Nanotechnology in food industry II: risk assessment and legislation

Currently, there is increasing use of nanomaterials in the food industry thanks to the many advantages offered and make the products that contain them more competitive in the market. Their physicochemical properties often differ from those of bulk materials, which require specialized risk assessment. This should cover the risks to the health of workers and consumers as well as possible environmental risks. The risk assessment methods must go updating due to more widespread use of nanomaterials, especially now that are making their way down to consumer products. Today there is no specific legislation for nanomaterials, but there are several european dispositions and regulations that include them. This review gives an overview of the risk assessment and the existing current legislation regarding the use of nanotechnology in the food industry.

El autocuidado y apoyo social de mujeres de un proyecto de seguimiento mamográfico en Porto Alegre/Brasil

Objective: Identify preventive self-care practices and analyze the configurations of the network support for women with and without breast cancer registered in a mammography-monitoring project from Porto Alegre/Brazil.Method: a mixed sequential delimitation was performed, which expanded the results of the quantitative step (cross and correlation section) in a qualitative step (narrative interviews). 37 women diagnosed with breast cancer (group 1) and 72 without this diagnosis (group 2 – monitoring) participated. The following instruments were used: Assessment Questionnaire Self-care Ability (ASA-A) and Assessment Questionnaire Perceived Social Support and Community. There were performed descriptive analysis and comparison of means (t test and ANOVA) between the two groups. To deepen the understanding of the data, we selected four women with breast cancer with extreme levels on the scale of Social Support to participate in the biographical narrative interviews.Results: the analysis indicate that women who had breast cancer have better self-care practices than the women from the monitoring project (t = 1.791, P = 0.027). As for the analysis of social support, there were no statistically significant differences between the two groups. All participants have an average level of perceived social and community support. It was highlighted by the qualitative data that it was after the diagnosis of breast cancer that women lived self-care aspects they had not previously experienced.Conclusions: the self-care was significantly bigger in the group of women with breast cancer, where the cancer diagnosis was a trigger to increase self-care.

La fictohistoria o historiografía imaginaria en las literaturas románicas desde el siglo XIX: ensayo de tipología y panorama de un género formal insospechado (II)

El doble aspecto documental y artístico de la escritura de la historia ha quedado prácticamente oculto por la insistencia en el carácter científico de la disciplina y su expulsión subsiguiente del canon literario desde el siglo XIX. El cultivo de la historiografía ficticia o imaginaria (fictohistoria) surgió entonces como un modo de salvar la literariedad de la historia, en su calidad de género formal, mediante el uso del discurso historiográfico como procedimiento retórico para conseguir un efecto de historicidad en textos que son, no obstante, claramente ficticios, y que tienen a menudo un carácter satírico o admonitorio. Esto no está reñido con el hecho de que la mayoría manifieste en primer lugar una reflexión sobre el devenir de la humanidad, es decir, sobre la Historia. Los ejemplos de este género son relativamente abundantes y se pueden clasificar en varias categorías temáticas. Esta segunda parte del estudio se centra en la historia prospectiva.

Association Between Results of a Gene Expression Signature Assay and Recurrence-Free Interval in Patients With Stage II Colon Cancer in Cancer and Leukemia Group B 9581 (Alliance)

PURPOSE: Conventional staging methods are inadequate to identify patients with stage II colon cancer (CC) who are at high risk of recurrence after surgery with curative intent. ColDx is a gene expression, microarray-based assay shown to be independently prognostic for recurrence-free interval (RFI) and overall survival in CC. The objective of this study was to further validate ColDx using formalin-fixed, paraffin-embedded specimens collected as part of the Alliance phase III trial, C9581.

PATIENTS AND METHODS: C9581 evaluated edrecolomab versus observation in patients with stage II CC and reported no survival benefit. Under an initial case-cohort sampling design, a randomly selected subcohort (RS) comprised 514 patients from 901 eligible patients with available tissue. Forty-nine additional patients with recurrence events were included in the analysis. Final analysis comprised 393 patients: 360 RS (58 events) and 33 non-RS events. Risk status was determined for each patient by ColDx. The Self-Prentice method was used to test the association between the resulting ColDx risk score and RFI adjusting for standard prognostic variables.

RESULTS: Fifty-five percent of patients (216 of 393) were classified as high risk. After adjustment for prognostic variables that included mismatch repair (MMR) deficiency, ColDx high-risk patients exhibited significantly worse RFI (multivariable hazard ratio, 2.13; 95% CI, 1.3 to 3.5; P < .01). Age and MMR status were marginally significant. RFI at 5 years for patients classified as high risk was 82% (95% CI, 79% to 85%), compared with 91% (95% CI, 89% to 93%) for patients classified as low risk.

CONCLUSION: ColDx is associated with RFI in the C9581 subsample in the presence of other prognostic factors, including MMR deficiency. ColDx could be incorporated with the traditional clinical markers of risk to refine patient prognosis.

A Phase II Biomarker-Embedded Study of Lapatinib plus Capecitabine as First-line Therapy in Patients with Advanced or Metastatic Gastric Cancer

An exploratory phase II biomarker-embedded trial (LPT109747; NCT00526669) designed to determine the association of lapatinib-induced fluoropyrimidine gene changes with efficacy of lapatinib plus capecitabine as first-line treatment for advanced gastric cancer or gastroesophageal junction adenocarcinoma independent of tumor HER2 status. Tumor biopsies obtained before and after 7-day lapatinib (1,250 mg) to analyze changes in gene expression, followed by a 14-day course of capecitabine (1,000 mg/m(2) twice daily, 14/21 days) plus lapatinib 1,250 mg daily. Blood samples were acquired for pharmacokinetic analysis. Primary clinical objectives were response rate (RR) and 5-month progression-free survival (PFS). Secondary objectives were overall survival (OS), PFS, time to response, duration of response, toxicity, and identification of associations between lapatinib pharmacokinetics and biomarker endpoints. Primary biomarker objectives were modulation of 5-FU-pathway genes by lapatinib, effects of germline SNPs on treatment outcome, and trough steady-state plasma lapatinib concentrations. Sixty-eight patients were enrolled; (75% gastric cancer, 25% gastroesophageal junction). Twelve patients (17.9%) had confirmed partial response, 31 (46.3%) had stable disease, and 16 (23.9%) had progressive disease. Median PFS and OS were 3.3 and 6.3 months, respectively. Frequent adverse events included diarrhea (45%), decreased appetite (39%), nausea (36%), and fatigue (36%). Lapatinib induced no changes in gene expression from baseline and no significant associations were found for SNPs analyzed. Elevated baseline HER3 mRNA expression was associated with a higher RR (33% vs. 0%; P = 0.008). Lapatinib plus capecitabine was well tolerated, demonstrating modest antitumor activity in patients with advanced gastric cancer. The association of elevated HER3 and RR warrants further investigation as an important player for HER-targeted regimens in combination with capecitabine