2024
Uncommon biphasic CAR-T expansion induces hemophagocytic lymphohistiocytosis-like syndrome and fatal multiple infections following BCMA CAR-T cell therapy: a case report
Yan W, Xiong Y, Lv R, Du C, Yu T, Zhang S, Sui W, Deng S, Xiao J, Xu Y, Zou D, Qiu L, An G. Uncommon biphasic CAR-T expansion induces hemophagocytic lymphohistiocytosis-like syndrome and fatal multiple infections following BCMA CAR-T cell therapy: a case report. Journal For ImmunoTherapy Of Cancer 2024, 12: e010080. PMID: 39608976, PMCID: PMC11603806, DOI: 10.1136/jitc-2024-010080.Peer-Reviewed Original ResearchConceptsCAR-T expansionMultiple myelomaCell infusionSevere toxicityChimeric antigen receptor (CAR)-T-cell therapyCAR-T cell infusionCAR-T cell therapyMesenchymal stem cell infusionCentral nervous system infectionCell expansion in vivoAnti-infective regimenRefractory multiple myelomaCytokine release syndromeStem cell infusionImmune cell componentsNervous system infectionCases of patientsExpansion in vivoImproving cytopeniasCytomegalovirus viremiaCAR-TSpectral flow cytometryPolymicrobial infectionsCase reportStandard treatment
2023
Biomarkers of immune checkpoint inhibitor response and toxicity: Challenges and opportunities
Goodman R, Jung S, Balko J, Johnson D. Biomarkers of immune checkpoint inhibitor response and toxicity: Challenges and opportunities. Immunological Reviews 2023, 318: 157-166. PMID: 37470280, PMCID: PMC10528475, DOI: 10.1111/imr.13249.Peer-Reviewed Original ResearchConceptsImmune checkpoint inhibitorsCheckpoint inhibitorsImmune checkpoint inhibitor responsePD-L1 stainingCheckpoint inhibitor responseBiomarkers of responseClinical trial enrollmentPD-L1Therapy discontinuationSevere toxicityTherapy selectionSevere morbidityInhibitor responseCancer therapyTrial enrollmentLack of responseTherapyTherapeutic biomarkersBiomarkersDrug developmentToxicityInhibitorsTumorMorbidityOptimal use
2022
Integrated approach to collecting patient reported toxicities in a colorectal cancer trial.
Gaddy J, Sanoff H, Deal A, Basch E, Wood W. Integrated approach to collecting patient reported toxicities in a colorectal cancer trial. Journal Of Clinical Oncology 2022, 40: 51-51. DOI: 10.1200/jco.2022.40.4_suppl.051.Peer-Reviewed Original ResearchDose decreaseSevere symptomsToxicity ratesSevere toxicityClinical trialsGenotype-guided dosing strategyAppropriate dose modificationPRO-CTCAEStandard drug dosesAdverse event assessmentMulti-center clinical trialClinically relevant issuesColorectal cancer trialsHematologic toxicityMCRC patientsDose modificationAbdominal painAdvanced CRCToxicity gradeCycling patientsClinical characteristicsDosing strategiesAdverse eventsDrug doseClinician grading
2020
Low toxicity and favorable overall survival in relapsed/refractory B-ALL following CAR T cells and CD34-selected T-cell depleted allogeneic hematopoietic cell transplant
Fabrizio VA, Kernan NA, Boulad F, Cancio M, Allen J, Higman M, Margossian SP, Mauguen A, Prockop S, Scaradavou A, Shah N, Spitzer B, Stieglitz E, Yeager N, O’Reilly R, Brentjens RJ, Jan Boelens J, Curran KJ. Low toxicity and favorable overall survival in relapsed/refractory B-ALL following CAR T cells and CD34-selected T-cell depleted allogeneic hematopoietic cell transplant. Bone Marrow Transplantation 2020, 55: 2160-2169. PMID: 32390002, PMCID: PMC7606268, DOI: 10.1038/s41409-020-0926-1.Peer-Reviewed Original ResearchConceptsCAR T cellsAllo-HSCTT cellsCumulative incidenceCell transplantAllogeneic hematopoietic stem cell transplantAllogeneic hematopoietic cell transplantHematopoietic stem cell transplantCAR T-cell therapyConsolidative allo-HSCTHematopoietic cell transplantYoung adult patientsFavorable overall survivalStem cell transplantT-cell therapyFavorable OSOverall survivalAdult patientsSevere toxicitySmall cohortDisease controlPatientsCD34IncidenceRelapse
2018
Radiotherapy plus cetuximab or cisplatin in human papillomavirus-positive oropharyngeal cancer (NRG Oncology RTOG 1016): a randomised, multicentre, non-inferiority trial
Gillison ML, Trotti AM, Harris J, Eisbruch A, Harari PM, Adelstein DJ, Jordan RCK, Zhao W, Sturgis EM, Burtness B, Ridge JA, Ringash J, Galvin J, Yao M, Koyfman SA, Blakaj DM, Razaq MA, Colevas AD, Beitler JJ, Jones CU, Dunlap NE, Seaward SA, Spencer S, Galloway TJ, Phan J, Dignam JJ, Le QT. Radiotherapy plus cetuximab or cisplatin in human papillomavirus-positive oropharyngeal cancer (NRG Oncology RTOG 1016): a randomised, multicentre, non-inferiority trial. The Lancet 2018, 393: 40-50. PMID: 30449625, PMCID: PMC6541928, DOI: 10.1016/s0140-6736(18)32779-x.Peer-Reviewed Original ResearchConceptsHPV-positive oropharyngeal carcinomaProgression-free survivalOverall survivalNon-inferiority trialCisplatin groupCetuximab groupOropharyngeal carcinomaSevere toxicityEligibility criteriaPositive oropharyngeal squamous cell carcinomaHuman papillomavirus-positive oropharyngeal cancerNational Cancer Institute-USAZubrod performance status 0Oropharyngeal squamous cell carcinomaAdequate bone marrowPerformance status 0Replacement of cisplatinZubrod performance statusInferior overall survivalTobacco smoking historyAmerican Joint CommitteeNon-inferiority criteriaSquamous cell carcinomaStandard of careNon-inferiority margin
2016
Veliparib Alone or in Combination with Mitomycin C in Patients with Solid Tumors With Functional Deficiency in Homologous Recombination Repair
Villalona-Calero M, Duan W, Zhao W, Shilo K, Schaaf L, Thurmond J, Westman J, Marshall J, Xiaobai L, Ji J, Rose J, Lustberg M, Bekaii-Saab T, Chen A, Timmers C. Veliparib Alone or in Combination with Mitomycin C in Patients with Solid Tumors With Functional Deficiency in Homologous Recombination Repair. Journal Of The National Cancer Institute 2016, 108: djv437. PMID: 26848151, PMCID: PMC4948564, DOI: 10.1093/jnci/djv437.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesDiarrheaDrug Administration ScheduleFanconi AnemiaFatigueFeasibility StudiesFemaleGenes, BRCA1Genes, BRCA2Germ-Line MutationHumansMaleMiddle AgedMitomycinNeoplasmsPedigreePoly(ADP-ribose) Polymerase InhibitorsRecombinational DNA RepairThrombocytopeniaConceptsPatient tumorsPARP inhibitorsFunctional deficiencySafety/feasibilityDose-escalation trialBRCA germline mutationsCancer patient tumorsClinical Laboratory Improvement AmendmentsArchival tumor materialCombination armEscalation trialAntitumor responseClinical benefitSevere toxicityTumor specimensPatientsDose levelsSolid tumorsGermline analysisGermline alterationsTumor materialTumorsVeliparibBRCA genesGermline mutations
2014
Virologic response and haematologic toxicity of boceprevir‐ and telaprevir‐containing regimens in actual clinical settings
Butt AA, Yan P, Shaikh OS, Freiberg MS, Re V, Justice AC, Sherman KE, Team T. Virologic response and haematologic toxicity of boceprevir‐ and telaprevir‐containing regimens in actual clinical settings. Journal Of Viral Hepatitis 2014, 22: 691-700. PMID: 25524834, PMCID: PMC5020421, DOI: 10.1111/jvh.12375.Peer-Reviewed Original ResearchConceptsSustained virologic responsePEG/RBVHaematologic toxicityActual clinical settingsSVR ratesVirologic responseClinical settingHaematologic adverse eventsHCV Infected VeteransInterferon/ribavirinHCV genotype 1HCV RNA valuesPivotal clinical trialsHepatitis C virusBaseline cirrhosisHIV coinfectionPrimary endpointTreatment-naïveAdverse eventsC virusClinical trialsGenotype 1Genotype 1aSevere toxicityBoceprevirImpact of prednisone on toxicities and survival in metastatic castration-resistant prostate cancer: A systematic review and meta-analysis of randomized clinical trials
Morgan C, Oh W, Naik G, Galsky M, Sonpavde G. Impact of prednisone on toxicities and survival in metastatic castration-resistant prostate cancer: A systematic review and meta-analysis of randomized clinical trials. Critical Reviews In Oncology/Hematology 2014, 90: 253-261. PMID: 24500033, DOI: 10.1016/j.critrevonc.2013.12.001.Peer-Reviewed Original ResearchConceptsMetastatic castration-resistant prostate cancerCastration-resistant prostate cancerNon-PE groupProstate cancerMeta-analysisMeta-analysis of randomized clinical trialsMeta-analysis of randomized trialsImpact of prednisoneDaily oral prednisoneRandomized clinical trialsOral prednisoneDiscontinued therapySevere toxicityRandomized trialsClinical trialsPrednisoneSystematic reviewTrialsTherapyCancerToxicityNon-PSGroupRegimensPatientsMeta-analysis of randomized trials to study the impact of prednisone on toxicities and survival in metastatic castration-resistant prostate cancer.
Naik G, Morgan C, Galsky M, Oh W, Sonpavde G. Meta-analysis of randomized trials to study the impact of prednisone on toxicities and survival in metastatic castration-resistant prostate cancer. Journal Of Clinical Oncology 2014, 32: 28-28. DOI: 10.1200/jco.2014.32.4_suppl.28.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerMeta-analysis of randomized trialsCastration-resistant prostate cancerOverall survivalDaily oral prednisoneNon-PE groupRandomized trialsOral prednisoneProstate cancerMeta-analysisSevere toxicityImpact of prednisoneToxicity grade 3Discontinued therapyEstramustine phosphateOS analysisGrade 3P. CONCLUSIONSPrednisonePreferred Reporting ItemsAnalysis of toxicityTherapyPatientsGVAXSystematic review
2013
The Impact of Gender on Outcomes in Patients With Metastatic Urothelial Carcinoma
Haines L, Bamias A, Krege S, Lin C, Hahn N, Ecke T, Moshier E, Sonpavde, Godbold J, Oh W, Galsky M. The Impact of Gender on Outcomes in Patients With Metastatic Urothelial Carcinoma. Clinical Genitourinary Cancer 2013, 11: 346-352. PMID: 23673281, DOI: 10.1016/j.clgc.2013.04.010.Peer-Reviewed Original ResearchConceptsMetastatic urothelial cancerMetastatic urothelial carcinomaUrothelial cancerFemale patientsUrothelial carcinomaNo significant differenceSurvival outcomesMale patientsCisplatin-based combination chemotherapyPresence of visceral metastasesSurvival of male patientsInferior survival outcomesCycles of chemotherapyPhase III trialsBaseline performance statusEfficacy of chemotherapySignificant differenceProportion of patientsIndividual patient dataVisceral metastasesCombination chemotherapyMedian survivalIII trialsPerformance statusSevere toxicity
2010
Phase II Randomized Study of Two Regimens of Sequentially Administered Mitomycin C and Irinotecan in Patients with Unresectable Esophageal and Gastroesophageal Adenocarcinoma
Lustberg M, Bekaii-Saab T, Young D, Otterson G, Burak W, Abbas A, McCracken-Bussa B, Lustberg M, Villalona-Calero M. Phase II Randomized Study of Two Regimens of Sequentially Administered Mitomycin C and Irinotecan in Patients with Unresectable Esophageal and Gastroesophageal Adenocarcinoma. Journal Of Thoracic Oncology 2010, 5: 713-718. PMID: 20354452, PMCID: PMC3641556, DOI: 10.1097/jto.0b013e3181d7776d.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAntineoplastic Combined Chemotherapy ProtocolsBone NeoplasmsCamptothecinCarcinoma, Squamous CellEsophageal NeoplasmsEsophagogastric JunctionFemaleHumansIrinotecanLiver NeoplasmsLung NeoplasmsLymphatic MetastasisMaleMiddle AgedMitomycinNeoplasm StagingStomach NeoplasmsSurvival RateTreatment OutcomeConceptsMitomycin CDay 1Day 2Phase II Randomized StudyComplete pathologic responsePhase II evaluationGastroesophageal junction adenocarcinomaUnresectable esophagealEvaluable patientsGastroesophageal adenocarcinomaJunction adenocarcinomaPathologic responseRandomized studyArm AGastroesophageal junctionFuture trialsEsophageal cancerII evaluationSevere toxicityPatientsIrinotecanResponse ratePhase IAdenocarcinomaTopoisomerase 1
2007
Local Administration of Interleukin-11 Ameliorates Intestinal Radiation Injury in Rats
Boerma M, Wang J, Burnett AF, Santin AD, Roman JJ, Hauer-Jensen M. Local Administration of Interleukin-11 Ameliorates Intestinal Radiation Injury in Rats. Cancer Research 2007, 67: 9501-9506. PMID: 17909060, DOI: 10.1158/0008-5472.can-07-0810.Peer-Reviewed Original ResearchConceptsIntestinal radiation injuryRadiation injuryRhIL-11Bowel loopsMucosal mast cell numbersIL-11Whole body radiation exposureRecombinant human IL-11Small bowel loopsED2-positive cellsRadiation injury scoreIntestinal wall thickeningMast cell numbersIntestinal radiation responseLocal administrationHuman IL-11Pelvic radiotherapySurgical transpositionIntraluminal administrationInjury scoreIntestinal loopsMale ratsSystemic administrationSevere toxicityDrug Administration
2003
Physician attitudes toward cytotoxic chemotherapy use in patients with advanced prostate carcinoma
Oh W, Tully P, Kantoff P, Regan M. Physician attitudes toward cytotoxic chemotherapy use in patients with advanced prostate carcinoma. Cancer 2003, 97: 2171-2179. PMID: 12712468, DOI: 10.1002/cncr.11344.Peer-Reviewed Original ResearchConceptsHormone-refractory prostate carcinomaAdvanced prostatic carcinomaProstate carcinomaRecommended chemotherapyHypothetical patient scenariosRadiation oncologistsMedical oncologistsAppropriateness of chemotherapyHormone-refractory diseaseBaseline demographic dataLack of benefitCytotoxic chemotherapyChemotherapy useEffects of specific drugsSevere toxicityChemotherapyCarcinomaRandomized trialsMultivariate analysisProstatePatientsOncologistsDemographic dataSpecific drugsReturn of surveys
2000
Phase II trial of gemcitabine plus cisplatin in patients with metastatic urothelial cancer.
Kaufman D, Raghavan D, Carducci M, Levine E, Murphy B, Aisner J, Kuzel T, Nicol S, Oh W, Stadler W. Phase II trial of gemcitabine plus cisplatin in patients with metastatic urothelial cancer. Journal Of Clinical Oncology 2000, 18: 1921-7. PMID: 10784633, DOI: 10.1200/jco.2000.18.9.1921.Peer-Reviewed Original ResearchConceptsMetastatic urothelial cancerTreatment of metastatic urothelial cancerChemotherapy-naive patientsUrothelial cancerMedian time to treatment failurePhase II trial of gemcitabineTreatment of chemotherapy-naive patientsDay 1Time to treatment failureStage IV carcinomaTrial of gemcitabineCombination of gemcitabinePhase II trialClinical safety profileHematologic toxicityCisplatin doseIV carcinomaPartial responseMedian survivalTreatment failureSafety profileSevere toxicityGemcitabineChemotherapeutic agentsDisease progression
1999
5‐Fluorouracil‐induced small bowel toxicity in patients with colorectal carcinoma
Fata F, Ron I, Kemeny N, O'Reilly E, Klimstra D, Kelsen D. 5‐Fluorouracil‐induced small bowel toxicity in patients with colorectal carcinoma. Cancer 1999, 86: 1129-1134. PMID: 10506695, DOI: 10.1002/(sici)1097-0142(19991001)86:7<1129::aid-cncr5>3.0.co;2-4.Peer-Reviewed Original ResearchConceptsSmall bowel toxicityBowel toxicityColorectal carcinomaColon carcinomaLow dose of 5-FUAcute small bowel toxicityDose of 5-FUAbdominal computed tomography scanAcute abdominal painRecurrence of symptomsGastrointestinal side effectsSmall bowel damageDecreased mucosal blood flowMucosal blood flowAcute toxicity episodesLower gastrointestinal tractGastrointestinal toxicityAbdominal painOral mucositisSchedule-dependentSevere toxicityTomography scanBowel damageClinical pictureLow doses
1978
Advanced Ovarian Adenocarcinoma — A Prospective Clinical Trial of Melphalan (L-PAM) versus Combination Chemotherapy
Young R, Chabner B, Hubbard S, Fisher R, Bender R, Anderson T, Simon R, Canellos G, DeVita V. Advanced Ovarian Adenocarcinoma — A Prospective Clinical Trial of Melphalan (L-PAM) versus Combination Chemotherapy. New England Journal Of Medicine 1978, 299: 1261-1266. PMID: 101843, DOI: 10.1056/nejm197812072992301.Peer-Reviewed Original ResearchConceptsAdvanced ovarian adenocarcinomaFour-drug combinationOverall response rateOvarian adenocarcinomaComplete remissionMedian survivalResidual diseaseResponse rateHigher overall response rateExtensive residual diseaseFour-drug regimenProspective clinical trialsLonger median survivalMinimal residual diseaseAdvanced diseaseCombination chemotherapyClinical trialsSevere toxicityMelphalanPatientsAdenocarcinomaDiseaseRemissionTrialsSurvivalHexamethylmelamine in alkylating agent‐resistant ovarian carcinoma
Johnson B, Fisher R, Bender R, Devita V, Chabner B, Young R. Hexamethylmelamine in alkylating agent‐resistant ovarian carcinoma. Cancer 1978, 42: 2157-2161. PMID: 102417, DOI: 10.1002/1097-0142(197811)42:5<2157::aid-cncr2820420511>3.0.co;2-7.Peer-Reviewed Original ResearchConceptsDose modificationOvarian cancerDiscontinuation of therapyAdvanced ovarian cancerMedian durationObjective responseAgent therapyProspective studyOvarian carcinomaDay courseSevere toxicityPatientsAttractive agentTherapyToxic effectsHexamethylmelamineCancerDegree of toxicityToxicityActive agentsDiscontinuationChemotherapyNeurologicCarcinomaHematologic
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