2020
Phase I Trial of Expanded, Activated Autologous NK-cell Infusions with Trastuzumab in Patients with HER2-positive Cancers
Lee S, Shimasaki N, Lim J, Wong A, Yadav K, Yong W, Tan L, Koh L, Poon M, Tan S, Ow S, Bharwani L, Yap Y, Foo M, Coustan-Smith E, Sundar R, Tan L, Chong W, Kumarakulasinghe N, Lieow J, Koe P, Goh B, Campana D. Phase I Trial of Expanded, Activated Autologous NK-cell Infusions with Trastuzumab in Patients with HER2-positive Cancers. Clinical Cancer Research 2020, 26: 4494-4502. PMID: 32522887, DOI: 10.1158/1078-0432.ccr-20-0768.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedBiopsyBreast NeoplasmsCoculture TechniquesCombined Modality TherapyDose-Response Relationship, DrugFemaleHumansImmunotherapyK562 CellsKiller Cells, NaturalMaleMiddle AgedReceptor, ErbB-2Response Evaluation Criteria in Solid TumorsStomach NeoplasmsTransplantation, AutologousTrastuzumabConceptsAntibody-dependent cell cytotoxicityAutologous NK cellsNK cellsPhase I trialI trialNK cells expressed high levelsNatural killer (NK) cellsActivated autologous NK cellsHER2-positive solid tumorsPhase I dose escalationPeripheral blood NK cellsHER2-positive malignanciesNK cell infusionNK cell therapyBlood NK cellsNK cell expansionIncreased NK cellsPhase II trialPreliminary antitumor activityNK cell activityCells expressing high levelsHER2-positive cancersStable diseasePartial responseII trial
2019
Evaluation of Electronic Activity Monitors (EAMs) during phase I clinical trials.
Scaranti M, Sundar R, Daly R, Collins D, Dolling D, Gennatas S, Rao Baikady B, Kaye S, Banerji U, Lopez J, De Bono J, Minchom A. Evaluation of Electronic Activity Monitors (EAMs) during phase I clinical trials. Journal Of Clinical Oncology 2019, 37: e18175-e18175. DOI: 10.1200/jco.2019.37.15_suppl.e18175.Peer-Reviewed Original ResearchPhase I trialI trialMean step countPhase I clinical trialPatient's physical functionHeart ratePredicting patient survivalDrug Development UnitStep countsECOG PSPhysical functionPatient survivalElectronic activity monitorsMedical oncologistsRecord heart ratePatient groupPhysician biasTreatment cyclesTreatment decisionsPatientsActivity monitoringPatient outcomesStatistical significanceOSPhysicians
2018
A study of 1088 consecutive cases of electrolyte abnormalities in oncology phase I trials
Garces A, Ang J, Ameratunga M, Chénard-Poirier M, Dolling D, Diamantis N, Seeramreddi S, Sundar R, de Bono J, Lopez J, Banerji U. A study of 1088 consecutive cases of electrolyte abnormalities in oncology phase I trials. European Journal Of Cancer 2018, 104: 32-38. PMID: 30316017, PMCID: PMC6259582, DOI: 10.1016/j.ejca.2018.08.019.Peer-Reviewed Original ResearchConceptsPhase I clinical trialElectrolyte abnormalitiesBaseline hypoalbuminaemiaOverall survivalClinical significanceDose-limiting toxicity windowPrognostic factors of OSOncology phase I trialsInferior median OSFactors of OSPhase I patientsPhase I trialRetrospective chart reviewSerum albumin levelAssociated with hypomagnesaemiaRoyal Marsden HospitalCox regression analysisPhase I populationDrug Development UnitMedian OSPrognostic factorsPrognostic significanceI patientsI trialAlbumin levelsVistusertib (dual m-TORC1/2 inhibitor) in combination with paclitaxel in patients with high-grade serous ovarian and squamous non-small-cell lung cancer
Basu B, Krebs M, Sundar R, Wilson R, Spicer J, Jones R, Brada M, Talbot D, Steele N, Garces A, Brugger W, Harrington E, Evans J, Hall E, Tovey H, de Oliveira F, Carreira S, Swales K, Ruddle R, Raynaud F, Purchase B, Dawes J, Parmar M, Turner A, Tunariu N, Banerjee S, de Bono J, Banerji U. Vistusertib (dual m-TORC1/2 inhibitor) in combination with paclitaxel in patients with high-grade serous ovarian and squamous non-small-cell lung cancer. Annals Of Oncology 2018, 29: 1918-1925. PMID: 30016392, PMCID: PMC6158767, DOI: 10.1093/annonc/mdy245.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntineoplastic Combined Chemotherapy ProtocolsBenzamidesCarcinoma, Non-Small-Cell LungDrug Administration ScheduleFemaleHumansLung NeoplasmsMaleMaximum Tolerated DoseMechanistic Target of Rapamycin Complex 1Mechanistic Target of Rapamycin Complex 2Middle AgedMorpholinesOvarian NeoplasmsPaclitaxelPhosphorylationProtein Kinase InhibitorsPyrimidinesResponse Evaluation Criteria in Solid TumorsRibosomal Protein S6 KinasesConceptsHigh-grade serous ovarian cancerSquamous non-small-cell lung cancerNon-small-cell lung cancerWeekly paclitaxelOvarian cancerSchedule ALung cancerIntermittent scheduleRecommended phase II doseResponse rateDose-escalated armPhase II doseRECIST response rateDose-limiting toxicityProgression-free survivalAdvanced solid tumorsPhase I trialSerous ovarian cancerResistance to chemotherapyP-S6K levelsConsecutive daysII doseDose escalationExpansion cohortI trialClinical outcomes of adolescents and young adults with advanced solid tumours participating in phase I trials
Sundar R, McVeigh T, Dolling D, Petruckevitch A, Diamantis N, Ang J, Chenard-Poiriér M, Collins D, Lim J, Ameratunga M, Khan K, Kaye S, Banerji U, Lopez J, George A, de Bono J, van der Graaf W. Clinical outcomes of adolescents and young adults with advanced solid tumours participating in phase I trials. European Journal Of Cancer 2018, 101: 55-61. PMID: 30025230, DOI: 10.1016/j.ejca.2018.06.003.Peer-Reviewed Original ResearchConceptsPhase I trialPhase I clinical trialAdvanced solid tumorsI trialOverall survivalAYA patientsSolid tumorsCancer syndromesCohort of AYA patientsMolecular characterisation of tumoursOutcomes of AYA patientsClinical benefit rateMedian overall survivalOutcomes of AYAsSomatic genetic aberrationsSignificant family historyRoyal Marsden HospitalHereditary cancer syndromesCharacterisation of tumoursTherapeutic treatment optionsClinical outcomes of adolescentsClinical trial dataDrug Development UnitYoung adultsGenetic aberrations
2017
Clinical Outcome of Patients with Advanced Biliary Tract Cancer in a Dedicated Phase I Unit
Sundar R, Custodio A, Petruckevich A, Chénard-Poirier M, Ameratunga M, Collins D, Lim J, Kaye S, Tunariu N, Banerji U, de Bono J, Lopez J. Clinical Outcome of Patients with Advanced Biliary Tract Cancer in a Dedicated Phase I Unit. Clinical Oncology 2017, 30: 185-191. PMID: 29224898, DOI: 10.1016/j.clon.2017.11.011.Peer-Reviewed Original ResearchConceptsAdvanced biliary tract carcinomaPhase I clinical trialPhase I unitABC patientsAdvanced biliary tract cancerMolecular characterisation of tumoursClinical outcomes of patientsClinical benefit rateBiliary tract carcinomaBiliary tract cancerComprehensive molecular profilingPhase I trialOutcomes of patientsCharacterisation of tumoursStable diseaseI unitsAdvanced diseaseI trialBenefit rateTargeted therapyTreatment detailsTrial discontinuationExceptional respondersPTEN lossClinical outcomes398P Drug-induced electrolyte abnormalities in oncology phase I trials: Analysis of 1088 cases treated at The Royal Marsden Hospital
Garces A, Ang J, Ameratunga M, Chenard-Poirier M, Dolling D, Diamantis N, Seeramreddi S, Sundar R, de Bono J, Lopez J, Banerji U. 398P Drug-induced electrolyte abnormalities in oncology phase I trials: Analysis of 1088 cases treated at The Royal Marsden Hospital. Annals Of Oncology 2017, 28: v132-v133. DOI: 10.1093/annonc/mdx367.031.Peer-Reviewed Original ResearchAdherence to novel oral anticancer therapies in the phase I setting: The Royal Marsden experience.
Chenard-Poirier M, Ang J, Harris S, Ingles Garces A, Seeramreddi S, Sundar R, Collins D, Ameratunga M, Lopez J, De Bono J, Banerji U. Adherence to novel oral anticancer therapies in the phase I setting: The Royal Marsden experience. Journal Of Clinical Oncology 2017, 35: 2542-2542. DOI: 10.1200/jco.2017.35.15_suppl.2542.Peer-Reviewed Original ResearchPhase I trialOral anticancer therapyI trialInvestigational medicinal productsAdherence ratesAnticancer therapyAssociated with improved adherenceEarly-phase trial designsFasting requirementsRoyal Marsden HospitalAnti-emetic useAssociated with poor adherenceDrug Development UnitAssociations to adherenceIntracranial metastasesGeneral cancer populationSystemic therapyConcomitant medicationsMedian agePost-doseInterpretation of toxicityMedian timeDiary cardsUnivariate analysisAnti-emeticsClinical outcomes of adolescents and young adults (AYA) with advanced solid tumors participating in phase I trials.
Sundar R, McVeigh T, Petruckevitch A, Diamantis N, Ang J, Chenard-Poirier M, Collins D, Lim J, Ameratunga M, Khan K, Kaye S, Banerji U, Lopez J, De Bono J, Van Der Graaf W. Clinical outcomes of adolescents and young adults (AYA) with advanced solid tumors participating in phase I trials. Journal Of Clinical Oncology 2017, 35: 10536-10536. DOI: 10.1200/jco.2017.35.15_suppl.10536.Peer-Reviewed Original ResearchPhase I trialAdvanced solid tumorsPhase I studyAYA patientsI trialFamily historySolid tumorsDrug Development UnitClinical outcomesOutcomes of AYA patientsMedian progression free survivalMolecular characterization of tumorsClinical benefit rateProgression free survivalSomatic genetic aberrationsRoyal Marsden HospitalHereditary cancer syndromesClinical outcomes of adolescentsCharacterization of tumorsMedian OSSystemic chemotherapyFree survivalGenetic aberrationsPredictive biomarkersBenefit rate