Masanori Fukushima

• Professor
• CEO at Foundation for Biomedical Research and Innovation at Kobe

Background Cilostazol, a selective type‐3 phosphodiesterase inhibitor, ameliorates β‐amyloid accumulation by facilitating intramural periarterial drainage. Method Patients with mild cognitive impairment were registered in the COMCID study, an investigator‐initiated, double‐blinded, multi‐center, phase‐II clinical trial. The primary endpoint was th...

Importance Recent evidence indicates the efficacy of β-amyloid immunotherapy for the treatment of Alzheimer disease, highlighting the need to promote β-amyloid removal from the brain. Cilostazol, a selective type 3 phosphodiesterase inhibitor, promotes such clearance by facilitating intramural periarterial drainage. Objective To determine the safe...

INTRODUCTION The purpose of this study is to identify the risk factors and risk classification associated with the conversion from mild cognitive impairment (MCI) to Alzheimer’s disease (AD) dementia to facilitate early intervention and the design of clinical trials for AD. METHODS The study comprised a prospective cohort study of 400 subjects wit...

Stroke is the leading cause of severe long-term disability. Cell therapy has recently emerged as an approach to facilitate functional recovery in stroke. Although administration of peripheral blood mononuclear cells preconditioned by oxygen-glucose deprivation (OGD-PBMCs) has been shown to be a therapeutic strategy for ischemic stroke, the recovery...

Introduction: Vascular factors have been shown to be associated with increased risk of dementia. However, clinical trials have so far been unsuccessful, suggesting new approaches are needed. The aim of this study was to use population-based real world data to investigate risk factors and preventive factors for dementia, including the effects of tr...

Abstract Background This study investigated how cognitive function-related simple questions can be used to identify older individuals who are at risk of needing long-term care. Methods This cohort study was conducted in Kobe city, Japan. In 2015, the municipal office distributed the Kihon Checklist by post, a 25-item questionnaire including three c...

Background/objective The purpose of this study was to report the outcomes of a clinical trial conducted in Japan to assess the safety and effectiveness of third-generation autologous chondrocyte implantation (ACI) using IK-01 (CaReS™), which does not require flap coverage, in the treatment of patients with focal cartilage injury of the knee. Metho...

This study aimed to clarify the etiologic factors predicting acute ocular progression in SJS/TEN, and identify patients who require immediate and intensive ophthalmological treatment. We previously conducted two Japanese Surveys of SJS/TEN (i.e., cases arising between 2005–2007 and between 2008–2010), and obtained the medical records, including det...

Importance Among patients with hyperphosphatemia undergoing dialysis, it is unclear whether non–calcium-based phosphate binders are more effective than calcium-based binders for reducing cardiovascular events. Objective To determine whether lanthanum carbonate reduces cardiovascular events compared with calcium carbonate in patients with hyperphos...

Background/aims To investigate the long-term outcomes of cultivated oral mucosal epithelial transplantation (COMET) for fornix reconstruction in eyes with chronic cicatrising disease. Methods This retrospective cohort study involved 16 eyes of 15 patients who underwent COMET for symblepharon release and fornix reconstruction between June 2002 and...

Aims: In this study, we integrated two randomized control trials, PROSPECTIVE and IMPACT, to address the effect of probucol on cerebrocardiovascular events and carotid intima-media thickness (IMT) in Japanese, Korean, and Chinese patients with coronary artery disease (CAD). Methods: A total of 1,025 patients from the PROSPECTIVE and IMPACT studies...

Objective To evaluate the efficacy and safety of regenerative treatment for tympanic membrane perforation (TMP) using gelatin sponge, basic fibroblast growth factor (bFGF), and fibrin glue. Methods This was a multicenter, non-randomized, single-arm study conducted at tertiary referral centers. Twenty patients with chronic TMP (age 23–78 years, 6 m...

The pandemic of novel coronavirus disease (COVID‐19) is not yet close to being over, more than eight months after the first cases, but researchers are making great progress in fighting the disease. We have conducted a brief review of the geographic differences in the prevalence of COVID‐19, the updated pathological findings, prognostic factors, and...

Stevens-Johnson syndrome, ocular cicatricial pemphigoid, and severe thermal or chemical injury are considered severe ocular surface disorders (OSDs) because they affect the entire ocular surface, including corneal and conjunctival epithelial stem cells. In patients with severe OSDs, the long-term prognosis for limbal transplantation is poor, and th...

Aim: To identify the factors protecting Abeta-positive subjects with normal cognition (NC) or mild cognitive impairment (MCI) from conversion to Alzheimer's disease (AD). Methods: Subjects with MCI in the Alzheimer's Disease Neuroimaging Initiative (ADNI) database, with baseline data for neuropsychological tests, brain beta amyloid (Abeta), magn...

Stroke remains a major cause of serious disability because the brain has a limited capacity to regenerate. In the last two decades, therapies for stroke have dramatically changed. However, half of the patients cannot achieve functional independence after treatment. Presently, cell-based therapies are being investigated to improve functional outcome...

Aims: Although intensive statin therapy reduced cardiovascular risks, cardiovascular events have not been completely prevented. Probucol is a potent antioxidant and reduces tendon xanthomas in familial hypercholesterolemia patients despite reduction of high-density lipoprotein (HDL)-cholesterol (HDL-C). We investigated whether probucol can reduce c...

PurposeTo prospectively evaluate the value of whole-body cancer screening with multiple modalities including FDG-PET in a healthy population.Methods The study was conducted in 1197 healthy individuals aged ≥ 35 years at enrollment between August 2003 and July 2004. All participants were scheduled to receive annual whole-body cancer screening five t...

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Purpose: To evaluate long-term health-related quality of life (HRQOL) impact of I-125 permanent seed implantation (PI) in Japanese patients with localized prostate cancer. Materials and methods: This is a longitudinal, prospective study of 2353 patients who enrolled in the nationwide Japanese-Prostate Cancer Outcome Study by Permanent I-125 Seed...

Purpose It is unclear whether experience at high-volume institute improves the treatment quality of prostate seed implantation. The aim of this study was to evaluate the effect of institutional experience on postimplant dosimetric parameters in a nationwide prospective cohort study. Methods From July 2005 to June 2007, 2354 patients were registere...

Purpose: The purpose of this study was to evaluate acute and late genitourinary (GU) toxicity and to elucidate factors associated with GU toxicity in patients with prostate cancer treated with permanent seed implantation (PI) enrolled in a nationwide prospective cohort study in Japan. Methods and materials: Of 2,354 patients enrolled in this stu...

Purpose: To evaluate the biochemical freedom from failure (bFFF) by risk group and treatment modality and the predictive factors of bFFF by risk group in patients with prostate cancer undergoing permanent seed implantation (PI) with or without external beam radiation therapy (EBRT) in a nationwide prospective cohort study (Japanese Prostate Cancer...

We previously showed that the agamid lizard Pogona vitticeps responded to an extremely low-frequency electromagnetic field (ELF-EMF; frequency: 6 and 8 Hz; peak magnetic field: 2.6 µT; peak electric field: 10 V/m) with tail-lifting behavior. In addition, the tail-lifting response to ELF-EMF disappeared when the parietal eyes of the lizards were cov...

Aim The present population‐based study investigated the predictive ability of the Kihon Checklist (a self‐reported frailty questionnaire) and the cognitive domain therein for incident long‐term care need certification. This is the first large population‐based study to investigate an association between the Kihon Checklist and the outcome measure, l...

Background & objective: The purpose of this study is to identify the risk factors associated with the conversion from mild cognitive impairment (MCI) to Alzheimer's disease (AD) dementia for the early detection of AD. Methods: The study comprised a prospective cohort study that included 400 MCI subjects with annual follow-ups for 3 years. Resul...

Background: Investigating oncological outcomes in patients registered in the Japanese Prostate Cancer Outcome Study of Permanent Iodine-125 Seed Implantation (J-POPS) in terms of biochemical relapse-free survival (bRFS) by the Phoenix and the newly developed J-POPS definitions, exploration of predictive factors for bRFS, and preliminary verificati...

Regional demographics of spinal cord injuries (SCIs) are fundamental to identifying and implementing appropriate preventive measures. The current study was conducted as a longitudinal analysis of all patients with SCIs admitted to the Hyogo Rehabilitation Center over a 19-year period. The sex and age of the patient, time and nature of injury (i.e.,...

PurposeTo report research participants’ baseline characteristics in the AMD2000 study, a prospective, multicenter, 5-year, observational cohort study of Japanese age-related macular degeneration (AMD). The characteristics were determined using multimodal imaging. Methods Patients with AMD were recruited at 18 clinical sites in Japan between April 2...

PurposeIn this study (AMD2000), we aimed to determine the visual prognosis of Japanese patients with age-related macular degeneration (AMD). Methods This was a multicenter prospective observational cohort study. In total, 460 patients with AMD were recruited from April 2006 to March 2009 from 18 clinical trial sites in Japan. They were followed up...

Bone marrow stromal cells (BMSCs) have been studied for the treatment of spinal cord injury (SCI). In previous studies, we showed that the transplantation of BMSCs, even though they disappeared from the host spinal cord within 1-3 weeks after transplantation, improved locomotor behaviors and promoted axonal regeneration. This result led to the hypo...

Cerebral amyloid angiopathy (CAA) induces various forms of cerebral infarcts and hemorrhages from vascular amyloid-β accumulation, resulting in acceleration of cognitive impairment, which is currently untreatable. Soluble amyloid-β protein likely impairs cerebrovascular integrity as well as cognitive function in early stage Alzheimer’s disease. Tax...

The effects of multiple-injection of bone marrow mononuclear cells (BMNCs) on spinal cord injury (SCI) were compared with those of single-injection in rats. BMNCs separated by density-gradient centrifugation from a bone marrow perfusate were injected 3 times (once weekly) through the cerebrospinal fluid (CSF) via the 4th ventricle, and the locomoto...

Objective: The objective of this study was to evaluate safety and efficacy of regenerative treatment using gelatin sponge with basic fibroblast growth factor (bFGF) in patients with tympanic membrane perforation (TMP). Methods: The current study was a prospective, multicenter, open-label, single-arm, and exploratory clinical trial to evaluate th...

Objectives: To evaluate efficacy and safety of a treatment comprising basic fibroblast growth factor (bFGF) with atelocollagen solution in patients with critical limb ischemia (CLI) due to peripheral artery disease (PAD) or Burger’s disease (TAO). Methods: Human recombinant bFGF (200μg) with 4.8 mL of 3% atelocollagen solution was prepared and inje...

Introduction There are currently no effective treatments preventing conversion from mild cognitive impairment (MCI) to Alzheimer's disease. Cilostazol is a selective type-3 phosphodiesterase inhibitor that ameliorates accumulation of amyloid-β and has prevented cognitive decline in rodent models. Furthermore, cilostazol is known to suppress platele...

Purpose: To evaluate the incidence and the associated factors of rectal toxicity in patients with prostate cancer undergoing permanent seed implantation (PI) with or without external beam radiation therapy (EBRT) in a nationwide prospective cohort study in Japan (J-POPS) during the first 2 years. Methods and materials: A total of 2,339 subjects...

Purpose: The effect of the transplantation of choroid plexus epithelial cells (CPECs) on locomotor improvement and tissue repair including axonal extension in spinal cord lesions was examined in rats with spinal cord injury (SCI). Methods: CPECs were cultured from the choroid plexus of green fluorescent protein (GFP)-transgenic rats, and transpl...

Background: Reduction of serum LDL-cholesterol by statins was shown to improve clinical outcomes in patients with coronary heart disease (CHD). Although intensive statin therapy significantly reduced cardiovascular risks, atherosclerotic cardiovascular events have not been completely prevented. Therefore, effective pharmacologic therapy is necessa...

Amyotrophic lateral sclerosis (ALS) is a motor neuron disease characterized by serious muscle atrophy and weakness. The purpose of this study was to find prognostic factors in patients with mild ALS using application forms for the Specified Disease Treatment Research Program in Japan. We classified ALS as mild, moderate and severe. The subjects con...

Background: The incidence and associated factors of loose seed migration were investigated in cohort 1 of the Japanese Prostate Cancer Outcome Study of Permanent Iodine-125 Seed Implantation (J-POPS). Methods: The study subjects were 2160 patients, consisting of 1641 patients who underwent permanent iodine-125 seed implantation (PI) and 519 pati...

Background: Ethnicity has a significant impact on coronary artery disease (CAD). This study investigated the long-term outcomes of Japanese patients undergoing revascularization compared with US patients belonging to multiple ethnic groups. Methods and results: We evaluated clinical outcomes, based on ethnicity, of patients included in the Coron...

To suggest an objective score for grading the acute ocular severity of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), and to determine predictive factors for severe acute ocular involvement such as ocular surface epithelial defect and/or pseudomembrane formation. Retrospective cohort study. The medical records of SJS (N=87) an...

To investigate contemporary rates of variation in the biopsy Gleason grading in prostate cancer, between local and central pathologists, based on central review of the pathological slides from Seed and Hormone for Intermediate-risk Prostate Cancer (SHIP) 0804, a phase III, multicenter, randomized, controlled study. From April 2008 to May 2011, 18 J...

We conducted a phase III study to evaluate S-1 as compared with UFT as control in patients after curative therapy for stage III, IVA, or IVB squamous-cell carcinoma of the head and neck (SCCHN). Patients were randomly assigned to the UFT group (300 or 400 mg day-1 for 1 year) or the S-1 group (80, 100, or 120 mg day-1 for 1 year). The primary end p...

Summary The objective of the study was to explore the survival trends of centenarians in Japan. A cohort of centenarians born between 1881 and 1900 was analysed based on national census data, and the average life expectancy at 100 years of age, risk of death and maximum age were estimated. An analysis of covariance and a Cox regression analysis wer...

Background: To evaluate the safety and efficacy of brachytherapy with permanent iodine-125 seed implantation (PI) for prostate cancer. The nationwide Japanese Prostate Cancer Outcome Study of Permanent Iodine-125 Seed Implantation (J-POPS) has continued since July 2005. This manuscript presents the rationale, J-POPS study design, and the character...

PurposeTo assess the clinical efficacy of cultivated oral mucosal epithelial transplantation (COMET) for the treatment of persistent epithelial defect (PED).Methods We treated 10 eyes of nine patients with PED (Stevens–Johnson syndrome: three eyes; thermal/chemical injury: five eyes; ocular cicatricial pemphigoid: two eyes) with COMET at Kyoto Pref...

Progressive cognitive decline is a characteristic hallmark of AD. It is important to identify prognostic markers to improve patient care and long-term planning. We aimed to identify the characteristics of disease progression in AD patients, focusing on cognitive decline and its related factors. Clinically diagnosed AD patients in a memory clinic we...

Purpose: This study was conducted to assess the safety and feasibility of intrathecal transplantation of autologous bone marrow-derived mononuclear cells for the treatment of patients with spinal cord injury. Methods: Ten patients were included in the study. Approximately 120 ml of bone marrow aspirate was obtained from bilateral iliac bone of p...

Some previous studies have shown a positive relation between geomagnetic disturbances and an increased incidence of suicide. If such a relation exists, stronger geomagnetic fields may affect the number of suicides, because stronger geomagnetic fields generally cause larger geomagnetic field disturbances. Therefore, we here investigated the relation...

73 Background: The purpose of this report is to describe acute and late rectal toxicities and to evaluate factors associated with rectal toxicity in permanent seed implantation (PI) patients enrolled in a nationwide cohort study in Japan. Methods: A total of 2,339 patients in 46 institutes were evaluated. They were treated in the nationwide cohort...

Most bone fractures typically heal, although a significant proportion (5%-10%) of fractures fail to heal, resulting in delayed union or persistent nonunion. Some preclinical evidence shows the therapeutic potential of peripheral blood CD34(+) cells, a hematopoietic/endothelial progenitor cell-enriched population, for bone fracture healing; however,...

Background: A prior phase I/IIa clinical trial provided evidence for safety, feasibility and potential efficacy of i.m. injection of granulocyte colony-stimulating factor (G-CSF)-mobilized CD34+ cells in patients with critical limb ischemia (CLI). Methods and results: A phase II trial of CD34+ cell therapy was conducted in patients with CLI to e...

To assess, in a nationwide multi-institutional cohort study begun in 2005 and in which 6927 subjects were enrolled by 2010, the urinary and rectal toxicity profiles of subjects who enrolled during the first 2 years, and evaluate the toxicity profiles for permanent seed implantation (PI) and a combination therapy with PI and external beam radiation...

It has been demonstrated that the infusion of bone marrow stromal cells (BMSCs) through the cerebrospinal fluid (CSF) has beneficial effects on acute spinal cord injury (SCI) in rats. The present study examined whether BMSC infusion into the CSF is effective for subacute (1- and 2-week post-injury), and/or chronic (4-week post-injury) SCI in rats....

Definition of endpoints Appendix 2 J-STARS Group: organizational structure and participants

Previous studies have shown a positive relationship between geomagnetic disturbances and an increased incidence of suicide. The Japanese suicide rate is the ninth highest in the world, but there have been no reports examining the relationship between geomagnetic disturbance and the number of suicides, and, therefore, this paper examines this relati...

We retrospectively review outcomes of applying boron neutron capture therapy (BNCT) to unresectable advanced or recurrent head and neck cancers. Patients who were treated with BNCT for either local recurrent or newly diagnosed unresectable head or neck cancers between December 2001 and September 2007 were included. Clinicopathological characteristi...

e16090 Background: Brachytherapy with permanent iodine-125 seed implantation (PI) has been approved in 2003 in Japan. Multi-institutional cohort study (Japanese Prostate Cancer Outcome Study of Permanent Seed Implantation; J-POPS, NCT00534196) assessing the treatment feature, efficacy, safety and health-related quality of life (QOL) has started in...

Preserving isolated islets at low temperature appears attractive because it can keep islet quantity comparable to freshly isolated islets. In this study, we evaluated the effect of serum as an additive to preservation solutions on islet quality after short-term hypothermic storage. Isolated mouse islets were preserved at 4°C in University of Wiscon...

The use of electronic medical record (EMR) data is necessary to improve clinical research efficiency. However, it is not easy to identify patients who meet research eligibility criteria and collect the necessary information from EMRs because the data collection process must integrate various techniques, including the development of a data warehouse...

Purpose: To report the effectiveness, disease-specific outcomes, and safety of cultivated oral mucosal epithelial sheet transplantation (COMET), with the primary objective of visual improvement. Design: Noncomparative, retrospective, interventional case series. Participants: This study involved 46 eyes in 40 patients with complete limbal stem...

Our phase I/IIa clinical trial revealed that intramuscular transplantation of autologous, GCSF-mobilized CD34+ cells was safe, feasible and potentially effective at week 4 and 12 post cellular therapy in 17 patients with chronic critical limb ischemia (CLI) (5 patients with atherosclerotic peripheral arterial disease (PAD) and 12 with Buerger's dis...

Critical limb ischemia (CLI) is commonly caused by atherosclerotic arterial obstruction or stenosis in the leg, as demonstrated by rest pain, skin ulcers and gangrene (Fontaine III or IV), often fails to respond to conservative treatments, and carries a high risk for limb amputation, with a particularly dismal prognosis. Although surgical revascula...

Background: Various information technologies currently are used to improve the efficiency of clinical trials. However, electronic medical records (EMRs) are not yet linked to the electronic data capture (EDC) system. Therefore, the data must be extracted from medical records and transcribed to the EDC system. Clinical pathways are planned process...

Patients with high Gleason score, elevated prostate specific antigen (PSA) level, and advanced clinical stage are at increased risk for both local and systemic relapse. Recent data suggests higher radiation doses decrease local recurrence and may ultimately benefit biochemical, metastasis-free and disease-specific survival. No randomized data is av...

The objective of this study was to develop new risk classifications for conversion to Alzheimer's disease (AD) by comparing the relative reliability of classifiers in patients with mild cognitive impairment (MCI). The 397 MCI subjects and all baseline data, including characteristics, neuropsychological tests, cerebrospinal fluid biomarkers and MRI...

Approximately 25% of patients who undergo percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) have diabetes, and the diagnosis of diabetes roughly doubles the mortality risk associated with coronary artery disease. However, the impact of diabetes may differ according to ethnicity. Our objective was to examine the impa...

To determine whether intrathecal administration of cultured autologous bone marrow stromal cells (BMSCs) is safe and feasible for treatment of subacute spinal injury. Five patients with complete tetraplegia due to cervical spinal injury on admission were included. A small amount of bone marrow was obtained during surgery for spinal fusion. BMSCs we...

There is some evidence that exposure of various animals to a power-frequency magnetic field can cause increases in body mass. However, the precise nature of the relationship is not clear, particularly for long-term exposure. To clarify the relationship between long-term power-frequency magnetic field exposure (2 years) and animal body mass, we cond...

Purpose: To determine the maximum tolerated dose of amrubicin (AMR) with a fixed dose of irinotecan (CPT-11). Methods: Patients having pathologically proven small cell lung cancer (SCLC) relapsed after one or two chemotherapies, and Eastern Cooperative Oncology Group performance status of 0 to 2 were eligible for the study. CPT-11 was delivered...

Background Our aims were to investigate whether the association between smoking and survival is significant when adjusted for prognostic factors including use of epidermal growth factor tyrosine kinase inhibitors and the Glasgow Prognostic Score, an established score for inflammation, and to explore prognostic factors. Methods We analyzed 244 patie...

Although implantation of crude bone marrow cells has been applied in a small number of patients for fracture healing, transplantation of peripheral blood CD34(+) cells, the hematopoietic/endothelial progenitor cell-enriched population, in patients with fracture has never been reported. Here, we report the first case of tibial nonunion receiving aut...

A randomized trial of vinorelbine plus gemcitabine followed by docetaxel (VGD) versus paclitaxel plus carboplatin (PC) in patients with advanced non-small-cell lung cancer showed no difference in overall survival (median survival time: 13.6 versus 14.1 months) between the two treatment groups. We report here the results of quality-of-life (QOL) stu...

To improve the poor prognosis in patients with stage IV (StIV) gastric cancer (GC), we conducted a multicenter phase II study of preoperative S-1 plus cisplatin followed by gastrectomy and postoperative S-1 for StIV GC (the protocol is registered at the clinical trial site of the National Cancer Institute; KYUH-UHA-GC03-01, NCT00088816). Eligibilit...

We aimed to evaluate the efficacy and safety of gemcitabine/S-1 combination chemotherapy for the treatment of patients with advanced biliary tract cancer. Patients with histologically or cytologically confirmed unresectable or recurrent biliary tract cancer were eligible for inclusion. The primary endpoint was overall survival. Gemcitabine was admi...

Clinical course of patient 1 with FHSA, the first patient receiving intravenous rh-HGF. We first administered rh-HGF to a 67-year-old Japanese man with FHSA caused by hepatitis E virus infection. On admission, he presented with hepatic encephalopathy, jaundice, ascites, edema, and microhematuria caused by bladder catheter. Although ALT had already...

Serum levels of TGF-β were not affected by rh-HGF dosing. Serum TGF-β concentrations before and after the rh-HGF dosing period were determined by ELISA. Although patient 2 exhibited an increase in serum TGF-β after 14-day rh-HGF administration, there was no significant difference in serum levels of TGF-β (mean ± SE: 230.4 ± 21.0 vs 266.4 ± 68.1 pg/...

Clinical course of patient 2 with FHSA, who survived. The second patient (patient 2) was a 71-year-old Japanese woman with FHSA of undetermined etiology. She presented with mild hepatic encephalopathy with flapping tremor, jaundice, and urinary findings, including proteinuria and microhematuria, caused by bladder catheter. Platelet count and serum...

Clinical course of patient 3, with LOHF, who died within the observation period. Sixty four-year-old Japanese woman with LOHF of undetermined etiology suffered from advanced hepatic encephalopathy (HE). She presented with platelet count of 9.2 × 104/μL, PT of 37% (PT-INR 1.78), T-Bil level of 11.7 mg/dL, ALT level of 260 IU/L, and serum albumin lev...

Clinical course of patient 4, with FHSA caused by a drug, who survived. Forty-year-old Japanese man with FHSA, which was caused by a supplement containing coenzyme Q-10, showed platelet count of 7.0 × 104/μL, PT of 43% (PT-INR 1.62), T-Bil level of 27.6 mf/dL, ALT level of 253 IU/L, and serum albumin level of 2.9 g/dL, but not hepatic encephalopath...

Hepatocyte growth factor (HGF) stimulates hepatocyte proliferation, and also acts as an anti-apoptotic factor. Therefore, HGF is a potential therapeutic agent for treatment of fatal liver diseases. We performed a translational medicine protocol with recombinant human HGF (rh-HGF), including a phase I/II study of patients with fulminant hepatitis (F...

In breast cancer, the validity of surrogate endpoints for overall survival (OS) is a matter of controversy. In order to generate a hypothesis, we evaluated whether tumor response or progression-free survival (PFS) could be valid surrogates for OS in patients with metastatic breast cancer. Data from 30 patients were available from a phase II study o...

The effects of extremely low-frequency electromagnetic fields (ELF-EMFs) on blood pressure (BP) are controversial. In this double-blind, randomized, sham-controlled study, we examined the effects of repeated exposure to a 1-μT ELF-EMF on BP in 20 humans with mild-to-moderate hypertension. Subjects were randomly assigned to either the ELF-EMF group...

Hypersensitivity reaction (HSR) and sensory neuropathy are major complications of oxaliplatin-based chemotherapy. Preplanned withdrawal of oxaliplatin after the first six cycles and reintroduction at the time of disease progression (stop-and-go strategy) may reduce neurotoxicity. However, the effect of an oxaliplatin-free interval on HSR occurrence...