2019
A phase I study of TAS-102 in combination with oxaliplatin (TAS-OX) for refractory metastatic colorectal cancer (mCRC).
Cecchini M, Kortmansky J, Lacy J, Fischbach N, Thumar J, Sabbath K, Gomez C, Sporn J, Stein S, Hochster H. A phase I study of TAS-102 in combination with oxaliplatin (TAS-OX) for refractory metastatic colorectal cancer (mCRC). Journal Of Clinical Oncology 2019, 37: 630-630. DOI: 10.1200/jco.2019.37.4_suppl.630.Peer-Reviewed Original ResearchDisease control rateMetastatic colorectal cancerTAS-102Progressive diseaseDay 1Thymidine phosphorylase inhibitorRefractory metastatic colorectal cancerDose-escalating studyECOG PS 0Phase II doseEfficacy of oxaliplatinUsual laboratory parametersEligible patientsEvaluable patientsMeasurable diseaseUnexpected AEsStarting doseTreatment discontinuationPS 0Improved survivalLaboratory parametersOral combinationColorectal cancerPatient populationControl rateAntitumor activity of margetuximab (M) plus pembrolizumab (P) in patients (pts) with advanced HER2+ (IHC3+) gastric carcinoma (GC).
Catenacci D, Lim K, Uronis H, Kang Y, Ng M, Gold P, Enzinger P, Lee K, Lacy J, Park H, Yen J, Odegaard J, Franovic A, Baughman J, Wynter-Horton A, Chen F, Moore P, Wu T, Davidson-Moncada J, Bang Y. Antitumor activity of margetuximab (M) plus pembrolizumab (P) in patients (pts) with advanced HER2+ (IHC3+) gastric carcinoma (GC). Journal Of Clinical Oncology 2019, 37: 65-65. DOI: 10.1200/jco.2019.37.4_suppl.65.Peer-Reviewed Original ResearchDisease control rateObjective response ratePD-L1 expressionGastric carcinomaHER2 expressionHigh PD-L1 expressionStandard first-line therapyTumor PD-L1 expressionChemo-free regimenDrug-related SAEsFirst-line therapyProgression-free survivalAnti-HER2 agentsAutoimmune hepatitisExploratory endpointsMedian overallDiabetic ketoacidosisAcceptable tolerabilityAdvanced HER2Adverse eventsPD-L1Control rateIHC 3Grade 3Archival tumors
2018
Phase II LAPACT trial of nab -paclitaxel ( nab -P) plus gemcitabine (G) for patients with locally advanced pancreatic cancer (LAPC).
Hammel P, Lacy J, Portales F, Sobrero A, Pazo Cid R, Manzano Mozo J, Terrebonne E, Dowden S, Shiansong Li J, Ong T, Nydam T, Philip P. Phase II LAPACT trial of nab -paclitaxel ( nab -P) plus gemcitabine (G) for patients with locally advanced pancreatic cancer (LAPC). Journal Of Clinical Oncology 2018, 36: 204-204. DOI: 10.1200/jco.2018.36.4_suppl.204.Peer-Reviewed Original ResearchProgression-free survivalDisease control rateOverall response rateTreatment failureAdverse eventsProgressive diseaseOverall survivalICS treatmentEastern Cooperative Oncology Group performance statusInvestigator's choiceGrade 3 peripheral neuropathyMedian progression-free survivalTreatment-emergent adverse eventsCycles of nabAdvanced pancreatic cancerKey secondary endpointMedian TTFTreatment-naive patientsPhase 2 trialUnacceptable adverse eventsPancreatic tumor burdenInduction therapyUnresectable LAPCInduction regimenNab-paclitaxel
2017
Interim results of a multicenter phase II trial of nab -paclitaxel ( nab -P) plus gemcitabine (G) for patients (Pts) with locally advanced pancreatic cancer (LAPC).
Lacy J, Portales F, Hammel P, Pazo Cid R, Manzano Mozo J, Kim E, Dowden S, Borg C, Sastre J, Bathini V, Terrebonne E, Lopez-Trabada D, Rivera F, Asselah J, Damiani A, Hwang J, Ong T, Nydam T, Shiansong Li J, Philip P. Interim results of a multicenter phase II trial of nab -paclitaxel ( nab -P) plus gemcitabine (G) for patients (Pts) with locally advanced pancreatic cancer (LAPC). Journal Of Clinical Oncology 2017, 35: 358-358. DOI: 10.1200/jco.2017.35.4_suppl.358.Peer-Reviewed Original ResearchDisease control rateAdverse eventsMetastatic PCQOL scoresTreatment phaseDay 1Investigator's choiceMulticenter phase II trialInterim resultsCycles of nabECOG performance statusImproved symptom scoresQLQ-PAN26 questionnairesAdvanced pancreatic cancerG treatmentPhase II trialUnacceptable adverse eventsEORTC QLQ-C30Quality of lifeMPACT trialUnresectable LAPCII trialMost patientsNab-paclitaxelPerformance status
2016
LAPACT: An open-label, multicenter phase II trial of nab -paclitaxel ( nab -P) plus gemcitabine (Gem) in patients (pts) with locally advanced pancreatic cancer (LAPC).
Philip P, Lacy J, Dowden S, Sastre J, Bathini V, Cardin D, Ma W, Sobrero A, Koski S, Borg C, Tonini G, Rivera F, Hwang J, Knoble J, Al Baghdadi T, Saif W, Meiri E, Kayitalire L, Li J, Hammel P. LAPACT: An open-label, multicenter phase II trial of nab -paclitaxel ( nab -P) plus gemcitabine (Gem) in patients (pts) with locally advanced pancreatic cancer (LAPC). Journal Of Clinical Oncology 2016, 34: tps477-tps477. DOI: 10.1200/jco.2016.34.4_suppl.tps477.Peer-Reviewed Original ResearchCycles of nabDisease control rateProgressive diseaseOverall survivalEastern Cooperative Oncology Group performance statusMulticenter phase II trialPhase III MPACT trialAdequate organ functionAdvanced pancreatic cancerCycles of therapySafety of nabEffective systemic therapyImproved local controlPhase II trialProgression-free survivalLonger overall survivalOverall response rateQuality of lifeMedian TTFMPACT trialSignificant ascitesUnresectable LAPCExploratory endpointsPrimary endpointSecondary endpoints