2024
Phase I/Ib Trial of Inavolisib Plus Palbociclib and Endocrine Therapy for PIK3CA-Mutated, Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced or Metastatic Breast Cancer
Jhaveri K, Accordino M, Bedard P, Cervantes A, Gambardella V, Hamilton E, Italiano A, Kalinsky K, Krop I, Oliveira M, Schmid P, Saura C, Turner N, Varga A, Cheeti S, Hilz S, Hutchinson K, Jin Y, Royer-Joo S, Peters U, Shankar N, Schutzman J, Juric D. Phase I/Ib Trial of Inavolisib Plus Palbociclib and Endocrine Therapy for PIK3CA-Mutated, Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced or Metastatic Breast Cancer. Journal Of Clinical Oncology 2024, 42: 3947-3956. PMID: 39236276, PMCID: PMC11575912, DOI: 10.1200/jco.24.00110.Peer-Reviewed Original ResearchTreatment-related adverse eventsDrug-drug interactionsPreliminary antitumor activityEndocrine therapyStudy treatmentHuman epidermal growth factor receptor 2-negativeBreast cancerTreatment-related adverse event ratesLack of drug-drug interactionsConfirmed objective response rateLocally advanced/metastatic breast cancerCirculating tumor DNA analysisEffect of study treatmentPK drug-drug interactionsAntitumor activityObjective response ratePhase I/IB StudyHormone receptor-positiveProgression-free survivalAdvanced/Metastatic Breast CancerTumor DNA analysisBiomarkers of responseMetastatic breast cancerYears of ageReceptor-positive
2023
EV-301 long-term outcomes: 24-month findings from the phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma☆
Rosenberg J, Powles T, Sonpavde G, Loriot Y, Duran I, Lee J, Matsubara N, Vulsteke C, Castellano D, Mamtani R, Wu C, Matsangou M, Campbell M, Petrylak D. EV-301 long-term outcomes: 24-month findings from the phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma☆. Annals Of Oncology 2023, 34: 1047-1054. PMID: 37678672, DOI: 10.1016/j.annonc.2023.08.016.Peer-Reviewed Original ResearchConceptsProgression-free survivalEnfortumab vedotinAdverse eventsUrothelial carcinomaTreatment-related adverse event ratesMeaningful overall survival benefitPrior platinum-containing chemotherapyWhite blood cell countEvent ratesAdvanced urothelial carcinomaMetastatic urothelial carcinomaOverall survival benefitPeripheral sensory neuropathyPlatinum-containing chemotherapyNew safety signalsPhase III trialsAdverse event ratesRisk of deathBlood cell countIII trialsMaculopapular rashNeutrophil countObjective responseOverall survivalSurvival benefit
2022
Phase 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 IIIInduction Chemotherapy with or without Erlotinib in Patients with Head and Neck Squamous Cell Carcinoma Amenable for Surgical Resection
Le X, Gleber-Netto FO, Rubin ML, Qing Y, Du R, Kies M, Blumenschein G, Lu C, Johnson FM, Bell D, Lewis J, Zhang J, Feng L, Wilson K, Marcelo-Lewis K, Wang J, Ginsberg L, Gillison M, Lee JJ, Meric-Berstam F, Mills GB, William W, Myers JN, Pickering CR. Induction Chemotherapy with or without Erlotinib in Patients with Head and Neck Squamous Cell Carcinoma Amenable for Surgical Resection. Clinical Cancer Research 2022, 28: 2796-2806. PMID: 35443062, DOI: 10.1158/1078-0432.ccr-21-3239.Peer-Reviewed Original ResearchOral squamous cell carcinomaProgression-free survivalSquamous cell carcinomaSurgical resectionCell carcinomaTreatment-related adverse event ratesAdvanced oral squamous cell carcinomaMajor pathologic response rateNeck squamous cell carcinomaPathologic response ratePlatinum-taxane chemotherapyCycles of chemotherapyAdverse event ratesMajor pathological responseExcellent clinical outcomesAddition of erlotinibCycles of treatmentPre-treatment samplesConcurrent erlotinibErlotinib armNeoadjuvant erlotinibInduction chemotherapyNeoadjuvant chemotherapySecondary endpointsDefinitive surgeryRadiotherapy combined with nivolumab or temozolomide for newly diagnosed glioblastoma with unmethylated MGMT promoter: An international randomized phase III trial
Omuro A, Brandes AA, Carpentier AF, Idbaih A, Reardon DA, Cloughesy T, Sumrall A, Baehring J, van den Bent M, Bähr O, Lombardi G, Mulholland P, Tabatabai G, Lassen U, Sepulveda JM, Khasraw M, Vauleon E, Muragaki Y, Di Giacomo AM, Butowski N, Roth P, Qian X, Fu AZ, Liu Y, Potter V, Chalamandaris AG, Tatsuoka K, Lim M, Weller M. Radiotherapy combined with nivolumab or temozolomide for newly diagnosed glioblastoma with unmethylated MGMT promoter: An international randomized phase III trial. Neuro-Oncology 2022, 25: 123-134. PMID: 35419607, PMCID: PMC9825306, DOI: 10.1093/neuonc/noac099.Peer-Reviewed Original ResearchConceptsOverall survivalUnmethylated MGMT promoterMedian OSPrimary endpointInternational randomized phase III trialTreatment-related adverse event ratesMedian progression-free survivalRandomized phase III trialMGMT promoterEfficacy of nivolumabLonger median OSMedian overall survivalNew safety signalsProgression-free survivalAddition of temozolomideAdverse event ratesPhase III trialsUse of temozolomideStandard of careStudy treatment armsImproved OSIII trialsTreatment armsStandard radiotherapyNivolumab
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