2024
A phase Ib/II study of an anti-CD137 agonist antibody ADG106 in combination with weekly paclitaxel and dose-dense doxorubicin/cyclophosphamide.
Lee M, Ow S, Wong A, Lim S, Lim J, Soo R, Cheng Ean C, Tan D, Yong W, Chan G, Ho J, Sooi K, Low Q, Ang C, Cheo S, Sundar R, Goh B, Lee S. A phase Ib/II study of an anti-CD137 agonist antibody ADG106 in combination with weekly paclitaxel and dose-dense doxorubicin/cyclophosphamide. Journal Of Clinical Oncology 2024, 42: e14507-e14507. DOI: 10.1200/jco.2024.42.16_suppl.e14507.Peer-Reviewed Original ResearchAdverse eventsG3 neutropeniaTumor biopsiesWeekly PPeripheral neuropathyHER2 negative breast cancer patientsPhase IbDose levelsRecommended phase 2 doseAll-grade adverse eventsNegative breast cancer patientsMatched tumor biopsiesPhase 2 doseTumor immune markersPneumocystis jiroveci pneumoniaAdvanced solid tumorsPalliative systemic therapyPhase Ib trialPhase II trialPhase IISerial tumor biopsiesBreast cancer patientsIgG4 monoclonal antibodyAcneiform rashAnti-CD137Efficacy and Safety of Trifluridine/Tipiracil-Containing Combinations in Colorectal Cancer and Other Advanced Solid Tumors: A Systematic Review
Shitara K, Falcone A, Fakih M, George B, Sundar R, Ranjan S, Van Cutsem E. Efficacy and Safety of Trifluridine/Tipiracil-Containing Combinations in Colorectal Cancer and Other Advanced Solid Tumors: A Systematic Review. The Oncologist 2024, 29: e601-e615. PMID: 38366864, PMCID: PMC11067808, DOI: 10.1093/oncolo/oyae007.Peer-Reviewed Original ResearchConceptsMetastatic colorectal cancerRefractory metastatic colorectal cancerAdverse eventsDiscontinuation rate due to adverse eventsColorectal cancerChemorefractory metastatic colorectal cancerSafety outcomesMedian overall survivalSafety of FTD/TPIProgression-free survivalAdvanced solid tumorsAssociated with improved outcomesEarly-phase studiesSystematic reviewOverall survivalFTD/TPIRetrospective studySolid tumorsBevacizumabClinical efficacyTargeted agentsTumor typesAntineoplastic agentsAdvanced cancerImprove outcomes
2023
A Phase I, First-in-Human Study of PRL3-zumab in Advanced, Refractory Solid Tumors and Hematological Malignancies
Chee C, Ooi M, Lee S, Sundar R, Heong V, Yong W, Ng C, Wong A, Lim J, Tan D, Soo R, Tan J, Yang S, Thura M, Al-Aidaroos A, Chng W, Zeng Q, Goh B. A Phase I, First-in-Human Study of PRL3-zumab in Advanced, Refractory Solid Tumors and Hematological Malignancies. Targeted Oncology 2023, 18: 391-402. PMID: 37060431, PMCID: PMC10192144, DOI: 10.1007/s11523-023-00962-w.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaAdvanced solid tumorsFirst-in-human studyEuropean Leukemia NetworkSolid tumorsHematologic malignanciesTreatment-emergent adverse eventsHuman antibodiesDose-escalation cohortsDose-limiting toxicityGrade 2 vomitingPRL-3Refractory solid tumorsResponse Evaluation CriteriaSolid tumor patientsDose-expansion cohortReduced tumor growthFirst-in-humanPhase IStable diseaseStoma outputEvaluation CriteriaMyeloid leukemiaPharmacodynamic relationshipsAdverse events
2022
Real-world experience on the efficacy and tolerability of biweekly trifluridine/tipiracil with or without bevacizumab in metastatic colorectal cancer.
Ang C, Low Q, Ho C, Walsh R, Asokumaran Y, Choo J, Chan G, Ho J, Ang Y, Tan H, Yong W, Sundar R, Chee C. Real-world experience on the efficacy and tolerability of biweekly trifluridine/tipiracil with or without bevacizumab in metastatic colorectal cancer. Journal Of Clinical Oncology 2022, 40: 3584-3584. DOI: 10.1200/jco.2022.40.16_suppl.3584.Peer-Reviewed Original ResearchMetastatic colorectal cancerTAS-102Median PFSBiweekly dosesDiscontinued treatment due to toxicityColorectal cancerDose of TAS-102Treated with TAS-102Treatment due to toxicityMetastatic colorectal cancer patientsGrade 3 neutropeniaThird-line treatmentInitiation of treatmentRetrospective observational studyBiweekly regimenDose delaysFebrile neutropeniaHigher neutropeniaStandard regimenDose reductionBevacizumabGrade 3Adverse eventsDisease progressionNeutropenia
2021
Cryotherapy for Prevention of Taxane-Induced Peripheral Neuropathy: A Meta-Analysis
Jia J, Guo Y, Sundar R, Bandla A, Hao Z. Cryotherapy for Prevention of Taxane-Induced Peripheral Neuropathy: A Meta-Analysis. Frontiers In Oncology 2021, 11: 781812. PMID: 34912720, PMCID: PMC8667340, DOI: 10.3389/fonc.2021.781812.Peer-Reviewed Original ResearchTaxane-induced peripheral neuropathyCommon Terminology Criteria for Adverse EventsChemotherapy-induced peripheral neuropathyPeripheral neuropathyDose reductionMeta-analysisSensory neuropathyIncidence of taxane-induced peripheral neuropathyIncidence of sensory neuropathyPrevent chemotherapy-induced peripheral neuropathyLimits chemotherapy doseEfficacy of cryotherapyIncidence of motorAssociated with reduced incidenceQuality of lifeNerve conduction studiesMeta-Analysis softwareReduce patients' qualityGynecological cancer therapyNeuropathy questionnaireChemotherapy doseClinical guidelinesMotor neuropathyAdverse eventsClinical evidenceThe impact of prior therapies on outcomes with trifluridine/tipiracil (FTD/TPI) in the phase III TAGS trial.
Shitara K, George B, Taieb J, Sundar R, Fakih M, Makris L, Benhadji K, Ghidini M. The impact of prior therapies on outcomes with trifluridine/tipiracil (FTD/TPI) in the phase III TAGS trial. Journal Of Clinical Oncology 2021, 39: 247-247. DOI: 10.1200/jco.2021.39.3_suppl.247.Peer-Reviewed Original ResearchFTD/TPI treatmentSafety profileAdverse eventsSafety of FTD/TPIGastroesophageal junction cancerThird-line chemotherapySecond-line treatmentPost hoc analysisHematologic toxicityOS benefitChemotherapy regimensJunction cancerSurvival benefitEfficacy benefitsFTD/TPIRamucirumabTagging trialsPlaceboPaclitaxelPrior treatmentAssociated with benefitsHoc analysisInfluence outcomesChemotherapySubgroup A
2020
Safety, pharmacokinetics and tissue penetration of PIPAC paclitaxel in a swine model
Tan H, Kim G, Charles C, Li R, Jang C, Shabbir A, Chue K, Tai C, Sundar R, Goh B, Bonney G, Looi W, Cheow E, So J, Wang L, Yong W. Safety, pharmacokinetics and tissue penetration of PIPAC paclitaxel in a swine model. European Journal Of Surgical Oncology 2020, 47: 1124-1131. PMID: 32800400, DOI: 10.1016/j.ejso.2020.06.031.Peer-Reviewed Original ResearchConceptsSolvent-based paclitaxelAdverse eventsGrade 2 hypersensitivity reactionSystemic exposure to paclitaxelAbsolute neutrophil countExposure to paclitaxelPhase I studyShort-term safetySignificant adverse eventsTissue drug concentrationsConcentrations of paclitaxelPotential adverse eventsYorkshire x Landrace pigsPeritoneal carcinomatosisPeritoneal biopsiesNeutrophil countPeritoneal surfaceToxicity profileBlood countIV infusionPeritoneal cavityPharmacokinetic analysisClinical trialsHigh dosesPharmacokinetic comparisonLimb Hypothermia for the Prevention of Chemotherapy-Induced Peripheral Neuropathy – Modality for Optimal Cooling
Bandla A, Santhanakrishnan P, Magarajah G, Vaidya G, Subramanian A, Wei H, Wilder-Smith E, Chin L, Thakor N, Sundar R. Limb Hypothermia for the Prevention of Chemotherapy-Induced Peripheral Neuropathy – Modality for Optimal Cooling. Annual International Conference Of The IEEE Engineering In Medicine And Biology Society (EMBC) 2020, 00: 5061-5064. PMID: 33019124, DOI: 10.1109/embc44109.2020.9175432.Peer-Reviewed Original ResearchConceptsChemotherapy-induced peripheral neuropathyPrevent chemotherapy-induced peripheral neuropathyFrozen glovesLimb hypothermiaHealthy subjectsPrevention of chemotherapy-induced peripheral neuropathyDose-limiting adverse effectsReduce chemotherapy-induced peripheral neuropathyNeurotoxic chemotherapeutic agentsNo adverse eventsTransient erythemaSafety profileAdverse eventsChemotherapeutic agentsPeripheral neuropathyCancer patientsClinical trialsOrthopaedic indicationsClinical utilityHypothermiaSports injuriesCooling modalitiesModalitiesSkin temperatureCryocompression
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
2017
First-in-human phase I study of an oral HSP90 inhibitor, TAS-116, in advanced solid tumors.
Yanagitani N, Horiike A, Kitazono S, Ohyanagi F, Kondo S, Shimomura A, Fujiwara Y, Doi T, Kuboki Y, Kawazoe A, Shitara K, Ohno I, Banerji U, Sundar R, Ohkubo S, Huang J, Nishio M, Yamamoto N. First-in-human phase I study of an oral HSP90 inhibitor, TAS-116, in advanced solid tumors. Journal Of Clinical Oncology 2017, 35: 2546-2546. DOI: 10.1200/jco.2017.35.15_suppl.2546.Peer-Reviewed Original ResearchTAS-116Solid tumorsFirst-in-human phase I studyAntitumor activityOral HSP90 inhibitorAccelerated titration designPhase 2 studyPhase I studyPreliminary antitumor activityPhase 1 studyEvidence of target engagementDose expansionFlat doseEscalating dosesDose proportionalityRepeated administrationQD scheduleSafety profileEye disordersIncreased creatinineAdverse eventsTitration designDays administrationNon-purinePatients