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PurposePharmacoepidemiological studies aimed to distinguish drug use in nursing home (NH) residents with and without dementia could be useful to target specific interventions to improve prescribing. This multicenter retrospective study aimed (i) to describe drug therapy in a large sample of NH residents according to the diagnosis of dementia, and (ii) to record the most frequent potentially severe drug-drug interactions.MethodsThis study was conducted in a sample of Italian long-term care NHs. Drug prescription information, diseases, and socio-demographic characteristics of NH residents were collected at three different times during 2018.ResultsThe mean number of drugs was significantly higher in NH residents without dementia than in those with (p = 0.05). Antipsychotics, laxatives, benzodiazepines, antiplatelets, and proton pump inhibitors (PPIs) were most commonly prescribed in patients with dementia, and PPIs, benzodiazepines, and laxatives in those without. The prevalence of patients with potentially severe drug-drug interactions was higher among those without dementia, 1216 (64.7%) and 518 (74.2%, p < 0.0001). There were significant differences between the mean numbers of drugs prescribed in individual NH after adjusting the analysis for age, sex, and mean Charlson index, the estimated mean number of drugs prescribed (± standard error) ranging from 5.1 (± 0.3) to 9.3 (± 0.3) in patients with dementia (p < 0.0001) and from 6.0 (± 0.7) to 10.9 (± 0.50) in those without dementia (p < 0.0001). Chronic use of psychotropic drugs was common in NH residents with and without dementia.ConclusionsThe wide variability between NHs in drug prescriptions and potentially inappropriate prescribing suggests the need to recommend a standardized approach to medication review of psychotropic drugs, antiulcer, laxatives, and antiplatelets in this complex and vulnerable population.

Purpose The VICTOR-1 study demonstrated that the all-oral metronomic combination of vinorelbine and capecitabine is highly active and well tolerated in hormone receptor-positive/HER2-negative patients. The VICTOR-2 study was designed to confirm these results. Methods Patients received mVNR 40 mg three times a week and mCAPE 500 mg three times a day, continuously. The primary endpoint was the clinical benefit rate (CBR); secondary endpoints were toxicity, objective response rate (ORR), and progression-free survival (PFS). Results Eighty patients were evaluable for the primary efficacy analysis. Median age was 65.3 years; most patients had HR-positive tumors (65 %). The CBR was 45.7 % (95 % CI 28.8–63.4) and 51.1 % (95 % CI 35.8–66.3) in first- and ≥ second-line therapy, respectively. The ORR was 35.5 % in first-line (95 % CI 19.2–54.6) and 25.6 % in ≥second-line (95 % CI 13.5–41.2). The median duration of response was 11.3 and 6.4 months and PFS rates at 1 year were 24.3 and 22.2 %, respectively. In triple-negative breast cancer patients ( N  = 28, 35 %) a lower, but clinically relevant CBR (35.7, 95 % CI 18.6–55.9) was observed. The main toxicities per cycle were non-febrile neutropenia (1.1 %), hand-foot syndrome (1.0 %), nausea and vomiting (1.0 %), leucopenia (0.8 %), fatigue (0.7 %), and diarrhea (0.4 %). Conclusion The VICTOR-2 study confirms the clinical activity of mVNR and mCAPE in HER2-negative breast cancer patients, suggesting that the easy schedule of administration, which requires monthly blood tests and limits patients’ dependence on hospitals, and the low cost of the drugs are valuable elements, even for countries with limited access to innovative or expensive drugs.

This study investigated, for the first time, the association between HER2 expression, immune infiltration inferred by CIBERSORTx, and immunotherapy response in HER2-negative early breast cancer (EBC). Gene expression was analyzed in prospective discovery ( n  = 104), confirmatory ( n  = 81), and independent (ABiM, n  = 318) cohorts. HER2 expression was measured using a 20-gene signature yielding progressively higher scores from HER2-0 to HER2-low, as routinely defined. Increased HER2 expression was consistently associated with reduced immune-infiltration, especially cytotoxic (CD8 + ) T cells and M1 macrophages; and hormone receptor (HR)-specific depletions with significant interactions for mast cells resting and neutrophils. In analysis of covariance, HER2 expression independently predicted low B-naïve and plasma cell abundance. In a neoadjuvant immunotherapy real-world cohort ( n  = 111), HER2-low primary tumors had numerically lower midcourse (28% vs. 44%) and pathological complete response (64% vs. 72%) compared to HER2-0. These findings show that HER2 expression defines immune-cold HER2-negative EBC, hindering immunotherapy and supporting HER2-targeted combination in HER2-low EBC patients.

Triple-negative breast cancer (TNBC) shows a very bad prognosis, even in early stages of disease. Metronomic chemotherapy refers to the minimum biologically effective dose of a chemotherapy agent given as a continuous dosing regimen with no prolonged drug-free breaks that leads to antitumor activity. In the present article, we review preclinical and clinical data of metronomic administration of chemotherapy agents with or without biological agents in TNBC cell lines and patients, contextually reporting data from the VICTOR-2 study in the subgroup of patients with TNBC, in order to stimulate new ideas for the design of clinical trials in this subset of patients.

It is well-known that male breast cancer (MBC) susceptibility is mainly due to high-penetrance BRCA1/2 mutations. Here, we investigated whether common low-penetrance breast cancer (BC) susceptibility alleles may influence MBC risk in Italian population and whether variant alleles may be associated with specific clinicopathological features of MBCs. In the frame of the Italian Multicenter Study on MBC, we genotyped 413 MBCs and 745 age-matched male controls at 9 SNPs annotating known BC susceptibility loci. By multivariate logistic regression models, we found a significant increased MBC risk for 3 SNPs, in particular, with codominant models, for rs2046210/ ESR1 (OR = 1.71; 95 % CI: 1.43–2.05; p  = 0.0001), rs3803662/ TOX3 (OR = 1.59; 95 % CI: 1.32–1.92; p  = 0.0001), and rs2981582 /FGFR2 (OR = 1.26; 95 % CI: 1.05–1.50; p  = 0.013). Furthermore, we showed that the prevalence of the risk genotypes of ESR1 tended to be higher in ER− tumors ( p  = 0.062). In a case–case multivariate analysis, a statistically significant association between ESR1 and ER− tumors was found (OR = 1.88; 95 % CI: 1.03–3.49; p  = 0.039). Overall, our data, based on a large and well-characterized MBC series, support the hypothesis that common low-penetrance BC susceptibility alleles play a role in MBC susceptibility and, interestingly, indicate that ESR1 is associated with a distinct tumor subtype defined by ER-negative status.

Purpose The VICTOR-1 study demonstrated that the all-oral metronomic combination of vinorelbine and capecitabine is highly active and well tolerated in hormone receptor-positive/HER2-negative patients. The VICTOR-2 study was designed to confirm these results. Methods Patients received mVNR 40 mg three times a week and mCAPE 500 mg three times a day, continuously. The primary endpoint was the clinical benefit rate (CBR); secondary endpoints were toxicity, objective response rate (ORR), and progression-free survival (PFS). Results Eighty patients were evaluable for the primary efficacy analysis. Median age was 65.3 years; most patients had HR-positive tumors (65 %). The CBR was 45.7 % (95 % CI 28.8-63.4) and 51.1 % (95 % CI 35.8-66.3) in first- and [greater than or equal to] second-line therapy, respectively. The ORR was 35.5 % in first-line (95 % CI 19.2-54.6) and 25.6 % in [greater than or equal to]second-line (95 % CI 13.5-41.2). The median duration of response was 11.3 and 6.4 months and PFS rates at 1 year were 24.3 and 22.2 %, respectively. In triple-negative breast cancer patients (N = 28, 35 %) a lower, but clinically relevant CBR (35.7, 95 % CI 18.6-55.9) was observed. The main toxicities per cycle were non-febrile neutropenia (1.1 %), hand-foot syndrome (1.0 %), nausea and vomiting (1.0 %), leucopenia (0.8 %), fatigue (0.7 %), and diarrhea (0.4 %). Conclusion The VICTOR-2 study confirms the clinical activity of mVNR and mCAPE in HER2-negative breast cancer patients, suggesting that the easy schedule of administration, which requires monthly blood tests and limits patients' dependence on hospitals, and the low cost of the drugs are valuable elements, even for countries with limited access to innovative or expensive drugs.

Male breast cancer (MBC) is rare and poorly understood. Like female breast cancer (FBC), MBCs are highly sensitive to hormonal changes, and hyperestrogenism, specifically, represents a major risk factor for MBC. MBC is considered similar to late-onset, post-menopausal estrogen/progesteron receptors positive FBC (ER+/PR+). Sulfotransferase 1A1 (SIJLT1A1) is an enzyme involved in the metabolism of estrogens. Recently, SULT1A1 common functional polymorphism [Arg.sup.213]His (638G > A) variant has been found to be associated with increased breast cancer (BC) risk, particularly in post-menopausal women. For this reason, we decided to explore whether SULT1A1 [Arg.sup.123] His could exert an effect on MBC development. The primary aim of this study was to evaluate the influence of the SULT1A1 [Arg.sup.213]His polymorphism on MBC risk. The secondary aim was to investigate possible associations with relevant clinical-pathologic features of MBC. A total of 394 MBC cases and 786 healthy male controls were genotyped for SULT1A1 [Arg.sup.21,]His polymorphism by PCR-RFLP and high-resolution melting analysis. All MBC cases were characterized for relevant clinical-pathologic features. A significant difference in the distribution of SULT1A1 [Arg.sup.213]His genotypes was found between MBC cases and controls (P < 0.0001). The analysis of genotype-specific risk showed a significant increased MBC risk in individuals with G/A (OR 1.97, 95 % Cl 1.50-2.59; P< 0.0001) and A/A (OR 3.09, 95 % Cl 1.83-5.23; P < 0.0001) genotypes in comparison to wild-type genotype, under co-dominant model. A significant association between SULT1A1 risk genotypes and HER2 status emerged. Results indicate that SULT1A1 [Arg.sup.213]His may act as a low-penetrance risk allele for developing MBC and could be associated with a specific tumor subtype associated with HER2 overexpression. Keywords Male breast cancer * Estrogens * Estrogen receptor * Sulfotransferase 1A1 (SULT1A1) * SULT1A1 [Arg.sup.213]His polymorphism

The aim of this study was to evaluate the production of the vasoactive amines, histamine and tyramine, and of other biogenic amines (putrescine, cadaverine, spermidine, and spermine) during the ripening of pecorino Carmasciano cheese, a traditional Italian cheese produced with raw sheep milk. Vasoactive amines, which may pose health risks for consumers, showed relatively low levels near the end of Carmasciano ripening (136.41 mg/kg tyramine and 65.5 mg/kg histamine). The other biogenic amines were also detected and showed increasing levels with time. Results demonstrated that the concentrations of the vasoactive amines were always below the limits established for other foods. However, the data concerning raw materials and the increasing trend of certain biogenic amines highlight the need to control indigenous bacterial populations responsible for amine production, including the implementation of Good Manufacturing Practices and adequate training of staff.

The increasing amount of farmed fish cannot be easily absorbed by the market as only fresh fish. The production and promotion of value-added fresh and processed fish products, which could fulfil consumers' present demands, may represent a solution to this problem. The aim of this paper is to review some of the most recent technologies, such as surface decontamination, use of “natural” additives and compounds, active packaging, used or experimented with to prolong shelf life, while ensuring the safety of fresh fish and fishery products.

Male breast cancer (MBC) is rare and poorly understood. Like female breast cancer (FBC), MBCs are highly sensitive to hormonal changes, and hyperestrogenism, specifically, represents a major risk factor for MBC. MBC is considered similar to late-onset, post-menopausal estrogen/progesteron receptors positive FBC (ER+/PR+). Sulfotransferase 1A1 (SULT1A1) is an enzyme involved in the metabolism of estrogens. Recently, SULT1A1 common functional polymorphism Arg 213 His (638G>A) variant has been found to be associated with increased breast cancer (BC) risk, particularly in post-menopausal women. For this reason, we decided to explore whether SULT1A1 Arg 213 His could exert an effect on MBC development. The primary aim of this study was to evaluate the influence of the SULT1A1 Arg 213 His polymorphism on MBC risk. The secondary aim was to investigate possible associations with relevant clinical–pathologic features of MBC. A total of 394 MBC cases and 786 healthy male controls were genotyped for SULT1A1 Arg 213 His polymorphism by PCR–RFLP and high-resolution melting analysis. All MBC cases were characterized for relevant clinical–pathologic features. A significant difference in the distribution of SULT1A1 Arg 213 His genotypes was found between MBC cases and controls ( P  < 0.0001). The analysis of genotype-specific risk showed a significant increased MBC risk in individuals with G/A (OR 1.97, 95 % CI 1.50–2.59; P  < 0.0001) and A/A (OR 3.09, 95 % CI 1.83–5.23; P  < 0.0001) genotypes in comparison to wild-type genotype, under co-dominant model. A significant association between SULT1A1 risk genotypes and HER2 status emerged. Results indicate that SULT1A1 Arg 213 His may act as a low-penetrance risk allele for developing MBC and could be associated with a specific tumor subtype associated with HER2 overexpression.