6 research outputs found

    Treatment of Elderly Patients with Head and Neck Cancer.

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    In our aging society, the proportion of cancer cases in the elderly (65 years) is steadily rising. In the developed countries, the majority of head and neck squamous cell cancer affect senior people. Despite that, elderly-specific prospective trials are lacking, and these patients represent a particularly challenging population to manage. They often have decreased physiologic reserves and suffer from chronic diseases. In addition to fluctuations in social support and economic resources, older age is also associated with enhanced susceptibility to stress and altered pharmacokinetics and pharmacodynamics. Consequently, owing to concerns about excessive toxicity and insufficient efficacy, multimodality treatment is frequently withheld in these patients compared with their younger counterparts. However, chronological age is not a reliable predictor of life expectancy or the risk of adverse events. It has repeatedly been shown that fit elderly individuals may, indeed, benefit from intensive therapies like reconstructive surgery with microvascular free tissue transfer, concurrent chemoradiotherapy in locoregionally advanced setting, and even from the standard first- and second-line palliative systemic therapies, being the PFE regimen (platinum/5-fluorouracil/cetuximab) and immune oncology drugs, respectively. In this respect, geriatric assessment tools have been developed to differentiate between fit and frail senior persons and guide treatment decisions. A comprehensive geriatric assessment (CGA), evaluating functional status, comorbidities, and some other parameters, requires skilled professionals, is time-consuming and not necessary in every case. Thus, geriatric screening tools (e.g. G8 and Flemish version of the Triage Risk Screening Tool) have been introduced to clinical practice enabling to decide who will need a full evaluation (CGA), who will benefit from a specific examination, and who needs no further testing. With the advent of immune checkpoint inhibitors, new questions have emerged as to whether immunotherapy is feasible and effective in the elderly. These issues including the changing portfolio of anti-cancer agents and integration of clinical practice-oriented assessment tools should be, therefore, further explored

    Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients

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    © 2017 Elsevier Ltd Aim To assess the safety and tolerability of adjuvant subcutaneous trastuzumab (Herceptin ® SC, H SC), delivered from an H SC Vial via hand-held syringe (Cohort A) or single-use injection device (Cohort B), with or without chemotherapy, for human epidermal growth factor receptor 2 (HER2)-positive stage I to IIIC early breast cancer (EBC) in the phase III SafeHer study (NCT01566721). Methods Patients received 600 mg fixed-dose H SC every 3 weeks for 18 cycles. The chemotherapy partner was at the investigators' discretion (H SC monotherapy was limited to ≤10% of the population). Data from the first H SC dose until 28 days (plus a 5-day window) after the last dose are presented. Results are descriptive. Results In the overall population, 2282/2573 patients (88.7%) experienced adverse events (AEs). Of the above, 128 (5.0%) patients experienced AEs leading to study drug discontinuation; 596 (23.2%) experienced grade ≥ 3 AEs and 326 (12.7%) experienced serious AEs. Grade ≥ 3 cardiac disorders were reported in 24 patients (0.9%), including congestive heart failure in eight (0.3%). As expected, the AE rates varied according to the timing of chemotherapy in both cohorts, with higher rates in concurrent versus sequential chemotherapy subgroups. In the concurrent chemotherapy subgroup, AEs were more common during the actual period of concurrent chemotherapy compared with the period when patients did not receive concurrent chemotherapy. Conclusion SafeHer confirms the safety and tolerability of the H SC 600 mg fixed dose for 1 year (every 3 weeks for 18 cycles) as adjuvant therapy with concurrent or sequential chemotherapy for HER2-positive EBC. These primary analysis results are consistent with the known safety profile for intravenous H and H SC.Link_to_subscribed_fulltex

    Aquatic and Wetland Vegetation Along the Sava River

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    Diverse hydrological, climate, and soil conditions along the Sava River caused significant diversification of vegetation. Therefore, the objective of this chapter is to integrate and present all the available data on variability of the aquatic and riparian plant communities along the Sava River and its main tributaries as well as to identify the environmental factors, which are related to the distribution of different vegetation types. Special attention has been also paid on the detection of threats for rare and endangered plant species and fragile wetland ecosystems along the Sava River. Based on data review, syntaxonomic revision of aquatic and riparian vegetation based on common, pan-European databank is required. Ecological studies that involve inventory, monitoring, modeling, and prediction of changes in populations, ecological communities, and ecosystems require both georeferenced databases and computational tools for application of statistical methods.Milačič R, Ščančar J, Paunović M, editors. The Sava River. Berlin, Heidelberg: Springer-Verlag; 2015. p. 249-316
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