Esophagogastroduodenoscopy (EGD) appropriateness in Open-Access System (OAS) is a relevant issue. The Gastropack Access System (GAS) is a new system to access gastroenterological services, based on ...the partnership between Gastroenterologists and GPs. This study aims to evaluate if GAS is superior to OAS in terms of EGDS appropriateness. Secondarily, we evaluated the diagnostic yield of EGDS according to ASGE guidelines. The GAS was developed in an area of Bologna where General Practitioners (GPs) could decide to directly prescribe EGDS through OAS or referring to GAS, where EGDS can be scheduled after contact between GPs and specialists sharing a patient's clinical information. Between 2016 and 2019, 2179 cases (M:F = 861:1318, median age 61, IQR 47.72) were referred to GAS and 1467 patients (65%) had a prescription for EGDS; conversely, 874 EGDS were prescribed through OAS (M:F = 383:491; median age 58 yrs, IQR 45.68). Indication was appropriate in 92% in GAS (1312/1424) versus 71% in OAS (618/874),
< 0.001. The rate of clinically significant endoscopic findings (CSEF) was significantly higher in GAS (49% vs. 34.8%,
< 0.001). Adherence to ASGE guidelines was not related to CSEF; however, surveillance for pre-malignant conditions was independently related to CSEF. All neoplasm were observed in appropriate EGD. GAS is an innovative method showing extremely high rates of appropriateness. ASGE guidelines confirmed their validity for cancer detection, but their performance for the detection of other conditions needs to be refined.
Systemic treatment Reig, Maria, MD; Gazzola, Alessia, MD; Di Donato, Roberto, MD ...
Baillière's best practice & research. Clinical gastroenterology,
10/2014, Letnik:
28, Številka:
5
Journal Article
Recenzirano
Abstract In the last years the management of patients with liver cancer has been improved. The BCLC staging/treatment strategy identifies the optimal candidates for each treatment option and ...sorafenib is the only effective systemic treatment. Others (sunitinib, brivanib, linifanib, everolimus, ramucirumab) have failed in terms of safety/survival benefit. Some patients at intermediate/early stage, may be considered for systemic therapy when options of higher priority may have failed or not be feasible. The 800 mg/day is the recommended starting dose. Close follow-up and easy access for the patients so that they can report any adverse event and implement dose adjustments is the key point in the management of them. Development of early dermatologic adverse events has been correlated with better outcome and the pattern of radiologic progression characterizes better the prognosis/outcome of these patients. Treatment beyond progression may be considered if there is no option for a second line research trial.
Prognostic assessment in patients with hepatocellular carcinoma (HCC) remains controversial. Using the Italian Liver Cancer (ITA.LI.CA) database as a training set, we sought to develop and validate a ...new prognostic system for patients with HCC.
Prospective collected databases from Italy (training cohort, n = 3,628; internal validation cohort, n = 1,555) and Taiwan (external validation cohort, n = 2,651) were used to develop the ITA.LI.CA prognostic system. We first defined ITA.LI.CA stages (0, A, B1, B2, B3, C) using only tumor characteristics (largest tumor diameter, number of nodules, intra- and extrahepatic macroscopic vascular invasion, extrahepatic metastases). A parametric multivariable survival model was then used to calculate the relative prognostic value of ITA.LI.CA tumor stage, Eastern Cooperative Oncology Group (ECOG) performance status, Child-Pugh score (CPS), and alpha-fetoprotein (AFP) in predicting individual survival. Based on the model results, an ITA.LI.CA integrated prognostic score (from 0 to 13 points) was constructed, and its prognostic power compared with that of other integrated systems (BCLC, HKLC, MESIAH, CLIP, JIS). Median follow-up was 58 mo for Italian patients (interquartile range, 26-106 mo) and 39 mo for Taiwanese patients (interquartile range, 12-61 mo). The ITA.LI.CA integrated prognostic score showed optimal discrimination and calibration abilities in Italian patients. Observed median survival in the training and internal validation sets was 57 and 61 mo, respectively, in quartile 1 (ITA.LI.CA score ≤ 1), 43 and 38 mo in quartile 2 (ITA.LI.CA score 2-3), 23 and 23 mo in quartile 3 (ITA.LI.CA score 4-5), and 9 and 8 mo in quartile 4 (ITA.LI.CA score > 5). Observed and predicted median survival in the training and internal validation sets largely coincided. Although observed and predicted survival estimations were significantly lower (log-rank test, p < 0.001) in Italian than in Taiwanese patients, the ITA.LI.CA score maintained very high discrimination and calibration features also in the external validation cohort. The concordance index (C index) of the ITA.LI.CA score in the internal and external validation cohorts was 0.71 and 0.78, respectively. The ITA.LI.CA score's prognostic ability was significantly better (p < 0.001) than that of BCLC stage (respective C indexes of 0.64 and 0.73), CLIP score (0.68 and 0.75), JIS stage (0.67 and 0.70), MESIAH score (0.69 and 0.77), and HKLC stage (0.68 and 0.75). The main limitations of this study are its retrospective nature and the intrinsically significant differences between the Taiwanese and Italian groups.
The ITA.LI.CA prognostic system includes both a tumor staging-stratifying patients with HCC into six main stages (0, A, B1, B2, B3, and C)-and a prognostic score-integrating ITA.LI.CA tumor staging, CPS, ECOG performance status, and AFP. The ITA.LI.CA prognostic system shows a strong ability to predict individual survival in European and Asian populations.
Summary
Background
In HCV‐infected cirrhotic patients with successfully treated early hepatocellular carcinoma (HCC), the time to HCC recurrence and the effects of sustained viral eradication (SVR) ...by interferon (IFN)‐based or IFN‐free regimens on HCC recurrence remain unclear.
Aim
To perform an indirect comparison of time to recurrence (TTR) in patients with successfully treated early HCC and active HCV infection with those of patients with SVR by IFN‐based and by IFN‐free regimens.
Methods
We evaluated 443 patients with HCV‐related cirrhosis and Barcelona Clinic Liver Cancer Stage A/0 HCC who had a complete radiological response after curative resection or ablation. Active HCV infection was present in 328, selected from the Italian Liver Cancer group cohort; 58 patients had SVR achieved by IFN‐free regimens after HCC cure, and 57 patients had SVR achieved by IFN‐based regimens after HCC cure. Individual data of patients in the last two groups were extracted from available publications.
Results
TTR by Kaplan–Meier curve was significantly lower in patients with active HCV infection compared with those with SVR both by IFN‐free (P = 0.02) and by IFN‐based (P < 0.001) treatments. TTR was similar in patients with SVR by IFN‐free or by IFN‐based (P = 0.49) strategies.
Conclusion
In HCV‐infected, successfully treated patients with early HCC, SVR obtained by IFN‐based or IFN‐free regimens significantly reduce tumour recurrence without differences related to the anti‐viral strategy used.
Objective: The objectives of our study were firstly to characterize the treatment stage migration phenomenon in early (Barcelona Clinic Liver Cancer BCLC-0/A) stage hepatocellular carcinoma (HCC) by ...comparing the efficacy of curative therapies with trans-arterial chemoembolization TACE and secondly, determining baseline and on-treatment predictors of survival.
Methods: All patients within BCLC-0/A stage from six tertiary hospitals who received curative therapy with either resection, transplantation, or ablation or TACE as first-line treatment were included in the analyses. The primary endpoint was overall survival; secondary end-points were transplant-free survival and recurrence-free survival.
Results: Between January 2000 and December 2013, we identified 253 BCLC-0/A HCC patients of whom 148 (58.5%) received curative therapy and 105 (41.5%) migrated to TACE. Patients undergoing TACE had lower median survival (2.7 vs. 6.7 years; p < .0001), transplant-free survival (2.6 vs. 4.8 years; p < .0001) and recurrence-free survival (1.3 vs. 2.7 years; p < .001). On multivariate analysis treatment allocation to TACE was an independent prognostic predictor for both lower overall survival (HR 1.70, p = .04) and for HCC recurrence (HR 2.25, p < .001). The main prognostic determinant for each target outcome was Child-Pugh score.
Conclusions: Our study confirms that curative treatments should always be preferred when applicable in early-stage HCC, but that in cases where this is not possible, TACE is a reasonable albeit inferior treatment option. In addition, it provides unique prognostic information on a significant proportion of patients with early-stage disease in whom curative therapy is not applicable.
Background & Aims
Determining risk for recurrence or survival after curative resection or ablation in patients with hepatitis C virus (HCV)‐related hepatocellular carcinoma (HCC) is important for ...stratifying patients according to expected outcomes in future studies of adjuvant therapy in the era of direct‐acting antivirals (DAAs). The aims of this meta‐analysis were to estimate the recurrence and survival probabilities of HCV‐related early HCC following complete response after potentially curative treatment and to identify predictors of recurrence and survival.
Methods
Studies reporting time‐dependent outcomes (HCC recurrence or death) after potentially curative treatment of HCV‐related early HCC were identified in MEDLINE through May 2016. Data on patient populations and outcomes were extracted from each study by three independent observers and combined using a distribution‐free summary survival curve. Primary outcomes were actuarial probabilities of recurrence and survival.
Results
Eleven studies met the inclusion criteria. Pooled estimates of actuarial recurrence rates were 7.4% at 6 months and 47.0% at 2 years. Pooled estimates of actuarial survival rates were 79.8% at 3 years and 58.6% at 5 years. Heterogeneity among studies was highly significant for all outcomes. By univariate meta‐regression analyses, lower serum albumin, randomized controlled trial study design and follow‐up were independently associated with higher recurrence risk, whereas tumour size and alpha‐foetoprotein levels were associated with higher mortality.
Conclusions
This meta‐analysis showed that recurrence risk and survival are extremely variable in patients with successfully treated HCV‐related HCC, providing a useful benchmark for indirect comparisons of the benefits of DAAs and for a correct design of randomized controlled trials in the adjuvant setting.
Summary
Background
Hepatitis C virus (HCV) and alcohol abuse are the main risk factors for hepatocellular carcinoma (HCC) in Western countries.
Aim
To investigate the role of alcoholic aetiology on ...clinical presentation, treatment and outcome of HCC as well as on each Barcelona Clinic Liver Cancer (BCLC) stage, as compared to HCV‐related HCCs.
Methods
A total of 1642 HCV and 573 alcoholic patients from the Italian Liver Cancer (ITA.LI.CA) database, diagnosed with HCC between January 2000 and December 2012 were compared for age, gender, type of diagnosis, tumour burden, portal vein thrombosis (PVT), oesophageal varices, liver function tests, alpha‐fetoprotein, BCLC, treatment and survival. Aetiology was tested as predictor of survival in multivariate Cox regression models and according to HCC stages.
Results
Cirrhosis was present in 96% of cases in both groups. Alcoholic patients were younger, more likely male, with HCC diagnosed outside surveillance, in intermediate/terminal BCLC stage and had worse liver function. After adjustment for the lead‐time, median (95% CI) overall survival (OS) was 27.4 months (21.5–33.2) in alcoholic and 33.6 months (30.7–36.5) in HCV patients (P = 0.021). The prognostic role of aetiology disappeared when survival was assessed in each BCLC stage and in the Cox regression multivariate models.
Conclusions
Alcoholic aetiology affects survival of HCC patients through its negative effects on secondary prevention and cancer presentation but not through a greater cancer aggressiveness or worse treatment result. In fact, survival adjusted for confounding factors was similar in alcoholic and HCV patients.
From its approval in 2008, sorafenib is the recommended treatment option for advanced-stage patients and its safety and efficacy has been confirmed by several studies. However, its mechanism of ...action is not completely understood and many efforts have been dedicated to investigating possible treatment response predictors. Dermatological adverse events occurring within the first 2 months of treatment are predictors of longer survival, while the same role for hypertension and diarrhea still needs a prospective confirmation. This association is opposite to the strategy of starting at a low dose as it may imply suboptimal drug exposure. In case of radiological progression, the appearance of new extrahepatic metastasis or vascular invasion significantly worsens life expectancy if compared to other patterns of progression. To date no genetic or biologic marker is available to predict response, even if some encouraging results have been reported by the study of polymorphism of VEGF and its receptor. Currently, data are conflicting about the possible predictive role of α-fetoprotein. Due to failure or the progression of therapies for earlier evolutionary stages (BCLC B) some patients in such a clinical profile may be treated with sorafenib. Indeed, almost 50% of the sorafenib-treated patients belong to this class. Patients with severely decompensated liver disease (jaundice, ascites in need of intense diuretic therapy/paracentesis) may not benefit from treatment. The use of sorafenib in the waiting list for liver transplantation is controversial, while its use at an advanced age requires careful evaluation of existing comorbidities that may increase the risk of adverse events. Many strides have been made in the field of hepatocellular carcinoma systemic therapy, and many remain to be realized. Considering the disappointing results of the trials conducted on new agents, a more dynamic interpretation of events together with the development of new strategies is key to enriching new and hopefully more successful trials.
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