Role of microsatellite instability and HER2 positivity in locally advanced esophago-gastric cancer patients treated with peri-operative chemotherapy

Purpose Neoadjuvant chemotherapy (NAC) significantly improved the prognosis of patients with locally advanced gastric cancer (LAGC). Several biomarkers, including HER2 and MMR/MSI are crucial for treatment decisions in the advanced stage but, currently, no biomarkers can guide the choice of NAC in clinical practice. Our aim was to evaluate the role of MSI and HER2 status on clinical outcomes. Methods We retrospectively collected LAGC patients treated with NAC and surgery +/- adjuvant chemotherapy from 2006 to 2018. HER2 and MSI were assessed on endoscopic and surgical samples. Pathologic complete response (pCR) rate, overall survival (OS), and event‐free survival (EFS) were estimated and evaluated for association with downstaging and MSI. Results We included 76 patients, 8% were classified as MSI-H, entirely consistent between endoscopic and surgical samples. Six percent of patients were HER2 positive on endoscopic and 4% on surgical samples. Tumor downstaging was observed in 52.5% of cases, with three pCR (5.1%), none in MSI-H cancers. According to MSI status, event-free survival (EFS) and overall survival (OS) were higher for MSI-H patients to MSS [EFS not reached vs 30.0 months, p = 0.08; OS not reached vs 39.6 months, p = 0.10]. Conclusion Our work confirms the positive prognostic effect of MSI-H in the curative setting of LAGC, not correlated with pathologic tumor downstaging. Prospective ad-hoc trial and tumor molecular profiling are eagerly needed (AU)

Role of microsatellite instability and HER2 positivity in locally advanced esophago-gastric cancer patients treated with peri-operative chemotherapy.

PURPOSE: Neoadjuvant chemotherapy (NAC) significantly improved the prognosis of patients with locally advanced gastric cancer (LAGC). Several biomarkers, including HER2 and MMR/MSI are crucial for treatment decisions in the advanced stage but, currently, no biomarkers can guide the choice of NAC in clinical practice. Our aim was to evaluate the role of MSI and HER2 status on clinical outcomes. METHODS: We retrospectively collected LAGC patients treated with NAC and surgery +/- adjuvant chemotherapy from 2006 to 2018. HER2 and MSI were assessed on endoscopic and surgical samples. Pathologic complete response (pCR) rate, overall survival (OS), and event-free survival (EFS) were estimated and evaluated for association with downstaging and MSI. RESULTS: We included 76 patients, 8% were classified as MSI-H, entirely consistent between endoscopic and surgical samples. Six percent of patients were HER2 positive on endoscopic and 4% on surgical samples. Tumor downstaging was observed in 52.5% of cases, with three pCR (5.1%), none in MSI-H cancers. According to MSI status, event-free survival (EFS) and overall survival (OS) were higher for MSI-H patients to MSS [EFS not reached vs 30.0 months, p = 0.08; OS not reached vs 39.6 months, p = 0.10]. CONCLUSION: Our work confirms the positive prognostic effect of MSI-H in the curative setting of LAGC, not correlated with pathologic tumor downstaging. Prospective ad-hoc trial and tumor molecular profiling are eagerly needed.

Colorectal cancer, Vitamin D and microbiota: A double-blind Phase II randomized trial (ColoViD) in colorectal cancer patients.

BACKGROUND: Several studies suggest a role of gut microbiota in colorectal cancer (CRC) initiation and progression. Vitamin D (vitD) blood levels are also inversely correlated with CRC risk and prognosis. However, these factors' interplay remains unknown. METHODS: 74 CRC patients after standard treatment were randomized to 1-year 2000 IU/day vitD or placebo.  Baseline and post-treatment fecal microbiota for shotgun metagenomics sequencing was collected. Coda-lasso and Principal Component Analysis were used to select and summarize treatment-associated taxa and pathways. Associations between vitD and taxa/pathways were investigated with logistic regression. Mediation analysis was performed to study if treatment-associated taxa mediated the effect of supplementation on 25(OH)D levels. Cox proportional-hazards model was used for disease-free survival (DFS). RESULTS: 60 patients were analyzed. Change in alpha diversity (Shannon: p = 0.77; Simpson: p = 0.63) and post-treatment beta diversity (p = 0.70) were comparable between arms. Post-treatment abundances of 63 taxa and 32 pathways differed between arms. The 63 taxa also mediated the effect of supplementation on 25(OH)D (p = 0.02). There were sex differences in vitD levels, microbiota and pathways. Pathways of essential amino acids' biosynthesis were more abundant in supplemented women. Fusobacterium nucleatum presence at baseline was associated with worse DFS (p = 0.02). Those achieving vitD sufficiency (25(OH)D≥30 ng/ml) had lower post-treatment abundances (p = 0.05). Women were more likely to have F. nucleatum post-treatment (p = 0.02). CONCLUSIONS: VitD supplementation may contribute shaping the gut microbiota and the microbiota may partially mediate the effect of supplementation on 25(OH)D. The observed sex-specific differences highlight the necessity of including sex/gender as a variable in microbiome studies.

Management of antithrombotic treatment and bleeding disorders in patients requiring venous access devices: A systematic review and a GAVeCeLT consensus statement.

Insertion of venous access devices (VAD) is usually considered a procedure with low risk of bleeding. Nonetheless, insertion of some devices is invasive enough to be associated with bleeding, especially in patients with previous coagulopathy or in treatment with antithrombotic drugs for cardiovascular disease. The current practices of platelet/plasma transfusion in coagulopathic patients and of temporary suspension of the antithrombotic treatment before VAD insertion are based on local policies and are often inadequately supported by evidence, since many of the clinical studies on this topic are not recent and are not of high quality. Furthermore, the protocols of antithrombotic treatment have changed during the last decade, after the introduction of new oral anticoagulant drugs. Though some guidelines address some of these issues in relation with specific procedures (port insertion, etc.), no evidence-based document covering all the aspects of this clinical problem is currently available. Thus, the Italian Group of Venous Access Devices (GAVeCeLT) has decided to develop a consensus on the management of antithrombotic treatment and bleeding disorders in patients requiring VADs. After a systematic review of the available evidence, the panel of the consensus (which included vascular access specialists, surgeons, intensivists, anesthetists, cardiologists, vascular medicine experts, nephrologists, infective disease specialists, and thrombotic disease specialists) has structured the final recommendations as detailed answers to three sets of questions: (1) which is an appropriate classification of VAD-related procedures based on the specific bleeding risk? (2) Which is the appropriate management of the patient with bleeding disorders candidate to VAD insertion/removal? (3) Which is the appropriate management of the patient on antithrombotic treatment candidate to VAD insertion/removal? Only statements reaching a complete agreement were included in the final recommendations, and all recommendations were offered in a clear and synthetic list, so to be easily translated into clinical practice.

WoCoVA consensus on the clinical use of in-line filtration during intravenous infusions: Current evidence and recommendations for future research.

The need for filtering intravenous infusions has long been recognized in the field of venous access, though hard scientific evidence about the actual indications for in-line filters has been scarce. In the last few years, several papers and a few clinical studies have raised again this issue, suggesting that the time has come for a proper definition of the type of filtration, of its potential benefit, and of its proper indications in clinical practice. The WoCoVA Foundation, whose goal is to increase the global awareness on the risk of intravenous access and on patients' safety, developed the project of a consensus on intravenous filtration. A panel of experts in different aspects of intravenous infusion was chosen to express the current state of knowledge about filtration and to indicate the direction of future research in this field. The present document reports the final conclusions of the panel.

Should we use a patient's port as the preferred intravenous route rather than inserting an additional venous access?

Early in 2021, the Infusion Nursing Society has released the latest version of the Infusion Therapy Standards of Practice. In the last two decades, these Standards have been representing one of the most important evidence-based documents available in the world of venous access. Nevertheless, we were quite concerned reading a recommendation included in chapter 26 (Vascular Access Device Planning: practice recommendation I, C): "Use a patient's port, unless contraindicated (e.g. existing complication) as the preferred IV route in preference to insertion of an additional VAD." Such recommendation is offered not on the basis of evidence, but as experts' opinion ("Committee Consensus"). This Editorial deals with the opinion of GAVeCeLT (The Italian Study Group for Long Term Central Venous Access) that strongly discourage the use of ports for intravenous treatment different from chemotherapy (or from the therapy that specifically required that long term, infrequent access). The rationale for this choice is based on the consideration that the patient's port-if used in a non-specialty ward-would be at high risk of complications, some of them potentially leading to the loss of the device, and that such complications might be particularly difficult to manage in this setting. The continuous or frequent use of a port transforms it into an external device, thus cancelling the main advantage of a totally subcutaneous location, while adding a significant disadvantage (need for repeated percutaneous punctures and risk of extravasation/infiltration due to improper insertion or dislocation of the non-coring needle). One exception is the possible use of port for radio-diagnostic purposes (as long as the port is power injectable). This strategy may be associated with advantages for the patient, and imaging quality improvement, but requires the adoption of specific protocols for prevention of infective and mechanical complications.

Neobladder and ablative pelvic radiotherapy: still a taboo?

The presence of a neobladder constitutes a limitation for the radiation oncologist, as there is no clear evidence about its tolerance to radiotherapy (RT). The limited literature only concerns the conventional postoperative treatment in patients with bladder cancer after cystectomy. Here we report a case of a patient with neobladder who underwent a stereotactic RT for a pelvic recurrence of disease, with response to treatment and no toxicity to the neobladder. This case represents a promising example of the chance to perform RT with ablative intent, using advanced techniques, even on lesions close to the neobladder.

Safe use of Peripherally Inserted Central Catheters for chemotherapy of solid malignancies in adult patients: A 1-year monocentric, prospectively-assessed, unselected cohort of 482 patients.

INTRODUCTION: Aim of this study was to analyze the overall complication and failure rates of Peripherally Inserted Central Catheters (PICCs), in a 1-year consecutive unselected cohort of 482 adult patients, affected by non-hematological malignancies undergoing chemotherapy. METHODS: Adult outpatients (aged 18-75 years), with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, bearing solid tumors and candidates for intravenous chemotherapy were eligible for the study. Exclusion criteria were active infections, coagulopathy (defined as platelet count <50,000/µL and/or prothrombin time more than 18 s), life expectancy <6 months, or inability to give written informed consent. Devices were all implanted in an outpatients' hospital facility, following predefined evidence-based institutional guidelines and protocols by a PICC-dedicated team at the European Institute of Oncology in Milan, Italy, during the 12-month period from January 1 to December 31, 2019. RESULTS: Five-hundred PICCs were implanted in a cohort of 482 patients during the time interval of this study. Thirty devices were overall removed (6.2%), 23 as a consequence of a complication occurred, and seven inadvertently. The inserted PICCs accounted for a total of 49,718 catheter days in situ, median duration was 85.5 days [interquartile range (IQR): 56-146]. Overall there were 42 (8.7%) complications, corresponding to 0.84 catheter-adverse events (CAE)/1000 PICC-days (95% CI: 0.61-1.14). There were N = 13 (2.7%) thromboses, N = 11 (2.3%) irreversible occlusions, N = 7 (1.5%) accidental removals, N = 5 (1.0%) infections [two Catheter Related Blood Stream Infection (CRBSI) and three exit site/local infection], N = 3 (0.6%) ruptures and N = 3 (0.6%) primary or secondary malpositions. CONCLUSION: This large prospective study supports the increasing use of PICCs in adult oncology outpatients treated in specialized centers with chemotherapy for non-hematological malignancies. In this clinical setting, PICC failure occurred in 6% only of the inserted devices.

GAVeCeLT-WoCoVA Consensus on subcutaneously anchored securement devices for the securement of venous catheters: Current evidence and recommendations for future research.

BACKGROUND: Subcutaneously anchored securement devices (or subcutaneous engineered securement devices) have been introduced recently into the clinical practice, but the number of published studies is still scarce. The Italian Group of Long-Term Central Venous Access Devices (GAVeCeLT)-in collaboration with WoCoVA (World Congress on Vascular Access)-has developed a Consensus about the effectiveness, safety, and cost-effectiveness of such devices. METHODS: After the definition of a panel of experts, a systematic collection and review of the literature on subcutaneously anchored securement devices was performed. The panel has been divided in two working groups, one focusing on adult patients and the other on children and neonates. RESULTS: Although the quality of evidence is generally poor, since it is based mainly on non-controlled prospective studies, the panel has concluded that subcutaneously anchored securement devices are overall effective in reducing the risk of dislodgment and they appear to be safe in all categories of patients, being associated only with rare and negligible local adverse effects; cost-effectiveness is demonstrated-or highly likely-in specific populations of patients with long-term venous access and/or at high risk of dislodgment. CONCLUSION: Subcutaneously anchored securement is a very promising strategy for avoiding dislodgment. Further studies are warranted, in particular for the purpose of defining (a) the best management of the anchoring device so to avoid local problems, (b) the patient populations in which it may be considered highly cost-effective and even mandatory, (c) the possible benefit in terms of reduction of other catheter-related complications such as venous thrombosis and/or infection, and-last but not least-(d) their impact on the workload and stress level of nurses taking care of the devices.

Determinants, time trends and dynamic consequences of postoperative hyperglycemia in nondiabetic patients undergoing major elective abdominal surgery: A prospective, longitudinal, observational evaluation.

BACKGROUND & AIMS: In retrospective studies an indisputable causal relationship between hyperglycemia and postoperative infections cannot be entirely disclaimed. We aimed investigate whether the time trends of blood glucose levels in the perioperative period could be a determinant of surgery-related infections. METHODS: Adult patients without diabetes who were candidates for elective major abdominal operation were prospectively enrolled in a longitudinal, observational multicenter study. The blood glucose level was measured every 6 h for 3 days. We calculated the association between blood glucose (BG) levels and the risk of occurrence of surgery-related infections using a joint regression modeling for longitudinal and time-to-event outcomes which accounts for the effect of other risk factors. RESULTS: Between January 2016 and November 2017, we obtained 6078 BG measures distributed on different time-points in 452 patients. There was a nearly 3-fold increased risk of having hyperglycemia, defined as BG ≥ 125 mg/dL, if the BG level at admission was >100 mg/dL (OR = 2.986, P < 0.001).The hazard of infection for each 10 mg/dL increase of BG levels over time was marginal (HR = 1.065, P = 0.045). The calculated risk of having an infection was 9.6% for BG going from 110 mg/dL during surgery to 84 mg/dL at the end of day 3, 10.5% for BG decreasing from 140 to 114, 11.8% for BG decreasing from 180 to 154 and 24.5% for BG increasing from 80 to 145, 24.7% for BG increasing from 110 to 175, and 25.4% for BG increasing from 140 to 205. CONCLUSIONS: The time trends of BG - as opposed to the absolute concentration -are major determinants of the risk of postoperative infections.

A rationale multidisciplinary approach for treatment of esophageal and gastroesophageal junction cancer: Accurate review of management and perspectives.

Cancer of the esophagus and of gastroesophageal junction can be cured, even if with lacking cure rate. Different approaches have been developed, mostly when carcinoma has loco-regional pattern. Multimodality therapy showed a survival rate superior than 10% if compared to a single approach. This is a systematic review, carried to assess the following matters: Which therapeutic opportunities are available? Who could benefit of them? Which adverse reactions could possibly verify? How can physicians definitely choose the proper strategy? Which is the role of surgery? We mean to give either General Practitioner or specialists clear and efficient updates about current treatment of this tumour, starting from physical examination. Four eminent guidelines were consulted for our study: Cancer Care Ontario's Program in Evidence-Based Care, NCCN, Belgian Health Care Knowledge Centre and Esmo.

Liver Resection or Resection Plus Intraoperative Echo-Guided Ablation in the Treatment of Colorectal Metastases: We Are Evaluating Their Effect for Cure.

This study determines the oncologic outcome of the combined resection and ablation strategy for colorectal liver metastases. Between January 1994 and December 2015, 373 patients underwent surgery for colorectal liver metastases. There were 284 patients who underwent hepatic resection only (Group 1) and 83 hepatic resection plus ablation (Group 2). Group 2 patients had a higher incidence of multiple metastases (100% in Group 2 vs 28.2% in Group 1; P < 0.001) and bilobar involvement (76.5% in Group 2 vs 12.9% in Group 1; P < 0.001) than Group 1 cases. Perioperative mortality was nil in either group, with a higher postoperative complication rate among Group 1 versus Group 2 cases (18 vs 0, respectively). The median follow-up was 90 months (range, 1-180), with a five-year overall survival for Group 1 and Group 2 of 51 per cent and 80 per cent, respectively (P = 0.193). Mean disease-free survival for patients with R0 resection was 55 per cent, 40 per cent, and 37 per cent at one, two, and three years, respectively, and remained steadily higher (at 50%) in those patients treated with resection combined with ablation up to five years (P = 0.069). The only intraoperative ablation failure was for a large lesion (≥5 cm). Our data support the use of intraoperative ablation when complete hepatic resection cannot be achieved.

Aggressive Surgical Approach for Treatment of Primary and Recurrent Retroperitoneal Soft Tissue Sarcoma.

To analyze treatment and survival in a series of resected patients with primary or recurrent retroperitoneal sarcoma (RPS) treated and prospectively followed at a single institution. Between July 1994 and December 2015, 89 patients (36 M, 53 F; mean age 60 years, range 25-79) were evaluated. For the purpose of analysis, complete resection was defined as removal of gross tumor with histologically confirmed clear resection margins. Eighty-three out of the 89 patients (93%), 46 of whom affected by primary RPS, and 37 by recurrent RPS, underwent surgical exploration. Sixty-two had a grossly and microscopically complete resection. Fifty-three out of 83 patients (64%) underwent removal of contiguous intra-abdominal organs. Preoperative mortality was nil and significant preoperative complications occurred in six cases only (7%). High-grade tumor pointed out to be a significant variable for a worse survival in all 83 patients amenable to undergo surgical resection (57% 5 years survival for low grade vs 14% for high grade; P = 0.0004). Among completely resected patients, only histologic grade clearly affected disease-free survival (72% 5 years survival for low grade vs 50% for high grade; P = 0.04), while the role of preoperative blood transfusions (67% 5 years survival for non-transfused patients vs 29% for transfused patients; P = 0.05) has to be evaluated in connection to patient complexity. Histological grade and recurrence are the most valuable prognostic predictors; in this clinical subset, an aggressive surgical approach in both primary and recurrent RPS is associated with a best long-term survival and disease-free survival.

Preoperative Oral Carbohydrate Load Versus Placebo in Major Elective Abdominal Surgery (PROCY): A Randomized, Placebo-controlled, Multicenter, Phase III Trial.

OBJECTIVE: To explore whether preoperative oral carbohydrate (CHO) loading could achieve a reduction in the occurrence of postoperative infections. BACKGROUND: Hyperglycemia may increase the risk of infection. Preoperative CHO loading can achieve postoperative glycemic control. METHODS: This was a randomized, controlled, multicenter, open-label trial. Nondiabetic adult patients who were candidates for elective major abdominal operation were randomized (1:1) to a CHO (preoperative oral intake of 800 mL of water containing 100 g of CHO) or placebo group (intake of 800 mL of water). The blood glucose level was measured every 4 hours for 4 days. Insulin was administered when the blood glucose level was >180 mg/dL. The primary endpoint was the occurrence of postoperative infection. The secondary endpoint was the number of patients needing insulin. RESULTS: From January 2011 through December 2015, 880 patients were randomly allocated to the CHO (n = 438) or placebo (n = 442) group. From each group, 331 patients were available for the analysis. Postoperative infection occurred in 16.3% (54/331) of CHO group patients and 16.0% (53/331) of placebo group patients (relative risk 1.019, 95% confidence interval 0.720-1.442, P = 1.00). Insulin was needed in 8 (2.4%) CHO group patients and 53 (16.0%) placebo group patients (relative risk 0.15, 95% confidence interval 0.07-0.31, P < 0.001). CONCLUSIONS: Oral preoperative CHO load is effective for avoiding a blood glucose level >180 mg/dL, but without affecting the risk of postoperative infectious complication.

Hereditary diffuse gastric cancer in two families: A case report.

Hereditary diffuse gastric cancer (HDGC) is associated with E-cadherin 1 (CDH1) germline mutations. In the present study, two unusual HDGC cases are described. Case 1 was a female with no family history of gastric cancer who developed Hodgkin's lymphoma at 19 years of age, and DGC at 32 years of age. Due to her young age (32 years), the patient was examined for CDH1 abnormalities and a deleterious mutation was identified. Her father and younger sister were identified to be carriers of the mutation. Case 2 was a 36-year-old female diagnosed with lobular breast cancer (LBC); her mother had LBC, and her grandmother had LBC and DGC. The molecular test was wild-type for breast cancer susceptibility genes 1 and 2; however, a large deletion in CDH1 was identified. At prophylactic gastrectomy, early DGC was identified. Early onset of DGC and LBC justifies testing for CDH1. A better knowledge of tumor natural history in carrier subjects is important to aid genetic counseling, in order to assess the surveillance time required prior to carrying out prophylactic surgery.

Feasibility of Transabdominal Cardiophrenic Lymphnode Dissection in Advanced Ovarian Cancer: Initial Experience at a Tertiary Center.

OBJECTIVES: The purpose of this retrospective report is to define the safety and feasibility, based on our preliminary experience, of surgical transdiaphragmatic resection of enlarged cardiophrenic lymph nodes (CPLNs), as a part of upfront debulking surgery. Supradiaphragmatic nodes located between the diaphragm and the heart are frequently a location for lymph node metastasis in advanced ovarian cancer, and their removal is aimed to obtain no gross residual disease at the primary cytoreductive surgery often requiring aggressive surgical procedures. PATIENTS AND METHODS: Between May 2012 and October 2016, a total of 22 patients among 443 with advanced high-grade serous ovarian cancer underwent cytoreductive procedures involving transdiaphragmatic resection of enlarged CPLNs at European Institute of Oncology in Milan. RESULTS: All patients who underwent CPLN resection had an extensive disease (median peritoneal cancer index, 18), and more than 77% required complex surgical procedures (complexity score, 3). No residual abdominal disease less than 5 mm at the end of surgery was described in 20 (90%) out of 22. All patients but one had confirmed CPLN positive nodes at histopathological study. The average operative time was 333 min (range, 244-455 min), and the average estimated blood loss was 1000 mL (range, 400-2000 mL). Blood transfusion was necessary in 13 out of 22 patients. Only 7 (33%) out of 21 patients required chest tube placement during the postoperative period. CONCLUSIONS: Transdiaphragmatic enlarged CPLN resection seems to be safe and feasible procedure when indicated to achieve no or minimal tumor residual disease. Nevertheless, its impact on survival of patients with stage IV ovarian cancer needs to be determined.

Multidisciplinary approach in the management of advanced ovarian cancer patients: A personalized approach. Results from a specialized ovarian cancer unit.

OBJECTIVE: The aim of the present study was to evaluate the impact of a multidisciplinary approach in patients' selection with advanced ovarian cancer (AOC) for different therapeutic strategies. METHODS: Patients referred at our institution between 2009 and 2012 for AOC were included. Primary multidisciplinary evaluation was performed in all patients. Different strategies included: 1. patients referred to primary neoadjuvant chemotherapy (NACT) and interval surgery (IDS) (group A); 2. patients considered for surgical exploration. After surgical exploration, patients were either considered for primary debulking (PDS; group B), or NACT (group C). RESULTS: A total of 363 patients were included. Of 38 patients (10.5%) in group A, 24 (63%) had sovradiaphragmatic/multiple liver metastases; 14 (37%) were excluded for PDS for anestehesiologic/medical reasons. Of 325 (89.5%) considered for surgical exploration, 295 (91%; group B) had primary surgery with debulking intent (N: 277) and were cytoreduced to no macroscopic disease (R0: N:200; 68%) o minimal RD<5mm (R1: N:77; 26%) or palliative intent (N:18; 6%); 30 (9%; group C) were referred for NACT. Of those, 27 (90%) underwent IDS, 3 had progressive disease. Overall survival (OS) and progression free survival (PFS) was different between the groups: OS: Group A: 34months; Group B: 59months; Group C: 29months; p<0.001. PFS: Group A: 10months; Group B; 21months; Group C: 12months; p<0.001. CONCLUSIONS: A multidisciplinary approach to patients referred to a tertiary center with AOC allows optimization of the treatment strategy, based on patients' characteristics (age, performance/nutritional status, comorbidities, functional status) and tumor diffusion (evaluated pre- and intraoperatively).

Evidence-based criteria for the choice and the clinical use of the most appropriate lock solutions for central venous catheters (excluding dialysis catheters): a GAVeCeLT consensus.

BACKGROUND: The most appropriate lock solution for central venous access devices is still to be defined. GAVeCeLT - the Italian group for venous access devices - has developed a consensus on the evidence-based criteria for the choice and the clinical use of the most appropriate lock solution for central venous catheters (excluding dialysis catheters). METHOD: After the constitution of a panel of experts, a systematic collection and review of the literature has been performed, focusing on clinical studies dealing with lock solutions used for prevention of occlusion (heparin, citrate, urokinase, recombinant tissue plasminogen activator [r-TPA], normal saline) or for prevention of infection (citrate, ethanol, taurolidine, ethylene-diamine-tetra-acetic acid [EDTA], vancomycin, linezolid and other antibiotics), in both adults and in pediatric patients. Studies on central lines used for dialysis or pheresis, on peripheral venous lines and on arterial lines were excluded from this analysis. Studies on lock solutions used for treatment of obstruction or infection were not considered. The consensus has been carried out according to the Delphi method. RESULTS: The panel has concluded that: (a) there is no evidence supporting the heparin lock; (b) the prevention of occlusion is based on the proper flushing and locking technique with normal saline; (c) the most appropriate lock solution for infection prevention should include citrate and/or taurolidine, which have both anti-bacterial and anti-biofilm activity, with negligible undesired effects if compared to antibiotics; (d) the patient populations most likely to benefit from citrate/taurolidine lock are yet to be defined. CONCLUSIONS: The actual value of heparinization for non-dialysis catheters should be reconsidered. Also, the use of lock with substances with anti-bacterial and anti-biofilm activity (such as citrate or taurolidine) should be taken into consideration in selected populations of patients.