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Background: Bone remodeling is disrupted in metastatic disease, which affects > 70% of metastatic castration-resistant prostate cancer (mCRPC) patients. As a result, abnormal levels of specific bone turnover biomarkers (BTMs) are released. In this prospective ancillary analysis of the Italian real-world study ABITUDE, four markers were measured during abiraterone acetate plus prednisone (AAP) treatment in chemotherapy-naïve mCRPC men failing androgen-deprivation therapy., Methods: Patients were enrolled if a blood sample was obtained before the first administration of abiraterone (baseline); ad-hoc blood samples were withdrawn during routine tests after 3, 6, and 12 months. A centralized lab measured bone alkaline phosphatase (BALP, osteoblast activity marker), type-I collagen-C-telopeptide (CTX-1, bone resorption marker), parathyroid hormone (PTH) and vitamin D (vitD). At each time point, intra-patient variations vs baseline were compared by the signed-rank test (statistical significance: P-value < 0.05)., Results: Of 481 patients enrolled in ABITUDE, 186 (median age: 76 [range: 53-93] years) met the substudy criteria: 74.7% had bone metastases, 11.8% were on bone-targeted therapies (BTT) and 14.0% on vitD supplementation. BALP decreased significantly at month 6 (P = 0.0010) and 12 (P < 0.0001) and CTX-1 at month 6 (P = 0.0028); PTH increased at month 3 (P < 0.0001); no significant difference in vitD levels was observed. Similar findings were observed in BTT-untreated patients. The reduction in BALP and CTX-1 levels was more pronounced in patients with than without bone metastases; in the latter group, no significant variation in BALP and CTX-1 levels was observed., Conclusions: AAP seems to exert an effect on the microenvironment of metastatic but not of normal bone, which likely contributes to its antitumoral activity., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: R. Bordonaro discloses honoraria/consulting or advisory role/speaker’s bureau from Bayer, AstraZeneca, Sanofi, Novartis, Amgen, Roche, Pfizer, Janssen Cilag, Bristol Mayer Squibb; travel accommodations expenses from Bayer, Pfizer, Astellas, Roche; fellowship or research program from AstraZeneca, Astellas. V.E. Chiuri discloses fees for Advisory Board and speaker from Bristol Mayer Squibb, Ipsen, Janssen Cilag and Pfizer. P. Carlini discloses congressional sponsorships from Sanofi, Aventis, Bayer SPA, Astellas, Janssen Cilag. F. Panebianco and P. Beccaglia are Janssen Cilag employees. G. Procopio discloses consultant or advisory board from AstraZeneca, Bayer, Bristol Mayer Squibb, Ipsen, Janssen Cilag, Merk, MSD, Pfizer, Novartis. The other authors have nothing to disclose., (© 2020 The Authors.)

Background and Aims: European and international guidelines advice against initiating tube-feeding in patients with severe dementia. These recommendations are based on studies with important methodological limitations that evaluated the benefits of artificial nutrition in patients with percutaneous endoscopic gastrostomy almost exclusively in terms of the prolongation of survival. The aims of this study were to assess the harmful effects of home enteral nutrition administered via the nasogastric tube and percutaneous endoscopic gastrostomy in patients with advanced dementia in terms of mechanical, gastrointestinal and metabolic complications, to estimate the survival, to explore the risk factors for mortality and to compare the outcomes of patients with advanced dementia with those of patients without dementia., Methods: The retrospective observational study was carried out on 585 consecutive patients of the mean age of 85.6 ± 6.9 years. They were treated using home enteral nutrition from 2010 to 2015 according to follow-up protocols adopted by the Clinical Nutrition Unit of an Italian geriatric research hospital (IRCCS-INRCA, Ancona). Incidence rates of mechanical, gastrointestinal and metabolic complications and survival rates in patients with severe dementia were compared to those in patients without dementia. The Cox proportional hazards model was used to evaluate the mortality risk factors., Results: There was no difference between the incidence rates of complications in patients with severe dementia and those in patients without dementia. The incidence of mechanical complications was 1.35/1000 days for patients without dementia vs. 1.53/1000 days for patients with dementia (p = 0.270), the incidence of gastrointestinal complications was 1.30/1000 days for patients without dementia vs. 1.35/1000 days for patients with dementia (p = 0.984) and the incidence of metabolic complications was 0.36/1000 days for patients without dementia vs. 0.35/1000 days for patients with dementia (p = 0.252). The Kaplan Mailer analyses showed that there was no evidence to support the theses on poorer prognosis of survival of patients with dementia (median survival was 193 days for patients without dementia vs. 192 days for patients with dementia, (p > 0.05)). The female gender, advanced age, nasogastric tube, diabetes mellitus and chronic renal failure were identified as risk factors. Subjects whose Geriatric Nutritional Risk Index values were higher had a lower risk of mortality., Conclusions: The discussion on the appropriateness of enteral nutrition in patients with severe dementia is still open. Our results show that, if there is a medical prescription for tube-feeding and a patient's surrogate decision-makers express free and informed consent to the tube-feeding of the patient, enteral nutrition should not be contraindicated a priori if the patient has severe dementia. Regular follow-up is mandatory to guarantee adherence to the therapy and achieve its initial aims and to ensure that the principles of beneficence and nonmaleficence are respected., (Copyright © 2018 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.)

Background & Aims: The purpose of this study was to comprehend and describe the views, experiences and adaptations of caregivers who assist older patients treated with Home Enteral Nutrition. The objective was to gather empirical evidence to improve the delivery of Home Enteral Nutrition for old patients taking into account the caregivers' support needs., Methods: A qualitative methodology with focus groups as data collection method was used to collect the testimonies of 30 informal and formal caregivers of older patients treated with Home Enteral Nutrition by the Clinical Nutrition Service of INRCA (Ancona) during 2014. Quantitative methodology was used to collect socio-demographic data. Partially modified Silver's "Home Enteral Nutrition Caregiver Task Checklist" was used to identify training needs. The constant comparison method was used to code and categorize data and to develop themes of focus groups. Simple descriptive statistics were used to summarize questionnaires., Results: Five main themes were identified from focus groups: acceptance of the therapy, skill acquisition process, need for psychological and practical support at home from healthcare professionals, lifestyle adaptation, affirmation of life and family. All caregivers testified the initial fear and refusal to manage the nutrition pump and the therapy. They expressed the need to be trained gradually, starting during a patient's hospitalization, and continuing in the community. With reference to their overall QoL, it emerged that informal caregivers suffered mostly from the reduction of their free time while formal caregivers suffered social isolation and psychological burden. For both groups the monthly home visit was the most important element of the HEN service. Informal caregivers highlighted the importance of having their loved ones at home. Unsatisfied training needs were identified by the modified Silver's "Home Enteral Nutrition Caregiver Task Checklist"., Conclusions: This qualitative study underlined the challenges and adaptations of caregivers who assist older patients treated with Home Enteral Nutrition, which should be considered when defining clinical protocols and supporting caregivers., (Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.)

We present the rationale and study design of the Tarceva Italian Lung Optimization trial phase III, multicenter, open-label, randomized trial on efficacy of second-line therapies in different subgroups of non-small-cell lung cancer (NSCLC) patients identified using molecular and clinical evaluations. To date, we can assume that advanced NSCLC epidermal growth factor receptor (EGFR)-mutated patients benefit from EGFR tyrosine kinase inhibitors, such as gefitinib and erlotinib, whereas their role in the treatment of patients who do not have EGFR mutations is controversial. The aim of this study is to assess whether it is possible to optimize second-line treatment in NSCLC patients with absence of EGFR mutations. Moreover, the predictive value of the K-ras mutation, EGFR protein expression, and EGFR gene copy number, as well as a smoking habit and histotype for determining a different effect of erlotinib compared with chemotherapy will be assessed in patients who do not have EGFR mutations. The primary endpoint is overall survival; the secondary endpoints are progression-free survival, response rate, quality of life, and toxicity. We have planned to collect blood samples to identify different prognosis-related polymorphisms and to assess their sensitivity and specificity in the detection of EGFR and K-ras mutations with respect to histologic samples., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: Knowledge of independent, baseline risk factors for catheter-related thrombosis (CRT) may help select adult cancer patients who are at high risk to receive thromboprophylaxis., Objectives: We conducted a meta-analysis of individual patient-level data to identify these baseline risk factors., Patients/methods: MEDLINE, EMBASE, CINAHL, CENTRAL, DARE and the Grey literature databases were searched in all languages from 1995 to 2008. Prospective studies and randomized controlled trials (RCTs) were eligible. Studies were included if original patient-level data were provided by the investigators and if CRT was objectively confirmed with valid imaging. Multivariate logistic regression analysis of 17 prespecified baseline characteristics was conducted. Adjusted odds ratios (ORs) and 95% confidence intervals (CIs) were estimated., Results: A total sample of 5636 subjects from five RCTs and seven prospective studies was included in the analysis. Among these subjects, 425 CRT events were observed. In multivariate logistic regression, the use of implanted ports as compared with peripherally implanted central venous catheters (PICCs), decreased CRT risk (OR, 0.43; 95% CI, 0.23-0.80), whereas past history of deep vein thrombosis (DVT) (OR, 2.03; 95% CI, 1.05-3.92), subclavian venipuncture insertion technique (OR, 2.16; 95% CI, 1.07-4.34) and improper catheter tip location (OR, 1.92; 95% CI, 1.22-3.02), increased CRT risk., Conclusions: CRT risk is increased with use of PICCs, previous history of DVT, subclavian venipuncture insertion technique and improper positioning of the catheter tip. These factors may be useful for risk stratifying patients to select those for thromboprophylaxis. Prospective studies are needed to validate these findings., (© 2011 International Society on Thrombosis and Haemostasis.)

Background: Recent guidelines do not recommend antithrombotic prophylaxis (AP) to prevent catheter-related thrombosis in cancer patients with a central line., Patients and Methods: This study assessed the management of central lines in cancer patients, current attitude towards AP, catheter-related and systemic venous thromboses, and survival., Results: Of 1410 patients enrolled, 1390 were seen at least once in the 6-month median follow-up. Continuous AP, mainly low-dose warfarin, was given to 451 (32.4%); they were older, with a more frequent history of venous thromboembolism (VTE), and more advanced cancer. There was no difference in catheter-related thrombosis in patients given AP or not (2.8% and 2.2%, odds ratio 1.29, 95% confidence interval 0.64-2.6). The median time to first catheter-related complication was 120 days. Systemic VTE including deep and superficial thromboses and pulmonary embolism, were less frequent with AP (4% versus 8.2%, P = 0.005). Mortality was also lower (25% versus 44%, P = 0.0001). Multiple logistic regression analysis found only advanced cancer and no AP significantly associated with mortality. No major bleeding was recorded with AP., Conclusions: Current AP schedules do not appear to prevent catheter-related thrombosis. Systemic VTE and mortality, however, appeared lower after prophylaxis.