Search results for "Common Terminology Criteria for Adverse Events"

showing 10 items of 17 documents

Safety and effectiveness of regorafenib in patients with metastatic colorectal cancer in routine clinical practice in the prospective, observational …

2019

Abstract Background Regorafenib prolonged overall survival (OS) versus placebo in patients with treatment-refractory metastatic colorectal cancer (mCRC) in phase III trials. We conducted an observational study of regorafenib for patients with mCRC in real-world clinical practice. Methods The international, prospective, CORRELATE study recruited patients with mCRC previously treated with approved therapies, for whom the decision to treat with regorafenib was made by the treating physician according to the local health authority approved label. The primary objective was safety, assessed by treatment-emergent adverse events (TEAEs; National Cancer Institute Common Terminology Criteria for Adve…

0301 basic medicineMaleCancer ResearchLung NeoplasmsColorectal cancerPyridinesGTP Phosphohydrolaseschemistry.chemical_compound0302 clinical medicineObservational studyProspective StudiesNeoplasm MetastasisFatiguePeritoneal NeoplasmsRegorafenibAged 80 and overLiver NeoplasmsCommon Terminology Criteria for Adverse EventsMiddle AgedProgression-Free SurvivalOncology030220 oncology & carcinogenesisHypertensionFemaleHand-Foot SyndromeColorectal NeoplasmsAdultProto-Oncogene Proteins B-rafmedicine.medical_specialtyBone NeoplasmsPlaceboProto-Oncogene Proteins p21(ras)03 medical and health sciencesYoung AdultRegorafenibInternal medicinemedicineHumansAdverse effectSurvival analysisAgedAdverse effectsbusiness.industryPhenylurea CompoundsCarcinomaCancerMembrane ProteinsSurvival analysismedicine.disease030104 developmental biologychemistryObservational studyLymph NodesbusinessAdverse effects; Observational study; Regorafenib; Survival analysisEuropean journal of cancer (Oxford, England : 1990)
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Cisplatin and 5-fluorouracil with or without epidermal growth factor receptor inhibition panitumumab for patients with non-resectable, advanced or me…

2020

Background Palliative chemotherapy of advanced oesophageal squamous cell cancer (ESCC) consists of cisplatin/5-fluorouracil (CF) to target epidermal growth factor receptor (EGFR) with panitumumab (P); chemotherapy enhanced overall survival (OS) in advanced colorectal or squamous cell head and neck cancers. With prospective serum and tumour biomarkers, we tested if P added to CF (CFP) improved OS in advanced ESCC. Patients and methods Eligible patients with confirmed ESCC that was not curatively resectable or did not qualify for definitive radiochemotherapy, were randomised 1 : 1 to receive CF [cisplatin (C) 100 mg/m2 i.v., day 1; 5-fluorouracil (F) 1000 mg/m2 i.v., days 1–4] or CF plus P (9…

0301 basic medicinemedicine.medical_specialtyEsophageal Neoplasmsmedicine.medical_treatmentPopulationMedizinGastroenterologyDisease-Free Survival03 medical and health sciences0302 clinical medicineInternal medicineAntineoplastic Combined Chemotherapy ProtocolsmedicinePanitumumabHumansProspective StudieseducationCisplatineducation.field_of_studyChemotherapybusiness.industryPanitumumabHazard ratioCommon Terminology Criteria for Adverse EventsHematologymedicine.diseaseErbB Receptors030104 developmental biologyTreatment OutcomeOncologyFluorouracil030220 oncology & carcinogenesisCarcinoma Squamous CellFluorouracilCisplatinbusinessProgressive diseasemedicine.drugAnnals of oncology : official journal of the European Society for Medical Oncology
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Patients with adenoid cystic carcinomas of the salivary glands treated with lenvatinib: Activity and quality of life

2019

The treatment of patients with recurrent and/or metastatic (R/M) salivary gland adenoid cystic carcinoma (ACC) remains an unmet need.Patients with R/M disease with a history of clinical or symptomatic disease progression within 6 months and a maximum of 1 previous line of chemotherapy or a multiple kinase inhibitor received oral lenvatinib at a dose of 24 mg/day. The primary endpoint was the objective response rate; secondary endpoints included quality of life (QOL) (according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Items [EORTC QLQ-C30] and the European Organization for Research and Treatment of Cancer Quality of Life Question…

AdultMaleadenoid cystic carcinoma; lenvatinib; quality of life; toxicityCancer Researchmedicine.medical_specialtyAdenoid cystic carcinomaAntineoplastic Agentslenvatinib03 medical and health scienceschemistry.chemical_compound0302 clinical medicineSwallowingQuality of lifeInternal medicinemedicineClinical endpointHumansadenoid cystic carcinomaProspective Studies030212 general & internal medicineNeoplasm MetastasisProtein Kinase InhibitorsDose-Response Relationship Drugbusiness.industryPhenylurea CompoundstoxicityCancerCommon Terminology Criteria for Adverse EventsMiddle AgedSalivary Gland Neoplasmsmedicine.diseaseCarcinoma Adenoid CysticSurvival AnalysisSalivary Gland Adenoid Cystic Carcinomaquality of lifeOncologychemistry030220 oncology & carcinogenesisQuinolinesFemaleNeoplasm Recurrence LocalbusinessLenvatinibCancer
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Systemic chemotherapy and pressurized intraperitoneal aerosol chemotherapy (PIPAC): A bidirectional approach for gastric cancer peritoneal metastasis

2019

Abstract Background Few patients affected by gastric cancer peritoneal metastasis (GCPM) are offered locoregional treatment, despite several proof-of-efficacy trials. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) has emerged in recent years as a promising tool to control peritoneal carcinomatosis. The combination of PIPAC with systemic chemotherapy may offer a greater clinical benefit than standard treatment alone. Methods A single-center cohort of 28 consecutive patients affected by GCPM was scheduled for bidirectional treatment, comprising PIPAC and systemic chemotherapy, from September 2017 to September 2019. Data recorded included safety, efficacy and survival outcomes. Ascit…

AdultMalemedicine.medical_specialtyIntraoperative Complicationmedicine.medical_treatmentPopulation03 medical and health sciences0302 clinical medicineStomach NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsmedicinePressureHumansProspective StudieseducationPeritoneal NeoplasmsAgedRetrospective StudiesAerosolseducation.field_of_studyChemotherapyPressurized intraperitoneal aerosol chemotherapy (PIPAC)business.industryStandard treatmentCommon Terminology Criteria for Adverse EventsMiddle AgedPrognosisSurgerySurvival RateOncologyDoxorubicin030220 oncology & carcinogenesisCohortConventional PCIPeritoneal metastasisPeritoneal Cancer Index030211 gastroenterology & hepatologySurgeryFemaleCisplatinbusinessGastric cancerFollow-Up Studies
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Association Between ABCB1 Genetic Variants and Persistent Chemotherapy-Induced Alopecia in Women With Breast Cancer

2020

Importance Persistent chemotherapy-induced alopecia (pCIA) has been recently described in patients with breast cancer and in its most severe form occurs in up to 10% of these patients. Genetic risk factors associated with pCIA have not been adequately explored. Objective To identify genetic variants associated with pCIA. Design, Setting, and Participants In this genetic association study, 215 women with breast cancer treated with docetaxel-based chemotherapy with a follow-up of 1.5 to 10 years after the end of the treatment were recruited retrospectively through 3 hospital oncology units across Spain between 2005 and 2018. Severe pCIA was defined as lack of scalp hair recovery (Common Termi…

AdultOncologymedicine.medical_specialtyATP Binding Cassette Transporter Subfamily BBiopsyBreast NeoplasmsGenome-wide association studyDocetaxelDermatologyPolymorphism Single Nucleotide030207 dermatology & venereal diseases03 medical and health sciences0302 clinical medicineBreast cancerRisk FactorsInternal medicineAntineoplastic Combined Chemotherapy ProtocolsmedicineHumansGenetic Predisposition to DiseasePromoter Regions GeneticAdverse effectRetrospective StudiesDose-Response Relationship Drugbusiness.industryAge FactorsCase-control studyAlopeciaCommon Terminology Criteria for Adverse EventsRetrospective cohort studyOdds ratioMiddle Agedmedicine.diseaseEnhancer Elements GeneticDocetaxelCase-Control Studies030220 oncology & carcinogenesisFemalebusinessHair FollicleFollow-Up StudiesGenome-Wide Association Studymedicine.drugJAMA Dermatology
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Electronic Patient-Reported Outcome Measures Evaluating Cancer Symptoms: A Systematic Review.

2021

Abstract Objectives This systematic review aims to evaluate the psychometric properties and the methodologic quality of studies describing smartphone-, tablet- or computer-based questionnaires for Patient-Reported Outcome Measures (PROM) evaluating symptoms in oncology and hematology patients. Data Sources A literature search was conducted in PubMed, Scopus, Cochrane, Cinahl, Cuiden, Lilacs, and PsycINFO. Criteria for inclusion were (i) primary studies evaluating scales for symptoms assessment, (ii) developed in adult population (>18 years) with an oncology or hematology malignancy diagnosis, (iii) validations tested via phone or computer, and (iv) describing at least one psychometric prope…

Adultmedicine.medical_specialtyPsychometricsPsychometricsOncology (nursing)business.industryConstruct validityReproducibility of ResultsCommon Terminology Criteria for Adverse EventsPsycINFOCINAHLElectronic patient-reported outcomeChecklist03 medical and health sciences0302 clinical medicine030220 oncology & carcinogenesisNeoplasmsmedicineContent validityHumansMedical physics030212 general & internal medicinePatient Reported Outcome MeasuresElectronicsbusinessSeminars in oncology nursing
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Moderate Hypofractionated Postprostatectomy Volumetric Modulated Arc Therapy With Daily Image Guidance (VMAT-IGRT): A Mono-institutional Report on Fe…

2017

The aim of this study was to evaluate the acute toxicity profiles of a moderate hypofractionated regimen with volumetric modulated arc therapy (VMAT) in patients with prostate cancer (PC) who underwent radical prostatectomy.From December 2012 to February 2016, 125 patients, previously having undergone radical prostatectomy, received adjuvant (64 patients) or salvage (61 patients) radiotherapy (RT) inside an institutional protocol of moderate hypofractionation schedule using the VMAT technique (Varian RapidArc, Palo Alto, CA). Eligible patients were 85 years old, with an Eastern Cooperative Oncology Group performance status of 0 to 2, histologically proven adenocarcinoma of the prostate with…

MaleOncologymedicine.medical_specialtyUrologymedicine.medical_treatmentUrologyUrinary incontinenceDisease-Free Survival030218 nuclear medicine & medical imaging03 medical and health sciencesProstate cancersymbols.namesake0302 clinical medicineInternal medicinemedicineHumansAdjuvantFisher's exact testAgedNeoplasm StagingAged 80 and overProstatectomySalvage TherapyProstate cancerRadiotherapyAdjuvant; Hypofractionation; Prostate cancer; Radiotherapy; Salvage; Oncology; Urologybusiness.industryProstatectomyProstatic NeoplasmsCommon Terminology Criteria for Adverse EventsMiddle AgedProstate-Specific Antigenmedicine.diseaseAcute toxicityRadiation therapyRegimenTreatment OutcomeOncology030220 oncology & carcinogenesissymbolsHypofractionationSalvageRadiation Dose HypofractionationRadiotherapy AdjuvantRadiotherapy Intensity-Modulatedmedicine.symptombusinessRadiotherapy Image-GuidedClinical Genitourinary Cancer
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High-dose-rate brachytherapy boost for prostate cancer: Analysis of dose-volume histogram parameters for predicting late, rectal toxicity

2017

PURPOSE: To determine the significance of dose-volume histogram parameters for predicting late rectal toxicity (LRT) after single-fraction high-dose-rate brachytherapy (HDRBT) boost and external beam radiotherapy (EBRT) in prostate cancer. MATERIALS AND METHODS: Three hundred patients with intermediate- or high-risk prostate cancer were included between August 2010 and March 2015. Treatment comprised a single-fraction HDRBT boost of 15.0 Gy plus EBRT (46.0 Gy delivered in 23 fractions) or an HDRBT boost of 9.5 Gy plus EBRT (60.0 Gy delivered in 30 fractions) if the seminal vesicles were infiltrated using real-time transrectal ultrasound-based planning. LRT was evaluated every 3 months after…

MaleOrgans at RiskDose-volume histogramTime Factorsmedicine.medical_treatmentBrachytherapyBrachytherapyRectumLate rectal toxicity030218 nuclear medicine & medical imaging03 medical and health sciencesProstate cancerOrgan at risk0302 clinical medicinemedicineHumansRadiology Nuclear Medicine and imagingProspective StudiesExternal beam radiotherapyRadiation InjuriesAgedAged 80 and overProstate cancerbusiness.industryRadiotherapy Planning Computer-AssistedBiologically equivalent doseRectumProstatic NeoplasmsCommon Terminology Criteria for Adverse EventsMiddle Agedmedicine.diseaseCombined Modality TherapyHigh-Dose Rate BrachytherapyHigh-dose-rate brachytherapy boostRadiation therapyDose-volume histogram parametermedicine.anatomical_structureOncology030220 oncology & carcinogenesisRegression AnalysisDose Fractionation RadiationNuclear medicinebusinessFollow-Up Studies
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Folfirinox in elderly patients with pancreatic or colorectal cancer-tolerance and efficacy

2016

AIM To study the tolerance and the efficiency of FOLFIRINOX in elderly patients diagnosed with colorectal or pancreatic cancer. METHODS This retrospective study included elderly patients aged over 70 years of age treated at Georges-Francois Leclerc Center by FOLFIRINOX for histological proved colorectal or pancreatic cancer between January 2009 and January 2015. Chemotheapy regimen consisted of oxaliplatin (85 mg/m(2) in over 120 min) followed by leucovorin (400 mg/m(2) in over 120 min), with the addition, after 30 min of irinotecan (180 mg/m(2) in over 90 min) then 5 fluorouracil (5FU) (400 mg/m(2) administred intravenous bolus), followed by 5FU (2400 mg/m2 intraveinous infusion over 46 h)…

MaleTime FactorsOrganoplatinum CompoundsColorectal cancerFOLFIRINOXLeucovorinPooled AnalysisInternational-SocietyKaplan-Meier EstimateOlder PatientsGastroenterology0302 clinical medicineRisk FactorsAntineoplastic Combined Chemotherapy Protocols030212 general & internal medicineAged 80 and overAge FactorsGastroenterologyCommon Terminology Criteria for Adverse EventsGeneral Medicine3. Good healthOxaliplatinTreatment Outcome030220 oncology & carcinogenesisDisease ProgressionFolfirinoxFemale[ SDV.MHEP.HEG ] Life Sciences [q-bio]/Human health and pathology/Hépatology and GastroenterologyFluorouracilFranceFolfirinox RegimenColorectal Neoplasmsmedicine.drugmedicine.medical_specialtyOxaliplatin FolfirinoxIrinotecanDisease-Free SurvivalDrug Administration Schedule03 medical and health sciencesPancreatic CancerRetrospective StudyInternal medicinePancreatic cancermedicineHumansChemotherapyGeriatric AssessmentAgedRetrospective StudiesColorectal CancerChi-Square DistributionPerformance statusbusiness.industry[SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and GastroenterologyElderly Patientsmedicine.diseasePhase-Ii Trial1st-Line TreatmentSurgeryPancreatic NeoplasmsIrinotecanRegimenMultivariate AnalysisCamptothecinOpen-LabelFeasibility TreatmentTomography X-Ray Computedbusiness
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Efficacy of nivolumab in pre-treated non-small-cell lung cancer patients harbouring KRAS mutations

2018

Background: The present study investigated the efficacy and safety of nivolumab in pre-treated patients with advanced NSCLC harbouring KRAS mutations. Methods: Clinical data and KRAS mutational status were analysed in patients treated with nivolumab within the Italian Expanded Access Program. Objective response rate, progression-free survival and overall survival were evaluated. Patients were monitored for adverse events using the National Cancer Institute Common Terminology Criteria for Adverse Events. Results: Among 530 patients evaluated for KRAS mutations, 206 (39%) were positive while 324 (61%) were KRAS wild-type mutations. KRAS status did not influence nivolumab efficacy in terms of …

OncologyAdultMalemedicine.medical_specialtyCancer Researchmedicine.disease_causePredictive markersArticleProto-Oncogene Proteins p21(ras)03 medical and health sciences0302 clinical medicineInternal medicineCarcinoma Non-Small-Cell LungmedicineCarcinoma80 and overHumansProgression-free survivalLung cancerNon-Small-Cell LungneoplasmsAgedAged 80 and overbusiness.industryCarcinomaCancerCommon Terminology Criteria for Adverse EventsMiddle Agedmedicine.diseasedigestive system diseasesProgression-Free Survivalrespiratory tract diseasesNivolumabOncologyAdult; Aged; Aged 80 and over; Carcinoma Non-Small-Cell Lung; Female; Humans; Male; Middle Aged; Mutation; Nivolumab; Progression-Free Survival; Proto-Oncogene Proteins p21(ras); ImmunotherapyOncology; Cancer Research030220 oncology & carcinogenesisExpanded accessMutationFemaleKRASImmunotherapyNivolumabbusinessNon-small-cell lung cancer
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