Local excision in rectal cancer patients with major or complete clinical response after neoadjuvant therapy: a case-matched study.

PURPOSE: To assess the long-term oncological outcomes in patients with locally advanced rectal cancer who underwent neoadjuvant therapy followed by local or total mesorectal excision. METHODS: Patients with locally advanced rectal adenocarcinoma who received neoadjuvant therapy from 2005 to 2017 were evaluated. Those with major or complete clinical response underwent a full-thickness local excision. Kaplan-Meier estimates were used to evaluate overall, disease-free, and local recurrence-free survival of patients who underwent local excision (LE group) and were compared with a matched cohort of patients who underwent total mesorectal excision (TME group). RESULTS: Among 252 patients who received neoadjuvant therapy for rectal cancer, 51 (20.2%) underwent a local excision. At a median follow-up of 61 months, patients who underwent local excision were stoma-free in 88.2% of cases and with rectum preserved in 78.5% of cases, respectively. The estimated 5-year local, disease-free, and overall survival was 91.8% vs 97.6% (95% CI: 79.5-96.8 vs 84.6-99.6), 86.7% vs 86.4% (95% CI: 72.5-93.9 vs 70.1-94.1), and 85% vs 90% (95% CI: 69.0-93.0% vs 75.3-96.2), in the study and matched control group, respectively. None of the differences was statistically significant. CONCLUSIONS: One-fifth of patients with locally advanced rectal cancer are manageable with a rectum-sparing approach after neoadjuvant therapy. With this strategy, about 80% patients will have their rectum preserved and 90% will be without stoma at long term.

Percutaneous ablation techniques for renal cell carcinoma: current status and future trends.

Percutaneous ablation is an increasingly applied technique for the treatment of localized renal tumors, especially for elderly or co-morbid patients, where co-morbidities increase the risk of traditional nephrectomy. Ablative techniques are technically suited for the treatment of tumors generally not exceeding 4 cm, which has been set as general consensus cutoff and is described as the upper threshold of T1a kidney tumors. This threshold cutoff is being challenged, but with still limited evidence. Percutaneous ablation techniques for the treatment of renal cell carcinoma (RCC) include radiofrequency ablation, cryoablation, laser or microwave ablation; the main advantage of all these techniques over surgery is less invasiveness, lower complication rates and better patient tolerability. Currently, international guidelines recommend percutaneous ablation either as intervention for frail patients or as a first line tool, provided that the tumor can be radically ablated. The purpose of this article is to describe the basic concepts of percutaneous ablation in the treatment of RCC. Controversies concerning techniques and products and the need for patient-centered tailored approaches during selection among the different techniques available will be discussed.

In-hospital mortality, 30-day readmission, and length of hospital stay after surgery for primary colorectal cancer: A national population-based study.

INTRODUCTION: The simultaneous assessment of multiple indicators for quality of care is essential for comparisons of performance between hospitals and health care systems. The aim of this study was to assess the rates of in-hospital mortality and 30-day readmission and length of hospital stay (LOS) in patients who underwent surgical procedures for colorectal cancer between 2005 and 2014 in Italy. METHODS: All patients in the National Italian Hospital Discharge Dataset who underwent a surgical procedure for colorectal cancer during the study period were included. The adjusted odd ratios for risk factors for in-hospital mortality, 30-day readmission, and LOS were calculated using multilevel multivariable logistic regression. RESULTS: Among the 353 941 patients, rates of in-hospital mortality and 30-day readmission were 2.5% and 6%, respectively, and the median LOS was 13 days. High comorbidity, emergent/urgent admission, male gender, creation of a stoma, and an open approach increased the risks of all the outcomes at multivariable analysis. Age, hospital volume, hospital geographic location, and discharge to home/non-home produced different effects depending on the outcome considered. The most frequent causes of readmission were infection (19%) and bowel obstruction (14.6%). CONCLUSIONS: We assessed national averages for mortality, LOS and readmission and related trends over a 10-year time. Laparoscopic surgery was the only one that could be modified by improving surgical education. Higher hospital volume was associated with a LOS reduction, but our findings only partially support a policy of centralization for colorectal cancer procedures. Surgical site infection was identified as the most preventable cause of readmission.

CD4 and CD4/CD8 ratio progression in HIV-HCV infected patients after achievement of SVR.

BACKGROUND: In HIV-HCV co-infected patients, the long-term effects of HCV eradication on HIV disease progression are still unclear. OBJECTIVES: This study aims to determine if CD4 and CD4/CD8 ratio slopes improved after anti-HCV treatment in patients achieving a sustained virological response (SVR). STUDY DESIGN: A total of 116 HIV-HCV co-infected patients, previously treated with Peg-IFN/RBV, were divided into two groups: SVR (55 patients who had achieved SVR), and non-SVR (61 patients). Retrospective data before and after anti-HCV therapy were obtained for all patients, with a median 8 year-follow-up. Multilevel mixed models were fitted to assess the trends over time of FIB-4 score, APRI score, CD4, CD8 cell count and CD4/CD8 ratio. RESULTS: Median HIV-infection duration, HCV-RNA and GGT baseline levels were higher in non-SVR compared to the SVR group. A significantly decreased FIB-4 (p<0.001) and APRI trend (p<0.001) after SVR was observed in SVR patients compared to those non-SVR. After adjustment for HIV duration, there was no significant difference between the two groups for absolute CD4 (p=0.08) or percentage CD4 slope (p=0.6) over time. The CD4/CD8 ratio trend also demonstrated a similar progressive increase in both groups (p=0.2). During follow-up, six deaths were reported in the non-SVR group versus no death for the SVR group, while no difference in AIDS and non-AIDS events was observed. CONCLUSIONS: Achievement of SVR determines an important beneficial impact in terms of liver-related mortality and fibrosis regression, but does not seem to alter neither the slope of long term CD4 gain nor the CD4/CD8 ratio evolution in ART-treated HIV-HCV co-infected patients.

Surgical Unit volume and 30-day reoperation rate following primary resection for colorectal cancer in the Veneto Region (Italy).

BACKGROUND: The aim of this study was to evaluate the impact of Surgical Unit volume on the 30-day reoperation rate in patients with CRC. METHODS: Data were extracted from the regional Hospital Discharge Dataset and included patients who underwent elective resection for primary CRC in the Veneto Region (2005-2013). The primary outcome measure was any unplanned reoperation performed within 30 days from the index surgery. Independent variables were: age, gender, comorbidity, previous abdominal surgery, site and year of the resection, open/laparoscopic approach and yearly Surgical Unit volume for colorectal resections as a whole, and in detail for colonic, rectal and laparoscopic resections. Multilevel multivariate regression analysis was used to evaluate the impact of variables on the outcome measure. RESULTS: During the study period, 21,797 elective primary colorectal resections were performed. The 30-day reoperation rate was 5.5% and was not associated with Surgical Unit volume. In multivariate multilevel analysis, a statistically significant association was found between 30-day reoperation rate and rectal resection volume (intermediate-volume group OR 0.75; 95% CI 0.56-0.99) and laparoscopic approach (high-volume group OR 0.69; 95% CI 0.51-0.96). CONCLUSIONS: While Surgical Unit volume is not a predictor of 30-day reoperation after CRC resection, it is associated with an early return to the operating room for patients operated on for rectal cancer or with a laparoscopic approach. These findings suggest that quality improvement programmes or centralization of surgery may only be required for subgroups of CRC patients.

The evolving burden of HIV infection compared with other chronic diseases in northern Italy.

OBJECTIVES: The aim of the study was to estimate the burden and direct costs of diseases in HIV-infected patients (either opportunistic illnesses or other chronic diseases) with respect to the HIV-uninfected population. These estimates will be useful for the projection of future direct costs of HIV care. PATIENTS AND METHODS: A population-based study was conducted in the Brescia Local Health Agency in northern Italy. An administrative database recorded diagnoses, deaths, drug prescriptions and health resource utilization for all medical and surgical patients in the region from 2003 to 2007. The study estimated the prevalence of HIV infection as well as HIV-related mortality and annual cost per patient, and compared mortality and costs related to HIV infection with those for a set of 15 other chronic diseases. The standardized hazard ratio (SHR) and standardized mortality ratio (SMR) were obtained using an indirect standardization method. RESULTS: The prevalence of HIV infection increased from 218 per 100,000 inhabitants in 2003 to 263 per 100,000 in 2007. Although mortality rates decreased markedly (from 24 per 1000 HIV-infected patients in 2003 to 16 per 1000 in 2007), the data show that mortality was still higher in HIV-infected patients compared with the general population in the most recent years (SMR 8.8 in 2007). In each year included in the study, HIV-infected patients had higher rates of care-seeking for chronic diseases, including liver diseases (SHR>8), neuropathy, oesophagus-gastro-duodenum diseases, serious psychiatric disorders and renal failure (SHR approximately 3 for each). Also, the rate of medical attendance for neoplasias, chronic pulmonary disease, diabetes, and cardiovascular disease increased over time in HIV-infected patients compared with the general population. Ranking diseases in order of their total cost to the health system, HIV infection ranked 12th, with total costs of €28.6 million in 2007. Ranking in order of cost per patient, HIV infection ranked third, with a cost per patient of €9894 in 2007. HIV-infected patients with concomitant chronic diseases had higher average costs. The cost per patient in 2007 was €8104 for HIV-infected patients without other chronic diseases, €9908 for HIV infection plus cardiovascular disease, €11,370 for HIV infection plus chronic liver disease and €12,013 for HIV infection plus neoplasias. CONCLUSIONS: The prevalence and population cost of people living with HIV are likely to increase as a result of prolonged survival, aging of HIV-infected patients and increased risk of other chronic diseases. In the near future, HIV infection will rank as one of the most costly chronic diseases. Prevention strategies need to be more widely adopted to control the growing burden of the HIV epidemic and other chronic diseases affecting HIV-infected patients.

HCV screening to enable early treatment of hepatitis C: a mathematical model to analyse costs and outcomes in two populations.

Early treatment of acute hepatitis C virus (HCV) infections reflects a new clinical paradigm and a significant option to reduce the socioeconomic burden of HCV. Therefore, this approach seems suitable as a new strategy to face HCV and prevent end stage liver diseases and premature deaths due to progressed chronic HCV-infections. The main limitation of this approach is that the majority of acute infections show an asymptomatic course and do thus not present to the health-care settings. Screening for HCV has already been extensively studied in the literature. This paper offers further insights in screening for HCV using cost effectiveness analysis for the impact of screening in two cohorts: Injecting Drug Users (IDUs) and Individuals With Surgery (IWSs). The setting of the cost effectiveness simulation is the Veneto Region in the North-east of Italy. Using a Markov model of the natural history of HCV infection we derive costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness related to screening vs. no-screening strategies. In the IDUs cohort, the screening strategy can result in a substantial difference in premature deaths and dominates (less costs better outcomes) the no-screening one. The overall outcomes of the screening strategy are mostly affected by the prevalence of HCV and of genotypes that are more relatively more difficult to treat (above 10% of prevalence for its cost effectiveness). The number of premature deaths prevented in the IWSs cohort is lower and there seems to be an unacceptable incremental cost per QALY gained, which may be unsustainable for society.