45,557 results match your criteria primary endpoint


Extracorporeal photopheresis vs standard therapies for steroid-refractory chronic graft-vs-host disease: Pharmacoeconomic assessment of hospital resource use in Spain.

J Clin Apher 2021 May 8. Epub 2021 May 8.

Haematology Department, Hospital Universitari i Politècnic La Fe, Valencia, Spain.

Background: This study assessed pharmacoeconomic costs associated with extracorporeal photopheresis (ECP) compared with other available second-line therapies for chronic graft-vs-host disease (cGvHD) in a tertiary Spanish institution.

Methods: Patients (≥18 years) diagnosed with steroid-refractory cGvHD were eligible. Data were collected retrospectively from index date until 1 year or relapse. Read More

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Applicability of the PAINESD risk score for 30-day mortality prediction post ventricular tachycardia catheter ablation in Chagas disease.

J Interv Card Electrophysiol 2021 May 8. Epub 2021 May 8.

Instituto do Coração FMUSP, São Paulo, Brazil.

Purpose: The PAINESD risk score was developed in 2015 as a tool to stratify the risk of acute hemodynamic decompensation during ventricular tachycardia (VT) ablation in structural heart disease patients and further then used for post procedure 30-day mortality prediction. The original cohort however did not include Chagas disease (ChD) patients. We aim to evaluate the relevance of the score in a ChD population. Read More

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Health economic analysis of total extraperitoneal repair versus Lichtenstein surgery for inguinal hernia: data from a randomized clinical trial.

BJS Open 2021 May;5(3)

Department of Surgery, CLINTEC, Karolinska Institute, Enköping Hospital, Sweden.

Background: The aim was to compare cost-effectiveness of Lichtenstein under local anaesthesia (LLA) with total extraperitoneal repair (TEP) under general anaesthesia for primary inguinal hernia in men. An endoscopic approach to inguinal hernia repair is often considered costlier. The cost of endoscopic hernia repair, however, has not been compared to open inguinal hernia repair in a cost-effective setting. Read More

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Low-dose antithymocyte globulin inhibits chronic graft-versus-host disease in peripheral blood stem cell transplantation from unrelated donors.

Bone Marrow Transplant 2021 May 7. Epub 2021 May 7.

Department of Hematology, Hokkaido University Hospital, Sapporo, Japan.

Antithymocyte globulin (ATG) has been shown to reduce chronic graft-versus-host disease (GVHD) particularly in allogeneic peripheral blood stem cell transplantation (PBSCT) from unrelated donors; however, anti-GVHD effects of lower doses of ATG remains to be elucidated. We conducted a nationwide retrospective study to compare the outcomes of unrelated PBSCT with or without rabbit ATG (thymoglobulin) in 287 patients. A median ATG dose was 2. Read More

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Neoadjuvant immunoradiotherapy results in high rate of complete pathological response and clinical to pathological downstaging in locally advanced head and neck squamous cell carcinoma.

J Immunother Cancer 2021 May;9(5)

Providence Cancer Institute, Portland, Oregon, USA

Background: Checkpoint inhibitors targeting programmed death receptor-1 (PD-1) have been tested in the neoadjuvant setting for the treatment of locoregionally advanced head and neck squamous cell carcinoma (HNSCC); however, response rates are modest. We hypothesized that adding stereotactic body radiation therapy (SBRT) to anti-PD-1 would be safe prior to definitive surgical resection and would enhance pathological response compared with historical cohorts of patients with locoregionally advanced HNSCC treated with checkpoint inhibitor alone.

Methods: The Neoadjuvant Immuno-Radiotherapy Trial was an investigator-initiated single institution phase Ib clinical trial that enrolled patients with previously untreated locally advanced HPV-positive and HPV-negative HNSCC between 2018 and 2019. Read More

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Checkpoint inhibition in combination with an immunoboost of external beam radiotherapy in solid tumors (CHEERS): study protocol for a phase 2, open-label, randomized controlled trial.

BMC Cancer 2021 May 7;21(1):514. Epub 2021 May 7.

Cancer Research Institute Ghent (CRIG), Ghent University, Ghent, Belgium.

Background: While the introduction of checkpoint inhibitors (CPIs) as standard of care treatment for various tumor types has led to considerable improvements in clinical outcome, the majority of patients still fail to respond. Preclinical data suggest that stereotactic body radiotherapy (SBRT) could work synergistically with CPIs by acting as an in situ cancer vaccine, thus potentially increasing response rates and prolonging disease control. Though SBRT administered concurrently with CPIs has been shown to be safe, evidence of its efficacy from large randomized trials is still lacking. Read More

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Phase 3 multicenter randomized trial of PSMA PET/CT prior to definitive radiation therapy for unfavorable intermediate-risk or high-risk prostate cancer [PSMA dRT]: study protocol.

BMC Cancer 2021 May 7;21(1):512. Epub 2021 May 7.

Department of Nuclear Medicine, University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Hufelandstraße 55, 45131, Essen, Germany.

Background: Definitive radiation therapy (dRT) is an effective initial treatment of intermediate-risk (IR) and high-risk (HR) prostate cancer (PCa). PSMA PET/CT is superior to standard of care imaging (CT, MRI, bone scan) for detecting regional and distant metastatic PCa. PSMA PET/CT thus has the potential to guide patient selection and the planning for dRT and improve patient outcomes. Read More

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Thoracic radiotherapy and concurrent almonertinib for unresectable stage III EGFR-mutated non-small-cell lung cancer: a phase 2 study.

BMC Cancer 2021 May 7;21(1):511. Epub 2021 May 7.

Department of Thoracic Oncology, Key Laboratory of Clinical Cancer Pharmacology and Toxicology Research of Zhejiang Province, Affiliated Hangzhou Cancer Hospital, Zhejiang University School of Medicine, Hangzhou, 310002, People's Republic of China.

Background: Concurrent chemo-radiotherapy remains the standard treatment in unresectable stage III non-small-cell lung cancer (NSCLC) patients. Several studies have shown a potential value of concurrent epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) with thoracic radiotherapy in EGFR-mutated population, but a high risk of radiation pneumonitis raised a major concern. This study intends to explore the safety and efficacy of concurrent almonertinib, a new third-generation EGFR-TKI, with radiotherapy in locally advanced EGFR-mutated NSCLC patients. Read More

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Tenofovir Alafenamide for Drug-Resistant Hepatitis B: A Randomized Trial for Switching from Tenofovir Disoproxil Fumarate.

Clin Gastroenterol Hepatol 2021 May 4. Epub 2021 May 4.

Department of Gastroenterology, Liver Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. Electronic address:

Background & Aims: It remains unknown whether tenofovir alafenamide (TAF) could replace tenofovir disoproxil fumarate (TDF) in patients with drug-resistant hepatitis B virus (HBV).

Methods: In this multi-center randomized non-inferiority trial, 174 patients with HBV resistant to multiple drugs (lamivudine, entecavir, and/or adefovir) under TDF monotherapy for ≥96 weeks were randomized 1:1 to switch to TAF (n=87) or continue TDF (n=87) for 48 weeks. The primary endpoint was proportion of patients with HBV DNA<60 IU/mL at week 48. Read More

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Antiarrhythmic therapy and risk of cumulative ventricular arrhythmias in arrhythmogenic right ventricle cardiomyopathy.

Int J Cardiol 2021 May 4. Epub 2021 May 4.

Cardiothoracovascular Department, Cattinara Hospital, Azienda Sanitaria Universitaria Giuliano Isontina and University of Trieste, Trieste, Italy.

Objectives: The aim of our study was to investigate the benefit of antiarrhythmic drugs (AAD) - beta-blockers, sotalol or amiodarone - in a cohort of Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) patients with long-term longitudinal follow up.

Background: AAD are prescribed in ARVC to prevent ventricular arrhythmias and control symptoms. However, there are no controlled clinical trials and knowledges regarding the efficacy of AAD in ARVC are limited. Read More

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Trastuzumab deruxtecan (DS-8201) in patients with HER2-expressing metastatic colorectal cancer (DESTINY-CRC01): a multicentre, open-label, phase 2 trial.

Lancet Oncol 2021 May 4. Epub 2021 May 4.

National Cancer Center Hospital East, Kashiwa, Japan. Electronic address:

Background: HER2 amplification has been identified in 2-3% of patients with colorectal cancer, although there are currently no approved HER2-targeted therapies for colorectal cancer. We aimed to study the antitumour activity and safety of trastuzumab deruxtecan (an antibody-drug conjugate of humanised anti-HER2 antibody with topoisomerase I inhibitor payloads) in patients with HER2-expressing metastatic colorectal cancer.

Methods: DESTINY-CRC01 is an open-label, phase 2 study that recruited patients from 25 clinics and hospitals in Italy, Japan, Spain, the UK, and the USA. Read More

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Adhesive small bowel obstruction in elderly patients: a single-center analysis of treatment strategies and clinical outcomes.

Scand J Gastroenterol 2021 May 7:1-7. Epub 2021 May 7.

Digestive Surgery Unit, Fondazione Policlinico Agostino Gemelli IRCCS di Roma, Rome, Italy.

Introduction: The incidence of adhesive bowel obstruction (ASBO) progressively increases with age. Strong evidences on the influencing role of age on ASBO clinical course and management are still lacking. Aim of this study is to retrospectively analyze the clinical outcomes of patients older than 65 years of age admitted to a tertiary referral Emergency Department with a diagnosis of ASBO. Read More

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Update on Treatment of Hypertension After Renal Transplantation.

Curr Hypertens Rep 2021 May 7;23(5):25. Epub 2021 May 7.

Department of Internal Medicine 4-Nephrology, University Hospital of Erlangen, Erlangen, Germany.

Purpose Of Review: To incorporate novel findings on pathophysiology and treatment of posttransplant hypertension.

Recent Findings: (1) The sodium retaining effects of CNIs are mediated by stimulation of the thiazide-sensitive sodium chloride co-transporter in the distal convoluted tubule and in this regard chlorthalidone was proven to be an effective antihypertensive drug in renal transplantation. (2) Local and not systemic activation of the renin-angiotensin-aldosterone system plays a crucial role in the pathogenesis of posttransplant hypertension. Read More

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Restrictive fluid management versus usual care in acute kidney injury (REVERSE-AKI): a pilot randomized controlled feasibility trial.

Intensive Care Med 2021 May 7. Epub 2021 May 7.

Department of Intensive Care, Austin Hospital, Melbourne, Australia.

Purpose: We compared a restrictive fluid management strategy to usual care among critically ill patients with acute kidney injury (AKI) who had received initial fluid resuscitation.

Methods: This multicenter feasibility trial randomized 100 AKI patients 1:1 in seven ICUs in Europe and Australia. Restrictive fluid management included targeting negative or neutral daily fluid balance by minimizing fluid input and/or enhancing urine output with diuretics administered at the discretion of the clinician. Read More

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Clustering of blood cell count abnormalities and future risk of death.

Eur J Clin Invest 2021 May 7:e13562. Epub 2021 May 7.

Department of Clinical Sciences, Lund University, Malmö, Sweden.

Background: The identification of novel predictors of poor outcome may help stratify cardiovascular risk. Aim was to evaluate the individual contribution of blood cell count parameters, as well as their clustering, on the risk of death and cardiovascular events over the long term in the population-based Malmö Diet and Cancer Study cohort.

Methods: In 30,447 individuals (age 57 ± 8 years), we assessed the incidence of all-cause death (primary endpoint) and major adverse cardiovascular events (MACE, secondary outcome measure) according to absence or presence of one, two and three factors at baseline out of the following: anaemia, leukocytosis and thrombocytosis. Read More

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Design and rationale of the EMPA-VISION trial: investigating the metabolic effects of empagliflozin in patients with heart failure.

ESC Heart Fail 2021 May 6. Epub 2021 May 6.

Oxford Centre for Clinical Magnetic Resonance Research (OCMR), Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, John Radcliffe Hospital, Headley Way, Oxford, OX3 9DU, UK.

Aims: Despite substantial improvements over the last three decades, heart failure (HF) remains associated with a poor prognosis. The sodium-glucose co-transporter-2 inhibitor empagliflozin demonstrated significant reductions of HF hospitalization in patients with HF independent of the presence or absence of type 2 diabetes mellitus in the EMPEROR-Reduced trial and cardiovascular mortality in the EMPA-REG OUTCOME trial. To further elucidate the mechanisms behind these positive outcomes, this study aims to determine the effects of empagliflozin treatment on cardiac energy metabolism and physiology using magnetic resonance spectroscopy (MRS) and cardiovascular magnetic resonance (CMR). Read More

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A phase I open label dose-escalation study to evaluate the tolerability, safety and immunological efficacy of sub-urothelial durvalumab injection in adults with muscle-invasive or high-risk non-muscle-invasive bladder cancer (SUBDUE-1, SUB-urothelial DUrvalumab injection-1 study): clinical trial protocol.

BJU Int 2021 May 6. Epub 2021 May 6.

University of Western Australia (UWA) Medical School, University of Western Australia, Perth, WA, Australia.

Objectives: This article presents the clinical trial protocol for a phase I open label dose-escalation study to evaluate the tolerability, safety and immunological efficacy of sub-urothelial durvalumab injection in adults with muscle-invasive or high-risk non-muscle-invasive bladder cancer (NMIBC), the SUB-urothelial DUrvalumab injection-1 study (SUBDUE-1). The primary objectives of this study are to assess the safety of sub-urothelial injection of durvalumab using patient reported outcome measures and observed local or systemic adverse events. The secondary objectives are to examine the local immunological efficacy of sub-urothelial administration of durvalumab. Read More

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Efficacy and safety of subcutaneous prophylaxis with dalcinonacog alfa in adults with haemophilia B.

Haemophilia 2021 May 6. Epub 2021 May 6.

Catalyst Biosciences, San Francisco, CA, USA.

Aim: Phase 2b study to assess efficacy, safety, thrombogenicity, immunogenicity and tolerability with 28 days of daily dosing of subcutaneous (SQ) dalcinonacog alfa as prophylaxis for haemophilia B (HB).

Methods: Adult males with a confirmed diagnosis of congenital HB (factor IX [FIX] activity <2%) received daily dalcinonacog alfa 100 IU/kg SQ until day 28. The primary efficacy endpoint was the number of participants who achieved a steady-state FIX activity level ≥12%. Read More

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Model for End-Stage Liver Disease Score Predicts the Mortality of Patients with Coronary Heart Disease Who Underwent Percutaneous Coronary Intervention.

Cardiol Res Pract 2021 17;2021:6401092. Epub 2021 Apr 17.

Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.

Background: Coronary heart disease (CHD) is caused by the blockage or spasm of coronary arteries. Evidence shows that liver disease is related to CHD. However, the correlation between the Model for End-Stage Liver Disease (MELD) score and outcomes in patients after percutaneous coronary intervention (PCI) was unclear. Read More

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Patient-reported outcomes from a randomized, double-blind, placebo controlled, phase III study of baricitinib placebo in patients with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate therapy: results from the RA-BALANCE study.

Ther Adv Musculoskelet Dis 2021 20;13:1759720X211006964. Epub 2021 Apr 20.

Department of Rheumatology and Immunity, Center of Clinical Immunology, Peking University People's Hospital, Xicheng District, Beijing, P.R. China.

Introduction: To assess the effect of baricitinib on patient-reported outcomes (PROs) in patients with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response to methotrexate (MTX).

Methods: This was a 52-week, randomized, double-blind, placebo controlled, phase III study in patients with RA who had an inadequate response to MTX. Patients ( = 290) receiving stable background MTX were randomly assigned (1:1) to receive placebo or baricitinib 4 mg once daily with a primary endpoint at week 12. Read More

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Anthracycline-containing carboplatin-containing neoadjuvant chemotherapy in combination with trastuzumab for HER2-positive breast cancer: the neoCARH phase II randomized clinical trial.

Ther Adv Med Oncol 2021 20;13:17588359211009003. Epub 2021 Apr 20.

Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, No.123 Huifu West, Yuexiu District, Guangzhou, Guangdong 510080, China.

Background: Although dual blockade HER2-based neoadjuvant chemotherapy is associated with excellent outcomes for human epidermal growth factor receptor 2 (HER2)-positive breast cancer, pertuzumab is not available to all patients due to cost. The optimal neoadjuvant chemotherapy for HER2-positive breast cancer in the presence of a single HER2 blockade is unknown. This study aimed to compare the efficacy and safety of epirubicin/cyclophosphamide followed by docetaxel/trastuzumab (EC-TH) with docetaxel/carboplatin/trastuzumab (TCH) neoadjuvant setting for HER2-positive breast cancer under the single HER2 blockade. Read More

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Beneficial Potential of for Stress-Sensitive Functional Dyspepsia via Modulation of Ghrelin: A Randomized Controlled Trial.

Front Pharmacol 2021 20;12:636752. Epub 2021 Apr 20.

Liver and Immunology Research Center, College of Korean Medicine, Daejeon University, Daejeon, Republic of Korea.

Functional dyspepsia (FD) is a highly complex pathophysiologic disease, which shows low recovery and high relapse rates. Therefore, a growing number of clinicians and patients are looking for alternative herbal medicine. (BST) is an herbal prescription for treating a wide range of dyspepsia in traditional Korean medicine (TKM). Read More

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Artificial intelligence-enabled electrocardiograms for identification of patients with low ejection fraction: a pragmatic, randomized clinical trial.

Nat Med 2021 May 6. Epub 2021 May 6.

Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.

We have conducted a pragmatic clinical trial aimed to assess whether an electrocardiogram (ECG)-based, artificial intelligence (AI)-powered clinical decision support tool enables early diagnosis of low ejection fraction (EF), a condition that is underdiagnosed but treatable. In this trial ( NCT04000087 ), 120 primary care teams from 45 clinics or hospitals were cluster-randomized to either the intervention arm (access to AI results; 181 clinicians) or the control arm (usual care; 177 clinicians). ECGs were obtained as part of routine care from a total of 22,641 adults (N = 11,573 intervention; N = 11,068 control) without prior heart failure. Read More

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Impact of an electronic medical record-based appointment order on outpatient cardiology follow-up after hospital discharge.

NPJ Digit Med 2021 May 6;4(1):77. Epub 2021 May 6.

Heart, Vascular and Thoracic Institute Center for Healthcare Delivery Innovation, Cleveland Clinic, Cleveland, OH, USA.

Outpatient follow-up after hospital discharge improves continuity of care and reduces readmissions, but rates of follow-up remain low. It is not known whether electronic medical record (EMR)-based tools improve follow-up. The aim of this study was to determine if an EMR-based order to secure cardiology follow-up appointments at hospital discharge would improve follow-up rates and hospital readmission rates. Read More

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Continuing versus withdrawing ixekizumab treatment in patients with axial spondyloarthritis who achieved remission: efficacy and safety results from a placebo-controlled, randomised withdrawal study (COAST-Y).

Ann Rheum Dis 2021 May 6. Epub 2021 May 6.

Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.

Objectives: The objective of COAST-Y was to evaluate the effect of continuing versus withdrawing ixekizumab (IXE) in patients with axial spondyloarthritis (axSpA) who had achieved remission.

Methods: COAST-Y is an ongoing, phase III, long-term extension study that included a double-blind, placebo (PBO)-controlled, randomised withdrawal-retreatment period (RWRP). Patients who completed the originating 52-week COAST-V, COAST-W or COAST-X studies entered a 24-week lead-in period and continued either 80 mg IXE every 2 (Q2W) or 4 weeks (Q4W). Read More

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Previous upper abdominal surgery is a risk factor for nasogastric tube reinsertion after pancreaticoduodenectomy.

Surgery 2021 May 3. Epub 2021 May 3.

Second Department of Surgery, School of Medicine, Wakayama Medical University, Wakayama, Japan.

Background: Pancreaticoduodenectomy without subsequent nasogastric tube management has not been widely adopted due to delayed gastric emptying, the specific and frequent morbidity associated with this surgical procedure. We assessed the feasibility of pancreaticoduodenectomy without use of nasogastric tubes and the risk factors for subsequent nasogastric tube reinsertion.

Methods: We retrospectively reviewed 465 patients who underwent pancreaticoduodenectomy at a single institution between 2010 and 2019. Read More

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Validation of the 2019 Expert Consensus Algorithm for the Management of Conduction Disturbances After TAVR.

JACC Cardiovasc Interv 2021 May;14(9):981-991

Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland. Electronic address:

Objectives: The aim of this study was to validate the 2019 consensus algorithm in a large cohort of contemporary transcatheter aortic valve replacement (TAVR) patients.

Background: The optimal management of patients with atrioventricular conduction disturbances after TAVR is unknown. Guidance was consolidated in an expert consensus algorithm in 2019. Read More

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Individualized Nutritional Support for Hospitalized Patients With Chronic Heart Failure.

J Am Coll Cardiol 2021 May;77(18):2307-2319

Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Basel, Switzerland. Electronic address:

Background: Deterioration of nutritional status during hospitalization in patients with chronic heart failure increases mortality. Whether nutritional support during hospitalization reduces these risks, or on the contrary, may be harmful due to an increase in salt and fluid intake, remains unclear.

Objectives: The purpose of this trial was to study the effect of nutritional support on mortality in patients hospitalized with chronic heart failure who are at nutritional risk. Read More

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Using the geometric average hazard ratio in sample size calculation for time-to-event data with composite endpoints.

BMC Med Res Methodol 2021 May 6;21(1):99. Epub 2021 May 6.

Department of Statistics and Operations Research, Universitat Politècnica de Catalunya, Jordi Girona, 31, Barcelona, 08034, Spain.

Background: Sample size calculation is a key point in the design of a randomized controlled trial. With time-to-event outcomes, it's often based on the logrank test. We provide a sample size calculation method for a composite endpoint (CE) based on the geometric average hazard ratio (gAHR) in case the proportional hazards assumption can be assumed to hold for the components, but not for the CE. Read More

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Randomized phase II study of daily and alternate-day administration of S-1 for adjuvant chemotherapy in completely-resected stage I non-small cell lung cancer: results of the Setouchi Lung Cancer Group Study 1301.

BMC Cancer 2021 May 6;21(1):506. Epub 2021 May 6.

Department of General Thoracic Surgery and Breast and Endocrinological Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science, 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan.

Background: The aim of this multicenter, randomized phase II study was to analyze the feasibility and safety of alternate-day S-1, an oral fluoropyrimidine, for adjuvant chemotherapy in patients with completely resected pathological stage I (tumor diameter > 2 cm) non-small cell lung cancer (NSCLC).

Methods: Patients were randomly assigned to receive adjuvant chemotherapy for 1 year comprising either alternate-day oral administration of S-1 (80 mg/m/day) for 4 days a week (Group A) or a 2-week oral administration of S-1 (80 mg/m/day) followed by 1 week of rest (Group B). The primary endpoint was feasibility, which was defined as the proportion of patients who completed the allocated intervention for 6 months with a relative dose intensity (RDI) of 70% or more. Read More

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