2024
Phase III Randomized, Placebo-Controlled Trial of Endocrine Therapy ± 1 Year of Everolimus in Patients With High-Risk, Hormone Receptor–Positive, Early-Stage Breast Cancer
Chavez-MacGregor M, Miao J, Pusztai L, Goetz M, Rastogi P, Ganz P, Mamounas E, Paik S, Bandos H, Razaq W, O'Dea A, Kaklamani V, Silber A, Flaum L, Andreopoulou E, Wendt A, Carney J, Sharma P, Gralow J, Lew D, Barlow W, Hortobagyi G. Phase III Randomized, Placebo-Controlled Trial of Endocrine Therapy ± 1 Year of Everolimus in Patients With High-Risk, Hormone Receptor–Positive, Early-Stage Breast Cancer. Journal Of Clinical Oncology 2024, 42: 3012-3021. PMID: 38833643, PMCID: PMC11565489, DOI: 10.1200/jco.23.02344.Peer-Reviewed Original ResearchInvasive disease-free survivalHormone receptor-positiveEndocrine therapyOverall survivalBreast cancerHazard ratioReceptor-positiveHigh riskSubset analysisHormone receptor-positive metastatic breast cancerRisk groupsHormone receptor-positive BCEarly-stage breast cancerStratified log-rank testProgression-free survivalEfficacy of everolimusDisease-free survivalMetastatic breast cancerPlacebo-controlled trialSecondary end pointsLog-rank testHighest grade 3Treatment completion ratesPhase IIIEverolimus armA Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (DARA-VCD) Induction Followed by Autologous Stem Cell Transplant or DARA-VCD Consolidation and Daratumumab Maintenance in patients with Newly Diagnosed AL Amyloidosis PA145 (#114)
Hagen P, Hoering A, Sidana S, Parker T, Walker B, Sanchorawala V, Zonder J, Kourelis T, D’Souza A, Landau H, Rosenthal A, Ailawadhi S, Z. R. A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (DARA-VCD) Induction Followed by Autologous Stem Cell Transplant or DARA-VCD Consolidation and Daratumumab Maintenance in patients with Newly Diagnosed AL Amyloidosis PA145 (#114). 2024 DOI: 10.26226/m.65f9bf89e6f73964e1d4eb32.Peer-Reviewed Original Research
2023
The Clinical Utility of Antroduodenal Manometry in the Evaluation of Children with Upper Gastrointestinal Symptoms
Arbizu R, Trauernicht S, Pinillos S, Nurko S, Rodriguez L. The Clinical Utility of Antroduodenal Manometry in the Evaluation of Children with Upper Gastrointestinal Symptoms. Journal Of Pediatric Gastroenterology And Nutrition 2023, 77: 734-740. PMID: 37756372, DOI: 10.1097/mpg.0000000000003956.Peer-Reviewed Original ResearchConceptsGroup B symptomsUpper gastrointestinal symptomsIdiopathic etiologyB symptomsGastrointestinal symptomsPhase IIITreatment responseInitial successful responseIntestinal phase IIIOverall treatment responseSuccessful treatment responseSmall bowel motilityEvaluation of childrenSuccessful responseManometry measuresUGI symptomsAbdominal distentionAntroduodenal manometryPredominant symptomBowel motilityRetrospective reviewClinical findingsClinical utilitySymptomsEtiologyAtezolizumab plus stereotactic ablative radiotherapy for medically inoperable patients with early-stage non-small cell lung cancer: a multi-institutional phase I trial
Monjazeb A, Daly M, Luxardi G, Maverakis E, Merleev A, Marusina A, Borowsky A, Mirhadi A, Shiao S, Beckett L, Chen S, Eastham D, Li T, Vick L, McGee H, Lara F, Garcia L, Morris L, Canter R, Riess J, Schalper K, Murphy W, Kelly K. Atezolizumab plus stereotactic ablative radiotherapy for medically inoperable patients with early-stage non-small cell lung cancer: a multi-institutional phase I trial. Nature Communications 2023, 14: 5332. PMID: 37658083, PMCID: PMC10474145, DOI: 10.1038/s41467-023-40813-w.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerStereotactic ablative radiotherapyEarly-stage non-small cell lung cancerCell lung cancerAblative radiotherapyLung cancerMulti-institutional phase I trialSingle-arm phase IThird of patientsPhase I trialEx vivo stimulationT cell activationInoperable patientsPrimary endpointSecondary endpointsEfficacy signalsI trialT cellsAdaptive immunityCell activationPatientsPhase IPhase IIIEarly responseAtezolizumabA phase III randomized trial of eribulin (E) with or without gemcitabine vs standard of care (SOC) for metastatic urothelial carcinoma (UC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937.
Sadeghi S, Plets M, Lara P, Tangen C, Bangs R, Lerner S, Flaig T, Petrylak D, Thompson I. A phase III randomized trial of eribulin (E) with or without gemcitabine vs standard of care (SOC) for metastatic urothelial carcinoma (UC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937. Journal Of Clinical Oncology 2023, 41: tps4608-tps4608. DOI: 10.1200/jco.2023.41.16_suppl.tps4608.Peer-Reviewed Original ResearchStandard of careMedian overall survivalObjective response rateProgression-free survivalMedian progression-free survivalMetastatic urothelial carcinomaOverall survivalUrothelial carcinomaMetastatic UCPlatinum-based first-line chemotherapyCurrent SOCCisplatin-ineligible patientsCommon genitourinary cancerCommon grade 3Non-platinum regimenFirst-line chemotherapyPhase IIIStandard dosingIneligible patientsLine chemotherapyMedian OSPrior regimensFree survivalFGFR alterationsGenitourinary cancersClinical Utility of Ileal Motility in Children With Defecation Disorders and Children With Chronic Intestinal Pseudo‐Obstruction
Colliard K, Nurko S, Flores A, Rodriguez L. Clinical Utility of Ileal Motility in Children With Defecation Disorders and Children With Chronic Intestinal Pseudo‐Obstruction. Journal Of Pediatric Gastroenterology And Nutrition 2023, 77: 327-331. PMID: 37229777, DOI: 10.1097/mpg.0000000000003841.Peer-Reviewed Original ResearchConceptsAntroduodenal manometryDefecation disordersPostprandial responseGroup BChronic Intestinal Pseudo-ObstructionIntestinal Pseudo-ObstructionNormal postprandial responseModerate agreementSmall bowel motilityLogistic regression analysisOstomy closurePseudo-ObstructionBowel motilityRetrospective reviewIleal motilityIndication groupGroup AClinical utilityYounger agePatientsMotility patternsPhase IIIMotor complexDisordersManometryEvidence of publication bias in multiple sclerosis clinical trials: a comparative analysis of published and unpublished studies registered in ClinicalTrials.gov
Rivero-de-Aguilar A, Pérez-Ríos M, Ruano-Raviña A, Candal-Pedreira C, Puente-Hernandez M, Ross J, Varela-Lema L. Evidence of publication bias in multiple sclerosis clinical trials: a comparative analysis of published and unpublished studies registered in ClinicalTrials.gov. Journal Of Neurology Neurosurgery & Psychiatry 2023, 94: 597-604. PMID: 36977551, DOI: 10.1136/jnnp-2023-331132.Peer-Reviewed Original ResearchConceptsClinical trialsPeer-reviewed journalsTrial publicationsPublication biasMultivariate logistic regression analysisMultiple sclerosis clinical trialsFavorable primary outcomeMS clinical researchPhase IIILogistic regression analysisMultiple sclerosis drugsCase-control designTreatment tolerabilityMore patientsPrimary outcomeUnpublished trialsMS drugsTreatment decisionsLower oddsStudy design characteristicsMultivariate analysisClinical researchUnpublished studiesTrialsGoogle ScholarA phase III randomized trial of eribulin (E) with or without gemcitabine vs standard of care (SOC) for metastatic urothelial carcinoma (UC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937.
Sadeghi S, Plets M, Lara P, Tangen C, Bangs R, Lerner S, Flaig T, Petrylak D, Thompson I. A phase III randomized trial of eribulin (E) with or without gemcitabine vs standard of care (SOC) for metastatic urothelial carcinoma (UC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937. Journal Of Clinical Oncology 2023, 41: tps581-tps581. DOI: 10.1200/jco.2023.41.6_suppl.tps581.Peer-Reviewed Original ResearchStandard of careObjective response rateMedian overall survivalProgression-free survivalMedian progression-free survivalMetastatic urothelial carcinomaOverall survivalUrothelial carcinomaMetastatic UCPlatinum-based first-line chemotherapyCurrent SOCCisplatin-ineligible patientsCommon genitourinary cancerCommon grade 3Non-platinum regimenFirst-line chemotherapyPhase IIIStandard dosingIneligible patientsLine chemotherapyMedian OSPrior regimensFree survivalFGFR alterationsGenitourinary cancersEfficacy and safety of iclepertin (BI 425809) in patients with schizophrenia: CONNEX, a Phase III randomised controlled trial programme
Reuteman-Fowler C, Blahova Z, Ikezawa S, Marder S, Falkai P, Krystal J. Efficacy and safety of iclepertin (BI 425809) in patients with schizophrenia: CONNEX, a Phase III randomised controlled trial programme. Neuroscience Applied 2023, 2: 102592. DOI: 10.1016/j.nsa.2023.102592.Peer-Reviewed Original Research
2022
A phase III randomized trial of eribulin (E) with or without gemcitabine versus standard of care (SOC) for metastatic urothelial carcinoma (UC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937.
Sadeghi S, Plets M, Lara P, Tangen C, Bangs R, Lerner S, Flaig T, Petrylak D, Thompson I. A phase III randomized trial of eribulin (E) with or without gemcitabine versus standard of care (SOC) for metastatic urothelial carcinoma (UC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937. Journal Of Clinical Oncology 2022, 40: tps4608-tps4608. DOI: 10.1200/jco.2022.40.16_suppl.tps4608.Peer-Reviewed Original ResearchStandard of careMedian overall survivalObjective response rateProgression-free survivalMedian progression-free survivalMetastatic urothelial carcinomaOverall survivalUrothelial carcinomaMetastatic UCPlatinum-based first-line chemotherapyCurrent SOCCisplatin-ineligible patientsCommon genitourinary cancerCommon grade 3Non-platinum regimenFirst-line chemotherapyPhase IIIStandard dosingIneligible patientsLine chemotherapyMedian OSPrior regimensFree survivalFGFR alterationsGenitourinary cancersA phase II/III trial of chemotherapy plus cetuximab versus chemotherapy plus bevacizumab versus atezolizumab plus bevacizumab following progression on immune checkpoint inhibition in recurrent/metastatic head and neck cancers: ECOG-ACRIN EA3202.
Bhatia A, Flamand Y, Johnson J, Ishizuka J, Duan F, Tang M, Karivedu V, Subramaniam R, Burtness B. A phase II/III trial of chemotherapy plus cetuximab versus chemotherapy plus bevacizumab versus atezolizumab plus bevacizumab following progression on immune checkpoint inhibition in recurrent/metastatic head and neck cancers: ECOG-ACRIN EA3202. Journal Of Clinical Oncology 2022, 40: tps6098-tps6098. DOI: 10.1200/jco.2022.40.16_suppl.tps6098.Peer-Reviewed Original ResearchProgression-free survivalVascular endothelial growth factorM HNSCCOverall survivalPrimary endpointExperimental armControl armHigher treatment-related adverse eventsPhase II/III trialsOne-sided alpha levelRecurrent/metastatic headTreatment-related adverse eventsEffector T cell responsesMyeloid-derived suppressor cellsPhase II/IIIPhase IIStratified log-rank testEfficacy of atezolizumabPlatinum-doublet chemotherapyImmune checkpoint inhibitionFirst-line pembrolizumabAnti-tumor immunityPhase IIIDendritic cell maturationPhase III evaluationPhase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter
Lim M, Weller M, Idbaih A, Steinbach J, Finocchiaro G, Raval RR, Ansstas G, Baehring J, Taylor JW, Honnorat J, Petrecca K, De Vos F, Wick A, Sumrall A, Sahebjam S, Mellinghoff IK, Kinoshita M, Roberts M, Slepetis R, Warad D, Leung D, Lee M, Reardon DA, Omuro A. Phase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter. Neuro-Oncology 2022, 24: 1935-1949. PMID: 35511454, PMCID: PMC9629431, DOI: 10.1093/neuonc/noac116.Peer-Reviewed Original ResearchConceptsProgression-free survivalOverall survivalMGMT promoterBaseline corticosteroidsTreatment-related adverse event ratesImmune checkpoint inhibitor nivolumabNew safety signalsPhase III trialsAdverse event ratesCheckpoint inhibitor nivolumabCare radiotherapyInhibitor nivolumabPrimary endpointIII trialsSame regimenExperience recurrenceNivolumabSafety signalsPlaceboPatientsRadiotherapyTemozolomideEvent ratesMonthsPhase IIIA Phase III, prospective, double-blind, randomized, placebo-controlled trial of thrombolysis in imaging-eligible, late-window patients to assess the efficacy and safety of tenecteplase (TIMELESS): Rationale and design
Albers G, Campbell B, Lansberg M, Broderick J, Butcher K, Froehler M, Schwamm L, Nouh A, Liebeskind D, Toy F, Yang M, Massaro L, Schoeffler M, Purdon B. A Phase III, prospective, double-blind, randomized, placebo-controlled trial of thrombolysis in imaging-eligible, late-window patients to assess the efficacy and safety of tenecteplase (TIMELESS): Rationale and design. International Journal Of Stroke 2022, 18: 237-241. PMID: 35262424, DOI: 10.1177/17474930221088400.Peer-Reviewed Original ResearchConceptsAcute ischemic strokeInternal carotid arteryPlacebo-controlled trialRankin Scale scoreSymptom onsetDay 90Scale scoreMiddle cerebral artery occlusionEfficacy of tenecteplaseLate-window patientsSafety of tenecteplaseSymptomatic intracranial hemorrhageCerebral artery occlusionLarge vessel occlusionPhase IIIPrimary efficacy objectiveBetter clinical outcomesAdverse eventsArtery occlusionEndovascular thrombectomyIschemic strokeMCA occlusionClinical outcomesIntracranial hemorrhageSalvageable tissueEfficacy and safety of BI 425809 in patients with schizophrenia: CONNEX, a Phase III randomised controlled trial programme
Wunderlich G, Blahova Z, Hake S, Ikezawa S, Marder S, Falkai P, Krystal J. Efficacy and safety of BI 425809 in patients with schizophrenia: CONNEX, a Phase III randomised controlled trial programme. Neuroscience Applied 2022, 1: 100342. DOI: 10.1016/j.nsa.2022.100342.Peer-Reviewed Original Research
2021
Apathy in Dementia Methylphenidate Trial 2 (ADMET2): Results of a phase III, placebo‐controlled, double‐blind, 6‐month, multi‐center, randomized clinical trial
Mintzer J, Scherer R, Drye L, Lanctôt K, Rosenberg P, Herrmann N, Padala P, Brawman‐Mintzer O, Lerner A, Levey A, Porsteinsson A, van Dyck C. Apathy in Dementia Methylphenidate Trial 2 (ADMET2): Results of a phase III, placebo‐controlled, double‐blind, 6‐month, multi‐center, randomized clinical trial. Alzheimer's & Dementia 2021, 17 DOI: 10.1002/alz.051489.Peer-Reviewed Original ResearchAlzheimer's diseasePlacebo groupMethylphenidate groupClinical trialsAD Cooperative Study-Clinical Global ImpressionPhase IIITreatment of apathyClinical Global ImpressionRatings of improvementADCS-CGICAdverse eventsSecondary outcomesMonth 6Primary outcomeNeuropsychiatric symptomsSafety profileGlobal ImpressionSmall studyViable treatmentStudy participantsMean differenceMonthsMethylphenidatePrevious trialsTrialsBCG vaccination to reduce the impact of COVID-19 in healthcare workers: Protocol for a randomised controlled trial (BRACE trial)
Pittet L, Messina N, Gardiner K, Orsini F, Abruzzo V, Bannister S, Bonten M, Campbell J, Croda J, Dalcolmo M, Elia S, Germano S, Goodall C, Gwee A, Jamieson T, Jardim B, Kollmann T, Lacerda M, Lee K, Legge D, Lucas M, Lynn D, McDonald E, Manning L, Munns C, Perrett K, Aymerich C, Richmond P, Shann F, Sudbury E, Villanueva P, Wood N, Lieschke K, Subbarao K, Davidson A, Curtis N, Abreu C, Abruzzo V, Addlem L, Agius S, Barbosa A, Alamrousi A, Santos A, Al-Hindawi Y, Da Silveira S, Cruz L, Anderson J, Anthony C, Pereira A, Almajano F, Arnold A, Arrowsmith B, Azzopardi K, Marti C, Bahaduri T, Bannister S, Barney S, Barrera L, Barriocanal A, Barros D, Barry S, Bartlett A, Muranaka L, Baulman T, Bealing M, Beardsley J, Gutierrez A, Bell J, Benson S, Bennett-Wood V, Bergant N, Barbosa F, Bijllaardt W, Bimboese P, Andrade C, Blake S, Blauwendraat K, Boersma W, Garcia P, Bonnici R, Bonten M, Boon A, Bourke A, Bowes K, Brasil L, Brophy C, Botten R, Buchanan S, Bucholc J, Burns A, Burrell E, Bustos N, Byrne B, Byrne A, Calbo E, Montes J, Camesella B, Campbell J, Cangas A, Carlin J, Roque M, Diogo R, Carvalho E, Casas I, Castro E, Castro R, Catterick H, Escobar R, Chan J, Cheah J, Chern T, Chengodu T, Ciaverella M, Clark S, Espindola M, Cobbledick A, Colaco C, Collopy S, Comella P, Corbett M, Castro G, Costa E, Coya R, Crawford N, Croda J, Cruz A, Curtis N, Cushnahan J, Czajko A, da Silva R, Daitiri B, Dalcolmo M, Dalton K, Dao A, Davidson A, Dawe P, Dawson D, Costa M, De La Cruz K, de Serna A, de Morais Batista F, de Oliveira A, del Rey Morillo R, Desylva M, Dijkstra H, Dixon R, Lopez M, Dominguez J, Doran C, Castellano A, Dos Santos G, Lencina J, Silva D, Douglas M, Dunn R, Dunn A, Dunnill J, Eden G, Edmund H, Eiffler N, Elborough H, Elia S, Elkington O, England M, Ayala W, Esteve M, Evans N, Evans S, Ewe K, Álvarez M, Fahey K, Fairweather J, Faustman D, Silva E, Fernandez M, Fidler G, Filius P, Finn A, Finucane C, Firth S, Fletcher E, Flynn C, Flynn L, Fouracre L, Fowler S, Freitas T, Furtado A, Oliveira M, Santos A, Gonçalves L, Galletta L, Gama L, Gamage D, Ganpat R, García C, Croda M, Gardiner K, Gardiner E, Gell G, Oliveira A, Germano S, Gibbons M, Gibson C, Gifford A, Poderos T, Ginsberg A, Gisolf J, Gladanac B, Glenn P, Godinho V, Santos M, Goikoetxea J, Goldenberg T, Gomes A, Marcos S, Rico C, Goodall C, Gordon V, Greven F, Capella A, Griffith L, Guo C, Campos D, Cuadra M, Gwee A, Hall R, Hall L, Hamilton K, Hannan M, Harbech H, Harding A, Haker N, Harrison R, Hassing R, Rosa T, Haywood Z, Heath C, Henare N, Andrade P, Herrmann S, Hill E, Hilton S, Huijbens D, Hutton H, James J, Jamieson T, Janssen A, Jardim B, Jardim T, Jarvis L, Jenkins N, Jones J, Jones J, Jones K, Jorge L, Vilegas M, Joshi S, Joyce R, Junior J, Kandasamy R, Karunanayake A, Karuppasamy H, Keeble T, Kent J, Kloeg P, Kluytmans J, Knight B, Kollmann T, Korman T, Krastev A, Krieg M, La N, Lacerda M, Lacoma A, Lagunday R, Lalich D, Latkovic E, Latorre I, Leandro P, Lee K, Legge D, Lemmers T, Leurink T, Lieschke K, Lim K, Lockhart G, Bogéa C, Santos K, Marques R, Lucas M, Lynn D, Lynn M, Freitas M, Ma N, Macalister S, Machado C, Ramos M, Machingaifa F, Maia I, Maia B, Malley R, Manning L, Manton S, Carrerero J, Barriocanal A, Alves C, Pereira R, Arruda B, Marins A, Marshall H, Markow A, Martin C, Almeida K, Mather W, Mathers M, Gomes F, Tadokoro M, Mazarakis N, Mazurega K, McAlister S, McAndrews A, McDonald E, McDonald F, McElroy R, McMillan M, McMullan B, McPhate N, Mead L, Meehan A, Meek B, Melo R, Mena G, Mesquita D, Messina N, Mezzetti I, Vieira H, Miller S, Mitchell K, Mitchell M, Mojeed J, Molenaar K, Molina G, Molina B, Montgomery L, Moore C, Moore J, Moorlag S, Morawakage T, Moss J, Moyle W, Mulholland K, Munns C, Nascimento E, Navarrette N, Netea M, Neves J, Newman G, Ngien B, Nguyen J, Nguyen K, Noonan F, Norton W, O’Donnell M, O’Bryan J, O’Connell A, Odoi S, O’Donnell L, Oliveira R, Oliveira M, Oliveira T, Oliveira I, Olivier N, Olivio L, Ong B, Ong J, Ong J, Onysk J, Ooi I, Oppedisano F, Orsini F, Ortika B, Group O, Otsuka A, Overton K, Owens R, Paes R, Palasanthiran P, Jiménez V, Pandine G, Parkin K, Hernandez A, Paternotte N, Paterson D, Souza A, Pelayo L, Pell C, Pelser S, Pereira H, Pereira G, Perez G, Perez C, Porcuna T, Perlen S, Perrett K, Floy A, Pitkin S, Pittet L, Pon R, Calderón I, Post J, Power C, Prado C, Prajitno E, Prat-Aymerich C, Preijers L, Puga M, Queiroz E, Quinn L, Rak A, Figueiredo L, de Arellano E, Ramos P, Oliveira K, Ren J, Reynolds S, Rhodes S, Santos C, Richards C, Richmond P, Richmond H, Souza A, Rocha J, Rodrigues T, Rodrigues L, Rodrigues B, Fernandes I, Rodríguez-Baño J, Roescher N, Rogers S, Rol A, Romme J, Rosell A, Font M, Sallent S, Sacca D, Sampaio V, Sanchez N, Sanchez B, Santos D, Santos T, Sartim A, Sastry A, Sawka A, Schultz N, Seamark C, Seamark D, Septer-Bijleveld E, Serrano R, Shann F, Sharma K, Shave M, Shen L, Sidaway-Lee K, Baena A, Silva R, Silva J, Silva E, Simão M, Singh R, Siqueira M, Chaves M, Sondag T, Sooriyarachchi E, Sousa A, Spry L, Statton S, Steer A, Santos D, Sterling K, Steve L, Stevens L, Stevens N, Stewart C, Stiglmayer L, Stooper L, Studham J, Subbarao K, Sudbury E, Suiker A, Symons L, Taks E, Tan N, Meireles B, Riele M, Oever J, Lima G, Heine R, Angelo J, Thomson H, Toh R, Trindade A, Tripp H, Tristán E, Troeman D, Truelove A, Tsuha D, Uffing M, Val F, Valero O, Valls E, van Ven C, Van Heuvel L, van Veen S, van Waal M, van Leusen J, van Mook L, van Onzenoort H, van Opdorp M, van Rijen M, van Sluis N, Vasconcelos A, Vega N, Velagapudi S, Vennells L, Venton T, Verheij H, Verhoeven P, Ramos C, Silva P, Vidal S, Vieira P, Oliveira M, Ortega R, Villanueva P, Villar R, Vlahos A, Wadia U, Walker M, Wall K, Wallace R, Waring J, Warren R, Warris A, Watts E, Wearing-Smith M, Webber-Rookes D, Wedderburn J, Wee-Hee A, Wesselingh S, Teo J, Whale B, Williams P, Wolters B, Wood N, Xie I, Younes A, Young A, Batista F, Zhou C, Zwart V, Goodchild L. BCG vaccination to reduce the impact of COVID-19 in healthcare workers: Protocol for a randomised controlled trial (BRACE trial). BMJ Open 2021, 11: e052101. PMID: 34711598, PMCID: PMC8557250, DOI: 10.1136/bmjopen-2021-052101.Peer-Reviewed Original ResearchConceptsBCG vaccinationHealthcare workersSARS-CoV-2 infectionCOVID-19Multicentre phase IIISevere COVID-19Episodes of illnessPeer-reviewed open access journalsSARS-CoV-2Respiratory illnessSafety profileClinical detailsWork absenteeismImmune responseBlood samplesVaccinationImmune systemInexpensive interventionSecondary objectiveUnrelated pathogensPhase IIIOff-target effectsImmunological analysisIllnessGovernance approvalLBA25 Final overall survival (OS) analysis from ARCHES: A phase III, randomized, double-blind, placebo (PBO)-controlled study of enzalutamide (ENZA) + androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC)
Armstrong A, Iguchi T, Azad A, Szmulewitz R, Holzbeierlein J, Villers A, Alcaraz A, Alekseev B, Shore N, Petrylak D, Rosbrook B, Zohren F, Yamada S, Haas G, Stenzl A. LBA25 Final overall survival (OS) analysis from ARCHES: A phase III, randomized, double-blind, placebo (PBO)-controlled study of enzalutamide (ENZA) + androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC). Annals Of Oncology 2021, 32: s1300-s1301. DOI: 10.1016/j.annonc.2021.08.2101.Peer-Reviewed Original ResearchPD-L1 Immunohistochemistry Assay Comparison in Atezolizumab Plus nab-Paclitaxel–Treated Advanced Triple-Negative Breast Cancer
Rugo HS, Loi S, Adams S, Schmid P, Schneeweiss A, Barrios CH, Iwata H, Diéras V, Winer EP, Kockx MM, Peeters D, Chui SY, Lin JC, Nguyen-Duc A, Viale G, Molinero L, Emens LA. PD-L1 Immunohistochemistry Assay Comparison in Atezolizumab Plus nab-Paclitaxel–Treated Advanced Triple-Negative Breast Cancer. Journal Of The National Cancer Institute 2021, 113: 1733-1743. PMID: 34097070, PMCID: PMC8634452, DOI: 10.1093/jnci/djab108.Peer-Reviewed Original ResearchConceptsNab-paclitaxelPD-L1Metastatic triple-negative breast cancer patientsAdvanced triple-negative breast cancerAnalytical concordanceTriple-negative breast cancer patientsTriple-negative breast cancerDouble-positive casesCombined positive scorePD-L1 statusPD-L1 assaysBreast cancer patientsSingle positive caseMore patientsSP263 assaysClinical outcomesClinical benefitCancer patientsClinical activityBreast cancerSP142SP263PatientsPhase IIIPositive scorePublication Bias in Gastrointestinal Oncology Trials Performed over the Past Decade
Peters GW, Tao W, Wei W, Miccio JA, Jethwa KR, Cecchini M, Johung KL. Publication Bias in Gastrointestinal Oncology Trials Performed over the Past Decade. The Oncologist 2021, 26: 660-667. PMID: 33728733, PMCID: PMC8342580, DOI: 10.1002/onco.13759.Peer-Reviewed Original ResearchConceptsGI oncologyPublication biasImpact of RCTsFuture trial designMultivariable logistic regressionSignificant publication biasPast trialsAccrual completionCancer RCTsEvidence-based practiceGastrointestinal cancerClinical managementTrial completionTrial designOncology trialsClinical practicePublication statusRCTsTrial questionModern RCTsLogistic regressionHalf of trialsTrialsPhase IIIGold standard
2020
Systemic Therapy for Advanced Hepatocellular Carcinoma: ASCO Guideline.
Gordan JD, Kennedy EB, Abou-Alfa GK, Beg MS, Brower ST, Gade TP, Goff L, Gupta S, Guy J, Harris WP, Iyer R, Jaiyesimi I, Jhawer M, Karippot A, Kaseb AO, Kelley RK, Knox JJ, Kortmansky J, Leaf A, Remak WM, Shroff RT, Sohal DPS, Taddei TH, Venepalli NK, Wilson A, Zhu AX, Rose MG. Systemic Therapy for Advanced Hepatocellular Carcinoma: ASCO Guideline. Journal Of Clinical Oncology 2020, 38: 4317-4345. PMID: 33197225, DOI: 10.1200/jco.20.02672.Peer-Reviewed Original ResearchConceptsAdvanced hepatocellular carcinomaFirst-line treatmentSecond-line therapyChild-Pugh classFirst-line therapyHepatocellular carcinomaSystemic therapyLiver diseaseTherapy optionsEastern Cooperative Oncology Group performance status 0Evidence-based clinical practice guidelinesSecond-line therapy optionsTyrosine kinase inhibitor sorafenibECOG PS 0Performance status 0Third-line therapyPhase IIIClinical practice guidelinesKinase inhibitor sorafenibTyrosine kinase inhibitorsAppropriate candidatesStatus 0ASCO guidelinesMost patientsPS 0
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