2024
A single arm phase 2 clinical trial of YIV-906 with neoadjuvant concurrent chemo-radiation therapy in patients with locally advanced rectal cancer
Verma N, Johung K, Kortmansky J, Zaheer W, Lacy J, Cecchini M, Stein S, Cheng Y, Lam W, Liu S, Reddy V, Hochster H, Higgins S. A single arm phase 2 clinical trial of YIV-906 with neoadjuvant concurrent chemo-radiation therapy in patients with locally advanced rectal cancer. Journal Of Gastrointestinal Oncology 2024, 15: 1050-1059. PMID: 38989411, PMCID: PMC11231844, DOI: 10.21037/jgo-24-23.Peer-Reviewed Original ResearchCombining antivascular endothelial growth factor and anti-epidermal growth factor receptor antibodies: randomized phase II study of irinotecan and cetuximab with/without ramucirumab in second-line colorectal cancer (ECOG-ACRIN E7208)
Hochster H, Catalano P, Weitz M, Mitchell E, Cohen D, O’Dwyer P, Faller B, Kortmansky J, O’Hara M, Kricher S, Lacy J, Lenz H, Verma U, Benson A. Combining antivascular endothelial growth factor and anti-epidermal growth factor receptor antibodies: randomized phase II study of irinotecan and cetuximab with/without ramucirumab in second-line colorectal cancer (ECOG-ACRIN E7208). Journal Of The National Cancer Institute 2024, 116: 1487-1494. PMID: 38775718, PMCID: PMC11378308, DOI: 10.1093/jnci/djae114.Peer-Reviewed Original ResearchProgression-free survivalDisease-control ratePhase 3 trialColorectal cancerAnti-VEGFAnti-VEGFRAnti-EGFRKRAS-wild type colorectal cancerPhase II study of irinotecanKRAS wild-type colorectal cancerMedian progression-free survivalRandomized phase II studyKRAS wild-type tumorsWild-type colorectal cancerAnti-VEGFR antibodiesAnti-VEGF drugsTreated with ICSecond-line treatmentStudy of irinotecanWild-type tumorsAdvanced colorectal cancerPhase 2 studyAnti-EGFR antibodiesAnti-VEGF antibodyECOG PS
2023
NCI10066: a Phase 1/2 study of olaparib in combination with ramucirumab in previously treated metastatic gastric and gastroesophageal junction adenocarcinoma
Cecchini M, Cleary J, Shyr Y, Chao J, Uboha N, Cho M, Shields A, Pant S, Goff L, Spencer K, Kim E, Stein S, Kortmansky J, Canosa S, Sklar J, Swisher E, Radke M, Ivy P, Boerner S, Durecki D, Hsu C, LoRusso P, Lacy J. NCI10066: a Phase 1/2 study of olaparib in combination with ramucirumab in previously treated metastatic gastric and gastroesophageal junction adenocarcinoma. British Journal Of Cancer 2023, 130: 476-482. PMID: 38135713, PMCID: PMC10844282, DOI: 10.1038/s41416-023-02534-1.Peer-Reviewed Original ResearchQuantitative DNA Repair Biomarkers and Immune Profiling for Temozolomide and Olaparib in Metastatic Colorectal Cancer
Cecchini M, Zhang J, Wei W, Sklar J, Lacy J, Zhong M, Kong Y, Zhao H, DiPalermo J, Devine L, Stein S, Kortmansky J, Johung K, Bindra R, LoRusso P, Schalper K. Quantitative DNA Repair Biomarkers and Immune Profiling for Temozolomide and Olaparib in Metastatic Colorectal Cancer. Cancer Research Communications 2023, 3: 1132-1139. PMID: 37387791, PMCID: PMC10305782, DOI: 10.1158/2767-9764.crc-23-0045.Peer-Reviewed Original ResearchConceptsWhole-exome sequencingMGMT protein expressionColorectal cancerStable diseaseQuantitative immunofluorescenceT cellsProtein expressionPromoter hypermethylationLow MGMT protein expressionPARP inhibitorsRadiographic tumor regressionMetastatic colorectal cancerAdvanced colorectal cancerPretreatment tumor biopsiesEffector T cellsTumor-infiltrating lymphocytesMGMT proteinDNA repair biomarkersBaseline CD8Eligible patientsIncreased CD8Methylguanine-DNA methyltransferaseObjective responseProgressive diseaseImmune markersPre-operative chemoradiotherapy with or without induction chemotherapy for operable locally-advanced esophageal cancer
Peters G, Talcott W, Peters N, Dhanasopan A, Lacy J, Cecchini M, Kortmansky J, Stein S, Lattanzi S, Park H, Boffa D, Johung K, Jethwa K. Pre-operative chemoradiotherapy with or without induction chemotherapy for operable locally-advanced esophageal cancer. Journal Of Gastrointestinal Oncology 2023, 14: 1181-1192. PMID: 37435226, PMCID: PMC10331751, DOI: 10.21037/jgo-22-1005.Peer-Reviewed Original ResearchProgression-free survivalMedian progression-free survivalOverall survivalIC-CRTInduction chemotherapySingle-institution retrospective cohort studyPre-operative chemoradiotherapyAdvanced esophageal cancerAdvanced esophageal carcinomaPathologic complete responseRetrospective cohort studyKaplan-Meier methodSubset of patientsProportional hazards regressionCycles of inductionAdenocarcinoma histologyCRT cohortCohort studyComplete responsePathologic responseTreatment cohortsDistant metastasisHazards regressionEsophageal cancerEsophageal carcinoma
2020
259 Phase Ib/II open-label, randomized evaluation of atezolizumab (atezo) + selicrelumab (seli) + gemcitabine+nab-paclitaxel (gem+nabP) or bevacizumab (bev) vs control in MORPHEUS-PDAC, -TNBC and -CRC
Manji G, Bahary N, Chung V, Dalenc F, Ducreux M, Gomez-Roca C, Im S, Kortmansky J, Lacy J, Segal N, Tredan O, Cirovic O, DuPree K, Lenain C, Lu D, Robert L, Xu J, Zhang X, Kim S. 259 Phase Ib/II open-label, randomized evaluation of atezolizumab (atezo) + selicrelumab (seli) + gemcitabine+nab-paclitaxel (gem+nabP) or bevacizumab (bev) vs control in MORPHEUS-PDAC, -TNBC and -CRC. 2020, a157-a158. DOI: 10.1136/jitc-2020-sitc2020.0259.Peer-Reviewed Original ResearchAssociation of Neoadjuvant Treatment Modality with Negative Margin and Pathologic Downstaging in Patients Undergoing Pancreatic Cancer Resection: A National Cancer Database Analysis
Miccio J, Mokhtech M, Jabbour S, Anker C, Patel T, Park H, Cecchini M, Salem R, Kuntsman J, Stein S, Kortmansky J, Lacy J, Narang A, Herman J, Haddock M, Hallemeier C, Johung K, Jethwa K. Association of Neoadjuvant Treatment Modality with Negative Margin and Pathologic Downstaging in Patients Undergoing Pancreatic Cancer Resection: A National Cancer Database Analysis. International Journal Of Radiation Oncology • Biology • Physics 2020, 108: e662. DOI: 10.1016/j.ijrobp.2020.07.1980.Peer-Reviewed Original ResearchThe Utility of Neoadjuvant Radiotherapy after Neoadjuvant Multiagent Chemotherapy in Patients with Localized Pancreatic Cancer
Miccio J, Talcott W, Patel T, Park H, Cecchini M, Salem R, Stein S, Kortmansky J, Lacy J, Johung K, Jethwa K. The Utility of Neoadjuvant Radiotherapy after Neoadjuvant Multiagent Chemotherapy in Patients with Localized Pancreatic Cancer. International Journal Of Radiation Oncology • Biology • Physics 2020, 108: e31-e32. DOI: 10.1016/j.ijrobp.2020.02.538.Peer-Reviewed Original Research
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 rateOutcomes for patients with borderline resectable (BR) and locally advanced (LA) pancreatic cancer (PC) treated with induction FOLFIRINOX (FFX) +/- radiation (RT) followed by surgery compared to induction FFX followed by consolidative RT.
Cecchini M, Miccio J, Pahade J, Lacy J, Salem R, Johnson S, Stein S, Kortmansky J, Johung K. Outcomes for patients with borderline resectable (BR) and locally advanced (LA) pancreatic cancer (PC) treated with induction FOLFIRINOX (FFX) +/- radiation (RT) followed by surgery compared to induction FFX followed by consolidative RT. Journal Of Clinical Oncology 2019, 37: 437-437. DOI: 10.1200/jco.2019.37.4_suppl.437.Peer-Reviewed Original Research
2018
P-320 Pilot trial of YIV-906 with neoadjuvant chemoradiotherapy (CRT) in patients with locally advanced rectal cancer
Johung K, Kann B, Lacy J, Stein S, Kortmansky J, Zaheer W, Cheng Y, Lam W, Liu S, Decker R, Hochster H, Higgins S. P-320 Pilot trial of YIV-906 with neoadjuvant chemoradiotherapy (CRT) in patients with locally advanced rectal cancer. Annals Of Oncology 2018, 29: v90. DOI: 10.1093/annonc/mdy151.319.Peer-Reviewed Original ResearchO-030 Randomized trial of irinotecan and cetuximab (IC) versus irinotecan, cetuximab and ramucirumab (ICR) as 2nd line therapy of advanced colorectal cancer (CRC) following oxaliplatin and bevacizumb based therapy: Result of E7208
Hochster H, Catalano P, O'Dwyer P, Mitchell E, Cohen D, Faller B, Kortmansky J, Kircher S, Lacy J, Lenz H, Verma U, Benson A, ECOG-ACRIN. O-030 Randomized trial of irinotecan and cetuximab (IC) versus irinotecan, cetuximab and ramucirumab (ICR) as 2nd line therapy of advanced colorectal cancer (CRC) following oxaliplatin and bevacizumb based therapy: Result of E7208. Annals Of Oncology 2018, 29: v110. DOI: 10.1093/annonc/mdy149.029.Peer-Reviewed Original ResearchRandomized trial of irinotecan and cetuximab (IC) versus irinotecan, cetuximab and ramucirumab (ICR) as 2nd line therapy of advanced colorectal cancer (CRC) following oxaliplatin and bevacizumb based therapy: Result of E7208.
Hochster H, Catalano P, O'Dwyer P, Mitchell E, Cohen D, Faller B, Kortmansky J, Kircher S, Lacy J, Lenz H, Verma U, Benson A. Randomized trial of irinotecan and cetuximab (IC) versus irinotecan, cetuximab and ramucirumab (ICR) as 2nd line therapy of advanced colorectal cancer (CRC) following oxaliplatin and bevacizumb based therapy: Result of E7208. Journal Of Clinical Oncology 2018, 36: 3504-3504. DOI: 10.1200/jco.2018.36.15_suppl.3504.Peer-Reviewed Original ResearchA phase IB/II randomized study of mFOLFIRINOX (mFFOX) + pegylated recombinant human hyaluronidase (PEGPH20) versus mFFOX alone in patients with good performance status metastatic pancreatic adenocarcinoma (mPC): SWOG S1313 (NCT #01959139).
Ramanathan R, McDonough S, Philip P, Hingorani S, Lacy J, Kortmansky J, Thumar J, Chiorean E, Shields A, Behl D, Mehan P, Gaur R, Seery T, Guthrie K, Hochster H. A phase IB/II randomized study of mFOLFIRINOX (mFFOX) + pegylated recombinant human hyaluronidase (PEGPH20) versus mFFOX alone in patients with good performance status metastatic pancreatic adenocarcinoma (mPC): SWOG S1313 (NCT #01959139). Journal Of Clinical Oncology 2018, 36: 208-208. DOI: 10.1200/jco.2018.36.4_suppl.208.Peer-Reviewed Original ResearchMetastatic pancreatic adenocarcinomaPhase II studyOverall survivalII studyPhase Ib/IIProphylactic growth factor supportUntreated metastatic pancreatic adenocarcinomaRandomized phase II studyGemcitabine/nab-paclitaxelAdequate organ functionMedian overall survivalGrowth factor supportInterim futility analysisRecombinant human hyaluronidaseClinical trial informationDelivery of gemcitabineBolus 5FULMWH prophylaxisMedian OSTumor hyaluronanCombination armNab-paclitaxelPrimary endpointThromboembolic eventsStandard arm
2016
Final analysis of a phase II study of modified FOLFIRINOX in locally advanced and metastatic pancreatic cancer.
Stein S, James E, Cong X, Deng Y, Salem R, Cha C, Chang B, Hochster H, Doddamane I, Boustani A, Patel V, Kortmansky J, Li J, Staugaard C, Lacy J. Final analysis of a phase II study of modified FOLFIRINOX in locally advanced and metastatic pancreatic cancer. Journal Of Clinical Oncology 2016, 34: 395-395. DOI: 10.1200/jco.2016.34.4_suppl.395.Peer-Reviewed Original Research
2015
Phase II study of Yale modified FOLFIRINOX (mFOLFIRINOX) in locally advanced pancreatic cancer (LAPC).
Stein S, Cong X, Yao X, Hahn C, Li J, Kortmansky J, Chang B, Cha C, Salem R, Hochster H, Lacy J. Phase II study of Yale modified FOLFIRINOX (mFOLFIRINOX) in locally advanced pancreatic cancer (LAPC). Journal Of Clinical Oncology 2015, 33: e15274-e15274. DOI: 10.1200/jco.2015.33.15_suppl.e15274.Peer-Reviewed Original ResearchFinal analysis of a phase II study of Yale-modified FOLFIRINOX (mFOLFIRINOX) in metastatic pancreatic cancer (MPC).
James E, Cong X, Yao X, Hahn C, Kaley K, Li J, Kortmansky J, Fischbach N, Cha C, Salem R, Stein S, Hochster H, Lacy J. Final analysis of a phase II study of Yale-modified FOLFIRINOX (mFOLFIRINOX) in metastatic pancreatic cancer (MPC). Journal Of Clinical Oncology 2015, 33: 395-395. DOI: 10.1200/jco.2015.33.3_suppl.395.Peer-Reviewed Original ResearchMetastatic pancreatic cancerResponse rateProphylactic pegfilgrastimEntire cohortPhase II open-label studyFinal analysisECOG PS 0ECOG PS 0/1Grade 3/4 toxicitiesOpen-label studyPhase II studyBolus 5FUPS 0/1Febrile neutropeniaLAPC patientsPeritoneal diseaseII studyPS 0Surgical resectionUnacceptable toxicityImproved tolerabilityPeripheral neuropathyMetastatic sitesPancreatic cancerFOLFIRINOX
2014
Interim analysis of a phase II study of dose-modified FOLFIRINOX (mFOLFIRINOX) in locally advanced (LAPC) and metastatic pancreatic cancer (MPC).
James E, Yao X, Cong X, Li J, Hahn C, Kaley K, Kortmansky J, Fischbach N, Chang B, Salem R, Cha C, Stein S, Hochster H, Lacy J. Interim analysis of a phase II study of dose-modified FOLFIRINOX (mFOLFIRINOX) in locally advanced (LAPC) and metastatic pancreatic cancer (MPC). Journal Of Clinical Oncology 2014, 32: e15226-e15226. DOI: 10.1200/jco.2014.32.15_suppl.e15226.Peer-Reviewed Original Research
2013
Phase II study of mFOLFOX with bevacizumab (Bev) in metastatic gastroesophageal and gastric (GE) adenocarcinoma (AC).
Li J, Kortmansky J, Fischbach N, Stein S, Yao X, Hochster H, Lacy J. Phase II study of mFOLFOX with bevacizumab (Bev) in metastatic gastroesophageal and gastric (GE) adenocarcinoma (AC). Journal Of Clinical Oncology 2013, 31: 4084-4084. DOI: 10.1200/jco.2013.31.15_suppl.4084.Peer-Reviewed Original ResearchCisplatin-based regimensOverall survivalGE adenocarcinomaResponse rateMetastatic sitesProspective phase II trialECOG PS 0/1Grade 3/4 toxicitiesMedian overall survivalPhase II studyPhase II trialPhase III studyDVT/PELiver 19Median TTPPrior gastrectomyPS 0/1GI perforationHemorrhagic eventsII studyII trialIII studyMedian survivalMedian ageGastric adenocarcinoma
2010
Phase II study of mFOLFOX6 with bevacizumab (Bev) in metastatic gastric and esophageal (GE) adenocarcinoma.
Li J, Kortmansky J, Saif M, Fischbach N, Ravage-Mass L, Elligers K, Hahn C, Cohenuram M, Lacy J. Phase II study of mFOLFOX6 with bevacizumab (Bev) in metastatic gastric and esophageal (GE) adenocarcinoma. Journal Of Clinical Oncology 2010, 28: tps203-tps203. DOI: 10.1200/jco.2010.28.15_suppl.tps203.Peer-Reviewed Original Research