Search results for "ADVERSE EVENTS"
showing 10 items of 85 documents
Efficacy of nivolumab in pre-treated non-small-cell lung cancer patients harbouring KRAS mutations
2018
Background: The present study investigated the efficacy and safety of nivolumab in pre-treated patients with advanced NSCLC harbouring KRAS mutations. Methods: Clinical data and KRAS mutational status were analysed in patients treated with nivolumab within the Italian Expanded Access Program. Objective response rate, progression-free survival and overall survival were evaluated. Patients were monitored for adverse events using the National Cancer Institute Common Terminology Criteria for Adverse Events. Results: Among 530 patients evaluated for KRAS mutations, 206 (39%) were positive while 324 (61%) were KRAS wild-type mutations. KRAS status did not influence nivolumab efficacy in terms of …
70 Patient reported outcome in platinum-resistant recurrent ovarian cancer and metastatic breast cancer treated with metronomic chemotherapy
2021
Introduction/Background* In the treatment of both platinum-resistant recurrent ovarian cancer (ROC) and metastatic breast cancer (MBC), symptom control and maintenance of quality of life (QoL) play a crucial role. In the advanced stage of disease, metronomic chemotherapy (MCT) may be a favourable treatment option. The aim of this study is to assess the QoL of heavily pretreated patients with ROC and MBC treated with MCT. Methodology PROmetronomic, FoR.UM 19-02193, is a monocentric, open-label, single-arm observational study to assess health-related patient-reported outcome data in ROC and MBC patients treated with MCT (cyclophosphamide 50 mg p.o. daily ± methotrexate 2.5 mg p.o. every other…
Ten years of sorafenib in hepatocellular carcinoma: Are there any predictive and/or prognostic markers?
2018
Sorafenib has been considered the standard of care for patients with advanced unresectable hepatocellular carcinoma (HCC) since 2007 and numerous studies have investigated the role of markers involved in the angiogenesis process at both the expression and genetic level and clinical aspect. What results have ten years of research produced? Several clinical and biological markers are associated with prognosis. The most interesting clinical parameters are adverse events, Barcelona Clinic Liver Cancer stage, and macroscopic vascular invasion, while several single nucleotide polymorphisms and plasma angiopoietin-2 levels represent the most promising biological biomarkers. A recent pooled analysi…
Quality of Life in Patients With Severe Skin Reactions in Course of First-Generation Epidermal Growth Factor Receptor Inhibitors Monoclonal Antibodie…
2021
Background: Metastatic colorectal cancer (mCRC) with wild type expression of RAS and RAF genes can be treated with anti-epidermal growth factor receptor (EGFR) monoclonal antibodies, such as cetuximab, in combination with chemotherapy. Skin toxicity represents the most serious and frequent side effect in these patients. Skin manifestations occur in approximately 80% of patients. In this study, we investigated the consequences on body image and quality of life (QoL) of patients with severe skin toxicity. Methods: One hundred patients were enrolled with mCRC. All patients signed informed consent and completed questionnaires to assess QoL and body discomfort. Toxicity was assessed on Common Te…
Sorafenib: from literature to clinical practice
2013
Sorafenib is considered the standard systemic therapy for hepatocellular carcinoma (HCC), in patients with well-preserved liver function (Child-Pugh A class) and advanced-stage HCC (BCLC-C) or in patients with HCC progressing after locoregional therapies, with a high grade of recommendation. The approval of sorafenib for this indication was grounded on the efficacy and the safety results reported by two international randomized, controlled trials, the SHARP and the Asia-Pacific studies. In addition, the efficacy and the safety of sorafenib in clinical practice are addressed by several field-practice experiences, including the multinational GIDEON study and the SOFIA study. Finally, further …
French Endocrine Society Guidance on endocrine side effects of immunotherapy.
2018
The management of cancer patients has changed due to the considerably more frequent use of immune checkpoint inhibitors (ICPIs). However, the use of ICPI has a risk of side effects, particularly endocrine toxicity. Since the indications for ICPI are constantly expanding due to their efficacy, it is important that endocrinologists and oncologists know how to look for this type of toxicity and how to treat it when it arises. In view of this, the French Endocrine Society initiated the formulation of a consensus document on ICPI-related endocrine toxicity. In this paper, we will introduce data on the general pathophysiology of endocrine toxicity, and we will then outline expert opinion focusing…
Risk assessment in ginecology and obstetrics in Sicily: an approach based on Wolff's Criteria
2013
Objectives To apply Wolff’s Criteria to hospital discharge records (HDR) in order to detect adverse events worthy of further study. Methods Gynecology and Obstetrics Units of three Sicilian hospitals were considered and HDR regarding ordinary and day hospital admissions in 2008 were collected. A matched case-control study was designed, by random selection of 10 controls at maximum for each case. Matching was performed on the variables age and speciality of admission (gynecology or obstetrics). Results Out of a total of 7011 HDR examined, 114 cases were identified with Wolff’s Criteria. Multivariate analysis confirmed a statistically significant association with the origin of admission, diag…
Impact of universal vaccination against varicella in Italy: Experiences from eight Italian Regions.
2014
In Italy, the introduction of Universal Varicella Vaccination (UVV) has been decided but postponed, as a national programme, until 2015, when data from Regions which have already implemented it will be available. Starting from 2003, eight Italian Regions (Basilicata, Calabria, Friuli Venezia Giulia, Apulia, Sardinia, Sicily, Tuscany and Veneto) have progressively introduced UVV, in their immunization programme, with different schedules in children aged 13-15 months and 5-6 years, currently a two-dose schedule is adopted by all Regions. In June 2013, an Interregional Group on Varicella Vaccination (IGVV) has been established in order to assess the effectiveness of varicella vaccination with …
Data of safety in a single-center alemtuzumab treated population
2020
Alemtuzumab is approved for highly active MS and, in Europe, can be employed after other disease-modifying treatments (DMTs) as an escalation approach or first therapeutic option. The occurrence of secondary autoimmune adverse events and infections differs depending on the employed approach.In the manuscript entitled “Alemtuzumab treatment of multiple sclerosis in real-world clinical practice: report from a single Italian center” by di Ioia M. and collaborators, efficacy and safety data of alemtuzumab were evaluated in a real-world MS population. The aim of the article is to describe in detail the unexpected serious adverse events which occurred in this cohort during and after the administr…
Adverse Events in Treatment of Inherited Factor VII Deficiency: Final Analysis of the STER
2012
Abstract Abstract 2279 Introduction No evidence-based guidelines are available for the treatment of Factor VII deficiency. Replacement therapy (RT) is still influenced by different factors as rarity of the disorder, availability and supply of products and economic reasons. All RTs are not exempt of side effects and scanty data is available about the safety of the products currently used. Aim of this study was to analyze adverse events (AEs) of RTs for congenital Factor VII deficiency, as reported in Seven Treatment Evaluation Registry (STER). Design and Methods FVII deficiency patients treated for bleeding episodes, prophylaxis, and surgery were investigated for RT-related AEs over a period…