rubrica

Registri di patologia

  • Emanuele Crocetti1

  1. UO Epidemiologia clinica e descrittiva, ISPO Firenze
Emanuele Crocetti -

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Ricerca bibliografica periodo dal 16 gennaio – 31 marzo 2013

Per leggere le caratteristiche di questa ROUTINE di ricerca clicca qui

Stringa: (("registries"[MeSH Terms] OR "registries"[All Fields] OR "registry"[All Fields]) OR ("registries"[MeSH Terms] OR "registries"[All Fields])) AND (("italy"[MeSH Terms] OR "italy"[All Fields]) OR italian[All Fields]) AND "humans"[MeSH Terms] AND ("2013/01/16"[PDat] : "2013/03/31"[PDat])

Di ogni articolo è disponibile l'abstract. Per visualizzarlo basta cliccare sul titolo.

1. Mitry D, Bunce C, Charteris D. Anti-vascular endothelial growth factor for macular oedema secondary to branch retinal vein occlusion. Cochrane Database Syst Rev. 2013 Jan 31;1:CD009510. doi:10.1002/14651858.CD009510.pub2.
Moorfields Eye Hospital NHS Foundation Trust, London, UK.mitryd@gmail.com.

Abstract BACKGROUND: Branch retinal vein occlusion (BRVO) is one of the most common occurring retinal vascular abnormalities. The pathogenesis of BRVO is thought to involve both retinal vein compression and damage to the vessel wall, possibly leading to thrombus formation at sites where retinal arterioles cross retinal veins. The most common cause of visual loss in patients with BRVO is macular oedema (MO). Grid or focal laser photocoagulation has been shown to reduce the risk of visual loss and improve visual acuity (VA) in up to two thirds of individuals with MO secondary to BRVO, however, limitations to this treatment exist and newer modalities have suggested equal or improved efficacy. Recently, antiangiogenic therapy with anti-vascular endothelial growth factor (anti-VEGF) has been used successfully to treat MO resulting from a variety of causes. As elevated intraocular levels of VEGF have been demonstrated in patients with retinal vein occlusions there is a strong basis for the hypothesis that anti-VEGF agents may be beneficial in the treatment of vascular leakage and MO. OBJECTIVES: To investigate the efficacy and safety of intravitreal anti-VEGF agents for preserving or improving vision in the treatment of MO secondary to BRVO. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2012, Issue 7), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to August 2012), EMBASE (January 1980 to August 2012), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to August 2012, the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 7 August 2012 and the clinical trials registers on 10 September 2012. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTS of at least six months duration where anti-VEGF treatment was compared with another treatment, no treatment, or placebo. We excluded trials where combination treatments (anti-VEGF plus other treatments) were used and trials that investigated the dose and duration of treatment without a comparison group (other treatment/no treatment/sham). DATA COLLECTION AND ANALYSIS: Two review authors independently extracted the data. The primary outcome was the proportion of participants with an improvement from baseline in best-corrected visual acuity (BCVA) of greater than or equal to 15 letters (3 lines) on the Early Treatment in Diabetic Retinopathy Study (ETDRS) Chart at six months and at 12 months of follow-up. The secondary outcomes we report are the proportion of participants who lost greater than or equal to 15 ETDRS letters (3 lines) and the mean VA change at six months and any additional follow-up intervals as well as the change in central retinal thickness on optical coherence tomography (OCT) from baseline and final reported follow-up, the number and type of complications, the number of additional interventions administered and any adverse outcomes. Where available, the cost benefit and quality of life data reported in the primary studies is presented. MAIN RESULTS: We found one RCT and one quasi-RCT that met the inclusion criteria after independent and duplicate review of the search results. The studies used different anti-VEGF agents and different study groups which were not directly comparable.One multi-centre RCT (BRAVO) conducted in the USA randomised 397 individuals and compared monthly intravitreal ranibizumab (0.3 mg and 0.5 mg) injections with sham injection. The study only included individuals with non-ischaemic BRVO. Although repeated injections of ranibizumab appeared to have a favourable effect on the primary outcome, approximately 50% of the ranibizumab 0.3 mg group and 45% of the ranibizumab 0.5 mg group received rescue laser treatment which may have an important effect on the primary outcome. In addition, during the six-month observation period 93.5% of individuals in the sham group received intravitreal ranibizumab (0.5 mg). This cross-over design limits the ability to compare the long-term impact of ranibizumab versus a pure control group.The second trial was a small study (n = 30) from Italy with limitations in study design that reported a benefit of as-required intravitreal bevacizumab (1.25 mg) over laser photocoagulation in MO secondary to BRVO. We present the evidence from these trials and other interventional case series. AUTHORS' CONCLUSIONS: The available RCT evidence suggests that repeated treatment of non-ischaemic MO secondary to BRVO with the anti-VEGF agent ranibizumab may improve clinical and visual outcomes at six and 12 months. However, the frequency of re-treatment has not yet been determined and the impact of prior or combined treatment with laser photocoagulation on the primary outcome is unclear. Results from ongoing studies should assess not only treatment efficacy but also, the number of injections needed for maintenance and long-term safety and the effect of any prior treatment.

2. Valenti R, Vergara R, Migliorini A, Parodi G, Carrabba N, Cerisano G, Dovellini EV, Antoniucci D. Predictors of reocclusion after successful drug-eluting stent-supported percutaneous coronary intervention of chronic total occlusion. J Am Coll Cardiol. 2013 Feb 5;61(5):545-50. doi: 10.1016/j.jacc.2012.10.036. Epub 2012 Dec 26.
Division of Cardiology, Careggi Hospital, Florence, Italy. Comment in J Am Coll Cardiol. 2013 Feb 5;61(5):551-2.

Abstract OBJECTIVES: This study sought to assess the incidence of reocclusion and identification of predictors of angiographic failure after successful chronic total occlusion (CTO) drug-eluting stent-supported percutaneous coronary intervention (PCI). BACKGROUND: Large registries have shown a survival benefit in patients with successful CTO PCI. Intuitively, sustained vessel patency may be considered as a main variable related to long-term survival. Very few data exist about the angiographic outcome after successful CTO PCI. METHODS: The Florence CTO PCI registry started in 2003 and included consecutive patients treated with drug-eluting stents for at least 1 CTO (>3 months). The protocol treatment included routine 6- to 9-month angiographic follow-up. Clinical, angiographic, and procedural variables were included in the model of multivariable binary logistic regression analysis for the identification of the predictors of reocclusion. RESULTS: From 2003 to 2010, 1,035 patients underwent PCI for at least 1 CTO. Of these, 802 (77%) had a successful PCI. The angiographic follow-up rate was 82%. Reocclusion rate was 7.5%, whereas binary restenosis (>50%) or reocclusion rate was 20%. Everolimus-eluting stents were associated with a significantly lower reocclusion rate than were other drug-eluting stents (3.0% vs. 10.1%; p = 0.001). A successful subintimal tracking and re-entry technique was associated with a 57% of reocclusion rate. By multivariable analysis, the subintimal tracking and re-entry technique (odds ratio [OR]: 29.5; p < 0.001) and everolimus-eluting stents (OR: 0.22; p = 0.001) were independently related to the risk of reocclusion. CONCLUSIONS: Successful CTO-PCI supported by everolimus-eluting stents is associated with a very high patency rate. Successful subintimal tracking and re-entry technique is associated with a very low patency rate regardless of the type of stent used.

3. Maisonneuve P, Marshall BC, Knapp EA, Lowenfels AB. Cancer risk in cystic fibrosis: a 20-year nationwide study from the United States. J Natl Cancer Inst. 2013 Jan 16;105(2):122-9. doi: 10.1093/jnci/djs481. Epub 2012 Nov 24.
Eng, Division of Epidemiology and Biostatistics, European Institute of Oncology, via Ripamonti 435, I-20141 Milan, Italy. patrick.maisonneuve@ieo.it

Abstract BACKGROUND: Many patients with cystic fibrosis (CF) now reach adulthood, at which time the risk of cancer is increased. The aim of this study was to determine cancer risks in nontransplanted and transplanted CF patients. METHODS: From 1990 to 2009, we followed 41,188 patients who received care at one of the 250 CF care center programs in the United States and compared the observed number of cancers in nontransplanted and transplanted patients with that expected in the general US population. RESULTS: In 344,114 patient-years of observation of nontransplanted patients, the overall cancer risk was similar to the background risk (standardized incidence ratio [SIR] = 1.1, 95% confidence interval [CI] = 1.0 to 1.3). However, we observed an elevated risk of digestive tract cancer (SIR = 3.5, 95% CI = 2.6 to 4.7) involving the esophago-gastric junction, biliary tract, small bowel, and colon. There was also an increased risk of testicular cancer (SIR = 1.7, 95% CI = 1.02 to 2.7) and lymphoid leukemia (SIR = 2.0, 95% CI = 1.2 to 3.1) and a decreased risk of malignant melanoma (SIR = 0.4, 95% CI = 0.2 to 0.9). In 8235 patient-years of observation of transplanted patients, 26 tumors were observed compared with 9.6 expected (SIR = 2.7, 95% CI = 1.8 to 3.9). The increased risk was particularly high for digestive tract cancers (SIR = 17.3, 95% CI = 10.7 to 26.5), with most cases arising in the bowel. CONCLUSIONS: The overall burden of cancer in CF patients remains low; however they have an increased risk of digestive tract cancer, particularly following transplantation. They also have increased risk of lymphoid leukemia and testicular cancer, and decreased risk of melanoma.

Breve commento a cura di E. Crocetti
Questo grande studio di coorte statunitense cerca di indagare la frequenza di tumori in 41188 pazienti con fibrosi cistica (CF) diagnosticati dal 1990 al 2009 in centri di alta specialità, confrontando quanto osservato con i tumori attesi in base ai tassi di incidenza del SEER. Un aumentato rischio di tumori, già evidenziato dagli autori in un precedente studio del 2003, potrebbe essere dovuto al disordine genetico che caratterizza la malattia, ad alcune condizioni favorenti i tumori che spesso sono associate alla CF(reflusso gastro-esofageo, malattie intestinali infiammatorie croniche, la colangite sclerosante), all’intenso follow-up radiologico, con esposizione a radiazioni ionizzanti, al quale i pazienti sono sottoposti, all’immunodepressione nei pazienti trapiantati o, ma questo gli autori non lo considerano, all’aumentata attenzione diagnostica. Lo studio conferma (344.114 anni persona) un aumento del rischio per tumori gastrointestinali , del tumore del testicolo e della leucemia acuta linfoide. L’incremento di tumori intestinali, specialmente del colonretto, è confermato anche nella sottocorte di pazienti sottoposti a trapianto (8235 anni-persona) e in quelli con il genotipo a maggior severità (2680/22248, omozigoti per la mutazione F508del). Per il melanoma si è osservato un rischio ridotto rispetto all’attesa, in particolare per i pazienti omozigoti per la mutazione F508del, questo potrebbe suggerire un ruolo protettivo di questa mutazione o piuttosto che questi pazienti soprattutto in età infantile a causa della CF hanno o possono avere avuto una limitata esposizione UV per la modesta attività all’aperto. La completezza della casistica viene analizzata relativamente al diverso percorso seguito dai pazienti, trapiantati e non, e possibili fonti di incompletezza sono suggerite. Lo studio conferma le evidenze note, ma non le trasforma in indicazioni per il follow-up clinico dei pazienti per il modesto incremento del rischio oncologico che richiede una valutazione individuale e l’identificazione di altri fattori di rischio. Solo la colonscopia è suggerita per i pazienti trapiantati.

4. Ciliberto D, Botta C, Correale P, Rossi M, Caraglia M, Tassone P, Tagliaferri P. Role of gemcitabine-based combination therapy in the management of advanced pancreatic cancer: a meta-analysis of randomised trials. Eur J Cancer. 2013 Feb;49(3):593-603. doi: 10.1016/j.ejca.2012.08.019. Epub 2012 Sep 16.
Medical Oncology Unit, Campus Salvatore Venuta, Department of Experimental and Clinical Medicine, ''Magna Graecia'' University and ''Tommaso Campanella'' Cancer Center, Catanzaro, Italy.

Abstract BACKGROUND: Pancreatic cancer is the fourth leading cause of cancer-related death worldwide. Gemcitabine is the mainstay treatment for advanced disease. However, almost all up-to-date trials, that evaluated the benefit of gemcitabine-combination schedules, failed to demonstrate an improvement in overall survival (OS). In this study, we performed a systematic review and a meta-analysis of randomised clinical trials (RCTs) to investigate the efficacy and safety of gemcitabine-based combination regimens as compared to gemcitabine alone in the management of pancreatic cancer. METHODS: Clinical trials were collected by searching different databases (PubMed, Embase and the Central Registry of Controlled Trials of the Cochrane Library) and abstracts from major cancer meetings. We considered period ranging from January 1997 to January 2012. Primary end-point was OS, secondary end-points were response rate (RR), disease control rate (DCR) and safety. Hazard ratios (HRs) of OS, odds-ratios (ORs) of RR, DCR and risk ratios of grade 3-4 toxicity rates (TRs), were extracted as presented in retrieved studies and used for statistical analysis. Meta-analytic estimates were derived using random-effects model. FINDINGS: Thirty-four trials for a total of 10,660 patients were selected and included in the final analysis. The analysis showed that combination chemotherapy confers benefit in terms of OS (HR: 0.93; 95% confidence interval (CI): 0.89-0.97; p=0.001). ORs for both RR and DCR demonstrated a significant advantage for combination therapy (OR for RR: 0.60, 95%CI: 0.47-0.76, p<0.001; OR for DCR: 0.79; 95%CI: 0.66-0.93; p=0.006). Toxicities were more frequent with the combination treatment and significance in terms of risk ratio was reached for diarrhoea (0.53, 95%CI: 0.36-0.79), nausea (0.74, 95%CI: 0.56-0.96), neutropenia (0.71, 95%CI: 0.59-0.85) and thrombocytopenia (0.57, 95%CI: 0.43-0.75). INTERPRETATION: The combination chemotherapy as compared to gemcitabine alone significantly improves OS in advanced pancreatic cancer (APC). However, this advantage is marginal whereas the treatment-related toxicity is increased, suggesting the use of gemcitabine-based combination regimens only in selected patient populations. New prospective trials, based on translational approaches and innovative validated biomarkers, are eagerly awaited on this topic.

5. Goffredo P, Roman SA, Sosa JA. Hurthle cell carcinoma: a population-level analysis of 3311 patients. Cancer. 2013 Feb 1;119(3):504-11. doi: 10.1002/cncr.27770. Epub 2012 Aug 14.
Milano-Bicocca University, Monza, Italy.

Abstract BACKGROUND: Hurthle cell carcinoma (HCC) is an uncommon and more aggressive thyroid cancer. To date, there is a paucity of data at a population level. In this study, demographic, clinical, and pathologic characteristics of HCC were investigated and compared with other types of differentiated thyroid cancers (ODTCs). The authors also evaluated disease-specific survival and compliance with American Thyroid Association (ATA) management guidelines from 2009. METHODS: The Surveillance, Epidemiology, and End Results (SEER) database from 1988 to 2009 was used to obtain data on patients with thyroid cancer. Data analyses were performed using chi-square tests, analysis of variance, Kaplan-Meier analysis, binary logistic regression, and Cox proportional hazards regression. RESULTS: In total, 3311 patients with HCC and 59,585 patients with ODTC were identified. Compared with ODTC, HCC was more common among men (31.1% vs 23.0% for ODTC; P < .001) and among older patients (mean age, 57.6 years vs 48.9 years for ODTC; P < .001). Patients with HCC presented with higher SEER disease stage (P < .001), and their tumors were larger (36.1 mm vs 20.2 mm for ODTC; P < .001). Fewer patients underwent total thyroidectomy (P = .028). Both overall and disease-specific survival were lower for patients with HCC (P < .001), and neither improved over the last 2 decades (P = .689). After adjustment, age ≥45 years, not undergoing surgery, and metastatic disease were strongly associated with a worse prognosis (hazard ratio >3.0). Compliance with recommended surgical treatment according to ATA guidelines was lower among patients with HCC aged ≥65 years (odds ratio [OR], 1.43; P = .002) and among unmarried patients (OR, 1.29; P = .004). Predictors of noncompliance with ATA guidelines for treatment with radioactive implants or radioisotopes were age ≥65 years (OR, 1.31; P = .017), diagnosis between 1988 and 1997, no surgery, and partial thyroidectomy (OR, 1.81, 19.48, and 4.02, respectively; P < .001). CONCLUSIONS: HCC has more aggressive behavior and compromised survival compared with ODTC. The current results indicated that it may be important to consider a different staging system or separate practice guidelines.

6. Di Eusanio M, Trimarchi S, Patel HJ, Hutchison S, Suzuki T, Peterson MD, Di Bartolomeo R, Folesani G, Pyeritz RE, Braverman AC, Montgomery DG, Isselbacher EM, Nienaber CA, Eagle KA, Fattori R. Clinical presentation, management, and short-term outcome of patients with type A acute dissection complicated by mesenteric malperfusion: observations from the International Registry of Acute Aortic Dissection. J Thorac Cardiovasc Surg. 2013 Feb;145(2):385-390.e1. doi:10.1016/j.jtcvs.2012.01.042. Epub 2012 Feb 15.
Cardiovascular Surgery Department, Sant'Orsola-Malpighi Hospital, Bologna University, Bologna, Italy. marco.dieusanio2@unibo.it

Abstract BACKGROUND: Few data exist on clinical/imaging characteristics, management, and outcomes of patients with type A acute dissection and mesenteric malperfusion. METHODS: Patients with type A acute dissection enrolled in the International Registry for Acute Dissection (IRAD) were evaluated to assess differences in clinical features, management, and in-hospital outcomes according to the presence/absence of mesenteric malperfusion. A mortality model was used to identify predictors of in-hospital mortality in patients with mesenteric malperfusion. RESULTS: Mesenteric malperfusion was detected in 68 (3.7%) of 1809 patients with type A acute dissection. Patients with mesenteric malperfusion were more likely to be older and to have coma, cerebrovascular accident, spinal cord ischemia, acute renal failure, limb ischemia, and any pulse deficit. They were less likely to undergo surgical/hybrid treatment (52.9% vs 87.9%) and more likely to receive only medical (30.9% vs 11.6%) or endovascular (16.2% vs 0.5%) management (P < .001). Overall in-hospital mortality was 63.2% and 23.8% in patients with and without mesenteric malperfusion, respectively (P < .001). In-hospital mortality of patients with mesenteric malperfusion receiving medical, endovascular, and surgical/hybrid therapy was 95.2%, 72.7%, and 41.7%, respectively (P < .001). At multivariate analysis, male gender (odds ratio [OR], 1.7; P = .002), age (OR, 1.1/y; P = .002), and renal failure (OR, 5.9; P = .020) were predictors of mortality whereas surgical/hybrid management (OR, 0.1; P = .005) was associated with better outcome. CONCLUSIONS: Type A acute aortic dissection complicated by mesenteric malperfusion is a rare but ominous complication carrying a high risk of hospital mortality. Surgical/hybrid therapy, although associated with 2-fold hospital mortality, appears to be associated with better long-term outcomes in the management of type A acute aortic dissection in this setting.

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