2021
A Phase II Study Evaluating Orteronel, an Inhibitor of Androgen Biosynthesis, in Patients With Androgen Receptor (AR)-Expressing Metastatic Breast Cancer (MBC)
Yardley DA, Young RR, Adelson KB, Silber AL, Najera JE, Daniel DB, Peacock N, Finney L, Hoekstra SJ, Shastry M, Hainsworth JD, Burris HA. A Phase II Study Evaluating Orteronel, an Inhibitor of Androgen Biosynthesis, in Patients With Androgen Receptor (AR)-Expressing Metastatic Breast Cancer (MBC). Clinical Breast Cancer 2021, 22: 269-278. PMID: 34824002, DOI: 10.1016/j.clbc.2021.10.011.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerCohort 2Cohort 1Breast cancerAndrogen biosynthesisAmylase/lipaseLimited clinical activityPrior chemotherapy regimenPrior chemotherapy regimensMedian treatment durationNausea/vomitingChemotherapy regimenChemotherapy regimensPrimary endpointObjective responseOverall survivalFemale patientsAndrogen receptorClinical activityGrade 3Targetable pathwaysPatientsTherapeutic targetAR modulationTreatment durationPhase II Single-Arm Study to Assess Trastuzumab and Vinorelbine in Advanced Breast Cancer Patients With HER2-Negative Tumors and HER2-Positive Circulating Tumor Cells
Parsons HA, Macrae ER, Guo H, Li T, Barry WT, Tayob N, Wulf GM, Isakoff SJ, Krop IE. Phase II Single-Arm Study to Assess Trastuzumab and Vinorelbine in Advanced Breast Cancer Patients With HER2-Negative Tumors and HER2-Positive Circulating Tumor Cells. JCO Precision Oncology 2021, 5: 896-903. PMID: 34994617, PMCID: PMC9848583, DOI: 10.1200/po.20.00461.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerHER2-positive CTCsHER2-negative metastatic breast cancerObjective response rateBreast cancerHER2-Positive Circulating Tumor CellsHER2-positive metastatic breast cancerResponse rateMedian progression-free survivalPhase II single-arm studyProgressive metastatic breast cancerHER2-negative breast cancerAdvanced breast cancer patientsHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Tumor cellsHER2-positive diseasePrior chemotherapy regimenTumor tissue testingClinical benefit ratePrimary end pointPhase II trialProgression-free survivalGrowth factor receptor 2HER2-negative tumors
2017
A phase I study of enfortumab vedotin (ASG-22CE; ASG-22ME): Updated analysis of patients with metastatic urothelial cancer.
Petrylak D, Perez R, Zhang J, Smith D, Ruether J, Sridhar S, Sangha R, Lang J, Heath E, Merchan J, Gartner E, Chu R, Anand B, Doñate F, Jackson L, Adams J, Melhem-Bertrandt A, Rosenberg J. A phase I study of enfortumab vedotin (ASG-22CE; ASG-22ME): Updated analysis of patients with metastatic urothelial cancer. Journal Of Clinical Oncology 2017, 35: 106-106. DOI: 10.1200/jco.2017.35.15_suppl.106.Peer-Reviewed Original ResearchTreatment-related adverse eventsMetastatic urothelial cancerOverall response rateNectin-4 expressionUrothelial cancerAntitumor activityMost treatment-related adverse eventsImmune checkpoint inhibitor therapyMedian progression-free survivalPhase IPrior chemotherapy regimenTreatment-related deathsCheckpoint inhibitor therapyMedian treatment durationFavorable tolerability profilePost-baseline assessmentProgression-free survivalUrinary tract infectionAnalysis of patientsMonomethyl auristatin EDifferent dose levelsArchival tumor specimensAntibody-drug conjugatesEvaluable ptsPrior therapy
2013
Survival and long-term follow-up of the phase I trial of nivolumab (Anti-PD-1; BMS-936558; ONO-4538) in patients (pts) with previously treated advanced non-small cell lung cancer (NSCLC).
Brahmer J, Horn L, Antonia S, Spigel D, Gandhi L, Sequist L, Sankar V, Ahlers C, Wigginton J, Kollia G, Gupta A, Gettinger S. Survival and long-term follow-up of the phase I trial of nivolumab (Anti-PD-1; BMS-936558; ONO-4538) in patients (pts) with previously treated advanced non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2013, 31: 8030-8030. DOI: 10.1200/jco.2013.31.15_suppl.8030.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerPhase I trialOverall survivalMedian OSI trialCommon drug-related AEsDrug-related AEsMedian overall survivalPrior chemotherapy regimenAcceptable safety profilePhase 1 studyCell lung cancerPD-1 receptorImmune checkpoint receptorsDrug-related deathsT cell activationNSCLC ptsOS benefitChemotherapy regimenDose cohortsCheckpoint receptorsDeath-1Safety profileDiscontinuation criteria
2012
Clinical activity and safety of anti-PD1 (BMS-936558, MDX-1106) in patients with advanced non-small-cell lung cancer (NSCLC).
Brahmer J, Horn L, Antonia S, Spigel D, Gandhi L, Sequist L, Wigginton J, McDonald D, Kollia G, Gupta A, Gettinger S. Clinical activity and safety of anti-PD1 (BMS-936558, MDX-1106) in patients with advanced non-small-cell lung cancer (NSCLC). Journal Of Clinical Oncology 2012, 30: 7509-7509. DOI: 10.1200/jco.2012.30.15_suppl.7509.Peer-Reviewed Original ResearchBMS-936558Advanced NSCLCClinical activityPrior tyrosine kinase inhibitorsPrior chemotherapy regimenECOG performance statusCo-inhibitory receptorsPlatinum-based chemotherapyCell lung cancerOverall tumor burdenCycles of treatmentPercent of ptsDrug-related deathsTyrosine kinase inhibitorsActivated T cellsCohort expansionNSCLC ptsPrior therapyRECIST 1.0Chemotherapy regimenMedian durationMetastatic diseaseMultiple histologiesPerformance statusLymph nodes
2011
OT3-01-01: Randomized Phase II Study of Fulvestrant Versus Fulvestrant Plus Bortezomib in Postmenopausal Women with Estrogen Receptor (ER) Positive, Aromatase-Inhibitor (AI) Resistant Metastatic Breast Cancer (MBC): New York Cancer Consortium Trial P8457.
Adelson K, Raptis G, Sparano J, Germain D. OT3-01-01: Randomized Phase II Study of Fulvestrant Versus Fulvestrant Plus Bortezomib in Postmenopausal Women with Estrogen Receptor (ER) Positive, Aromatase-Inhibitor (AI) Resistant Metastatic Breast Cancer (MBC): New York Cancer Consortium Trial P8457. Cancer Research 2011, 71: ot3-01-01-ot3-01-01. DOI: 10.1158/0008-5472.sabcs11-ot3-01-01.Peer-Reviewed Original ResearchMedian progression-free survivalMetastatic breast cancerProgression-free survivalAI therapyPostmenopausal womenMetastatic diseaseAI-resistant metastatic breast cancerResistant metastatic breast cancerAdjuvant AI therapyAI-resistant diseaseClinical benefit ratePrior chemotherapy regimenPhase II studyAdverse event ratesAddition of bortezomibHuman breast cancer cell linesEstrogen-receptor positiveRandomized phase II designsBreast cancer cell linesPhase II designUnfolded protein responseChemotherapy regimenEligible patientsMeasurable diseasePrior chemotherapy
2009
Paclitaxel in older women with breast cancer. Combined analysis of CALGB 9342 and 9840 with a focus on age.
Lichtman S, Hurria A, Cirrincione C, Seidman A, Winer E, Hudis C, Cohen H, Muss H. Paclitaxel in older women with breast cancer. Combined analysis of CALGB 9342 and 9840 with a focus on age. Cancer Research 2009, 69: 6112. DOI: 10.1158/0008-5472.sabcs-6112.Peer-Reviewed Original ResearchFirst-line therapyLines of therapyBreast cancerPatient ageOlder womenSide effectsLine therapyOlder adultsIncidence of gradeOnset of gradePrior chemotherapy regimenSecond-line patientsSingle-agent paclitaxelDoses of paclitaxelMetastatic breast cancerOnset of neurotoxicityRisk of fallsStandard prognostic variablesAge categoriesLikelihood of responseBetter performance scoresPerformance scoresBilirubin elevationPaclitaxel efficacyWeekly paclitaxel
2008
Phase II trial of romidepsin (NSC-630176) in previously treated colorectal cancer patients with advanced disease: a Southwest Oncology Group study (S0336)
Whitehead R, Rankin C, Hoff P, Gold P, Billingsley K, Chapman R, Wong L, Ward J, Abbruzzese J, Blanke C. Phase II trial of romidepsin (NSC-630176) in previously treated colorectal cancer patients with advanced disease: a Southwest Oncology Group study (S0336). Investigational New Drugs 2008, 27: 469. PMID: 18941712, PMCID: PMC3024913, DOI: 10.1007/s10637-008-9190-8.Peer-Reviewed Original ResearchConceptsMetastatic colorectal cancerColorectal cancerPerformance statusSouthwest Oncology Group studyAdequate bone marrowCombination of romidepsinPrior chemotherapy regimenPrior chemotherapy regimensSignificant cardiac diseaseHuman tumor xenograft modelsAdvanced colorectal cancerPhase II trialColorectal cancer patientsGroup of patientsTreatment of patientsTumor growth inhibitionTumor xenograft modelHistone deacetylase inhibitorsEligible patientsPrior chemotherapyPrior regimensStable diseaseAdvanced diseaseChemotherapy regimenChemotherapy regimens
2006
Phase II trial of depsipeptide (NSC-630176) in colorectal cancer patients who have received either one or two prior chemotherapy regimens for metastatic or locally advanced, unresectable disease: A Southwest Oncology Group study
Whitehead R, McCoy S, Wollner I, Wong L, Harker W, Hoff P, Gold P, Billingsley K, Blanke C. Phase II trial of depsipeptide (NSC-630176) in colorectal cancer patients who have received either one or two prior chemotherapy regimens for metastatic or locally advanced, unresectable disease: A Southwest Oncology Group study. Journal Of Clinical Oncology 2006, 24: 3598-3598. DOI: 10.1200/jco.2006.24.18_suppl.3598.Peer-Reviewed Original ResearchPrior chemotherapy regimensAdvanced colorectal cancerPhase II trialColorectal cancerEligible patientsChemotherapy regimensII trialPerformance statusSouthwest Oncology Group studyCommon grade 2Prior chemotherapy regimenZubrod performance statusMetastatic colorectal cancerMonths overall survivalColorectal cancer patientsSerum magnesium levelsSignificant anti-tumor activityKaplan-Meier estimatesAdditional active agentsAnti-tumor activityHistone deacetylase inhibitorsMurine model systemBaseline labsMeasurable diseasePrior regimensManaging cutaneous side effects associated with erlotinib in head and neck cancer (HNC) and non-small cell lung cancer (NSCLC) patients (pts)
Oishi K, Garey J, Burke B, Herbst R, Kim E. Managing cutaneous side effects associated with erlotinib in head and neck cancer (HNC) and non-small cell lung cancer (NSCLC) patients (pts). Journal Of Clinical Oncology 2006, 24: 18538-18538. DOI: 10.1200/jco.2006.24.18_suppl.18538.Peer-Reviewed Original ResearchGrade 1 rashPartial responseGrade 2Epidermal growth factor receptorGrade 3NSCLC ptsDose modificationComplete responseTreatment algorithmTreatment responseSide effectsNon-small cell lung cancer patientsGrade 1Cell lung cancer patientsPrior chemotherapy regimenPhase II studyCutaneous side effectsLung cancer patientsGrade 4Acneiform rashChemotherapy regimenDose delaysGrowth factor receptorII studyCutaneous toxicity
2004
Oblimersen Sodium (Genasense bcl-2 Antisense Oligonucleotide)A Rational Therapeutic to Enhance Apoptosis in Therapy of Lung Cancer
Herbst RS, Frankel SR. Oblimersen Sodium (Genasense bcl-2 Antisense Oligonucleotide)A Rational Therapeutic to Enhance Apoptosis in Therapy of Lung Cancer. Clinical Cancer Research 2004, 10: 4245s-4248s. PMID: 15217967, DOI: 10.1158/1078-0432.ccr-040018.Peer-Reviewed Original ResearchConceptsOblimersen sodiumLung cancerBcl-2 mRNASmall cell lung cancer patientsNon-small cell lung cancerBcl-2 protein translationFirst-line salvage therapyCell lung cancer patientsPhase IPrior chemotherapy regimenCombination of docetaxelBcl-2 antisense therapyCell lung cancerTraditional cytotoxic chemotherapyLung cancer patientsChemotherapy regimenSalvage therapyCytotoxic chemotherapyAntitumor responseCancer patientsHuman bcl-2 mRNAPreclinical studiesResponse durationResponse rateAnticancer treatment
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