Search results for "Side effects"
showing 10 items of 132 documents
Safety and Pharmacokinetics/Pharmacodynamics of the First-in-Class Dual Action HER3/EGFR Antibody MEHD7945A in Locally Advanced or Metastatic Epithel…
2015
Abstract Purpose: The novel dual-action humanized IgG1 antibody MEHD7945A targeting HER3 and EGFR inhibits ligand-dependent HER dimer signaling. This phase I study evaluated the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of MEHD7945A. Experimental Design: Patients with locally advanced or metastatic epithelial tumors received escalating doses of MEHD7945A (1–30 mg/kg) every 2 weeks (q2w) until disease progression or intolerable toxicity. An expansion cohort was enrolled at the recommended phase II dose (14 mg/kg, q2w). Plasma samples, tumor biopsies, FDG-PET were obtained for assessment of pharmacokinetics, and pharmacodynamic modulation downstream of EGFR and HER3. …
Safety and activity of trastuzumab-containing therapies for the treatment of metastatic breast cancer: our long-term clinical experience (GOIM study).
2007
Background: Trastuzumab is widely used as the treatment of choice for HER2-positive metastatic breast cancer (MBC). Patients and methods: Seventy patients, median age 57 years and range 31-81 years, were included in our retrospective analysis with the aim to evaluate safety and activity of trastuzumab-containing therapies. Results: We observed for first-line treatment response rate (RR) 41%, stable disease (SD) 47% and time to progression (TTP) 8 months (range 1-44). Corresponding numbers for second line were RR 23%, SD 62% and (TTP) 9 months (range 3-23) and beyond second line RR 22%, SD 78% and (TTP) 9 months (range 4-19). Overall survival was 19.2 months (3-62 months). The median cumulat…
Efficacy and safety of irinotecan-based chemotherapy for advanced colorectal cancer outside clinical trials: an observational study.
2010
Background: This prospective observational study in typical community-based outpatient clinics evaluated the efficacy and toxicity of weekly and biweekly irinotecan-based chemotherapies and their compatibility depending on age. Methods: 601 patients with advanced or metastatic colorectal cancer receiving first-, second-, or third-line irinotecanbased therapy were regularly analyzed for response and toxicity until the end of therapy. Results: The median age was 65 (28–87) years, approximately one-third of the patients were ≥70 years old. Of all patients, 405 were treated weekly and 68 biweekly. Median overall survival (OS) for first-line therapy was 26.5 months for the <70-year-old patients …
Comparative assessment of docetaxel for safety and efficacy between hormone-sensitive and castration-resistant metastatic prostate cancer.
2019
To compare toxicity and response of docetaxel chemotherapy between metastatic hormone-sensitive prostate cancer (mHSPC) and castration-resistant metastatic prostate cancer (mCRPC) patients of the same therapeutic era for assessing of upfront docetaxel against the benchmark of docetaxel in the castrate resistant stage in the setting outside of clinical trials.A prospectively collected database of real-world prostate cancer patients receiving docetaxel was divided in mHSPC and mCRPC cases and retrospectively analyzed. Principal objectives were toxicity measured by the common criteria of adverse events terminology and response characterized by Prostate specific antigen decline and radiographic…
Sorafenib in Patients with Hepatocellular Carcinoma-Results of the Observational INSIGHT Study.
2016
Abstract Purpose: Sorafenib is the only currently approved systemic therapy for advanced hepatocellular carcinoma (HCC). We aimed to evaluate the safety and efficacy of sorafenib therapy in patients with HCC under real-life conditions regarding patient, tumor characteristics, and any adverse events at study entry and at follow-up visits every 2 to 4 months. Experimental Design: The current INSIGHT study is a noninterventional, prospective, multicenter, observational study performed in 124 sites across Austria and Germany between 2008 and 2014. Results: Median overall survival and time to progression (RECIST) were found to be dependent on baseline Barcelona Clinic Liver Cancer (BCLC) tumor s…
Age- and Sex-Graded Data Evaluation of Vaccination Reactions after Initial Injection of the BNT162b2 mRNA Vaccine in a Local Vaccination Center in Ge…
2021
A high vaccination rate of older and particularly chronically ill people against coronavirus disease-2019 (COVID-19) is likely one of the most important factors in containing the pandemic. When Germany’s vaccination campaign started on December 2020, vaccination prioritization was initially carried out starting with older population groups. Side effect rates in 1065 individuals who had received the first dose of the messenger ribonucleic acid (mRNA) vaccine BNT162b2 Tozinameran from BioNTech/Pfizer three weeks earlier were examined retrospectively. An age- and gender-graded data analysis showed clear age and gender differences with regard to vaccine-related adverse effects. In 77% of all in…
Darwinism and pharmacogenomics: from 'one treatment fits all' to 'selection of the richest'?
2004
Pharmacogenomics and pharmacogenetics are relatively new fields, and have arisen from recent advances in genetic research. They offer new perspectives on the development of pharmaceuticals, allowing drug design to be targeted specifically to the genotype of selected populations. The discussion of who will be considered for the development of these tailored drugs and who will be excluded, in a situation in which both research resources and public expenditure are limited, is provoking and has led to several, still unanswered ethical questions and concerns about fairness and the potential discrimination of fringe groups. Based on the statistical analyses of population averages, patient groups …
Review of current and “omics” methods for assessing the toxicity (genotoxicity, teratogenicity and nephrotoxicity) of herbal medicines and mushrooms
2012
Ethnopharmacological relevance: The increasing use of traditional herbal medicines around the world requires more scientific evidence for their putative harmlessness. To this end, a plethora of methods exist, more or less satisfying. In this post-genome era, recent reviews are however scarce, not only on the use of new "omics" methods (transcriptomics, proteomics, metabonomics) for genotoxicity, teratogenicity, and nephrotoxicity assessment, but also on conventional ones. Methods: The present work aims (i) to review conventional methods used to assess genotoxicity, teratogenicity and nephrotoxicity of medicinal plants and mushrooms; (ii) to report recent progress in the use of "omics" techn…
Drug-induced and iatrogenic infiltrative lung disease.
2004
At present more than 350 drugs are known to cause injury of the lung parenchyma,upper and lower airways, pulmonary circulation, pleura, mediastinum, lymph nodes,and neuromuscular system. Infiltrative lung disease (ILD) is the most common pattern of drug-induced injury. This article, which is clinically oriented rather than drug oriented, reviews the patterns of ILD produced by therapeutic drugs and radiation therapy.
A European Observational Study to Evaluate the Safety and the Effectiveness of Safinamide in Routine Clinical Practice: The SYNAPSES Trial
2021
Background: Safinamide modulates both dopaminergic and glutamatergic systems with positive effects on motor and non-motor symptoms of Parkinson's disease (PD). The drug utilization study SYNAPSES was designed to investigate the use of safinamide in routine clinical practice, as recommended by the European Medicines Agency. Objective: To describe the occurrence of adverse events in PD patients treated with safinamide in real-life conditions. Methods: The SYNAPSES trial is an observational, European, multicenter, retrospective-prospective cohort study. Patients were followed up to 12 months with analyses performed in the overall population and in patients aged >75 years, with relevant comorbi…