2024
Phase I PIANO trial—PIPAC-oxaliplatin and systemic nivolumab combination for gastric cancer peritoneal metastases: clinical and translational outcomes
Sundar R, Chia D, Zhao J, Lee A, Kim G, Tan H, Pang A, Shabbir A, Willaert W, Ma H, Huang K, Hagihara T, Tan A, Ong C, Wong J, Seo C, Walsh R, Chan G, Cheo S, Soh C, Callebout E, Geboes K, Ng M, Lum J, Leow W, Selvarajan S, Hoorens A, Ang W, Pang H, Tan P, Yong W, Chia C, Ceelen W, So J. Phase I PIANO trial—PIPAC-oxaliplatin and systemic nivolumab combination for gastric cancer peritoneal metastases: clinical and translational outcomes. ESMO Open 2024, 9: 103681. PMID: 39288528, PMCID: PMC11421236, DOI: 10.1016/j.esmoop.2024.103681.Peer-Reviewed Original ResearchConceptsGastric cancer peritoneal metastasisPeritoneal cancer indexNivolumab combinationPeritoneal metastasisPeritoneal tumorsNaive CD8+ T cellsCD8+ central memoryEnhanced T cell infiltrationTreatment-related adverse eventsCD8+ T cellsGrade 4 vomitingRegression grade 1First-in-human trialImmune checkpoint inhibitionMemory CD4+T cell infiltrationImmunogenic cell deathSystemic immunotherapyCheckpoint inhibitionSystemic therapyCancer indexCD4+Intraperitoneal treatmentT cellsAdverse events
2023
Phase II study of trifluridine/tipiracil (FTD/TPI) in HER2-negative metastatic breast cancers with or without prior exposure to fluoropyrimidines.
Lim J, Ow S, Wong A, Lee M, Chan G, Low J, Sundar R, Choo J, Tai B, Lee S. Phase II study of trifluridine/tipiracil (FTD/TPI) in HER2-negative metastatic breast cancers with or without prior exposure to fluoropyrimidines. Journal Of Clinical Oncology 2023, 41: 1099-1099. DOI: 10.1200/jco.2023.41.16_suppl.1099.Peer-Reviewed Original ResearchObjective response rateMetastatic breast cancerProgression-free survivalPhase II studyLead-in phaseCohort ADose modificationBreast cancerDetermination of progression-free survivalSingle arm phase II studyHER2-negative metastatic breast cancerConsistent with known toxicitiesMedian progression-free survivalTreatment-related adverse eventsResponse rateDose-confirmation phaseEvents of neutropeniaTreated with FTD/TPIClinical benefit rateDose-limiting toxicityOral drug combinationsTreatment of patientsAnti-tumor activityThymidine phosphorylase inhibitorMetastatic setting
2022
Selective Internal Radiation Therapy with Yttrium-90 Resin Microspheres Followed by Gemcitabine plus Cisplatin for Unresectable Intrahepatic Cholangiocarcinoma: A Phase 2 Single-Arm Multicenter Clinical Trial
Chan S, Chotipanich C, Choo S, Kwang S, Mo F, Worakitsitisatorn A, Tai D, Sundar R, Ng D, Loke K, Li L, Ng K, Peng Y, Yu S. Selective Internal Radiation Therapy with Yttrium-90 Resin Microspheres Followed by Gemcitabine plus Cisplatin for Unresectable Intrahepatic Cholangiocarcinoma: A Phase 2 Single-Arm Multicenter Clinical Trial. Liver Cancer 2022, 11: 451-459. PMID: 36158588, PMCID: PMC9485918, DOI: 10.1159/000525489.Peer-Reviewed Original ResearchUnresectable intrahepatic cholangiocarcinomaProgression-free survivalSelective internal radiation therapyInternal radiation therapyIntrahepatic cholangiocarcinomaMedian OSRadiation therapyOverall survivalClinical trialsMedian cycle of chemotherapyMedian progression-free survivalResin yttrium-90 microspheresYttrium-90 resin microspheresTreatment-related adverse eventsIntent-to-treat populationResponse rateDisease control rateResponse Evaluation CriteriaYttrium-90 microspheresCycles of chemotherapyWithdrawal of consentMulticenter clinical trialInvestigator-initiated clinical trialStandard gemcitabineStandard chemotherapy
2019
First-in-human phase I study of an oral HSP90 inhibitor, TAS-116, in patients with advanced solid tumors
Shimomura A, Yamamoto N, Kondo S, Fujiwara Y, Suzuki S, Yanagitani N, Horiike A, Kitazono S, Ohyanagi F, Doi T, Kuboki Y, Kawazoe A, Shitara K, Ohno I, Banerji U, Sundar R, Ohkubo S, Calleja E, Nishio M. First-in-human phase I study of an oral HSP90 inhibitor, TAS-116, in patients with advanced solid tumors. Molecular Cancer Therapeutics 2019, 18: molcanther.0831.2018. PMID: 30679388, DOI: 10.1158/1535-7163.mct-18-0831.Peer-Reviewed Original ResearchConceptsGastrointestinal stromal tumorsPreliminary antitumor efficacyDose-escalation phaseAdvanced solid tumorsSolid tumorsTAS-116Eye disordersEscalation phaseFirst-in-human phase I studyPretreated gastrointestinal stromal tumoursHsp90 inhibitorsTreatment-related adverse eventsNon-small cell lung cancerFirst-in-human studyOral HSP90 inhibitorPhase I studyCell lung cancerPartial responseStromal tumorsDose proportionalityAntitumor efficacySafety profileSystemic exposureAdverse eventsLung cancer
2018
A phase I/Ib study of OTSGC-A24 combined peptide vaccine in advanced gastric cancer
Sundar R, Rha S, Yamaue H, Katsuda M, Kono K, Kim H, Kim C, Mimura K, Kua L, Yong W. A phase I/Ib study of OTSGC-A24 combined peptide vaccine in advanced gastric cancer. BMC Cancer 2018, 18: 332. PMID: 29587677, PMCID: PMC5870101, DOI: 10.1186/s12885-018-4234-8.Peer-Reviewed Original ResearchConceptsAdvanced gastric cancerCytotoxic T lymphocytesGastric cancerCancer vaccinesOverall survivalAdverse eventsRecommended phase 2 doseMedian progression free survivalSpecific cytotoxic T lymphocytesTreatment-related adverse eventsAdvanced gastric cancer patientsPeptide cancer vaccinesPhase 2 dosePhase I/Ib studyPositive CTL responsesDose-limiting toxicityMedian overall survivalProgression free survivalInjection site erythemaOptimal dosing scheduleGastric cancer patientsSingle-arm trialPhase I/IbStable diseaseFree survival