randomized controlled trial toxicity

BACKGROUND AND PURPOSE: Accelerated partial breast irradiation (APBI) technology has theoretical advantages in comparison with traditional adjuvant radiation therapy (whole-breast irradiation; WBI) after breast-conserving surgery. However, published randomized controlled trials have shown inconsistent outcomes. Therefore, a comprehensive assessment of the effectiveness and safety of APBI technology is needed. RESULTS: A total of 7 studies of 7452 patients were included in this analysis...

OBJECTIVE: To evaluate the efficacy of intra-articular injections of botulinum toxin A (BT-A) into the painful joint diseases through a systematic review of the literature and a meta-analysis of controlled randomized trials. Indeed, intra articular therapies (corticosteroids, hyaluronic acid) have limited efficacy and run a risk of toxicity in patients with joint pain. New therapeutic options are needed to treat painful osteo-articular disease. METHODS: We searched via Pubmed, ACR and EULAR congresses and grey literature for the studies reported until June 2016 and addressing the issue of BT intra articular injections in patients with refractory joint pain...

The aim of this meta-analysis was to evaluate the effects and toxicity of S-1 combined with radiotherapy in the treatment of nasopharyngeal cancer (NPC). Through a search of the databases of PubMed, Embase, the Chinese Biomedicine Database (CBM), China National Knowledge Infrastructure (CNKI), Wanfang system and Chongqing VIP Information (CQVIP), the efficacy and side effects data of S-1 combined with radiotherapy in the treatment of NPC patients from open published randomized controlled trials (RCTs) were collected...

Feeding cake with remaining oil content not only provides additional dietary energy but may also enrich pork with -3 fatty acids. Limited information is available on feeding camelina cake to pigs relating to feeding safety (toxicity), growth performance, and efficacy of -3 enrichment of pork. Therefore, we evaluated the effects of feeding increasing camelina cake (12.2% crude fat) inclusions in diets for nursery and grower-finisher pigs. In total, 128 pigs (9.2 kg BW) were randomly allocated by sex to 32 nursery pens for 4 wk and were then moved and combined into 16 mixed-sex grower-finisher pens...

Feeding cake with remaining oil contributes dietary energy (fat) in addition to protein (AA) and may provide an opportunity to enrich the n-3 fatty acid content of pork. Information regarding safety, growth performance, and efficacy of feeding camelina cake to pigs is limited. We therefore evaluated the effects of camelina cake inclusion in pig nursery diets. In total, 192 pigs (9.4 kg BW) were randomly allocated by sex to 48 pens, 2 heavy and 2 light pigs per pen. Pigs were fed 1 of 4 wheat-based diets including camelina cake (0%, 6%, 12%, or 18%; variety Celine) replacing soybean meal for 4 wk...

Brain metastasis is the leading cause of death among advanced non-small cell lung cancer (NSCLC) and breast cancer patients. The standard treatment for brain metastases is radiotherapy. The combination of radiotherapy and chemotherapy has been tested. However, the management of brain metastases has yet to be successful. Here, we aimed to determine the efficacy and safety of whole brain radiotherapy (WBRT) alone or in combination with temozolomide (TMZ) in NSCLC and breast cancer patients with brain metastases...

Toxic epidermal necrolysis (TEN) is a severe adverse drug reaction associated with the separation of skin and mucous membranes at the dermal-epidermal junction. Although it is rare, many treatments have been trialed because of its high mortality rate. Active interventions performed to date include the use of systemic corticosteroids, intravenous immunoglobulins (IVIg), cyclosporine, plasmapheresis, anti-tumor necrosis factor drugs and N-acetylcysteine, but none has been established as the most effective therapy...

BACKGROUND: In sub-Saharan Africa, among patients with advanced human immunodeficiency virus (HIV) infection, the rate of death from infection (including tuberculosis and cryptococcus) shortly after the initiation of antiretroviral therapy (ART) is approximately 10%. METHODS: In this factorial open-label trial conducted in Uganda, Zimbabwe, Malawi, and Kenya, we enrolled HIV-infected adults and children 5 years of age or older who had not received previous ART and were starting ART with a CD4+ count of fewer than 100 cells per cubic millimeter...

Adjuvant chemotherapy improves survival in patients with resected pancreatic cancer but the optimal regimen remains unclear. We aim to compare all possible adjuvant chemotherapy in terms of overall survival and toxic effects. Pubmed, Trial registries and Cochrane library databases for randomized controlled trials were searched until November 2016. Thirteen trials were included for network analysis and the hazard ratios (HRs) for survival and odds ratios for toxic effects were assessed via Aggregate Data Drug Information System software...

The role of adjuvant therapy following resection of biliary tract cancer (BTC) remains unclear. We therefore evaluated the feasibility and toxicity of adjuvant gemcitabine in patients with BTC. This clinical phase II trial was an open-label, single center, single-arm study. Within 8 weeks after gross complete resection of BTC, patients were started on intravenous infusions of gemcitabine 1000 mg/m2 over 30 min on days 1, 8, and 15 of every 28-day cycle. Intratumoral expression of cytidine deaminase (CDA), human equilibrative transporter-1 (hENT1), deoxycytidine kinase (dCK) and ribonucleotide reductase subunit 1 (RRM1) was measured by immunohistochemistry...

Patients suffering from chronic mountain sickness (CMS) have excessive erythrocytosis. Low -level cobalt toxicity as a likely contributor has been demonstrated in some subjects. We performed a randomized, placebo controlled clinical trial in Cerro de Pasco, Peru (4,380 m), where 84 participants with a hematocrit (HCT) ≥65% and CMS score>6, were assigned to four treatment groups of placebo, acetazolamide (ACZ, which stimulates respiration), N-acetylcysteine (NAC, an antioxidant that chelates cobalt) and combination of ACZ and NAC for 6 weeks...

BACKGROUND: Fatal adverse events (FAEs) have been reported in cancer patients receiving ipilimumab-a monoclonal antibody against cytotoxic T-lymphocyte antigen-4, but the risk of treatment-related mortality is unknown. We performed a systematic review and meta-analysis of randomised controlled trials (RCTs) of ipilimumab to determine the overall risk of FAEs associated with ipilimumab. METHODS: We systematically searched MEDLINE, EMBASE, Cochrane CENTRAL, ClinicalTrial...

Ramucirumab is an IgG1 monoclonal antibody specific for the vascular endothelial growth factor receptor-2. Ramucirumab, 8 mg/kg every two weeks, administered as monotherapy (REGARD) or in combination with paclitaxel (RAINBOW), was safe and effective in patients with previously treated advanced gastric or gastroesophageal junction (GEJ) cancer. We evaluated exposure-efficacy and exposure-safety relationships of ramucirumab from two randomized, placebo-controlled phase III trials. Sparse pharmacokinetic samples were collected and a population pharmacokinetic analysis was conducted to predict ramucirumab minimum trough concentration at steady-state (Cmin,ss)...

BACKGROUND: The use of prophylactic systemic antibiotics with nasal packing has been a controversial topic. There are few evidence-based studies to determine the need for prophylactic systemic antibiotics. We performed a systematic literature review to determine the role of prophylactic systemic antibiotics with nasal packing in the prevention of toxic shock syndrome and local nasal infections. OBJECTIVE: The purpose of this study was to perform a systematic literature review to determine the role of prophylactic systemic antibiotics with nasal packing in the prevention of toxic shock syndrome and local nasal infections...

BACKGROUND: The use of intensive pediatric protocols for the treatment of ALL is being extended to older adults. AIM OF THE STUDY: Analysis of the efficacy and toxicity results of pediatric DFCP vs. classic Hyper-CVAD protocol for the treatment of patients with ALL < 50 Y. PATIENTS AND METHODS: A retrospective single center comparative analysis of DFCP & classic Hyper-CVAD for first line treatment of patients with ALL < 50 Y. RESULTS: 73 patients were included, 43 received DFCP and 30 received Hyper-CVAD protocol...

Progress in the treatment options for small cell lung cancer (SCLC) remains poor. Concerns exist regarding the efficacy of bevacizumab in SCLC. The present study aimed to evaluate the efficacy of bevacizumab in extensive stage (ES)-SCLC. A meta-analysis on studies conducted and listed on the Medline, Cochrane Trials, ASCO, ESMO and ClinicalTrial databases, and Chinese databases prior to April 2015 was performed. All clinical trials in which patients with ES-SCLC were treated with bevacizumab were considered...

PURPOSE: Chronic use of corticosteroids for the treatment of uveitis has been linked with drug-associated toxicity and adverse events (AEs). This study examines the association between corticosteroid dosage and incidence rates of corticosteroid-related AEs. DESIGN: A post hoc analysis of the VISUAL-1 and VISUAL-2 placebo-controlled clinical trials. PARTICIPANTS: The clinical trials consisted of adults with active (VISUAL-1) and inactive (VISUAL-2) noninfectious intermediate, posterior, and panuveitis...

BACKGROUND AND PURPOSE: Local recurrence is frequent in locally advanced NSCLC and is primarily located in FDG-avid parts of tumour and lymph nodes. Aiming at improving local control without increasing toxicity, we designed a multi-centre phase-III trial delivering inhomogeneous dose-escalation driven by FDG-avid volumes, while respecting normal tissue constraints and requiring no increase in mean lung dose. Dose-escalation driven by FDG-avid volumes, delivering mean doses of 95Gy (tumour) and 74Gy (lymph nodes), was pursued and compared to standard 66Gy/33F plans...

BACKGROUND: Whole brain radiotherapy (WBRT) is the standard of care to improve intracranial control following resection of brain metastasis. However, stereotactic radiosurgery (SRS) to the surgical cavity is widely used in an attempt to reduce cognitive toxicity, despite the absence of high-level comparative data substantiating efficacy in the postoperative setting. We aimed to establish the effect of SRS on survival and cognitive outcomes compared with WBRT in patients with resected brain metastasis...

OBJECTIVES: We aimed to compare and rank the effects of 9 immune checkpoint inhibitor-related therapies for treating advanced melanoma. METHODS: We searched Pubmed, Cochrane databases, Web of Science, and ClinicalTrials.gov for randomized controlled trials of the immune checkpoint inhibitor-related treatments for advanced melanoma. Analysis was done on a Bayesian framework. RESULTS: Twelve trials including 5413 patients were identified. Ipilimumab plus nivolumab, nivolumab, and pembrolizumab were significantly more efficacious for progression-free survival (PFS) than ipilimumab (hazard ratio [HR], 0...