Abstract:
OBJECTIVE:This observational study was conducted to document the safety of capecitabine-based adjuvant therapy in patients with resected colon cancer under routine clinical conditions. RESEARCH AND DESIGN METHODS:ML20431 was a prospective, multicenter, non-interventional, observational study. It was designed to answer five research questions relating to safety, dosage and administration, and discontinuation from capecitabine-based adjuvant therapy. Patients were required to have R0 resected stage III colon cancer and have started treatment with capecitabine-based adjuvant therapy based on a decision by the investigator. Patients were followed over an observation period of ≤6 months after initiation of therapy. Investigators were required to complete the study case report form at study entry, each treatment cycle, and at the final examination. MAIN OUTCOME MEASURES:A total of 1485 patients were included in the study, and 1481 patients were treated with capecitabine and formed the analysis population. Most patients had colon cancer (78.3%), followed by rectal cancer (16.4%). Most patients had stage III disease (69.3%); the remaining patients had stage II disease (30.7%). The most common all-grade adverse reactions were hand-foot syndrome (46.9%), diarrhea (34.4%), and hemoglobin decreases (31.5%). Grade 3/4 adverse reactions were infrequent (<4%). Serious adverse events were reported in 96 patients (6.5%). Six or more cycles of treatment were completed by 77.9% of patients. Approximately two-thirds of patients (67.3%) received capecitabine monotherapy and the remainder (32.7%) received capecitabine in combination with ≥1 drugs, most commonly oxaliplatin (460 cases). Discontinuation of capecitabine was documented in 344 patients (23.2%). STUDY LIMITATIONS:no efficacy data were collected; the questionnaires for patients' expectations and satisfaction were not formally validated; and a few patients (<1.5%) had some retrospective data. CONCLUSIONS:The safety profile of capecitabine-based adjuvant therapy in a broad patient population with colon cancer is similar to that previously documented in phase III clinical trials.
journal_name
Curr Med Res Opinjournal_title
Current medical research and opinionauthors
Steffens CC,Tschechne B,Schardt C,Jacobs G,Valdix AR,Schmidt P,Hansen R,Kröning H,Wohlfarth T,Guggenberger Ddoi
10.1185/03007995.2015.1014030subject
Has Abstractpub_date
2015-04-01 00:00:00pages
731-41issue
4eissn
0300-7995issn
1473-4877journal_volume
31pub_type
杂志文章,多中心研究abstract:OBJECTIVES:Compare migraine duration with frovatriptan (versus baseline) in migraineurs reporting long- (24-72 h) or short-duration (<24 h) migraines at baseline. METHODS:Post hoc analysis of two postmarketing surveillance studies of migraineurs in German primary care clinics using frovatriptan (2.5 mg) to treat a sin...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2010.503488
更新日期:2010-09-01 00:00:00
abstract:BACKGROUND:For the prevention of chemotherapy-induced febrile aplasia, a single injection of pegfilgrastim per cycle has the same efficacy as six to ten injections of conventional granulocyte colony-stimulating factor (G-CSF). However, there are few data on the economic impact of pegfilgrastim use, especially in the co...
journal_title:Current medical research and opinion
pub_type: 杂志文章,多中心研究
doi:10.1185/03007990902918156
更新日期:2009-06-01 00:00:00
abstract:OBJECTIVE:To determine the effects of long-term atomoxetine treatment on sexual development in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) as compared with placebo and with a national US survey in non-Hispanic white children and adolescents. METHODS:This double-blind, placebo-controll...
journal_title:Current medical research and opinion
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1185/03007995.2011.599372
更新日期:2011-01-01 00:00:00
abstract:OBJECTIVE:This study evaluated the long-term cost-effectiveness of atorvastatin 20 mg, rosuvastatin 10 mg and simvastatin 40 mg in primary and secondary prevention of CHD in Finland. RESEARCH DESIGN AND METHODS:The effect of statin therapy on the incidence of CHD and the expected total costs of the disease were descri...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007990802144705
更新日期:2008-06-01 00:00:00
abstract:OBJECTIVE:In the four SMILE (Survival of Myocardial Infarction Long-Term Evaluation) studies, early administration of zofenopril in acute myocardial infarction (AMI) showed beneficial effects as compared to placebo and other angiotensin converting enzyme inhibitors (ACEIs). This study investigated whether the concomita...
journal_title:Current medical research and opinion
pub_type: 杂志文章,随机对照试验
doi:10.1080/03007995.2018.1496076
更新日期:2018-10-01 00:00:00
abstract:OBJECTIVE:A recent retrospective meta-analysis of cardiovascular events from long-term studies with acarbose in type 2 diabetes showed that treatment was associated with a significant reduction in the risk of cardiovascular events, supporting the hypothesis that postprandial hyperglycemia is a risk factor for cardiovas...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079906X115531
更新日期:2006-07-01 00:00:00
abstract::In gouty patients, urate lowering therapies (ULTs) are recommended to bring serum uric acid (SUA) levels below 6.0 mg/dL, with the aim of dissolving urate depositions, thereby reducing disease impact. However, patients with hyperuricemia often present with other conditions associated with cardiovascular (CV) risk, suc...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2015.1087979
更新日期:2015-01-01 00:00:00
abstract::An open, multi-centre study was carried out in 117 pregnant women presenting with vaginal candidosis to assess the effectiveness of econazole in providing mycological control and symptom relief, and in preventing, as far as possible, the risk of contamination of the newborn: nearly 50% of the patients were in the last...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章
doi:10.1185/03007998509109606
更新日期:1985-01-01 00:00:00
abstract:OBJECTIVE:The Glucose and Lipid Assessment in Diabetes (GLAD) trial examined the dose-response relationship of the dual peroxisome proliferator-activated receptor (PPAR) alpha/gamma agonist tesaglitazar in type 2 diabetic patients. STUDY DESIGN:GLAD was a 12-week, multicenter, international, randomized, parallel-group...
journal_title:Current medical research and opinion
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1185/030079906x154169
更新日期:2006-12-01 00:00:00
abstract::A metabolic study was carried out in 6 patients requiring enteral feeding to investigate the effectiveness and tolerance of 'Nutrauxil', a ready-made liquid nutritional preparation, over a period of 8 days. The results of anthropometric and laboratory measurements, made initially and at the end of two 4-day periods, s...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007998309109794
更新日期:1983-01-01 00:00:00
abstract:OBJECTIVE:To compare the analgesic efficacy and safety of oxymorphone extended release (ER) and oxycodone controlled release (CR) in patients with moderate to severe cancer pain. RESEARCH DESIGN AND METHODS:This randomized, multicenter, double-blind, 2-period crossover study included adult outpatients (>or= 18 years o...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1185/030079904125003854
更新日期:2004-06-01 00:00:00
abstract:OBJECTIVE:To describe the impact of migraine on psychological well-being of young women and to evaluate their communication with physicians about migraine. RESEARCH DESIGN AND METHODS:This cross-sectional telephone survey was conducted in Israel and eight European countries (Finland, Germany, Greece, Italy, Norway, Sp...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079905X56394
更新日期:2005-08-01 00:00:00
abstract:OBJECTIVE:To evaluate the clinical efficacy and safety of mometasone furoate administered via a dry powder inhaler (MF-DPI) in Japanese patients with intermittent or mild persistent asthma who were not previously receiving inhaled corticosteroids. RESEARCH DESIGN AND METHODS:This was an 8-week open-label study conduct...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007990903422380
更新日期:2010-01-01 00:00:00
abstract:BACKGROUND:Basal cell carcinoma (BCC) is the most common cancer. Most cases of BCCs are treated with only optimal surgical resection. However, unresectable, locally advanced or metastatic tumors might have potential to progress. In this patient group, there is no standardized treatment approach. Vismodegib is a new sel...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2015.1018988
更新日期:2015-04-01 00:00:00
abstract:OBJECTIVES:Chronic obstructive pulmonary disease (COPD) is becoming a leading cause of morbidity and mortality in China. In the IMPACT trial, fluticasone furoate[FF]/umeclidinium[UMEC]/vilanterol[VI] single-inhaler triple therapy demonstrated lower rates of moderate/severe exacerbations than dual therapy with FF/VI or ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2020.1844646
更新日期:2021-01-01 00:00:00
abstract:BACKGROUND:Undetected/uncontrolled diabetes is associated with substantial morbidity and mortality and consequent costs. Early detection through screening identifies patients at risk, allowing for earlier treatment initiation. OBJECTIVES:To determine the economic impact of screening for type 2 diabetes (T2DM). DATA S...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1080/03007995.2016.1257977
更新日期:2017-02-01 00:00:00
abstract::Objectives: Ethics guidelines such as the Declaration of Helsinki and the CIOMS International Ethical Guidelines for Health-related Research Involving Humans require the sponsors, in cooperation with relevant stakeholders, to provide post-trial access (PTA) to intervention and knowledge, especially in clinical trials ...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1080/03007995.2019.1644851
更新日期:2019-11-01 00:00:00
abstract::In order to assess the effect of ACTH on the adrenal cortex when used as a therapeutic or diagnostic agent, adrenocortical function was tested before and 2 hours after 0.5 mg tetracosactrin given intramuscularly in 31 healthy children, divided into 4 groups according to age and sex. Mean plasma cortisol levels were sh...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007997709115283
更新日期:1977-01-01 00:00:00
abstract:OBJECTIVE:To estimate the costs and consequences of using pamidronate compared to zoledronic acid in the prophylactic management of skeletal morbidity among breast cancer patients in the UK. DESIGN AND SETTING:This was a modelling study performed from the perspective of the UK's National Health Service (NHS). METHODS...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079905X40472
更新日期:2005-05-01 00:00:00
abstract:OBJECTIVE:The dopamine agonist rotigotine has shown efficacy and safety for the treatment of early and advanced Parkinson's disease (PD) in controlled clinical trials. This observational study evaluated rotigotine administration in combination with other antiparkinsonian medication in routine clinical practice. METHOD...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1185/03007995.2011.611630
更新日期:2011-10-01 00:00:00
abstract:OBJECTIVE:Statin dose, adherence, and cardiovascular (CV) outcomes are important factors when considering switching statin therapies. The objective of the study was to compare CV event rates and risk in managed care patients receiving atorvastatin versus those switched to simvastatin from atorvastatin. METHODS:Patient...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2013.802229
更新日期:2013-07-01 00:00:00
abstract:OBJECTIVE:Postpartum depression (PPD) is the most common medical complication of childbirth. PPD can be disabling, with potential negative effects on maternal health-related quality-of-life (HRQoL) as well as on children and partners. The objective of this study was to systematically review and summarize recently publi...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2018.1552039
更新日期:2019-03-01 00:00:00
abstract:OBJECTIVES:To compare compliance/persistence, health care resource utilization, and costs associated with single-pill combination (SPC) vs. free-combination (FC) therapies among adult hypertension patients at the national and state level. Combination therapies with angiotensin receptor blocker (ARB) + calcium channel b...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2010.494462
更新日期:2010-09-01 00:00:00
abstract:OBJECTIVES:The objectives were to estimate the prevalence of self-treated hypoglycaemia in patients using basal insulin analogues; identify demographic, treatment related and behavioural risk factors; and describe patient and physician responses to these events. RESEARCH DESIGN AND METHODS:The GAPP2 (Global Attitude o...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1185/03007995.2012.743457
更新日期:2012-12-01 00:00:00
abstract:OBJECTIVE:To compare the risk of developing uveitis in patients initiating anti-tumor necrosis factor (anti-TNF) agents (adalimumab, etanercept, and infliximab) for ankylosing spondylitis (AS). METHODS:Anti-TNF-naive patients with a diagnosis of AS and without a history of uveitis (N = 2115) who subsequently initiated...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2014.969368
更新日期:2014-12-01 00:00:00
abstract::A clinical study was carried out to evaluate the usefulness of intravenous lorazepam, given for sedation instead of opiate narcotics or diazepam, in 25 seriously-ill patients being treated in a respiratory and intensive care unit. All but 3 patients were on assisted ventilation. Standard doses of 4 mg lorazepam were g...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007997609109320
更新日期:1976-01-01 00:00:00
abstract:OBJECTIVE:To provide clinically relevant information on tadalafil 2.5 or 5 mg once daily for the treatment of erectile dysfunction (ED), by reviewing safety and efficacy study findings. Findings from an integrated analysis of trials of tadalafil 10 and 20 mg as needed are presented to provide context for the daily dosi...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007990802498440
更新日期:2008-12-01 00:00:00
abstract:OBJECTIVE:Non-adherence to pain medication is common in chronic pain patients and may result in unfavorable treatment outcomes. Interventions to improve adherence behavior often fail to significantly change medication use. In this report, we describe the application of a theoretical psychological model of behavior chan...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2017.1314955
更新日期:2017-07-01 00:00:00
abstract::Objective: Determine healthcare resource utilization (HCRU) and costs associated with fatigue and stiffness among patients with rheumatoid arthritis (RA).Methods: A retrospective claims analysis compared RA patients with fatigue or stiffness to matched RA control patients with neither. Claims from a large US commercia...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2019.1658974
更新日期:2020-01-01 00:00:00
abstract::Studies in several populations have indicated that genetic variation at the apolipoprotein E (apoE) structural locus influences the risk of coronary artery disease (CAD) and myocardial infarction (MI). This study aimed at investigating whether apoE polymorphism has an allelic and/or genotypic impact on the risk of MI ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079902125000444
更新日期:2002-01-01 00:00:00