2024
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)
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
Pre-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 carcinomaEffect of a MUC5AC Antibody (NPC-1C) Administered With Second-Line Gemcitabine and Nab-Paclitaxel on the Survival of Patients With Advanced Pancreatic Ductal Adenocarcinoma
Huffman B, Mallick A, Horick N, Wang-Gillam A, Hosein P, Morse M, Beg M, Murphy J, Mavroukakis S, Zaki A, Schlechter B, Sanoff H, Manz C, Wolpin B, Arlen P, Lacy J, Cleary J. Effect of a MUC5AC Antibody (NPC-1C) Administered With Second-Line Gemcitabine and Nab-Paclitaxel on the Survival of Patients With Advanced Pancreatic Ductal Adenocarcinoma. JAMA Network Open 2023, 6: e2249720. PMID: 36602796, PMCID: PMC9856813, DOI: 10.1001/jamanetworkopen.2022.49720.Peer-Reviewed Original ResearchConceptsAdvanced pancreatic ductal adenocarcinomaPancreatic ductal adenocarcinomaObjective response rateProgression-free survivalSecond-line treatmentNab-paclitaxelOverall survivalClinical trialsDuctal adenocarcinomaRandomized phase II clinical trialMedian progression-free survivalGemcitabine/nab-paclitaxelCox proportional hazards analysisEnd pointPhase II clinical trialChemotherapy dose reductionsFirst-line FOLFIRINOXSecond-line gemcitabineMedian overall survivalPrimary end pointSecondary end pointsProportional hazards analysisSurvival of patientsLow performance statusPretreatment clinical variables
2020
HALO 109-301: A randomized, double-blind, placebo-controlled, phase 3 study of pegvorhyaluronidase alfa (PEGPH20) + nab-paclitaxel/gemcitabine (AG) in patients (pts) with previously untreated hyaluronan (HA)-high metastatic pancreatic ductal adenocarcinoma (mPDA).
Tempero M, Van Cutsem E, Sigal D, Oh D, Fazio N, Macarulla T, Hitre E, Hammel P, Hendifar A, Bates S, Li C, De La Fouchardiere C, Heinemann V, Maraveyas A, Bahary N, Layos L, Sahai V, Zheng L, Lacy J, Bullock A. HALO 109-301: A randomized, double-blind, placebo-controlled, phase 3 study of pegvorhyaluronidase alfa (PEGPH20) + nab-paclitaxel/gemcitabine (AG) in patients (pts) with previously untreated hyaluronan (HA)-high metastatic pancreatic ductal adenocarcinoma (mPDA). Journal Of Clinical Oncology 2020, 38: 638-638. DOI: 10.1200/jco.2020.38.4_suppl.638.Peer-Reviewed Original ResearchMetastatic pancreatic ductal adenocarcinomaObjective response rateProgression-free survivalPhase 3 studyOverall survivalAdverse eventsTumor microenvironmentHazard ratioNab-paclitaxel/gemcitabineRandomized phase 2 studyMedian progression-free survivalIntolerable adverse eventsMedian overall survivalPhase 2 studyPancreatic ductal adenocarcinomaPegvorhyaluronidase alfaProphylactic enoxaparinRECIST v1.1Primary endpointSecondary endpointsTE eventsBaseline characteristicsMusculoskeletal eventsThromboembolism riskClinical outcomes
2019
1188PD Margetuximab (M) + pembrolizumab (P) for treatment of patients (pts) with HER2+ gastroesophageal adenocarcinoma (GEA) post-trastuzumab (T): Survival analysis
Catenacci D, Park H, Uronis H, Kang Y, Ng M, Enzinger P, Lee K, Lim K, Gold P, Lacy J, Park S, Huber K, Wynter-Horton A, Nordstrom J, Wu T, Wigginton J, Baughman J, Rosales M, Davidson-Moncada J, Bang Y. 1188PD Margetuximab (M) + pembrolizumab (P) for treatment of patients (pts) with HER2+ gastroesophageal adenocarcinoma (GEA) post-trastuzumab (T): Survival analysis. Annals Of Oncology 2019, 30: v484-v485. DOI: 10.1093/annonc/mdz253.014.Peer-Reviewed Original ResearchMedian progression-free survivalMedian overall survivalGenentech/RocheBristol-Myers SquibbGastroesophageal adenocarcinomaPD-L1Prime TherapeuticsOno PharmaceuticalOS ratesEMD SeronoMerck SeronoAstellas PharmaDaiichi SankyoGilead SciencesChemotherapy-free regimenPD-L1 CPSProgression-free survivalTreatment of patientsCancer ptsGuardant HealthMedian followMedian PFSCheckpoint inhibitorsExpansion cohortAcceptable tolerability
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