Single-Dose Intra-Articular Administration of a Hybrid Cooperative Complex of Sodium Hyaluronate and Sodium Chondroitin in the Treatment of Symptomatic Hip Osteoarthritis: A Single-Arm, Open-Label, Pilot Study

INTRODUCTION: Intra-articular (i.a.) hyaluronic acid is an accepted conservative therapy for knee osteoarthritis (OA). This study evaluated the safety and efficacy of a single i.a. injection of an innovative formulation of sodium hyaluronate 2.4% plus sodium chondroitin non-sulphated 1.6% of biotechnological origin (HA-SC) for the treatment of patients with radiographically confirmed symptomatic hip OA and moderate-to-severe pain.METHODS: In this prospective, multicenter, open-label, pilot study, HA-SC was administered using a standard ultrasound-guided procedure. Adverse events, global/local evaluation of tolerability, and use of rescue analgesics were recorded. Efficacy endpoints included visual analogue scale (VAS) measurement of hip pain, changes in Lequesne's algofunctional Index, and assessment of global status.RESULTS: Treatment was well tolerated; adverse device events of moderate-to-severe intensity, most commonly, injection site pain/localized arthralgia occurred in 20.8% of subjects. Global evaluation of tolerability was rated as excellent or good (75.0%), fair (16.7%), and poor (8.3%) by subjects and 77.1, 14.6, and 8.3%, respectively, by investigators. There was a rapid and significant decrease in hip pain after a single injection; VAS pain score decreased from a mean of 67.5mm at baseline to 29.3mm by day 7, with the effects sustained during 6months of follow-up (P<0.0001). There were significant improvements in Lequesne's Index for hip OA total scores at all time points during follow-up (P<0.0001). The majority of subjects reported 'Very much improved' or 'Slightly improved' global improvement at any time point. Use of rescue paracetamol was generally low.CONCLUSIONS: A single i.a. injection of an innovative HA-SC formulation was well tolerated, safe, and effective in the treatment of symptomatic hip OA

Follow-up after bariatric surgery: is it time to tailor it? Analysis of early predictive factors of 3-year weight loss predictors of unsuccess in bariatric patients

Bariatric surgery (BS) is the most effective treatment strategy for obesity. Nevertheless, a subset of patients does not reach a successful weight loss or experience long-term weight regain. Conflicting evidence exists regarding predictors of BS outcomes. We aimed to define the early factors linked to 3 year unsuccessful weight loss in order to promote a tailored close follow-up. We enrolled 443 patients who underwent BS from January 2014 to December 2018 with a 3 year follow-up. An unsuccessful BS outcome was defined as a percentage of total weight loss (%TWL) <20. We compared the characteristics between successful and unsuccessful patients in order to identify predictor factors of unsuccess after surgery. We found that the proportion of patients with unsuccessful weight loss progressively increased from one to three years after BS. In a multiple regression model, only 1 month %TWL and sleeve gastrectomy (SG) were significantly associated with 3 year unsuccessful weight loss. We stratified our cohort in four groups according to the risk of BS unsuccess, in terms of 1 month %TWL and type of surgery (SG vs gastric bypass). Interestingly, groups showed a significant difference in terms of %TWL at each follow-up point. Patients submitted to SG with lower 1 month %TWL must be considered at higher risk of future weight regain; consequently, they require a tailored and closer follow-up.[GRAPHICS]. © 2022, The Author(s)

PIK3CA mutation in gastric cancer and the role of microsatellite instability status in mutations of exons 9 and 20 of the PIK3CA gene

8noopenBackground. A better understanding of molecular gastric cancer (GC) entities may help in tailored treatments of that neoplasm. The PIK3CA mutation is one of the most important in many cancers. Objectives. We performed a comparison of clinical and pathological data of the PIK3CA mutation in GC patients. Material and methods. The analysis was done on 472 patients operated on in one center. Polymerase chain reaction (PCR) was used for the screening of PIK3CA (exon 9 and 20). For microsatellite instability (MSI) we used 5 quasi-monomorphic mononucleotide repeats − BAT-26, BAT-25, NR-24, NR-21, and NR-27. The clinical and pathological data was analyzed. Results. PIK3CA mutation was observed in 10 out of 472 GC patients (2.1%). Nine out of 10 were MSI (9 of 111 MSI patients – 8.1%). Half of the 10 patients had mutations in exon 9 and the other half in exon 20. A majority of patients with the PIK3CA mutation had MSI (p < 0.001). The 5-year survival of MSI patients with the PIK3CA mutation was 40% and without the mutation, 70.4% (p = 0.309). For patients with the mutation in exon 9, the 5-year survival was 0%, and for those with the mutation in exon 20, 80% (p = 0.031). The Cox proportional hazards regression analysis did not show that PIK3CA is statistically correlated with a worse overall survival. Conclusions. PIK3CA mutation in GC is a rare finding. It is strongly associated with the MSI molecular subgroup, presenting a worse outcome than other MSI patients. A completely different outcome is associated with the mutation in exon 9 compared to the mutation in exon 20, with the latter being more favorable.openPolom, Karol; Marrelli, Daniele; Roviello, Giandomenico; Pascale, Valeria; Voglino, Costantino; Vindigni, Carla; Generali, Daniele; Roviello, FrancoPolom, Karol; Marrelli, Daniele; Roviello, Giandomenico; Pascale, Valeria; Voglino, Costantino; Vindigni, Carla; Generali, Daniele; Roviello, Franc

A Knowledge, Attitude, and Perception Study on Flu and COVID-19 Vaccination during the COVID-19 Pandemic: Multicentric Italian Survey Insights

In January 2020, Chinese health authorities identified a novel coronavirus strain never before isolated in humans. It quickly spread across the world, and was eventually declared a pandemic, leading to about 310 million confirmed cases and to 5,497,113 deaths (data as of 11 January 2022). Influenza viruses affect millions of people during cold seasons, with high impacts, in terms of mortality and morbidity. Patients with comorbidities are at a higher risk of acquiring severe problems due to COVID-19 and the flu-infections that could impact their underlying clinical conditions. In the present study, knowledge, attitudes, and opinions of the general population regarding COVID-19 and influenza immunization were evaluated. A multicenter, web-based, cross-sectional study was conducted between 10 February and 12 July 2020, during the first wave of SARS-CoV-2 infections among the general population in Italy. A sample of 4116 questionnaires was collected at the end of the study period. Overall, 17.5% of respondents stated that it was unlikely that they would accept a future COVID-19 vaccine (n = 720). Reasons behind vaccine refusal/indecision were mainly a lack of trust in the vaccine (41.1%), the fear of side effects (23.4%), or a lack of perception of susceptibility to the disease (17.1%). More than 50% (53.8%; n = 2214) of the sample participants were willing to receive flu vaccinations in the forthcoming vaccination campaign, but only 28.2% of cases had received it at least once in the previous five seasons. A higher knowledge score about SARS-CoV-2/COVID-19 and at least one flu vaccination during previous influenza seasons were significantly associated with the intention to be vaccinated against COVID-19 and influenza. The continuous study of factors, determining vaccination acceptance and hesitancy, is fundamental in the current context, in regard to improve vaccination confidence and adherence rates against vaccine preventable diseases

Recurrence: Treatment or Just Palliation?

Recurrent esophago-gastric junction adenocarcinoma is not a rare event but its correct management is still debated. Many different approaches to the treatment of these patients exist, but only few studies compare the different techniques. Most of the studies are retrospectives series and describe the experiences of single institutions in the treatment of recurrent esophageal and esophago-gastric junction cancer. Nowadays, surgery is still the main and only treatment for curative intent. Among the alternative therapies that only have a palliative purpose is: endoscopic stent placement and balloon dilation, photodynamic therapy, thermal tumor ablation (laser photoablation and Argon plasma coagulation), radiation therapy and brachytherapy, and chemotherapy. The aim of this review is to investigate the different rates, patterns and timings of recurrence of this tumor, and eventually to explain the various approaches used for treating the recurrent esophago-gastric junction cancer

The pattern of lymph node metastases in microsatellite unstable gastric cancer

Background Microsatellite instability (MSI) is one of the new groups of molecular divisions of gastric cancer (GC). The aim of this study was to investigate the pattern of lymph node metastasis according to MSI status. Methods MSI analysis of 361 GC patients with information about lymph node stations was performed using 5 quasimonomorphic mononucleotide repeats. The metastasis rates for each lymphatic station was analyzed, combined with clinicopathologic characteristics. Stations were divided into compartments 1–3 on the basis of Japanese Classification. A median number (interquartile range, IQR) of 33 (18–50) lymph nodes were removed and analyzed. Results N0 status was observed in 53.7% MSI patients, and in 29.7% microsatellite stable (MSS) (p < 0.001).The median value of involved nodes was 1 in MSI vs. 5 in MSS (p < 0.001). Furthermore, the number of involved node stations was significantly lower in the MSI group (p < 0.001). MSS tumors showed a higher propensity to spread to second and third compartment nodes. In absence of lymphovascular invasion only 3.2% cases demonstrated positive nodes beyond the first compartment. Skip metastases were seen in 6.1% MSS patients and 0% MSI (p = 0.011). No difference in the 10-year cancer related survival among MSI and MSS patients was found, for both those with 1st compartment (p = 0.223) and with 2nd compartment involvement (p = 0.814). Conclusions MSI GC shows a high rate of N0 stage, a lower number of lymph node metastases, and a less extensive spread to lymph node stations than MSS tumors. These data indicate that tailored lymphadenectomy may be investigated for these patients

Clinical and oncological value of preoperative BMI in gastric cancer patients: A single center experience

Introduction. The impact of preoperative BMI on surgical outcomes and long-term survival of gastric cancer patients was investigated in various reports with contrasting results. Materials & Methods. A total of 378 patients who underwent a surgical resection for primary gastric cancer between 1994 and 2011 were retrospectively studied. Patients were stratified according to BMI into a normal group (<25, group A), an overweight group (25-30, group B), and an obesity group (≥30, group C). These 3 groups were compared according to clinical-pathological characteristics, surgical treatment, and long-term survival. Results. No significant correlations between BMI and TNM (2010), UICC stage (2010), Lauren's histological type, surgical results, lymph node dissection, and postoperative morbidity and mortality were observed. Factors related to higher BMI were male gender (P < 0.05), diabetes (P < 0.001), and serum blood proteins (P < 0.01). A trend to fewer lymph nodes retrieved during gastrectomy with lymphadenectomy in overweight patients (B and C groups) was observed, although not statistically significant. There was no difference in overall survival or disease-specific survival between the three groups. Conclusion. According to our data, BMI should not be considered a significant predictor of postoperative complications or long-term result in gastric cancer patients

Recurrence after surgery in esophago-gastric junction adenocarcinoma: Current management and future perspectives

Recurrent esophago-gastric junction adenocarcinoma is not a rare event and its correct management is still debated. Many approaches for the treatment of these patients exist, but only few studies compare the different techniques. Most of the studies are retrospectives series and describe the experiences of single institutions in the treatment of recurrent esophageal and esophago-gastric junction cancers. Nowadays surgery is still the main and only curative treatment. Other alternative palliative therapies could be endoscopic stent placement and balloon dilation, photodynamic therapy, thermal tumor ablation (laser photoablation and Argon plasma coagulation), radiation therapy and brachytherapy, and chemotherapy. The aim of this review is to investigate the different rates, patterns and timings of recurrence of this tumor, and to explain the various approaches used for the treatment of recurrent esophago-gastric junction cancer

Single Center Experience on Anatomy-and Histopathology-Based Gastric Cancer Molecular Classification

We analyzed the clinical utility of molecular classification based on anatomical and histological background. The study was conducted on 457 patients treated for gastric cancer with additional information about microsatellite instability status. We divided the patients in three groups of molecular classification based on anatomical and histological background: proximal non-diffused, diffused, and distal non-diffused groups. These groups varied in terms of clinical and pathological factors as well as survival rates. The molecular classification based on anatomical and histological data seems to be a useful tool in a simple classification of gastric cancer