A Descriptive Study of Repeated Hospitalizations and Survival of Patients with Metastatic Melanoma in the Northern Italian Region during 2004-2019.

BACKGROUND: Survival rates for metastatic melanoma (MM) patients have improved in recent years, leading to major expenses and health resource use. We conducted a non-concurrent prospective study to describe the burden of hospitalization in a real-world setting for patients with MM. METHODS: Patients were tracked throughout all hospital stays in 2004-2019 by means of hospital discharges. The number of hospitalizations, the rehospitalization rate, the average time spent in the hospital and the time span between consecutive admissions were evaluated. Relative survival was also calculated. RESULTS: Overall, 1570 patients were identified at the first stay (56.5% in 2004-2011 and 43.7% in 2012-2019). A total of 8583 admissions were retrieved. The overall rehospitalization rate was 1.78 per patient/year (95%CI = 1.68-1.89); it increased significantly with the period of first stay (1.51, 95%CI = 1.40-1.64 in 2004-2011 and 2.11, 95%CI = 1.94-2.29 thereafter). The median time span between hospitalizations was lower for patients hospitalized after 2011 (16 vs. 26 months). An improvement in survival for males was highlighted. CONCLUSIONS: The hospitalization rate of patients with MM was higher in the last years of the study. Compared with a shorter length of stay, patients were admitted to hospitals with a higher frequency. Knowledge of the burden of MM is essential for planning the allocation of healthcare resources.

A Meta-Analysis of Endoscopic Stenting Versus Surgical Treatment for Malignant Gastric Outlet Obstruction.

BACKGROUND AND AIM: Surgical gastrojejunostomy (GJJ) and endoscopic stenting (ES) are the two most available treatments for palliation of malignant gastric obstruction (MGOO). The aim of this study is to compare these two techniques regarding efficacy, safety, time of hospitalization and survival. METHODS: We performed a literature search from January 2010 to September 2020 to identify available randomized controlled studies and observational studies that compared ES and GJJ for the treatment of MGOO. RESULTS: A total of 17 studies were found. ES and GJJ showed similar technical and clinical success rate. ES was superior to obtain early oral re-feeding, shorter length of hospitalization and a lower incidence of complications than GJJ. Surgical palliation had a lower recurrence rate of obstructive symptoms and longer overall survival than ES. CONCLUSIONS: Both procedures have advantages and disadvantages. Probably we should not find the best palliation but the best approach based on the patient characteristics and tumor type.

Descriptive Epidemiology of Hospitalization of Patients with a Rare Tumor in an Italian Region.

OBJECTIVES: Rare tumors (RT) collectively account for one quarter of all malignancies in Italy. The low frequency and the large heterogeneity in natural history and outcome of individual diseases, together with a scarcity of epidemiological information make them a challenge for clinical practice, as well as for public healthcare organizations. We conducted a retrospective study to quantify the burden of hospitalization in a real-word setting in patients diagnosed with these diseases in an Italian region. METHODS: RT patients were tracked along all hospital stays from 2000 to 2019 using hospital discharge records. Frequency of hospitalizations, average time spent in hospital and median timespan between consecutive admissions were considered. Re-hospitalization rates were analyzed through a multivariable negative binomial regression analysis to adjust for confounding and allowing for over-dispersion in count data. RESULTS: As a whole, 57,329 patients were identified at first stay for all studied tumors. A total of 183,959 admissions were retrieved, along a median of 3 hospitalizations per patient. Median timespan between hospitalizations shortened in the course of the study years (12.5 months in 2000-2004 to 5.4 months in 2015-2019). The overall re-hospitalization rate increased from 0.92 per patient/year (95% CI = 0.81-1.04) in 2000-2004 to 2.17 (95% CI = 1.90-2.47) in 2015-2019. CONCLUSIONS: Overall, the hospitalization rate of patients with a RT increased in the twenty years since the 2000 and particularly doubled starting from 2015. A higher burden of hospitalizations was found for tumors of the central nervous system, thoracic cavity, digestive tract and sarcomas. To the best of our knowledge this is the first paper related to access to Italian healthcare facilities of patients with these tumors.

Cap-assisted EMR versus standard inject and cut EMR for treatment of large colonic laterally spreading tumors: a randomized multicenter study (with videos).

BACKGROUND AND AIMS: Piecemeal EMR of colorectal laterally spreading tumors (LSTs) >20 mm is effective. Experience is limited in the use of cap-assisted EMR (EMR-C) for resection of colonic lesions. We compared the efficacy and the safety of EMR-C for the removal of colonic LSTs ≥30 mm with "inject-and-cut" standard EMR (EMR-S). METHODS: In this randomized trial from 4 Italian centers, 138 patients were treated with EMR-C and 102 with EMR-S. The rates of residual lesions, percentage of recurrence after 12 months, and adverse events were evaluated. RESULTS: One hundred forty-three lesions were resected with EMR-C and 102 with EMR-S. Argon plasma coagulation (APC) was used as adjunctive treatment in 2.9% of EMR-Cs and in 22.5% of EMR-Ss (P < .001). The median time required was 20 minutes for EMR-C and 30 minutes for EMR-S (P < .001). Adverse events (AEs) occurred in 14 EMR-Cs (10.1%; 2 perforations, 11 bleeding events, and 1 stenosis) and in 22 EMR-Ss (21.6%; 1 perforation and 21 bleeding events) (P = .017). Intraprocedural AEs occurred in 3.6% of EMR-Cs and 16.7% of EMR-Ss (P = .001). Overall, residual lesions within 12 months were found to be significantly higher with EMR-S (32 patients, 31.4%) than with EMR-C (8 patients, 5.8%) (P < .001). Recurrence at follow-up colonoscopy in 12 months occurred in 7 EMR-Cs (5.1%) and 17 EMR-Ss (16.7%; P < .001). CONCLUSIONS: The study demonstrated the feasibility and safety of EMR-C for removing large colorectal LSTs, with higher eradication rates, shorter resection time, and less use of APC when compared with EMR-S. (Clinical trial registration number: NCT03498664.).

Antibody Response to COVID-19 mRNA Vaccines in Oncologic and Hematologic Patients Undergoing Chemotherapy.

BACKGROUND: Information on immune responses in cancer patients following mRNA COVID-19 vaccines is still insufficient, but generally, patients had impaired serological responses, especially those with hematological malignancies. We evaluated serological response to COVID-19 mRNA vaccine in cancer patients receiving chemotherapy compared with healthy controls. METHODS: In total, 195 cancer patients and 400 randomly selected controls who had been administered a Pfizer-BioNTech or Moderna COVID-19 vaccines in two doses were compared. The threshold of positivity was 4.33 BAU/mL. Patients were receiving anticancer treatment after the first and second dose of the vaccines. RESULTS: a TOTAL OF 169 patients (87%) had solid tumors and 26 hemolymphopoietic diseases. Seropositivity rate was lower in patients than controls (91% vs. 96%), with an age/gender-adjusted rate ratio (RR) of 0.95 (95% CL = 0.89-1.02). Positivity was found in 97% of solid cancers and in 50% of hemolymphopoietic tumors. Both advanced and adjuvant therapy seemed to slightly reduce seropositivity rates in patients when compared to controls (RR = 0.97, 95% CL = 0.89-1.06; RR = 0.94, 95% CL = 0.87-1.01). CONCLUSIONS: the response to vaccination is similar in patients affected by solid tumors to controls. On the contrary, hemolymphopietic patients show a much lower response than controls.

Serum Extracellular Vesicle-Derived microRNAs as Potential Biomarkers for Pleural Mesothelioma in a European Prospective Study.

Malignant pleural mesothelioma (MPM) is an aggressive cancer with a dismal prognosis. Early therapeutic interventions could improve patient outcomes. We aimed to identify a pattern of microRNAs (miRNAs) as potential early non-invasive markers of MPM. In a case-control study nested in the European Prospective Investigation into Cancer and Nutrition cohort, we screened the whole miRNome in serum extracellular vesicles (EVs) of preclinical MPM cases. In a subgroup of 20 preclinical samples collected five years prior MPM diagnosis, we observed an upregulation of miR-11400 (fold change (FC) = 2.6, adjusted p-value = 0.01), miR-148a-3p (FC = 1.5, p-value = 0.001), and miR-409-3p (FC = 1.5, p-value = 0.04) relative to matched controls. The 3-miRNA panel showed a good classification capacity with an area under the receiver operating characteristic curve (AUC) of 0.81 (specificity = 0.75, sensitivity = 0.70). The diagnostic ability of the model was also evaluated in an independent retrospective cohort, yielding a higher predictive power (AUC = 0.86). A signature of EV miRNA can be detected up to five years before MPM; moreover, the identified miRNAs could provide functional insights into the molecular changes related to the late carcinogenic process, preceding MPM development.

A new designed self-expandable metal stent for the management of benign radiotherapy-induced hypopharyngeal or cervical esophageal strictures.

BACKGROUND AND AIMS: The management of patients with hypopharyngeal or cervical esophageal refractory benign strictures (RBS) after surgery and radiotherapy ± chemotherapy for laryngeal cancer is challenging. We aimed to assess the long-term efficacy and safety of a new designed fully covered SEMS in these patients. METHODS: We reviewed the results of a prospectively collected database of 40 consecutive patients with dysphagia due to RBS of the cervical esophagus or hypopharynx after surgery and radiotherapy with or without chemotherapy for laryngeal cancer, unfit for surgery, referred in two tertiary-care endoscopic centers from June 2005 to December 2018. All of them were treated with placement of a Niti-S Conio cervical stent. RESULTS: After placement of the first stent, dysphagia improved in all patients. The total number of adverse events was 35 out of a total of 299 procedures (11.7%): 25 (8.4%) stent migrations, 6 (2%) tumor overgrowth, 3 severe pain and 1 pharyngo-cutaneous fistula. Stents were periodically changed. In only one patient with a cervical esophageal stricture the stent was definitively removed after 7 sessions of stent placement because of stricture resolution. Patients were followed-up for a median of 11.6 months and a significant improvement in dysphagia was reported in all patients (p < 0.001). CONCLUSIONS: The use of this conformable, small caliber new designed Niti-S stent, exchanged periodically, appeared safe and permitted durable oral intake in patients with difficult-to-treat hypopharyngeal or cervical esophagus strictures, avoiding the need for periodic dilations.

Liquid Biopsies from Pleural Effusions and Plasma from Patients with Malignant Pleural Mesothelioma: A Feasibility Study.

BACKGROUND: Malignant pleural mesothelioma (MPM) is a fatal tumor with a poor prognosis. The recent developments of liquid biopsies could provide novel diagnostic and prognostic tools in oncology. However, there is limited information about the feasibility of this technique for MPMs. Here, we investigate whether cancer-specific DNA sequences can be detected in pleural fluids and plasma of MPM patients as free circulating tumor DNA (ctDNA). METHODS: We performed whole-exome sequencing on 14 tumor biopsies from 14 patients, and we analyzed 20 patient-specific somatic mutations with digital droplet PCR (ddPCR) in pleural fluids and plasma, using them as cancer-specific tumor biomarkers. RESULTS: Most of the selected mutations could be detected in pleural fluids (94%) and, noteworthy, in plasma (83%) with the use of ddPCR. Pleural fluids showed similar levels of somatically mutated ctDNA (median = 12.75%, average = 16.3%, standard deviation = 12.3) as those detected in solid biopsies (median = 21.95%; average = 22.21%; standard deviation = 9.57), and their paired difference was weakly statistically significant (p = 0.048). On the other hand, the paired difference between solid biopsies and ctDNA from plasma (median = 0.29%, average = 0.89%, standard deviation = 1.40) was highly statistically significant (p = 2.5 × 10-7), corresponding to the important drop of circulating somatically mutated DNA in the bloodstream. However, despite the tiny amount of ctDNA in plasma, varying from 5.57% down to 0.14%, the mutations were detectable at rates similar to those possible for other tumors. CONCLUSIONS: We found robust evidence that mutated DNA is spilled from MPMs, mostly into pleural fluids, proving the concept that liquid biopsies are feasible for MPM patients.

Effectiveness and Safety of Immune Checkpoint Inhibitors for Patients with Advanced Non Small-Cell Lung Cancer in Real-World: Review and Meta-Analysis.

Immunotherapy based on anti PD-1/PD-L1 inhibitors is the new standard of advanced non-small cell lung cancers. Pembrolizumab, nivolumab and atezolizumab are used in clinical practice. The strict eligibility criteria of clinical trials do not allow researchers to fully represent treatment effects in the patients that will ultimately use these drugs. We performed a systematic review and a meta-analysis to evaluate the effectiveness and safety of these drugs, and more generally of ICIs, as second-line therapy in NSCLC patients in real world practice. MEDLINE, PubMed, Scopus and Web of Science were searched to include original studies published between January 2015 and April 2020. A total of 32 studies was included in the meta-analysis. The overall radiological response rate (ORR), disease control rate (DCR), median progression-free survival (PFS) and overall survival (OS) were 21%, 52%, 3.35 months and 9.98 months, respectively. The results did not change when analysis was adjusted for Eastern Cooperative Oncology Group performance status (ECOG PS) and age. A unitary increase in the percent of patients with liver and CNS metastases reduced the occurrence of DCR by 7% (p < 0.001) and the median PFS by 2% (p = 0.010), respectively. The meta-analysis showed that the efficacy and safety of immunotherapy in everyday practice is comparable to that in clinical trials.

Palliation of malignant esophageal obstruction using an anti-migration self-expandable metal stent: Results of a prospective multicenter study.

BACKGROUND: Self-expanding metal stents (SEMS) placement is primarily indicated to palliate dysphagia for patients with expected short-term survival. We aimed to assess the migration rate and other stent-related adverse events (AEs) of a fully covered SEMS with an anti-migration system (FCSEMS-AMS) for palliation of malignant dysphagia. METHODS: This is a prospective study including patients with inoperable esophageal cancer that received a FCSEMS-AMS (Taewoong, Niti-S Beta™), in five tertiary-care endoscopic centers from January 2014 to February 2016. RESULTS: Fifty-three consecutive patients were enrolled. Tumor location was proximal, mid and distal esophagus±esophago-gastric junction (EGJ) in 6, 14, and 33 cases, respectively. Overall, non-severe AEs were reported in 18 patients (34.0%), 13 of them required an additional endoscopic procedure. Migration occurred in 7 patients (13.2%): 3 from the upper and 4 from the lower esophagus and EGJ. Stent retrieval was necessary in one patient due to intolerable pain. Food bolus impaction and tumor overgrowth occurred in 2 patients (3.8%) and 4 (7.5%) patients respectively. Four patients complained of gastroesophageal reflux as late AEs. Median follow-up was 19.3 months. Dysphagia significantly improved until 3 and 6 months from stent insertion (median score before FCSEMS-AMS: 3, vs median score: 1). Median dysphagia-free time was 10 months. CONCLUSIONS: Placement of the Taewoong, Niti-S Beta™ stent appeared to be a safe and effective treatment of malignant dysphagia. The anti-migration system reduced the overall migration rate, although it remained high in strictures located in the upper esophagus and when the stent was placed across the EGJ.

Mid-term trends and recent birth-cohort-dependent changes in incidence rates of cutaneous malignant melanoma in Italy.

In Oceania, North America and north-western Europe, after decades of increase, cutaneous malignant melanoma (CMM) rates began to stabilise or decline before 2000. Anecdotal evidence suggests that the reversal of the incidence trend is extending to southern Europe. To obtain a formal confirmation, this nationwide study from Italy investigated the incidence trends by birth cohort. Twenty-one local cancer registries covering a population of 15 814 455 provided incidence data for primary CMM registered between 1994 and 2013. Trends in age-standardised rates were analysed using joinpoint regression models and age-period-cohort models. Age-standardised incidence showed a consistent increase throughout the period (estimated annual percent change, 3.6 [95% confidence interval, 3.2-4.0] among men and 2.5 [2.0-3.1] among women). This pattern was confirmed by a sensitivity analysis with removal of low-risk populations of southern Italy. The rates, however, showed a stabilisation or a decrease in men and women aged below 35. Using the cohort of 1949-the median cohort with respect to the number of cases for both genders-as a reference, the incidence rate ratio increased for successive cohorts born until 1973 (women) and 1975 (men), and subsequently tended to decline. For the most recent cohorts in both genders, the risk of disease returned to the level of the cohort of 1949. The changes observed in the latest generations can be interpreted as the earliest manifestations of a birth-cohort-dependent incidence decrease. Our study adds to previous data indicating that the reversal of the long-term upward incidence trend of CMM is extending to southern Europe.

Dietary Habits and Risk of Esophagitis and Barrett's Esophagus: A Multicenter Italian Case-Control Study.

BACKGROUND: Barrett's esophagus (BE) and esophagitis share potentially modifiable risk factors such as obesity, smoking, and alcohol. The role of diet on BE and esophagitis is still debated. AIMS: The objective of this study was to examine the association between some dietary habits and the risk of BE and esophagitis in Italy. METHODS: A multicenter case-control study involving 1285 individuals was carried out in 12 areas. Patients with a new diagnosis of BE (320) or esophagitis (359) and a group of endoscopic controls (606) were included. Information on personal history and dietary habits was collected using a structured questionnaire. RESULTS: No clear monotonic significant dose-response relationship was found for most of the considered food items. Nevertheless, the most extreme consumption category of red meat, cold cuts, dairy products, and fried foods showed esophagitis risk excesses varying from 19 to 49%. A higher fat rich diet seemed to increase risk by 49% for BE and 94% for esophagitis. A downward tendency in esophagitis (- 27%) and BE risk (- 20%) was found associated with higher frequency of fresh fruit intake. In addition, a statistically significant twofold increased risk for both BE and esophagitis was found for subjects eating late evening snacks more than once every three days in comparison with the lowest intake category (no consumption). CONCLUSIONS: BE and esophagitis patients appeared to be more likely than controls to follow a diet rich in fats and poor in fruit and vegetables. Late evening snacks were found to be associated with both disorders.

Impact of Rhabdomyosarcoma Treatment Modalities by Age in a Population-Based Setting.

Purpose: Rhabdomyosarcoma (RMS) has a worse prognosis in adults than in children, but there is evidence of a better outcome in the former if treated using a pediatric-like approach. This study describes treatment for RMS in patients more than 10 years old and examines to what extent treatment contributes to explain the different age-related survival observed and to what extent treatment centers impact treatment appropriateness. Methods: A retrospective population-based study was developed considering 104 RMS cases (excluding the pleomorphic subtype) diagnosed in Italy between 2000 and 2015. Patients were grouped by age (10-19 vs. 20-60 years old) and scored according to whether or not their chemotherapy was consistent with the schemes used in pediatric protocols (score 1 = chemotherapy in line with pediatric protocols). Treatment centers were grouped according to whether or not they have a pediatric-dedicated unit affiliated to the national pediatric oncology network (Associazione Italiana Ematologia Oncologia Pediatrica [AIEOP]). Results: Older patients were more likely to have tumors at unfavorable sites (p = 0.045). A treatment score of 1 was assigned to 85% of younger patients, but only to 32% of older patients (p < 0.001). Furthermore, the proportion of score 1 was higher in younger patients treated in centers with an AIEOP Unit. A multivariate model confirmed age as a significant prognostic factor (Hazard rate ratio [HR] = 2.06; p = 0.04) and showed a significant impact of treatment on survival (HR = 2.13; p = 0.03). Conclusions: Adult RMS patients are still relatively unlikely to be treated with pediatric protocols and in centers with a pediatric oncology expertise. This may explain the survival gap between older and younger patients.

Adolescent and Young Adult Cancer Survivors: Design and Characteristics of the First Nationwide Population-Based Cohort in Italy.

Purpose: Adolescent and young adult (AYA, 15-39 years) cancer survivors (alive at least 5 years after cancer diagnosis) are less studied than younger and older cancer survivors and research on their late effects is limited. To facilitate research on long-term outcomes of AYA cancer survivors, we established, in Italy, a population-based AYA cancer survivors' cohort. This article describes the study design and main characteristics of this cohort. Methods: The cohort derives from population-based cancer registries (CRs). Each CR identified AYA cancer patients retrospectively. Treatment for first primary cancer and all health events from diagnosis to death can be traced through linkage with available health databases, such as hospital discharge records (HDRs), mortality files, and outpatient and pharmaceutical databases. Results: Thirty-four CRs participated to the cohort which overall includes 93,291 AYAs with cancer and 67,692 cancer survivors. First primary cancer distribution in AYA cancer survivors differs by sex and age groups because of the different cancer types diagnosed in AYAs. Almost 78% of AYA cancer survivors have HDRs and 14.8% also pharmaceutical and outpatient databases. Conclusion: This cohort will be used to study, for the first time in Italy, the pattern and excess risk of late effects in AYA cancer survivors. HDRs, outpatient and pharmaceutical databases will be used to define primary treatment to assess its impact on AYA cancer survivors' late effects. This cohort exploiting data sources already available at CRs, minimize the data collection effort and it will contribute to assess the feasibility of using administrative database to study cancer survivors' late effects.

Epidemiology and biological characteristics of male breast cancer in Italy.

AIM: To evaluate the epidemiology of male breast cancer (MBC) in Italy and to describe incidence and survival data in relation to age, morphology, year of incidence, geographic area, and possible association with other cancers compared with female BC. METHODS: Cases were extracted from 40 Italian Cancer Registries. Standardized incidence rates (SIR), age-specific rates, and 5-year survival were calculated. The association with second tumors was also evaluated. All data were compared with data from female BCs. RESULTS: In the 2000-2014 period, 2175 new cases of MBC were registered, with an SIR of 1.7 × 100,000. The incidence showed a slight upward trend and increased with increasing age. The 5-year survival was 82% in the first two periods (2000-2004, 2005-2009), lower than in females (87%). The most frequent morphology was the ductal carcinoma (84%). Stage at diagnosis was 39.5% stage I, 33.1% stage II, 20.9% in stage III, and 6.4% in stage IV. Concerning receptor status, 96.4% had ER+ and 82.5% PR+; 46.5% had high Ki67 and 14.7% HER2 amplified. The risk of BC increased if the man had already had a previous tumor in any site (excess absolute risk, EAR = 2.7) and especially if he had had prostate cancer (EAR = 5.1). Instead, males with a previous diagnosis of BC had an increased risk of testicular, kidney and lung cancer. CONCLUSIONS: MBC requires more attention in terms of diagnosis and treatment as clinicians tend to follow the guidelines that have been developed for female BC management.

Effects of different doses of erythropoietin in patients with myelodysplastic syndromes: A propensity score-matched analysis.

BACKGROUND: Erythropoiesis-stimulating agents effectively improve the hemoglobin levels in a fraction of anemic patients with myelodysplastic syndromes (MDS). Higher doses (HD) of recombinant human erythropoietin (rhEPO) have been proposed to overcome suboptimal response rates observed in MDS patients treated with lower "standard doses" (SD) of rhEPO. However, a direct comparison between the different doses of rhEPO is lacking. METHODS: A cohort of 104 MDS patients treated with HD was retrospectively compared to 208 patients treated with SD in a propensity score-matched analysis to evaluate hematological improvement-erythroid (HI-E) rate induced by the different doses of rhEPO. The impact of rhEPO doses on survival and progression to leukemia was also investigated. RESULTS: Overall HI-E rate was 52.6%. No difference was observed between different rhEPO doses (P = .28) in matched cohorts; in a subgroup analysis, transfusion-dependent patients and patients with higher IPSS-R score obtained a higher HI-E rate with HD, although without significant impact on overall survival (OS). Achievement of HI-E resulted in superior OS. At univariate analysis, a higher HI-E rate was observed in transfusion-independent patients (P < .001), with a lower IPSS-R score (P < .001) and lower serum EPO levels (P = .027). Multivariate analysis confirmed that rhEPO doses were not significantly related to HI-E (P = .26). There was no significant difference in OS or progression to leukemia in patients treated with HD vs SD. CONCLUSION: SD are substantially equally effective to HD to improve anemia and influencing survival in MDS patients stratified according to similar propensity to be exposed to rhEPO treatment.

Neoadjuvant therapy for breast cancer.

OBJECTIVE: To evaluate the frequency of neoadjuvant therapy (NT) in women with stage I-III breast cancer in Italy and whether it is influenced by biological characteristics, screening history, and geographic area. METHODS: Data from the High Resolution Study conducted in 7 Italian cancer registries were used; they are a representative sample of incident cancers in the study period (2009-2013). Included were 3546 women aged <85 years (groups <50, 50-69, 70-64, and 75+) with stage I-III breast cancer at diagnosis who underwent surgery. Women were classified as receiving NT if they received chemotherapy, target therapy, and/or hormone therapy before the first surgical treatment. Logistic models were built to test the association with biological and contextual variables. RESULTS: Only 8.2% of women (290 cases) underwent NT; the treatment decreases with increasing age (14.5% in age <50 and 2.2% in age 75+), is more frequent in women with negative receptors (14.8%), HER2-positive (15.7%), and triple-negative (15.6%). The multivariable analysis showed the probability of receiving NT is higher in stage III (odds ratio [OR] 3.83; 95% confidence interval [CI] 2.83-5.18), luminal B (OR 1.87; 95% CI 1.27-2.76), triple-negatives (OR 1.88; 95% CI 1.15-3.08), and in symptomatic cancers (OR 1.98; 95% CI 1.13-3.48). Use of NT varied among geographic areas: Reggio Emilia had the highest rates (OR 2.29; 95% CI 1.37-3.82) while Palermo had the lowest (OR 0.41; 95% CI 0.24-0.68). CONCLUSIONS: The use of NT in Italy is limited and variable. There are no signs of greater use in hospitals with more advanced care.

Prognosis and cure of long-term cancer survivors: A population-based estimation.

BACKGROUND: Increasing evidence of cure for some neoplasms has emerged in recent years. The study aimed to estimate population-based indicators of cancer cure. METHODS: Information on more than half a million cancer patients aged 15-74 years collected by population-based Italian cancer registries and mixture cure models were used to estimate the life expectancy of fatal tumors (LEFT), proportions of patients with similar death rates of the general population (cure fraction), and time to reach 5-year conditional relative survival (CRS) >90% or 95% (time to cure). RESULTS: Between 1990 and 2000, the median LEFT increased >1 year for breast (from 8.1 to 9.4 years) and prostate cancers (from 5.2 to 7.4 years). Median LEFT in 1990 was >5 years for testicular cancers (5.8) and Hodgkin lymphoma (6.3) below 45 years of age. In both sexes, it was ≤0.5 years for pancreatic cancers and NHL in 1990 and in 2000. The cure fraction showed a 10% increase between 1990 and 2000. It was 95% for thyroid cancer in women, 94% for testis, 75% for prostate, 67% for breast cancers, and <20% for liver, lung, and pancreatic cancers. Time to 5-year CRS >95% was <10 years for testis, thyroid, colon cancers, and melanoma. For breast and prostate cancers, the 5-year CRS >90% was reached in <10 years but a small excess remained for >15 years. CONCLUSIONS: The study findings confirmed that several cancer types are curable. Became aware of the possibility of cancer cure has relevant clinical and social impacts.

Covered versus uncovered self-expandable metal stent for palliation of primary malignant extrahepatic biliary strictures: a randomized multicenter study.

BACKGROUND AND AIMS: Self-expandable metal stents (SEMSs) are used to relieve malignant biliary obstructions. We aimed to compare stent patency, the adverse events rate, and overall survival of covered versus uncovered self-conformable metal stents in patients with primary malignant extrahepatic biliary strictures, not eligible for surgery. METHODS: This is a multicenter randomized trial analyzing 158 patients with inoperable distal malignant biliary obstruction conducted in 5 Italian referral centers between December 2014 and October 2016. Seventy-eight patients were randomized to receive a fully covered SEMS (FCSEMS), and 80 patients received uncovered SEMSs (USEMSs). Data from 148 (72 FCSEMSs and 76 USEMSs) of 158 patients were analyzed. RESULTS: Median time of stent patency was lower for FCSEMSs (240 days vs 541 days for USEMSs; P = .031). Adverse events occurred with 19 FCSEMSs (26.4%) and 10 USEMSs (13.2%); P = .061. The main causes of FCSEMS dysfunction were migration (7% vs 0% in the USEMS group) and early occlusion mainly because of sludge or overgrowth; late stent occlusion because of tumor ingrowth occurred in 13.2% of patients in the USEMS group. There were no significant differences either in levels of conjugated bilirubin improvement or in overall survival between the FCSEMS and USEMS groups. Median survival was 134 days in the FCSEMS group and 112 days in the USEMS group (P = .23). CONCLUSION: The number of stent-related adverse events was higher, although not significantly, among patients in the FCSEMS group. FCSEMSs had a significantly higher rate of migration than USEMSs, and stent occlusion occurred earlier. A significant difference in the patency rate was observed in favor of the USEMS group. (Clinical trial registration number: NCT02102984.).

The impact of overdiagnosis on thyroid cancer epidemic in Italy,1998-2012.

AIMS: In Italy, incidence rates of thyroid cancer (TC) are among the highest worldwide with substantial intracountry heterogeneity. The aim of the study was to examine time trends of TC incidence in Italy and to estimate the proportion of TC cases potentially attributable to overdiagnosis. METHODS: Data on TC cases reported to Italian cancer registries during 1998-2012 aged <85 years were included. Age-standardised incidence rates (ASR) were computed by sex, period, and histology. TC overdiagnosis was estimated by sex, period, age, and Italian region. RESULTS: In Italy between 1998-2002 and 2008-2012, TC ASR increased of 74% in women (from 16.2 to 28.2/100,000) and of 90% in men (from 5.3 to 10.1/100,000). ASR increases were nearly exclusively due to papillary TC (+91% in women, +120% in men). In both sexes, more than three-fold differences emerged between regions with highest and lowest ASR. Among TC cases diagnosed in 1998-2012 in Italy, we estimated that overdiagnosis accounted for 75% of cases in women and 63% in men and increased over the study period leading to overdiagnosis of 79% in women and 67% in men in 2008-2012. Notably, overdiagnosis was over 80% among women aged <55 years, and substantial variations were documented across Italian regions, in both genders. CONCLUSION(S): Incidence rates of TC are steadily increasing in Italy and largely due to overdiagnosis. These findings call for an update of thyroid gland examination practices in the asymptomatic general population, at national and regional levels.