Abstract:
INTRODUCTION:In FRESCO (Fruquintinib Efficacy and Safety in 3+ Line Colorectal Cancer Patients) trial, fruquintinib demonstrated a statistically significant and clinically meaningful overall survival benefit in Chinese patients with metastatic colorectal cancer (mCRC). However, its safety profile, including adverse events of special interest (AESIs) and treatment-emergent adverse events (TEAEs) by age, sex, and body mass index (BMI), is not well known. The present analysis evaluated the safety profile and AESIs for fruquintinib in the FRESCO trial. METHODS:In FRESCO, eligible Chinese patients were randomized (2:1) to receive fruquintinib (5 mg once daily for 3 weeks, followed by 1 week off in 28-day cycles) or placebo plus best supportive care. Treatment-related AESIs and time to first occurrence of AESIs were summarized. Treatment-related TEAEs by age, sex, and BMI were also summarized. RESULTS:A total of 266 patients (95.7%) in the fruquintinib group and 97 (70.8%) in the placebo group had at least one treatment-related TEAE; the mean relative dose intensity was 92% and 98%, respectively. In the fruquintinib group, the most common (in > 40% of patients) treatment-related AESIs were hypertension (55.4%), palmar-plantar erythrodysesthesia syndrome [known as hand-foot skin reaction (HFSR)] (49.3%), and proteinuria (42.1%). The most common treatment-related grade ≥ 3 AESIs (≥ 3% of patients) were hypertension (21.2%), HFSR (10.8%), and proteinuria (3.2%); the median time to onset of these events was 10, 21, and 20 days, respectively. Subgroup analysis by age, sex, and BMI revealed that the frequencies of treatment-related TEAEs were similar across all subgroups, and were consistent with the overall safety profile of fruquintinib. CONCLUSIONS:The most common treatment-related grade ≥ 3 AEs were hypertension, HFSR, and proteinuria. The treatment-related TEAE profile of fruquintinib in Chinese patents with mCRC was comparable among different subgroups and consistent with that reported in the overall population. TRIAL REGISTRATION:Clinical Trials identifier NCT02314819.
journal_name
Adv Therjournal_title
Advances in therapyauthors
Li J,Guo W,Bai Y,Deng Y,Yang L,Chen Z,Zhong H,Xu R,Pan H,Shu Y,Yuan Y,Zhou J,Xu N,Liu T,Ma D,Wu C,Cheng Y,Xu J,Chen D,Li W,Sun S,Yu Z,Cao P,Shen L,Chen H,Wang S,Wang H,Fan S,Guo X,Wang N,Han Rdoi
10.1007/s12325-020-01477-wsubject
Has Abstractpub_date
2020-11-01 00:00:00pages
4585-4598issue
11eissn
0741-238Xissn
1865-8652pii
10.1007/s12325-020-01477-wjournal_volume
37pub_type
杂志文章abstract:INTRODUCTION:Evidence suggests that elevated plasma levels of B-type natriuretic peptide (BNP) are found in patients with chronic obstructive pulmonary disease (COPD) and right ventricular dysfunction. We examined the effects of exercise on plasma BNP levels in patients with COPD who have normal right ventricular funct...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章
doi:10.1007/s12325-008-0067-1
更新日期:2008-07-01 00:00:00
abstract::Multiple, potentially practice-changing cardiology trials have been presented or published over the past year. In this paper, we summarize and place in clinical context, new data regarding management of acute coronary syndrome and ST-elevation myocardial infarction (copeptin assessment, otamixaban, cangrelor, prasugre...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-014-0141-9
更新日期:2014-08-01 00:00:00
abstract:PURPOSE:To compare the efficacy of bromfenac 0.09% and dexamethasone 0.1% in the treatment of anterior chamber inflammation after uncomplicated cataract surgery. METHODS:Seventy-six patients with senile cataracts and no other ocular comorbidities who underwent uneventful phacoemulsification were randomized 1:1 to rece...
journal_title:Advances in therapy
pub_type: 杂志文章,随机对照试验
doi:10.1007/s12325-019-01076-4
更新日期:2019-10-01 00:00:00
abstract:BACKGROUND:The OPTIMA© (MSD, Courbevoie, France) questionnaire was developed to promote shared decisions and the set-up of specific micro-objectives in clinical practice by optimizing communication between type 2 diabetes (T2DM) patients and their physicians. The present study aimed to assess OPTIMA in clinical practic...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究
doi:10.1007/s12325-016-0341-6
更新日期:2016-06-01 00:00:00
abstract:INTRODUCTION:Recent research has suggested that serum tumor markers can give valuable prognostic information in gastric cancer. In this study, we examined the relationship between preoperative serum carcinoembryonic antigen (CEA), carbohydrate antigen (CA) 19-9, CA 72-4, and alfa fetoprotein (AFP) levels on clinicopath...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-008-0100-4
更新日期:2008-10-01 00:00:00
abstract:INTRODUCTION:Acute gastrointestinal bleeding (GIB) is a major cause of death in liver cirrhosis. This multicenter study aims to develop and validate a novel and easy-to-access model for predicting the prognosis of patients with cirrhosis and acute GIB. METHODS:Patients with cirrhosis and acute GIB were enrolled and ra...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究
doi:10.1007/s12325-019-01083-5
更新日期:2019-11-01 00:00:00
abstract::This 6-month randomized study evaluated the safety and efficacy of sibutramine in 57 overweight Hispanic patients with hypertension. Following a 2-week washout to confirm the diagnosis of hypertension, antihypertensive medication was adjusted to achieve a blood pressure less than 140/90 mm Hg before institution of eit...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1007/BF02850257
更新日期:2003-03-01 00:00:00
abstract::Liver transplantation has become a highly standardized, acceptable option for selected patients with end-stage liver disease and/or hepatocellular carcinoma in the setting of cirrhosis. Both conditions are associated with loss of skeletal muscle mass (sarcopenia) and physical deconditioning. Both conditions result in ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-018-0797-7
更新日期:2018-11-01 00:00:00
abstract:OBJECTIVES:This study set out to examine the efficacy and tolerability of two innovative implant forms of leuprorelin acetate in men with advanced hormone-dependent prostate cancer in everyday clinical practice. METHODS:Data were collected from 818 patients (from 273 centers across Germany) who were pretreated with sl...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-013-0010-y
更新日期:2013-03-01 00:00:00
abstract::Nateglinide is an oral antidiabetic medication that acts through rapid, short-term stimulation of insulin production. This study was undertaken to identify the incidence and nature of adverse effects of nateglinide and to assess its efficacy in clinical practice. Patients (n = 3254) were recruited from 606 centers in ...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究
doi:10.1007/BF02849871
更新日期:2005-09-01 00:00:00
abstract:INTRODUCTION:The long-term safety of dimethyl fumarate (DMF) in patients with relapsing-remitting multiple sclerosis (RRMS) has been studied in mainly Caucasian patients. The present interim analysis aimed to evaluate the 72-week safety of DMF in Japanese patients with RRMS. METHODS:Safety data of Japanese subjects en...
journal_title:Advances in therapy
pub_type: 杂志文章,随机对照试验
doi:10.1007/s12325-018-0788-8
更新日期:2018-10-01 00:00:00
abstract::This multicenter, double-masked, randomized, parallel-group study compared the efficacy and safety of ketorolac tromethamine 0.5% ophthalmic solution with levocabastine 0.05% and ketorolac tromethamine vehicle in patients with seasonal allergic conjunctivitis. One drop of ketorolac, levocabastine, or vehicle was insti...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1007/BF02854842
更新日期:2000-03-01 00:00:00
abstract::The aim of this prospective, randomized, open-label, blinded endpoint (PROBE) study was to compare the antihypertensive efficacy of 2 angiotensin II (AII) receptor antagonists with different pharmacologic profiles, valsartan and olmesartan, in patients with mild-to-moderate essential hypertension. After an initial 2-w...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1007/BF02850182
更新日期:2005-01-01 00:00:00
abstract:INTRODUCTION:The 1100delC CHEK2 allele has been associated with a 1.4-to 4.7-fold increased risk of breast cancer in women carrying this mutation. Our study investigated the frequency of this allele in a Chinese population. METHODS:Using touchdown polymerase chain reaction, we sequenced the CHEK2.1100delC mutation in ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-008-0057-3
更新日期:2008-05-01 00:00:00
abstract:INTRODUCTION:Anti-vascular endothelial growth factor therapy is the standard of care for neovascular age-related macular degeneration (nAMD). The dosage of two licensed agents, ranibizumab and aflibercept, was established through clinical trials; however, it is unclear if either agent is administered as recommended in ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-017-0624-6
更新日期:2017-12-01 00:00:00
abstract:PURPOSE:To compare the efficacy and safety of combined cataract extraction and either excisional goniotomy performed with the Kahook Dual Blade (KDB; phaco-KDB group) or single iStent trabecular bypass implantation (phaco-iStent group) in eyes with mild to moderate glaucoma and visually significant cataract. METHODS:T...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-019-01025-1
更新日期:2019-09-01 00:00:00
abstract:INTRODUCTION:Diuretic responsiveness in patients with chronic heart failure (CHF) is better assessed by urine production per unit diuretic dose than by the absolute urine output or diuretic dose. Diuretic resistance arises over time when the plateau rate of sodium and water excretion is reached prior to optimal fluid e...
journal_title:Advances in therapy
pub_type: 杂志文章,随机对照试验
doi:10.1007/s12325-015-0254-9
更新日期:2015-10-01 00:00:00
abstract:INTRODUCTION:Intanza® 9 μg (Sanofi Pasteur SA, Lyon, France), a split virion trivalent influenza vaccine delivered by intradermal injection with a microinjection system, became available as a vaccination for adults aged 18 to 59 years old, as of the 2010 southern hemisphere influenza season. METHODS:This study was des...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-011-0042-0
更新日期:2011-08-01 00:00:00
abstract::Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19), which can induce multisystem disease. Human angiotensin-converting enzyme 2 (ACE2) widely expressing in arterial and venous endothelial cells and arterial smooth muscle cells has been identified as a functional rec...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01399-7
更新日期:2020-07-01 00:00:00
abstract:INTRODUCTION:The purpose of this study was to determine prescribing trends in a specialist glaucoma clinic in the UK. Specifically, the aims were to determine which drugs were prescribed as first-, second-, and third-line treatment, the persistence of first-, second-, and third-line treatment regimens, and the proporti...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-017-0593-9
更新日期:2017-08-01 00:00:00
abstract::The extensive use of angiotensin-converting enzyme inhibitors (ACEIs) as antihypertensive agents and the huge amount of data collected in clinical trials and post-marketing studies has allowed the extending of the indication of ACEIs beyond blood pressure control. Current guidelines recommend ACEIs in symptomatic pati...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-020-01455-2
更新日期:2020-10-01 00:00:00
abstract:INTRODUCTION:It is unclear whether patients and their loved ones appreciate that cardiovascular disease (CVD) is the major cause of morbidity and mortality in type 2 diabetes mellitus (T2DM). The purpose of this survey was to evaluate the degree of awareness regarding the link between T2DM and CVD. METHODS:An online s...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-019-0871-9
更新日期:2019-03-01 00:00:00
abstract:INTRODUCTION:This retrospective study used data from a primary care database to compare two insulin products in routine clinical practice for the treatment of type 2 diabetes in the UK. PATIENTS AND METHODS:Records were analyzed for patients with type 2 diabetes who had been initiated on biphasic insulin aspart 30 (BI...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-010-0079-5
更新日期:2010-11-01 00:00:00
abstract:BACKGROUND:It is hypothesized that diabetes mellitus (DM) and mood disorders share points of pathophysiological commonality in the central nervous system. METHODS:A PubMed search of all English-language articles published between 1966 and March 2009 was performed with the following search terms: depression, mood disor...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-010-0011-z
更新日期:2010-02-01 00:00:00
abstract::Eupatorium laevigatum Lam. is a plant common to the central region of Brazil, where it is a widely used remedy for lesions such as buccal aphthae. These painful inflammatory ulcers affect 50% of the general population. For the first part of this two-part study, a phytotherapeutic preparation from E. laevigatum extract...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1007/BF02850010
更新日期:2000-11-01 00:00:00
abstract:INTRODUCTION:Janus kinase (JAK) inhibitors are a class of targeted therapies for rheumatoid arthritis (RA) with established clinical efficacy. However, little is known about their efficacy compared with each other. This network meta-analysis (NMA) estimated the comparative efficacy of JAK inhibitors currently approved ...
journal_title:Advances in therapy
pub_type: 杂志文章,meta分析
doi:10.1007/s12325-020-01303-3
更新日期:2020-05-01 00:00:00
abstract::Atrial fibrillation (AF) and venous thromboembolism (VTE) are highly prevalent and relevant healthcare issues. Direct oral anticoagulants (DOACs) are now the first-choice for anticoagulant treatment of these conditions displaying a better efficacy/safety profile than vitamin-K antagonists, mainly due to significantly ...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-020-01307-z
更新日期:2020-05-01 00:00:00
abstract:INTRODUCTION:Transient hepatic attenuation differences (THAD) are areas of high parenchymal enhancement observed during the hepatic arterial phase on computed tomography (CT). THAD in the left lobe of the liver can lead to surgical complications. METHODS:A retrospective study was conducted on patients who underwent mu...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01428-5
更新日期:2020-09-01 00:00:00
abstract::Real-world studies have become increasingly important in providing evidence of treatment effectiveness in clinical practice. While randomized clinical trials (RCTs) are the "gold standard" for evaluating the safety and efficacy of new therapeutic agents, necessarily strict inclusion and exclusion criteria mean that tr...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-018-0805-y
更新日期:2018-11-01 00:00:00
abstract::The purpose of this study was to evaluate risk pattern and mortality in a general population epidemiologic study performed by a staff of hypertension specialists working as the "good father of a family," with lifestyle and therapeutic advice and instrumental measurements. Mortality among the study population (n=856) d...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02850213
更新日期:2006-11-01 00:00:00