2024
Final Overall Survival Analysis of S1500: A Randomized, Phase II Study Comparing Sunitinib With Cabozantinib, Crizotinib, and Savolitinib in Advanced Papillary Renal Cell Carcinoma
Barata P, Tangen C, Plets M, Thompson I, Narayan V, George D, Heng D, Shuch B, Stein M, Gulati S, Tretiakova M, Tripathi A, Bjarnason G, Humphrey P, Adeniran A, Vaishampayan U, Alva A, Zhang T, Cole S, Lara P, Lerner S, Balzer-Haas N, Pal S. Final Overall Survival Analysis of S1500: A Randomized, Phase II Study Comparing Sunitinib With Cabozantinib, Crizotinib, and Savolitinib in Advanced Papillary Renal Cell Carcinoma. Journal Of Clinical Oncology 2024, 42: 3911-3916. PMID: 39255440, PMCID: PMC11575905, DOI: 10.1200/jco.24.00767.Peer-Reviewed Original ResearchAdvanced papillary renal cell carcinomaPapillary renal cell carcinomaRenal cell carcinomaOverall survivalCell carcinomaProlonged progression-free survivalLack of survival benefitProgression-free survivalRandomized phase IIMedian follow-upPrimary end pointOpen-label trialOverall survival analysisCrizotinib armMedian OSSurvival benefitClinical trial updateNo significant differenceCabozantinibTreatment armsSunitinibFollow-upClinical trialsSavolitinibCrizotinib
2021
Sunitinib versus cabozantinib, crizotinib or savolitinib in metastatic papillary renal cell carcinoma (pRCC): Results from the randomized phase II SWOG 1500 study.
Pal S, Tangen C, Thompson I, Haas N, George D, Heng D, Shuch B, Stein M, Tretiakova M, Humphrey P, Adeniran A, Narayan V, Bjarnason G, Vaishampayan U, Alva A, Zhang T, Cole S, Plets M, Wright J, Lara P. Sunitinib versus cabozantinib, crizotinib or savolitinib in metastatic papillary renal cell carcinoma (pRCC): Results from the randomized phase II SWOG 1500 study. Journal Of Clinical Oncology 2021, 39: 270-270. DOI: 10.1200/jco.2021.39.6_suppl.270.Peer-Reviewed Original ResearchMetastatic papillary renal cell carcinomaPapillary renal cell carcinomaProgression-free survivalMedian progression-free survivalEligible patientsPO QDPrior therapyOverall survivalAdverse eventsGrade 5 adverse eventsZubrod performance status 0Measurable metastatic diseasePerformance status 0Randomized phase IIRenal cell carcinomaMET kinase inhibitorType IMeaningful prolongationPo bidStatus 0Secondary endpointsMetastatic diseasePathologic reviewPFS eventsSystemic therapy
2015
Impact of Neoadjuvant Chemotherapy in Stage II–III Triple Negative Breast Cancer on Eligibility for Breast-conserving Surgery and Breast Conservation Rates
Golshan M, Cirrincione CT, Sikov WM, Berry DA, Jasinski S, Weisberg TF, Somlo G, Hudis C, Winer E, Ollila DW. Impact of Neoadjuvant Chemotherapy in Stage II–III Triple Negative Breast Cancer on Eligibility for Breast-conserving Surgery and Breast Conservation Rates. Annals Of Surgery 2015, 262: 434-439. PMID: 26222764, PMCID: PMC4710511, DOI: 10.1097/sla.0000000000001417.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinChemotherapy, AdjuvantDisease-Free SurvivalDoxorubicinFemaleHumansMastectomy, SegmentalMaximum Tolerated DoseMiddle AgedNeoadjuvant TherapyNeoplasm InvasivenessNeoplasm StagingPaclitaxelPatient SelectionPrognosisProspective StudiesSurvival AnalysisTreatment OutcomeTriple Negative Breast NeoplasmsYoung AdultConceptsNeoadjuvant systemic therapyBreast-conserving therapyTriple-negative breast cancerNegative breast cancerSuccessful breast-conserving therapyBCT candidatesBreast cancerStage IIAddition of carboplatinBCT-eligible patientsRandomized phase IIBreast conservation ratesTumor-free marginsBCT eligibilityNeoadjuvant paclitaxelNeoadjuvant chemotherapySystemic therapySurgical outcomesSurgical choiceTumor regressionPatient's discretionFactorial trialPatientsAbsolute increaseCancer
2014
Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer: An Integrated Safety Analysis
Diéras V, Harbeck N, Budd GT, Greenson JK, Guardino AE, Samant M, Chernyukhin N, Smitt MC, Krop IE. Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer: An Integrated Safety Analysis. Journal Of Clinical Oncology 2014, 32: 2750-2757. PMID: 25024070, DOI: 10.1200/jco.2013.54.4999.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerHER2-positive metastatic breast cancerHuman epidermal growth factor receptor 2Adverse eventsDrug discontinuationSafety profileT-DM1Trastuzumab emtansineBreast cancerGrade 3Dose reductionEpidermal growth factor receptor 2Human epidermal growth factor receptorCommon grade 3Grade adverse eventsRandomized phase IISelect adverse eventsBreast cancer settingGreater adverse eventsGrowth factor receptor 2Single-arm studyT-DM1 treatmentFavorable safety profileFactor receptor 2Epidermal growth factor receptorA randomized phase II, open-label study of sipuleucel-T with concurrent or sequential enzalutamide in metastatic castration-resistant prostate cancer (mCRPC).
Quinn D, Petrylak D, Pieczonka C, Sandler A, DeVries T, Sheikh N, Drake C. A randomized phase II, open-label study of sipuleucel-T with concurrent or sequential enzalutamide in metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2014, 32: e16071-e16071. DOI: 10.1200/jco.2014.32.15_suppl.e16071.Peer-Reviewed Original Research
2006
Phase II, parallel-design study of preoperative combined modality therapy and the matrix metalloprotease (mmp) inhibitor prinomastat in patients with esophageal adenocarcinoma
Heath EI, Burtness BA, Kleinberg L, Salem RR, Yang SC, Heitmiller RF, Canto MI, Knisely JP, Topazian M, Montgomery E, Tsottles N, Pithavala Y, Rohmiller B, Collier M, Forastiere AA. Phase II, parallel-design study of preoperative combined modality therapy and the matrix metalloprotease (mmp) inhibitor prinomastat in patients with esophageal adenocarcinoma. Investigational New Drugs 2006, 24: 135-140. PMID: 16502351, DOI: 10.1007/s10637-006-5934-5.Peer-Reviewed Original ResearchConceptsPathologic complete response rateThrombo-embolic eventsParallel design studyModality therapyResponse rateAdvanced esophageal cancer patientsRandomized phase IIComplete response rateEvidence of diseaseProgression-free survivalEsophageal cancer patientsOverall response ratePhase IIAdjuvant paclitaxelConcurrent radiotherapyEligible patientsPreoperative treatmentMusculoskeletal toxicityOverall survivalResectable adenocarcinomaDisease relapsePreoperative stagingTreatment armsDisease improvementContinuous infusion
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