Search results for "Randomized controlled"

showing 10 items of 2220 documents

A retrospective multicentric observational study of trastuzumab emtansine in HER2 positive metastatic breast cancer: A real-world experience

2017

We addressed trastuzumab emtansine (T-DM1) efficacy in HER2+ metastatic breast cancer patients treated in real-world practice, and its activity in pertuzumab-pretreated patients. We conducted a retrospective, observational study involving 23 cancer centres, and 250 patients. Survival data were analyzed by Kaplan Meier curves and log rank test. Factors testing significant in univariate analysis were tested in multivariate models. Median follow-up was 15 months and median T-DM1 treatment-length 4 months. Response rate was 41.6%, clinical benefit 60.9%. Median progression-free and median overall survival were 6 and 20 months, respectively. Overall, no differences emerged by pertuzumab pretreat…

0301 basic medicineOncologyHER2 positivereal-worldmedicine.medical_specialtyHER2 positive; T-DM1; metastatic breast cancer; previous pertuzumab; real-worldHER2 positive; Metastatic breast cancer; Previous pertuzumab; Real-world; T-DM1; OncologyT-DM1Previous pertuzumabHER2 positive; metastatic breast cancer; previous pertuzumab; real-world; T-DM1; oncologyECOG Performance Statuslaw.invention03 medical and health scienceschemistry.chemical_compound0302 clinical medicineRandomized controlled trialSettore MED/04 - PATOLOGIA GENERALElawInternal medicineMedicineUnivariate analysisSettore MED/06 - ONCOLOGIA MEDICAbusiness.industryCancerprevious pertuzumabmedicine.diseaseMetastatic breast cancerMetastatic breast cancerHER2 positive; Metastatic breast cancer; Previous pertuzumab; Real-world; T-DM1Log-rank testtrastuzumab030104 developmental biologyOncologychemistryReal-worldTrastuzumab emtansine030220 oncology & carcinogenesisHER2 positive Metastatic breast cancer Previous pertuzumab Real-world T-DM1 Oncologymetastatic breast cancerPertuzumabbusinessmedicine.drugResearch Paper
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Dissection of DLBCL microenvironment provides a gene expression-based predictor of survival applicable to formalin-fixed paraffin-embedded tissue

2018

Abstract Background Gene expression profiling (GEP) studies recognized a prognostic role for tumor microenvironment (TME) in diffuse large B-cell lymphoma (DLBCL), but the routinely adoption of prognostic stromal signatures remains limited. Patients and methods Here, we applied the computational method CIBERSORT to generate a 1028-gene matrix incorporating signatures of 17 immune and stromal cytotypes. Then, we carried out a deconvolution on publicly available GEP data of 482 untreated DLBCLs to reveal associations between clinical outcomes and proportions of putative tumor-infiltrating cell types. Forty-five genes related to peculiar prognostic cytotypes were selected and their expression …

0301 basic medicineOncologyMalePathologyHematologic MalignanciesBiopsyDatasets as TopicPredictive Value of TestDeconvolutionCohort StudiesTranscriptomeAntibodies Monoclonal Murine-Derived0302 clinical medicineprognosticatorsimmune system diseaseshemic and lymphatic diseasesTumor MicroenvironmentCluster Analysisdigital expression analysisRandomized Controlled Trials as TopicParaffin EmbeddingHematology; OncologyHematologyMiddle AgedPrognosisCorrigendaProgression-Free SurvivalAlgorithmOncology030220 oncology & carcinogenesisCell-of-originFemaleLymphoma Large B-Cell DiffuseSurvival AnalysiAlgorithmsHumanAdultmedicine.medical_specialtyStromal cellMicroenvironmentFormalin fixed paraffin embeddedPrognosiReproducibility of ResultDissection (medical)03 medical and health sciencesDigital expression analysiYoung AdultPrognosticatorPredictive Value of TestsFormaldehydeInternal medicinemedicineHumansProgression-free survivalGeneSurvival analysisAgedTumor microenvironmentCluster AnalysiProportional hazards modelbusiness.industryGene Expression ProfilingReproducibility of ResultsComputational BiologyOriginal Articlesmedicine.diseaseSurvival AnalysisGene expression profiling030104 developmental biologyDLBCLCohort StudieTranscriptomebusinessDiffuse large B-cell lymphomaDLBCL microenvironment deconvolution cell-of-origin digital expression analysis prognosticators
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Blood baseline neutrophil count predicts bevacizumab efficacy in glioblastoma

2016

// Aurelie Bertaut 1 , Caroline Truntzer 2 , Rachid Madkouri 3 , Coureche Guillaume Kaderbhai 4 , Valentin Derangere 5 , Julie Vincent 4 , Bruno Chauffert 6 , Marie Helene Aubriot-Lorton 7 , Wahlid Farah 3 , Klaus Luc Mourier 3 , Romain Boidot 5,8 and Francois Ghiringhelli 4,5,8,9 1 Biostatistics unit Georges Francois Leclerc Cancer Center, Dijon, France 2 CLIPP, Research Center, University of Burgundy, Dijon, France 3 Department of Neurosurgery, CHU, Dijon, France 4 Department of Medical Oncology, Georges Francois Leclerc Cancer Center, Dijon, France 5 Platform of Transfer in Cancer Biology Genetic and histology, Georges Francois Leclerc Cancer Center, Dijon, France 6 Department of Medical…

0301 basic medicineOncologyMaleVascular Endothelial Growth Factor Agenetic structuresNeutrophilsmedicine.medical_treatmentAngiogenesis InhibitorsBiomarkers Pharmacological[ SDV.CAN ] Life Sciences [q-bio]/CancerLeukocyte Count0302 clinical medicineAntineoplastic Combined Chemotherapy ProtocolsGranulocyte Colony-Stimulating FactorEndothelial Growth-Factorprognostic factorNeoadjuvant therapyRandomized Controlled Trials as TopicNeovascularization PathologicBrain NeoplasmsColony-Stimulating FactorAge FactorsChemoradiotherapyMiddle AgedPrognosisNeoadjuvant Therapy3. Good healthTreatment OutcomeOncology030220 oncology & carcinogenesisTo-Lymphocyte RatioAbsolute neutrophil countFemalemedicine.drugmedicine.medical_specialtyBevacizumabMalignant Glioma[SDV.CAN]Life Sciences [q-bio]/Cancer[SDV.BC]Life Sciences [q-bio]/Cellular BiologybevacizumabDisease-Free Survival03 medical and health sciencesInternal medicinemedicineHumansPretreatment NeutrophilKarnofsky Performance StatusSingle-Agent BevacizumabRetrospective StudiesNewly-Diagnosed GlioblastomaRecurrent Glioblastomabusiness.industry[ SDV.BC ] Life Sciences [q-bio]/Cellular BiologyGene Expression ProfilingglioblastomaCancerRetrospective cohort studyLomustinemedicine.diseasePhase-Ii Trialeye diseasesSurgeryIrinotecan030104 developmental biologyprognosistic factorBrain-Tumorssense organsClinical Research PaperNeoplasm Recurrence LocalbusinessChemoradiotherapyFollow-Up Studies
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Bladder cancer recurrence surveillance by urine metabolomics analysis.

2018

AbstractNon Muscle Invasive Bladder Cancer (NMIBC) is among the most frequent malignant cancers worldwide. NMIBC is treated by transurethral resection of the bladder tumor (TURBT) and intravesical therapies, and has the highest recurrence rate among solid tumors. It requires a lifelong patient monitoring based on repeated cystoscopy and urinary cytology, both having drawbacks that include lack of sensitivity and specificity, invasiveness and care costs. We conducted an investigative clinical study to examine changes in the urinary metabolome of NMBIC patients before and after TURBT, as well during the subsequent surveillance period. Adjusting by prior probability of recurrence per risk, dis…

0301 basic medicineOncologyMalemedicine.medical_specialtyUrinary systemlcsh:MedicineUrineArticlelaw.invention03 medical and health sciences0302 clinical medicineMetabolomicsRandomized controlled triallawCytologyInternal medicinemedicineMetabolomeBiomarkers TumorHumansMetabolomicslcsh:ScienceAgedAged 80 and overMultidisciplinaryBladder cancermedicine.diagnostic_testbusiness.industrylcsh:RCystoscopyMiddle Agedmedicine.disease030104 developmental biologyUrinary Bladder Neoplasms030220 oncology & carcinogenesisMetabolomelcsh:QFemalebusinessScientific reports
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Denosumab for bone health in prostate and breast cancer patients receiving endocrine therapy? A systematic review and a meta-analysis of randomized t…

2019

Highlights • Hormonal receptors positive breast tumor and prostate cancer are managed with endocrine therapies. • Endocrine therapies designed for breast and prostate cancer are often associated to serious adverse skeletal related events, such fractures. • Denosumab is a monoclonal anti-body binding RANKL which acts as inhibitor of osteoclasts activity, thus increasing bone mass. • Denosumab was showed to strongly prevent hormonal therapies-related skeletal issues. • Denosumab administration results safe in bone mass increase and reduction of fractures risk.

0301 basic medicineOncologyRCTs randomized clinical trialrandomized clinical trialslcsh:Diseases of the musculoskeletal systemSettore MED/06 - Oncologia MedicaOsteoporosisBMD bone mass densityReview Articleandrogen deprivation therapyADTlaw.inventionAndrogen deprivation therapyProstate cancerhazard ratio0302 clinical medicineRandomized controlled triallawHRMedicineBreastSAEsCancerProstateRANKLCIMD mean differencelcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogensRCTs randomized clinical trialsDenosumabOncology030220 oncology & carcinogenesisSAEs serious adverse eventsDenosumabmean differencemedicine.drugmedicine.medical_specialtylcsh:RC254-28203 medical and health sciencesBreast cancerRANKL receptor activator of nuclear factor-kB ligandBMDInternal medicineAdverse effectADT androgen deprivation therapyRCTsbusiness.industryMDmedicine.diseaseHR hazard ratioHormonereceptor activator of nuclear factor-kB ligandDiscontinuationCI confidence interval030104 developmental biologyFractureconfidence intervalADT androgen deprivation therapy; BMD bone mass density; Breast; CI confidence interval; Cancer; Denosumab; Fracture; HR hazard ratio; Hormone; MD mean difference; Prostate; RANKL receptor activator of nuclear factor-kB ligand; RCTs randomized clinical trials; SAEs serious adverse eventsserious adverse eventsbone mass densitylcsh:RC925-935businessJournal of Bone Oncology
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Clinical pharmacokinetics and pharmacodynamics of ramucirumab in the treatment of colorectal cancer

2016

Colorectal cancer is the third most common cancer worldwide. The prognosis of colorectal cancer patients still remains dismal and half of them will develop metastatic disease. Angiogenesis plays an essential role in colorectal tumorigenesis, and the VEGF pathway is one of the targets that has been validated up to now. The use of antiangiogenics along with chemotherapy has become an accepted standard for colorectal cancer.This review discusses the efficacy and safety profile of ramucirumab, a fully human immunoglobulin G1 monoclonal antibody against the vascular endothelial growth factor receptor-2 (VEGFR-2), for the treatment of second-line metastatic colorectal cancer upon progression to f…

0301 basic medicineOncologymedicine.medical_specialtyBevacizumabAngiogenesisColorectal cancermedicine.medical_treatmentDrug Evaluation PreclinicalAngiogenesis InhibitorsDiseaseAntibodies Monoclonal HumanizedToxicologyRamucirumab03 medical and health scienceschemistry.chemical_compoundClinical Trials Phase II as Topic0302 clinical medicineInternal medicinemedicineAnimalsHumansRandomized Controlled Trials as TopicPharmacologyChemotherapyClinical Trials Phase I as TopicNeovascularization Pathologicbusiness.industryAntibodies MonoclonalCancerGeneral Medicinemedicine.diseaseVascular endothelial growth factorDisease Models Animal030104 developmental biologyClinical Trials Phase III as Topicchemistry030220 oncology & carcinogenesisColorectal Neoplasmsbusinessmedicine.drugExpert Opinion on Drug Metabolism & Toxicology
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The role of chemotherapy in localized and locally advanced rectal cancer: A systematic revision

2017

Curative treatment of rectal cancer depends on an optimal surgical resection, with the addition of neoadjuvant radiotherapy (RT) with or without concomitant chemotherapy (ChT) in more advanced tumors. The role of adjuvant ChT is controversial and a more intensified neoadjuvant approach with the addition of ChT before or after RT, or even as single modality, is currently being explored in trials. A systematic review selecting randomised phase II and III trials on the role of ChT in localized rectal cancer was performed. Data show that neoadjuvant ChRT improves locoregional control in resected rectal cancer. Short-course RT (SCRT) could give similar outcomes to ChRT. The addition of oxaliplat…

0301 basic medicineOncologymedicine.medical_specialtyColorectal cancermedicine.medical_treatmentAntineoplastic Agents03 medical and health sciences0302 clinical medicineClinical Trials Phase II as TopicPreoperative chemoradiationInternal medicineMedicineCombined Modality TherapyHumansRadiology Nuclear Medicine and imagingRectal cancerNeoadjuvant therapyRandomized Controlled Trials as TopicChemotherapybusiness.industryRectal NeoplasmsGeneral MedicineAdjuvant chemotherapy; Preoperative chemoradiation; Rectal cancermedicine.diseaseCombined Modality TherapyNeoadjuvant TherapyOxaliplatinAdjuvant chemotherapyRadiation therapy030104 developmental biologyOncologyClinical Trials Phase III as Topic030220 oncology & carcinogenesisConcomitantRadiotherapy AdjuvantbusinessAdjuvantmedicine.drug
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Systematic review and meta-analysis on targeted therapy in advanced pancreatic cancer

2015

Abstract Aim A systematic review and meta-analysis from literature has been performed to assess the impact of targeted therapy in advanced pancreatic cancer. Methods By searching different literature databases and major cancer meetings proceedings, data from all randomized clinical trials designed to investigate molecular targeted agents in the treatment of advanced pancreatic cancer were collected. The time-frame between January 2007 and March 2015 was selected. Data on predefined end-points, including overall survival, progression-free survival in terms of Hazard Ratio and response-rate were extracted and analyzed by a random effects model. Pooled data analysis was performed according to …

0301 basic medicineOncologymedicine.medical_specialtyFunnel plotEndocrinology Diabetes and Metabolismmedicine.medical_treatmentAntineoplastic AgentsBioinformaticslaw.inventionTargeted therapy03 medical and health sciences0302 clinical medicineRandomized controlled triallawInternal medicineAntineoplastic Combined Chemotherapy ProtocolsHumansMedicineGenetic Predisposition to DiseaseMeta-analysiAdvanced pancreatic cancerHepatologybusiness.industryHazard ratioGastroenterologyCancerPancreatic cancerPublication biasmedicine.diseasePancreatic NeoplasmsClinical trial030104 developmental biology030220 oncology & carcinogenesisMeta-analysisRandomized clinical trialbusinessSignal TransductionPathwayPancreatology
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The Era of PARP inhibitors in ovarian cancer: “Class Action” or not? A systematic review and meta-analysis

2018

Abstract Introduction Carboplatin is the milestone of epithelial ovarian cancer (EOC) treatment, thus response to platinum is the major prognostic factor. Among platinum-sensitive patients, 40% carry a germline or somatic BRCA1/2 mutation. In this scenario a new class of drugs, the PARP inhibitors (PARPis), produced a significant improvement in long-term disease control. In order to make an aggregate evaluation of the impact of these agents, we performed a systematic review and meta-analysis. Patients and Methods Clinical trials were selected by searching “Pubmed” database and abstracts from major cancer meetings. We considered the January 2008 - April 2018 time frame. Progression free surv…

0301 basic medicineOncologymedicine.medical_specialtySettore MED/06 - Oncologia MedicaPoly (ADP-Ribose) Polymerase-1Poly(ADP-ribose) Polymerase Inhibitorslaw.invention03 medical and health sciences0302 clinical medicineRandomized controlled triallawOvarian cancerInternal medicinemedicineHumansMeta-analysiProgression-free survivalAdverse effectOvarian Neoplasmsbusiness.industryHazard ratioHematologyPrognosisClinical trial030104 developmental biologyPARP inhibitorOncology030220 oncology & carcinogenesisMeta-analysisRelative riskCohortFemaleRandomized clinical trialMaintenance therapybusiness
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Effect of dietary interventions during weaning period on parental practice and lipoproteins and vitamin D status in two-year-old children

2016

ABSTRACT Objective: Evaluate if a two-day course for parents on nutrition and applied baby food preparation had an effect on child’s intake of home-made foods, lipid concentration, and vitamin D status. Design: Randomized controlled trial at age 6 months and follow-up at ages 15 and 24 months. Setting: Four health care clinics in Kristiansand, Norway. Subjects: Thirty-nine pairs of 6-month-old children and their parents in the intervention group and 20 pairs in the control group. Results: At age 15 months, the intervention group had lower intakes of ready-made porridge (2.0 vs. 5.8 servings per week (p < 0.05)), lower intake of canned baby food (2.9 vs. 6.3 servings per week (p < 0.05)) and…

0301 basic medicinePediatricsmedicine.medical_specialtyIntervention groupfeeding practicesArticlelaw.inventionBaby food03 medical and health sciencesDietary interventionschemistry.chemical_compoundRandomized controlled triallawCooking classesVitamin D and neurologyMedicineWeaningtoddlers030109 nutrition & dieteticsNutrition and Dieteticsbusiness.industryCholesterolCanned baby foodPublic Health Environmental and Occupational HealthlipoproteinschemistrybusinessdietFood Science
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