time (mean difference 11 min (8% [95% CI 20.29-1.72], I-2 96%)). A significant reduction in complications was observed when 3D systems were used (RR 0.75, [95 CI% 0.60-0.94], I-2 0%) particularly for cases involving laparoscopic suturing (RR 0.57 [95% CI 0.35-0.90], I-2 0%). In 69 box trainer or simulator studies, 64% concluded trainees were significant faster and 62% performed fewer errors when using 3D. Conclusion We recommend the use of 3D vision in laparoscopy to reduce the operative time (grade of recommendation: low). Future robust clinical research is required to specifically investigate the potential benefit of 3D laparoscopy system on complication rates (grade of recommendation: high).

To evaluate in details the actual extent of double-J stent-related symptoms after semirigid (URS) and flexible (RIRS) ureteroscopy using a validated questionnaire. We asked to complete the Ureteric Stent Symptoms Questionnaire (USSQ) to all stone patients undergoing URS or RIRS with stent placement from 2010 to 2015. Stent-related symptoms’ prevalence, severity, and impact on daily life were analyzed using descriptive statistics and five-order Likert scales. Subgroups analyses were performed. 232 patients completed the USSQ. Stents had a deep impact on urinary symptoms (daily frequency ≥ 1 per hour 59.1%, ≥ 1 nocturnal micturition 90.1%, urgency 86.6%, burning 82.3%) that represented a problem for 88.4% of patients. 83.2% complained of pain, mostly in the kidney (67.9%) or in the bladder area (31.3%), particularly during physical activity (72.9%) and micturition (77.0%). Pain interfered with everyday life in 92.2%. General health, working, and sexual activity were also affected. 62.0% of patients would be dissatisfied (51.6% unhappy or terrible) if further ureteral stenting was proposed in future. Younger patients and females were more affected. Limitations include observational design and lack of baseline evaluation. Ureteral stents are responsible for significant urinary symptoms and pain after semirigid and flexible ureteroscopy. They also considerably affect general health, working and sexual activity. Urologists should consider it carefully before stenting, inform patients about stent-related symptoms, and minimize stent indwelling time.

We here describe a novel method for MYD88L265P mutation detection and minimal residual disease monitoring in Waldenstrom macroglobulinemia, by droplet digital polymerase chain reaction, in bone marrow and peripheral blood cells, as well as in circulating cell-free DNA. Our method shows a sensitivity of 5.00×10−5, which is far superior to the widely used allele-specific polymerase chain reaction (1.00×10−3). Overall, 291 unsorted samples from 148 patients (133 with Waldenstrom macroglobulinemia, 11 with IgG lymphoplasmacytic lymphoma and 4 with IgM monoclonal gammopathy of undetermined significance) were analyzed: 194 were baseline samples and 97 were followup samples. One hundred and twenty-two of 128 (95.3%) bone marrow and 47/66 (71.2%) baseline peripheral blood samples scored positive for MYD88L265P. To investigate whether MYD88L265P detection by droplet digital polymerase chain reaction could be used for minimal residual disease monitoring, mutation levels were compared with IGH-based minimal residual disease analysis in 10 patients, and was found to be as informative as the classical, standardized, but not yet validated in Waldenstrom macroglobulinemia, IGH-based minimal residual disease assay (r2=0.64). Finally, MYD88L265P detection by droplet digital polymerase chain reaction on plasma circulating tumor DNA from 60 patients showed a good correlation with bone marrow findings (bone marrow median mutational value 1.92×10−2, plasma circulating tumor DNA value: 1.4×10−2, peripheral blood value: 1.03×10−3). This study indicates that droplet digital polymerase chain reaction assay of MYD88L265P is a feasible and sensitive tool for mutation screening and minimal residual disease monitoring in Waldenstrom macroglobulinemia. Both unsorted bone marrow and peripheral blood samples can be reliably tested, as can circulating tumor DNA, which represents an attractive, less invasive alternative to bone marrow for MYD88L265P detection.

Aim Few studies have investigated Internet Addiction (IA) in adolescents in relation to personality characteristics. The aim of this study was to determine whether personality differences exist between adolescents with problematic/pathological Internet use and those with normal Internet use. Our hypothesis was that certain psychopathological personality traits may predispose to the development of maladaptive Internet use. Methods The Internet Addiction Test (IAT) and the Minnesota Multiphasic Personality Inventory-Adolescent (MMPI-A) were administered to a sample of 224 high school students. Results Analysis of IAT scores showed that 24.6% of the students had problematic Internet use and 1.6% had IA. Comparison of the MMPI-A scores between subjects with normal Internet use and those with problematic or pathological use based on the IAT score showed that some subscales, including schizophrenia and bizarre mentation, were strongly associated with problematic/pathological Internet use. Also, male sex, attending a vocational school, and unhappy childhood were found to be risk factors for IA. Conclusions Certain psychological dimensions regarding mood and the psychotic area, as well as low self-esteem, family, school and conduct problems could represent risk factors. Taken together, our data suggest a personality profile, with problems at various levels in subjects with problematic or pathological Internet use.

The aim of the study was to determine whether there are clinically relevant differences in outcomes between laparoscopic right colectomy (LRC) with intracorporeal ileocolic anastomosis (IIA) and LRC with extracorporeal IA (EIA).IIA and EIA are 2 well-established techniques for restoration of bowel continuity after LRC. There are no high-quality studies demonstrating the superiority of one anastomotic technique over the other.This is a double-blinded randomized controlled trial comparing the outcomes of LRC with IIA and LRC with EIA in patients with a benign or malignant right-sided colon neoplasm. Primary endpoint was length of hospital stay (LOS). This trial was registered with ClinicalTrials.gov, number NCT03045107.A total of 140 patients were randomized and analyzed. Median operative time was comparable in IIA versus EIA group {130 [interquartile range (IQR) 105-195] vs 130 (IQR 110-180) min; P = 0.770} and no intraoperative complications occurred. The quicker recovery of bowel function after IIA than EIA [gas: 2 (IQR 2-3) vs 3 (IQR 2-3) days, P = 0.003; stool: 4 (IQR 3-5) vs 4.5 (IQR 3-5) days, P = 0.032] was not reflected in any advantage in the primary endpoint: median LOS was similar in the 2 groups [6 (IQR 5-7) vs 6 (IQR 5-8) days; P = 0.839]. No significant differences were observed in the number of lymph nodes harvested, length of skin incision, 30-day morbidity (17.1% vs 15.7%, P = 0.823), reoperation rate, and readmission rate between the 2 groups.LRC with IIA is associated with earlier recovery of postoperative bowel function than LRC with EIA; however, it does not reflect into a shorter LOS.

BACKGROUND Multidisciplinary team (MDT) management decision-making process appears as an interesting tool to answer most aspects of prostate cancer (PCa) diagnosis and treatment, allowing a fairer choice of therapies. The aim of this study to prospectively investigate the impact on prostate cancer clinical management of the uro-oncology MDT meeting at an Italian tertiary referral center. METHODS All cases discussed over an 18-months period at San Luigi Hospital uro-oncology MDT were prospectively evaluated for the impact of the MDT discussion on PCa clinical decision-making. Dilemma and management plan in the monodisciplinary visit before and/or after primary treatment were recorded. Subsequently, the MDT discussed the case and reached a consensus decision, which was also recorded. Changes in diagnostic assessment and patient management from pre- to post-MDT meeting were evaluated by a consultant urologist. RESULTS Overall, 201 patients, of which 99, 81 and 21 with local, advanced and metastatic disease respectively, were selected for MDT evaluation. The most frequent reasons for MDT approach after either PCa diagnosis or primary treatment were metastatic disease or locally advanced disease/positive surgical margins/biochemical recurrence, respectively. Patients with local, advanced and metastatic disease had a significative change of diagnostic/therapeutic management in 23.2%, 46.9% and 33.4%, respectively (P

The evidence supporting the use of the air leak test (ALT) after laparoscopic left-sided colon resection (LLCR) to test the colorectal anastomosis (CA) integrity aiming at reducing the rate of postoperative CA leakage (CAL) is not conclusive. The aim of this study was to challenge the use of ALT after elective LLCR. It is a retrospective analysis of a prospectively collected database including all patients undergoing elective LLCR with primary CA and no proximal bowel diversion between January 1996 and June 2017. The decision to perform the ALT was based on the individual surgeon routine practice. A multivariate analysis was performed to identify independent risk factors for CAL. A total of 777 LLCR without proximal diversion were included in the analysis: the CA was tested in 398 patients (ALT group), while intraoperative ALT was not performed in 379 patients (No-ALT group). The two groups were similar in demographic characteristics, indication, and type of procedure. Intraoperative ALT was positive in 20 (5%) patients: a stoma was created in 14 (70%) patients, while 6 (30%) patients had a suture repair alone. Overall, postoperative CAL occurred in 32 patients (4.1%): the postoperative CAL rate was lower in ALT patients (2.5% vs. 5.8%, p = 0.025). A reoperation was needed in 87.5% of cases. No CAL occurred in the 20 patients with intraoperative positive ALT. Multivariate analysis showed that ASA score 3–4 (OR 5.39, 95% CI 2.53–11.51, p

Background: Guidelines recommend home parenteral nutrition (HPN) if incurable cancer patients are unable to meet their nutritional requirements by oral/enteral route and are at risk of death due to malnutrition. However, the evidence base is lacking and recommendation has been the result of expert consensus. The aim of this study was the comparison of incurable malnourished cancer patients who received HPN with a similar group of patients, equally eligible for HPN, who did not receive HPN for logistic reasons or refusal by the patient. Methods: In this prospective longitudinal cohort study, patients were assessed for HPN eligibility following the European guidelines. In the eligible population, those who received both HPN and chemotherapy were excluded, those receiving only HPN were included as the study group (HPN+ group) while who received neither HPN nor chemotherapy but only artificial hydration were included as the control group (HPN- group). The primary outcome was overall survival. Findings: Between October 1, 2012, and September 30, 2015, 301 patients were assessed for HPN eligibility and 86 patients (28·6%) were excluded for having severe organ dysfunction or Karnofsky Performance Status

Complications in colorectal surgery include a wide range of clinical conditions, which increase mortality, morbidity, hospital stay and costs. In some cases, the placement of a self-expanding metal stent may represent a possible therapeutic strategy, avoiding further surgery. In order to verify the feasibility and safety of the technique, we reviewed the medical literature, between January 1997 and 2015, selecting 32 studies. Inclusion criteria were based on Preferred Reporting Items for Systematic reviews and Meta-Analyses recommendations. The estimated rate of early success was 73.3% (95% CI 66.3–79.3), raising from 25 to 68% in the time frame 1997–2007. The rate of early complications was 31.4% (95% CI 25.3–38.3%), progressively decreasing from 75 to 43% up to 2009. The rate of surgery for acute complication was 9.3% (95% CI 6.0–14.2%), reduced on time course from 25 to 9%. The rate of closure of dehiscence was 74.5% (95% CI 62.8–83.5%), while the rate of long-lasting success was 57.3% (95% CI 50.3–64.0%). Endoscopic stenting in the early postoperative management of anastomotic complications after colorectal surgery should be considered in patients with minimal risk for sepsis, as a safe and often effective alternative to surgery. However, in order to establish the safety and efficacy of this technique, prospective studies involving a larger cohort of patients are required.

Rituximab (Rit) therapy added to involved-field radiation therapy (RT) has been proposed as an effective treatment for stage I-II follicular lymphoma (FL). The results of an observational multicenter study on the Rit-RT combination in limited-stage FL are here reported.Data have been collected from 2 consecutive cohorts of 94 patients with stage I-II FL treated between 1985 and 2011 at 5 Italian institutions. All patients had grade 1-3a FL, a median age of 54 years (range: 25-82). The first 51 patients received RT alone (control group), while the subsequent series of 43 patients received 4 rituximab courses (375 mg/m(2), days 1, 8, 15, 22) before RT (Rit-RT). Molecular disease was evaluated by nested bcl-2/IgH PCR or clonal IgH rearrangement was available in 33 Rit-RT patients.At a median follow-up of 10.9 years (range: 1.8-22.9), the 10-year progression-free survival (PFS) and overall survival (OS) projections for the whole cohort were 57% and 87.5%, respectively. The 10-year PFS was significantly longer (P.05) in the Rit-RT group (64.6%) compared to RT alone (50.7%), whereas the 10-year OS projections were not significantly different. On bivariate analysis controlling for stage, there was only a trend toward improved PFS for Rit-RT (HR, 0.55; P=.081). Follicular lymphoma international prognostic index and age were associated with OS but not with PFS on Cox regression analysis. Bone marrow molecular analysis showing PCR positivity at diagnosis was strongly associated with relapse risk upon univariate and multivariate analysis.This multicenter observational study suggests a potential benefit of adding rituximab to radiation therapy for stage I-II FL. The results of the currently ongoing randomized studies are required to confirm these results. The study underlines the importance of molecular disease monitoring also for patient with limited-stage disease.

Background The introduction of robotics revolutionized prostate cancer surgery because the magnified three-dimensional vision system and wristed instruments allow microsurgery to be performed. The advantages of robotic surgery could lead to improved continence outcomes in terms of early recovery compared with the traditional surgical methods. Objective To describe the total anatomical reconstruction (TAR) technique during robot-assisted radical prostatectomy (RARP). Primary endpoint: evaluation of the continence rate at different time points. Secondary endpoint: evaluation of urine leakage and anastomosis stenosis rates related to the technique. Design, setting, and participants June, 2013 to November, 2014; prospective consecutive series of patients with localized prostate cancer (cT1-3, cN0, cM0). Surgical procedure RARP with TAR was performed in all cases. Lymph node dissection was performed if the risk of lymph nodal metastasis was over 5%, according to the Briganti updated nomogram. Measurements Preoperative, intraoperative, postoperative, and pathological variables were analyzed. Enrolled patients were arbitrarily divided into three groups according to a time criterion. The relationships between the learning curve and the trend of the above-mentioned variables were analyzed using LOESS analysis. Continence was rigorously analyzed preoperatively and at 24h, 1 wk, 4 wk, 12 wk, and 24 wk after catheter removal. Results and limitations In total, 252 patients were analyzed. The continence rates immediately after catheter removal and at 1 wk, 4 wk, 12 wk, and 24 wk after RARP were 71.8%, 77.8%, 89.3%, 94.4%, and 98.0%, respectively. Multivariate analysis revealed that the nerve sparing technique, D'Amico risk groups, lymph node dissection, and prostate volume were involved in the early recovery of urinary continence. One ileal perforation requiring reoperation was recorded. The transfusion rate was 0.8%. Thirty-one (12.3%) postoperative complications were recorded up to 6 mo after surgery. Among these, eight acute urinary retentions (3.2%) and three urine leakages (1.2%) were recorded. There was a lack of randomization and comparison with other techniques. Both anatomical dissection of the prostatic apex and TAR were used. The results may not be generalized to low-volume centers. Conclusions The TAR technique showed promising results in the early recovery of urinary continence, as well as watertight anastomosis and a low rate of urine leakage. The oncologic results were not affected. Comparative studies are needed to support the quality of reported results. Patient summary On the basis of our findings, it seems that the risk of urinary incontinence following radical prostatectomy can be lowered via meticulous anatomical reconstruction using a robotic system. Comparative studies are required to support the reported results.

We report the clinical outcomes of 83 patients with acute lymphoblastic leukemia (median age, 46 years; range, 18-75 years) treated at our institution between 1999 and 2011. Treatment refers to clinical trials open for accrual at the time of diagnosis or to institutional guidelines. Upfront allografting was considered for younger high-risk patients. Seventy-eight of 83 (94%) patients achieved complete remission after induction, although 53% of them eventually relapsed. Forty of 70 patients younger than 61 years underwent allografting. The median follow-up was 7.4 years (range, 0.2-15.0 years). Overall, the 5-year overall survival (OS) and event-free survival (EFS) were 40% and 39%, respectively. In patients undergoing transplantation, OS and EFS at 5 years were both 53%, whereas in a nontransplantation setting, both OS and EFS were 35% at 5 years (P = .044 for both OS and EFS). By multivariate analysis, the independent predictors of OS and EFS were age and leukocytosis in the overall population and allografting in young patients.

Aim To evaluate the accuracy of multiparametric magnetic resonance-transrectal ultrasound fusion targeted biopsy (TBx) in the characterization of the index tumor, as confirmed by association with radical prostatectomy (RP) specimens. Patients and methods A total of 152 patients with TBx-confirmed prostate cancer (PCa) underwent robot-assisted RP. Stained whole-mount histological sections were used as the reference standard. All lesions with a volume >0.5 ml and/or pathological Gleason score (GS) >6 were defined as clinically significant PCa. The index lesion was defined as the largest tumor focus within the prostate gland. Results The pathological index tumours included: 147 lesions (96.7%) with a volume >0.5 ml and five (3.3%) with a volume ≤0.5 ml, but with a pathological GS ≥7; 135 (88.8%) were located in the peripheral zone. TBx accuracy in the detection of the correct site of the index lesion by reference standard was 82.2%. Sensitivity, specificity, positive and negative predictive value were: 82.3%, 50.4%, 82.8% and 49.7%, respectively. The primary/secondary Gleason grade and GS of the 152 index tumors were properly estimated in 130 (85.5%), 115 (75.6%) and 127 (83.6%) cases, respectively. The concordance of TBx with pathological GS was 83.6%. The rate of up-grading and down-grading of TBx Gleason sum was 12.2% and 4.2%, respectively. Conclusion TBx has a high sensitivity for characterization of index lesions, with a good concordance for topographic and Gleason grading accuracy between biopsy and surgical specimens.

Over the last decade, single-incision laparoscopic cholecystectomy (SLC) has gained popularity, although it is not evident if benefits of this procedure overcome the potential increased risk. Aim of the study is to compare the outcome of SLC with conventional multi-incision laparoscopic cholecystectomy (MLC) in a meta-analysis of randomized controlled trials only. A systematic Medline, Embase, and Cochrane Central Register of Controlled Trials literature search of articles on SLC and MLC for any indication was performed in June 2017. The main outcomes measured were overall adverse events, pain score (VAS), cosmetic results, quality of life, and incisional hernias. Linear regression was used to model the effect of each procedure on the different outcomes. Forty-six trials were included and data from 5141 participants were analysed; 2444 underwent SLC and 2697 MLC, respectively. Mortality reported was nil in both treatment groups. Overall adverse events were higher in the SLC group (RR 1.41; p

Real-time quantitative PCR (qPCR) is a well-established tool for minimal residual disease (MRD) detection in mature lymphoid malignancies. Despite remarkable sensitivity and specificity, qPCR has some limitations, particularly in the need for a reference standard curve, based on target serial dilutions. In this study, we established droplet digital PCR (ddPCR) for MRD monitoring in multiple myeloma, mantle cell lymphoma, and follicular lymphoma and compared it head-to-head with qPCR. We observed that ddPCR has sensitivity, accuracy, and reproducibility comparable with qPCR. We then compared the two approaches in 69 patients with a documented molecular marker at diagnosis (18 multiple myelomas, 21 mantle cell lymphomas assessed with the immunoglobulin gene rearrangement, and 30 follicular lymphomas with the use of the BCL2/immunoglobulin gene major breakpoint region rearrangement). ddPCR was successful in 100% of cases, whereas qPCR failed to provide a reliable standard curve in three patients. Overall, 222 of 225 samples were evaluable by both methods. The comparison highlighted a good concordance (r = 0.94, P

Background Multiple Myeloma (MM) is a neoplastic disorder characterized by clonal proliferation of malignant plasma cells (PCs). Flow cytometry is an essential tool to confirm diagnosis and evaluate minimal residual disease (MRD). This study aims at identifying new surface PC markers suitable for targeted therapy in MM and able to improve MRD detection. Methods The expression of 82 molecules provided by the “Ninth International Workshop on Leukocyte Antigens” was analyzed by flow cytometry in 5 MM cell lines and in 20 newly diagnosed MM (NDMM) patients. Based on the antigens expression and monoclonal antibody availability, CD150, CD48, CD229, CD352, CD319, CD272, CD86, CD200 and CD184 were subsequently tested in 24 NDMM, 8 relapsed MM (RMM), 6 plasma cell leukemia (PCL) and 13 healthy subjects. Results CD352 was less frequently expressed on NDMM than on healthy PCs; CD200 was more frequently expressed on NDMM than on RMM and healthy PCs. CD150, CD319, CD229, CD352 Mean Fluorescence Intensity (MFI) was lower in pathological than in healthy samples. The proportion of CD150-positive samples was lower in NDMM and RMM than in healthy subjects; CD86+ samples were less frequent in NDMM than in healthy subjects; CD200+ samples were more frequent in NDMM than in RMM and healthy subjects. Conclusions CD150, CD86 and CD200 can help to identify malignant PCs; CD272, CD319, CD229, CD48 are highly expressed on all PCs and could be considered for targeted therapy. All these antigens could be added to a routine panel for PCs identification and MRD evaluation. © 2015 International Clinical Cytometry Society

Several studies provided evidence of a consistent antileukemic effect induced by cytomegalovirus (CMV) replication in acute myeloid leukemia (AML) patients receiving allogeneic hematopoietic stem cell transplantation (HSCT), however the use of antithymocyte globulin (ATG) as graft-versus-host disease prophylaxis, may potentially abrogate the protective effect of CMV infection. To address this issue, we retrospectively analyzed the risk of relapse in a cohort of 101 patients with AML who received grafts from an unrelated donor after a conditioning regimen including ATG. The cumulative incidence of CMV reactivation, evaluated by RT qPCR, was 59% at 12 months, and 93% of CMV reactivations occurred within the first 100 days post HSCT. The 5-year cumulative incidence of relapse in patients with CMV reactivation was 29% compared with 37% for patients without CMV reactivation, and the only factor associated with a reduced 5-year cumulative incidence of relapse was the disease status at HSCT (P

We here describe a novel method for MYD88L265P mutation detection and minimal residual disease monitoring in Waldenström macroglobulinemia, by droplet digital polymerase chain reaction, in bone marrow and peripheral blood cells, as well as in circulating cell-free DNA. Our method shows a sensitivity of 5.00×10−5, which is far superior to the widely used allele-specific polymerase chain reaction (1.00×10−3). Overall, 291 unsorted samples from 148 patients (133 with Waldenström macroglobulinemia, 11 with IgG lymphoplasmacytic lymphoma and 4 with IgM monoclonal gammopathy of undetermined significance) were analyzed: 194 were baseline samples and 97 were followup samples. One hundred and twenty-two of 128 (95.3%) bone marrow and 47/66 (71.2%) baseline peripheral blood samples scored positive for MYD88L265P. To investigate whether MYD88L265P detection by droplet digital polymerase chain reaction could be used for minimal residual disease monitoring, mutation levels were compared with IGH-based minimal residual disease analysis in 10 patients, and was found to be as informative as the classical, standardized, but not yet validated in Waldenström macroglobulinemia, IGH-based minimal residual disease assay (r2=0.64). Finally, MYD88L265P detection by droplet digital polymerase chain reaction on plasma circulating tumor DNA from 60 patients showed a good correlation with bone marrow findings (bone marrow median mutational value 1.92×10−2, plasma circulating tumor DNA value: 1.4×10−2, peripheral blood value: 1.03×10−3). This study indicates that droplet digital polymerase chain reaction assay of MYD88L265P is a feasible and sensitive tool for mutation screening and minimal residual disease monitoring in Waldenström macroglobulinemia. Both unsorted bone marrow and peripheral blood samples can be reliably tested, as can circulating tumor DNA, which represents an attractive, less invasive alternative to bone marrow for MYD88L265P detection.

Chemo-refractory NHL has a very poor outcome; the addiction of RIT to salvage regiment pre ASCT had recently demonstrated promising results.We performed a retrospective sequential study to determine the feasibility of standard Zevalin with BEAM in high-risk relapse/refractory NHL. A matched cohort analysis with a group treated with standard BEAM without Zevalin was performed as secondary endpoint. Between October 2006 and January 2013, 37 NHL patients at high risk for progression or early (

Background Surgery is the elective treatment for cervical relapse from differentiated thyroid cancer (DTC) but it is technically challenging, with risk of failure and morbidity. We explored the feasibility and the efficacy of Radioguided Occult Lesion Localization (ROLL) with intratumoral 99mTc radiolabeled human albumin macroaggregates ([99mTc]MAA) injection in this setting. Methods Fifteen patients who underwent ROLL by ultrasonography (US)-guided intratumoral injection of [99mTc]MAA between December 2013 and October 2016 for DTC recurrence were considered for this study. An hand-held gamma-probe was employed for intrasurgical lesion detection. Mini-invasive ROLL-guided excision for soft tissue recurrence and ROLL-assisted modified radical neck dissection for lymph-node metastases were performed respectively. Results DTC recurrence was located in loco-regional lymph-nodes (n=8 patients) and in thyroid bed (n=7 patients). A total of 27 lesions was identified and injected before surgery. On a total of 124 lesions resected, histology showed 38 DTC metastases. In particular, 26 out of 27 lesions injected with [99mTc]MAA were correctly detected intra-operatively and resected without surgical complications. Ten patients received subsequent radioactive iodine (RAI) treatment to verify the complete recurrence resection. At a median follow-up of 16 months patients were classified in complete response (n=4), biochemical incomplete response (n=3), indeterminate response (n=1) with no evidence of structural disease. The remaining 7 patients were classified as structural incomplete response for cervical persistent disease (n=2), for cervical recurrence (n=2) and for both cervical and lung metastases progression (n=3). Conclusions ROLL is a simple and safe procedure in the surgical management of DTC loco-regional relapse.

The Briganti updated nomogram (BN) is the most popular predictive model aiming to predict the presence of lymph node invasion (LNI) in patients with prostate cancer (PCa), but it lacks information obtained by preoperative imaging. The primary aim of the study was to evaluate the role of multiparametric prostate magnetic resonance imaging (mp-MRI) in the indication to perform pelvic lymph nodes dissection (PLND) or not in patients with risk of LNI according to BN below 5%. Since March 2012 and September 2016, 310 patients who underwent a preoperative mp-MRI for staging purpose and subsequent robot-assisted extended PLND (RAEPLND) were retrospectively evaluated. Mp-MRIs were prospectively analyzed by two experienced radiologists. The imaging parameters analyzed were the presence of extracapsular extension (ECE), seminal vesicles invasion (SVI) and predominant Gleason pattern 4 (pG4). All patients underwent RAEPLND by two experienced surgeons with a standardized technique. A dedicated uropathologist performed all pathological analysis. Univariate analysis and multivariate logistic regression analysis were used in order to identify the predictors of LNI in patients with PCa. In the overall population, 57 (18.4%) patients had histologically proven pN1 disease. 48/250 patients (19.2%) with a risk of LNI ≥5% as calculated by the BN were staged pN1 at final histopathological analysis. 9/60 patients (15.0%) with a risk of LNI

Long-term follow-up of allogeneic stem cell transplantation in relapsed/refractory Hodgkin lymphoma

Since there is little knowledge regarding the quality of life (QoL) of cancer patients on home parenteral nutrition (HPN), we planned a prospective, longitudinal, double‐center study to investigate the changes of QoL in these patients. One hundred and eleven adult cancer patients who were candidates for HPN following the indications of the European guidelines were consecutively enrolled. For QoL analysis, EORTC QLQ‐C30 questionnaires were filled at the HPN start and after 1, 2, 3, and 4 months, and scores changes over time were analyzed according to the univariate mixed‐effects linear model for repeated measures. Most patients had gastrointestinal cancers, were severely malnourished, and were in stage IV; two‐thirds were still receiving oncologic treatments. Median weight loss over 3 months and body mass index were 11.7% and 20.7, respectively. Median survival was 4.7 (1–42) months; 67 and 34% of patients survived 3 and 6 months, respectively. Global QoL, physical functioning, role functioning, emotional functioning, appetite loss, and fatigue scores had a statistically significant trend over time (P

Objective To evaluate the variability in prostate cancer gene 3 (PCA3) score over time in men with elevated serum prostate-specific antigen (PSA) levels who are undergoing first or repeat prostate biopsy. Patients and Methods A total of 360 men from two Italian institutions who had undergone at least two PCA3 assessments were selected. Of these, 97.5% were scheduled for first or repeat prostate biopsy because of elevated PSA level and/or positive digital rectal examination (DRE). We compared the PCA3 scores in men with a negative biopsy (normal parenchyma, benign prostatic hyperplasia [BPH], chronic prostatitis, high-grade prostate intraepithelial neoplasia [HG-PIN]) with those in men with a positive biopsy. We evaluated PCA3 repeated measures biological variability and its possible association with basic patient characteristics (age, family history of prostate cancer, DRE, prostate volume, BPH, prostatitis and HG-PIN). Three different thresholds were used to evaluate the possible changes in risk class: the standard threshold (a PCA3 score of 35), a US Food and Drug Administation-approved PCA3 threshold of 25 and a threshold selected based on our previous research which was a PCA3 score of 50. Results The PCA3 scores varied significantly (P < 0.001) when comparing men with a negative biopsy with those with a positive biopsy (median [range] PCA3 score: 25 [2–276] vs 43 [7–331]). There was no significant difference in PCA3 scores in men with chronic prostatitis and HG-PIN compared with other men with negative biopsies. The median (range) time between the two PCA3 assessments was 16.2 (3–53.7) months. No association was found between PCA3 repeated measures modifications and age, family history of prostate cancer, DRE, BPH, prostatitis, HG-PIN and use of 5-α-reductase inhibitors. The variability of PCA3 scores on repeated measures confirmed the risk class for about 80% of patients; of the remaining 20% of patients, the risk class was upgraded in two thirds and downgraded in one third. Conclusion PCA3 score can be considered a stable marker over time in most cases but there is a group of men among whom there is clinically notable risk class change. Further investigation is required to determine the genesis of this phenomenon.

We evaluated a maintenance, post-remission treatment with low-dose chemotherapy plus differentiating agents on poor-prognosis acute myeloid leukemia (AML)/myelodysplastic syndrome (MDS) patients ineligible to allografting. Patients had either age over 60 and/or secondary AML, therapy-related AML, previous relapse, high-risk MDS. Forty-five patients received the maintenance therapy based on two alternated schedules: (a) 6-thioguanine + 13-cis retinoic acid + dihydroxylated vitamin D3 and (b) low-dose cytarabine + 6-mercaptopurine + all-trans retinoic acid + dihydroxylated vitamin D3. We compared their outcome, at a median follow-up of 52 months, to that of a matched population of 49 patients who stopped treatments after consolidation. Maintenance group had a lower relapse incidence (70.3 vs. 86.4 % at 5 years p = 0.007) and a longer disease-free survival (median 21.2 vs. 8.7 months, p = 0.017). The relapse reduction improved overall survival: median 40.4 months (35.9 % at 5 years) for maintenance group vs. 15.8 (14.2 % at 5 years) for controls (p = 0.005). At multivariate Cox analysis, both cytogenetic and maintenance therapies resulted independent outcome predictors for overall survival. Maintenance treatment also reduced minimal residual disease (detected by WT1 and CBFβ-MYH11) in five of eight evaluable patients. The present results suggest that our strategy of maintenance therapy might improve the outcome of poor-risk AML/MDS patients.

Novel agents in combination with melphalan and prednisone (MP) significantly improved progression-free survival (PFS) and overall survival (OS) in multiple myeloma (MM). Randomized trials comparing MP plus bortezomib (VMP) versus MP plus thalidomide (MPT) are lacking. Nine hundred and fifty-six elderly (>65 years) newly diagnosed MM patients from six European randomized trials were retrospectively analyzed and matched for age, albumin, and beta2-microglobulin at diagnosis, 296 patients were selected from the VMP groups, and 294 from MPT. Complete response rate was 21% in the VMP patients and 13% in the MPT patients (P = 0.007). After a median follow-up of 34 months (range, 1-92), VMP significantly prolonged both PFS (median 32.5 vs. 22.9 months, HR 0.65; 95% CI 0.52-0.82; P < 0.001) and OS (median 79.7 vs. 45.1 months, HR 0.44; 95% CI 0.32-0.59; P < 0.001) in comparison with MPT. The benefit in terms of OS of the VMP group was quite similar among patients with different risk factors defined by sex, ISS, ECOG performance status, or serum creatinine but not among patients ≥ 75 years. Multivariate analysis confirmed that VMP was an independent predictor of longer PFS and OS. In a control-case matched analysis, PFS and OS were prolonged in patients who received VMP in comparison with those treated with MPT.

Bone marrow-derived cells (BMCs) include stem cells capable of self-renewal and differentiation into a variety of cell types. Administration of granulocyte colony-stimulating factor (G-CSF) induces the circulation of BMCs in the peripheral blood. A phase II prospective trial was carried out for evaluation of BMC mobilization induced by multiple courses of G-CSF in cirrhotic patients. Fifteen patients with advanced liver cirrhosis (Child-Pugh score ≥6 points) were enrolled and treated with a 3-day G-CSF course, administered at 3-month intervals for a total of four courses. BMC mobilization was assessed by evaluating CD34+ve cells using flow cytometry. Expressions of multiple hepatic and stem markers were assessed on mobilized CD34+ve cells. Feasibility and safety were explored; clinical and adverse events were compared to those of a control group. Telomere length was monitored to rule out early cell aging caused by G-CSF. A significant increase in G-CSF-induced circulating CD34+ve cells was consistently observed, although a progressive reduction of peak values was documented from cycle I to IV (p

The role of laparoscopy in the treatment of extraperitoneal rectal cancer is still controversial. The aim of the study was to evaluate differences in safety of laparoscopic rectal resection for extraperitoneal cancer, compared with open surgery.A systematic review from 2000 to July 2012 was performed searching the MEDLINE and EMBASE databases (PROSPERO registration number CRD42012002406). We included randomized and prospective controlled clinical studies comparing laparoscopic and open resection for rectal cancer. Primary endpoints were 30-day mortality and morbidity. Then a meta-analysis was conducted by a fixed-effect model, performing a sensitivity analysis by a random-effect model. Relative risk (RR) was used as an indicator of treatment effect.Eleven studies, representing 1684 patients, met the inclusion criteria: four were randomized for a total of 814 patients. Mortality was observed in 1.2% of patients in the laparoscopic group and in 2.3% of patients in the open group, with an RR of 0.56 (95% CI 0.19-1.64, p = 0.287). The overall incidence of short-term complications was lower in the laparoscopic group (31.5%) compared to the open group (38.2%), with an RR of 0.83 (95% CI 0.73-0.94, p = 0.004). Surgical complications, wound complications, blood loss and the need for blood transfusion, time for bowel movement recovery, food intake recovery, and hospital stay were significantly lower or less frequent in the laparoscopic group. The incidence of intra-operative injuries, anastomotic leakages, and surgical re-interventions was similar in the two groups. Only operative time was in favour of the open group.Based on the evidence of both randomized and prospective controlled series, mortality was lower after laparoscopy although not significantly so, while the short-term morbidity RR, including subgroup analysis, was significantly lower after laparoscopy for extraperitoneal rectal cancer compared to open surgery.