2024
Tislelizumab plus cetuximab and irinotecan in refractory microsatellite stable and RAS wild-type metastatic colorectal cancer: a single-arm phase 2 study
Xu X, Ai L, Hu K, Liang L, Lv M, Wang Y, Cui Y, Li W, Li Q, Yu S, Feng Y, Liu Q, Yang Y, Zhang J, Xu F, Yu Y, Liu T. Tislelizumab plus cetuximab and irinotecan in refractory microsatellite stable and RAS wild-type metastatic colorectal cancer: a single-arm phase 2 study. Nature Communications 2024, 15: 7255. PMID: 39179622, PMCID: PMC11343749, DOI: 10.1038/s41467-024-51536-x.Peer-Reviewed Original ResearchConceptsMetastatic colorectal cancerVariant allele frequencyPhase 2 studyEpidermal growth factor receptorAdverse eventsRAS wild-type metastatic colorectal cancerRAS wt metastatic colorectal cancerSingle-arm phase 2 studyWild-type metastatic colorectal cancerColorectal cancerTreatment-related adverse eventsAnti-PD-1Disease control rateProgression-free survivalRAS wild-typeTumor immune responseCombined treatment regimenWild-typeGrowth factor receptorIrinotecan combinationOverall survivalAnti-EGFRPrimary endpointTumor DNASingle-armPrecision treatment paradigm: Genomic features and therapeutic implications in mesenchymal‐epithelial transition‐amplified gastric cancer
Yu Y, Zhang Z, Zhu M, Shan Y, Wang Y, Wei L, Huang X, Sun D, Peng Z, Liu T. Precision treatment paradigm: Genomic features and therapeutic implications in mesenchymal‐epithelial transition‐amplified gastric cancer. Clinical And Translational Discovery 2024, 4 DOI: 10.1002/ctd2.350.Peer-Reviewed Original ResearchSingle nucleotide variantsCopy number variationsGenomic featuresMET amplificationOverall survivalCohort 1TCGA cohortMesenchymal-epithelial transitionGastric cancerSignificant copy number variationsCohort 2Nucleotide variantsPI3K pathwayCancer Genome AtlasNumber variationsRNA dataExpression analysisMutational landscapeProgression-freeClinical responseK pathwayMET therapyChinese patientsKaplan-MeierTreated patientsDevelopment and validation of an individualized nomogram for gastric cancer patients treated with perioperative chemotherapy followed by radical surgery
Wang Y, Zhang S, Ding B, Tang Z, Ji Y, Yu Y, Cui Y, Wang X, Sun Y, Liu T. Development and validation of an individualized nomogram for gastric cancer patients treated with perioperative chemotherapy followed by radical surgery. Translational Gastroenterology And Hepatology 2024, 0: 0-0. PMID: 39091661, PMCID: PMC11292059, DOI: 10.21037/tgh-23-75.Peer-Reviewed Original ResearchLocally advanced GC patientsProgression-free survivalAdvanced GC patientsOverall survivalDecision curve analysisTumor-node-metastasisRadical surgeryGC patientsReceiver operating characteristicNeoadjuvant chemotherapyPerioperative chemotherapyPrognostic factorsStaging systemC-indexTumor-node-metastasis (TNM) staging systemGastric cancerLocally advanced gastric cancerPatients treated with perioperative chemotherapyMultivariate Cox regression modelAssociated with clinical characteristicsAdvanced gastric cancerRisk group classificationExternal validation cohortIndependent external cohortLow-risk groupEncorafenib and cetuximab versus irinotecan/cetuximab or FOLFIRI/cetuximab in Chinese patients with BRAF V600E mutant metastatic colorectal cancer: The NAUTICAL CRC study.
Wang X, Deng Y, Zhang Y, Liu T, Yuan X, Yang J, Zhang T, Zang A, Liu Y, Huang L, Ye F, Zong H, Ba Y, Klauck I, Vedovato J, Groc M, Guo A, Shen L. Encorafenib and cetuximab versus irinotecan/cetuximab or FOLFIRI/cetuximab in Chinese patients with BRAF V600E mutant metastatic colorectal cancer: The NAUTICAL CRC study. Journal Of Clinical Oncology 2024, 42: lba3559-lba3559. DOI: 10.1200/jco.2024.42.17_suppl.lba3559.Peer-Reviewed Original ResearchMutant metastatic colorectal cancerTreatment-emergent adverse eventsMetastatic colorectal cancerBRAF V600E mutationChinese patientsControl armMetastatic treatmentV600E mutationGrade 3BRAF V600E-mutated mCRCFrequent treatment-emergent adverse eventsColorectal cancerTreatment-related grade 3CRC studyBaseline ECOG performance statusCombination of encorafenibSafety lead-inEmergent adverse eventsData cut-offMedian patient ageECOG performance statusPrimary cancer siteConfirmed ORRMedian OSMedian PFS419P Nivolumab (NIVO) + chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): Additional analyses from 4-year (y) follow-up (FU) of CheckMate 649
Wyrwicz L, Shitara K, Moehler M, Ajani J, Shen L, Garrido M, Araneda C, Yamaguchi K, Cleary J, Elimova E, Maya R, Karamouzis M, Skoczylas T, Bragagnoli A, Liu T, Tehfe M, Feeney K, Wang R, Zhang J, Janjigian Y. 419P Nivolumab (NIVO) + chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): Additional analyses from 4-year (y) follow-up (FU) of CheckMate 649. Annals Of Oncology 2024, 35: s169-s170. DOI: 10.1016/j.annonc.2024.05.333.Peer-Reviewed Original ResearchNivolumab (NIVO) + chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 4-year follow-up of CheckMate 649.
Elimova E, Shitara K, Moehler M, Ajani J, Shen L, Garrido M, Gallardo C, Wyrwicz L, Yamaguchi K, Cleary J, Bruges Maya R, Karamouzis M, Skoczylas T, Bragagnoli A, Liu T, Tehfe M, Feeney K, Wang R, Nathani R, Janjigian Y. Nivolumab (NIVO) + chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 4-year follow-up of CheckMate 649. Journal Of Clinical Oncology 2024, 42: 4040-4040. DOI: 10.1200/jco.2024.42.16_suppl.4040.Peer-Reviewed Original ResearchProgression-free survivalBlinded independent central reviewCombined positive scoreObjective response ratePD-L1Overall survivalFollow-upCheckMate 649Clinically meaningful progression-free survivalPD-L1 combined positive scoreProgression-free survival benefitProgrammed death-ligand 1Dual primary endpointsHER2+ patientsDeath-ligand 1Analysis of OSIndependent central reviewLong-term efficacyFollow-up resultsEarly follow-upClinically meaningful improvementsMedian OSOS benefitPD-1Central reviewCadonilimab with chemotherapy in HER2-negative gastric or gastroesophageal junction adenocarcinoma: the phase 1b/2 COMPASSION-04 trial
Gao X, Ji K, Jia Y, Shan F, Chen Y, Xu N, Jia Z, Liu T, Yang N, Zhong H, Li C, Guo Z, Fan Q, Lin X, Zhang Y, Ren H, Yang H, Yao Z, Liu W, Wang Z, Li B, Xia M, Shen L, Li Z, Ji J. Cadonilimab with chemotherapy in HER2-negative gastric or gastroesophageal junction adenocarcinoma: the phase 1b/2 COMPASSION-04 trial. Nature Medicine 2024, 30: 1943-1951. PMID: 38778212, DOI: 10.1038/s41591-024-03007-5.Peer-Reviewed Original ResearchGastroesophageal junction adenocarcinomaRecommended phase 2 dosePD-L1 CPSPhase 2 doseProgression-free survivalDuration of responsePD-L1Overall survivalGastroesophageal junctionMedian OSPD-1Primary endpointHuman epidermal growth factor receptor 2-negativeAnti-programmed cell death protein 1Cytotoxic T-lymphocyte antigen 4Cell death 1 ligand 1Programmed cell death 1 ligand 1Anti-PD-1 therapyMedian duration of responsePhase 1bTreatment-related grade 3Cell death protein 1T-lymphocyte antigen-4Antibodies targeting PD-1Response rateCamrelizumab plus famitinib in previously chemo-immunotherapy treated patients with advanced NSCLC: results from an open-label multicenter phase 2 basket study
Ren S, Xiong A, Yu J, Wang X, Han B, Pan Y, Zhao J, Cheng Y, Hu S, Liu T, Li Y, Cheng Y, Feng J, Yi S, Gu S, Gao S, Luo Y, Liu Y, Liu C, Duan H, Wang S, Yang X, Fan J, Zhou C. Camrelizumab plus famitinib in previously chemo-immunotherapy treated patients with advanced NSCLC: results from an open-label multicenter phase 2 basket study. Cancer Immunology, Immunotherapy 2024, 73: 124. PMID: 38727837, PMCID: PMC11087418, DOI: 10.1007/s00262-024-03715-4.Peer-Reviewed Original ResearchConceptsProgression-free survivalDisease control ratePlatinum-doublet chemotherapyOverall survivalAdvanced NSCLCCohort of advanced NSCLC patientsCombination of immune checkpoint inhibitorsMedian progression-free survivalPalmar-plantar erythrodysesthesia syndromeTreatment-related adverse eventsMedian follow-up durationFrequent grade 3Immune checkpoint inhibitorsSafety of camrelizumabTreated with camrelizumabAdvanced NSCLC patientsAdvanced solid tumorsDuration of responseDecreased neutrophil countFollow-up durationTreating multiple cancersMedian DoRCheckpoint inhibitorsMedian OSOS ratesFirst-line treatment with camrelizumab plus famitinib in advanced or metastatic NSCLC patients with PD-L1 TPS ≥1%: results from a multicenter, open-label, phase 2 trial
Ren S, Wang X, Han B, Pan Y, Zhao J, Cheng Y, Hu S, Liu T, Li Y, Cheng Y, Feng J, Yi S, Gu S, Gao S, Luo Y, Liu Y, Liu C, Duan H, Wang S, Yang X, Fan J, Zhou C. First-line treatment with camrelizumab plus famitinib in advanced or metastatic NSCLC patients with PD-L1 TPS ≥1%: results from a multicenter, open-label, phase 2 trial. Journal For ImmunoTherapy Of Cancer 2024, 12: e007227. PMID: 38388167, PMCID: PMC10882294, DOI: 10.1136/jitc-2023-007227.Peer-Reviewed Original ResearchConceptsMetastatic NSCLC patientsDisease control rateProgression-free survivalFirst-line treatmentNSCLC patientsOS ratesPD-L1Overall survivalOpen-labelSafety profileTreatment-related adverse events of grade 3Adverse events of grade 3Combination of immune-checkpoint inhibitorsEvents of grade 3Median progression-free survivalPhase 2 basket trialProgrammed death-ligand 1Treatment-related adverse eventsGrade 5 hemoptysisImmune-checkpoint inhibitorsPD-L1 TPSSafety of camrelizumabSolid Tumors V.1.1Death-ligand 1Response Evaluation CriteriaEfficacy of nab‑paclitaxel vs. Gemcitabine in combination with S‑1 for advanced pancreatic cancer: A multicenter phase II randomized trial
Guo X, Lou W, Xu Y, Zhuang R, Yao L, Wu J, Fu D, Zhang J, Liu J, Rong Y, Jin D, Wu W, Xu X, Ji Y, Wu L, Lv M, Yao X, Liu X, Wang D, Kuang T, Liu L, Wang W, Liu T, Zhou Y. Efficacy of nab‑paclitaxel vs. Gemcitabine in combination with S‑1 for advanced pancreatic cancer: A multicenter phase II randomized trial. Oncology Letters 2024, 27: 161. PMID: 38449794, PMCID: PMC10915801, DOI: 10.3892/ol.2024.14293.Peer-Reviewed Original ResearchProgression-free survivalAdvanced pancreatic cancerC-reactive proteinPancreatic cancerAS regimenNab-paclitaxelAdvanced PCPrimary endpointGene mutationsEfficacy of nab-paclitaxelPatients treated with GSSafety of nab-paclitaxelMedian progression-free survivalMedian follow-up timePhase II randomized trialC-reactive protein levelsHigh C-reactive proteinImproved overall survivalSubsets of patientsFollow-up timeCost-effective treatment regimenOS benefitData cutoffOpen-labelOverall survivalFruquintinib plus paclitaxel versus paclitaxel as second-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma (FRUTIGA): A randomized, multicenter, double-blind, placebo-controlled, phase 3 study.
Xu R, Wang F, Shen L, Guo W, Liu T, Li J, Qin S, Bai Y, Chen Z, Wang J, Pan Y, Shu Y, Zhao F, Cheng Y, Ye F, Gu K, Zhang T, Pan H, Zhong H, Su W. Fruquintinib plus paclitaxel versus paclitaxel as second-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma (FRUTIGA): A randomized, multicenter, double-blind, placebo-controlled, phase 3 study. Journal Of Clinical Oncology 2024, 42: 438780-438780. DOI: 10.1200/jco.2024.42.36_suppl.438780.Peer-Reviewed Original ResearchPhase 3 studyAntitumor therapyMedian OSDouble-blindPrimary endpointInhibitor of VEGFR-1Dose of study drugSecond-line treatment optionDual primary endpointsPlacebo (PBO)-controlledFirst-line chemotherapyGastroesophageal junction adenocarcinomaMetastatic colorectal cancerSecond-line therapyLymph node metastasisTreatment of paclitaxelStatistical significanceCox proportional hazards modelsPost hoc analysisOral inhibitorJunction adenocarcinomaEligible ptsPlacebo-controlledStudy drugStatistically significant improvementUpdated efficacy and safety of larotrectinib (laro) in patients (pts) with TRK fusion gastrointestinal (GI) cancer.
Shen L, Andre T, Chung H, Deeken J, Garralda E, Italiano A, Leyvraz S, Liu T, Burcoveanu D, Grugel R, Mussi C, Xu R, Hong D, Drilon A, Berlin J. Updated efficacy and safety of larotrectinib (laro) in patients (pts) with TRK fusion gastrointestinal (GI) cancer. Journal Of Clinical Oncology 2024, 42: 109-109. DOI: 10.1200/jco.2024.42.3_suppl.109.Peer-Reviewed Original ResearchMicrosatellite-instability-highTreatment-related adverse eventsProgression-free survivalPartial responseNTRK gene fusionsOverall survivalProgressive diseaseGI cancersImmune-oncologyMedian time to responseNext-generation sequencing testSafety of larotrectinibTRK fusion cancerEsophageal squamous cell carcinomaSquamous cell carcinomaTime to responseIO therapyMedian DoRStable diseaseData cutoffGene fusionsGrade 1/2Systemic therapyMedian durationCell carcinomaNivolumab (NIVO) + chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 4 year (yr) follow-up of CheckMate 649.
Shitara K, Moehler M, Ajani J, Shen L, Garrido M, Gallardo C, Wyrwicz L, Yamaguchi K, Cleary J, Elimova E, Bruges Maya R, Karamouzis M, Skoczylas T, Bragagnoli A, Liu T, Tehfe M, Feeney K, Wang R, Nathani R, Janjigian Y. Nivolumab (NIVO) + chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 4 year (yr) follow-up of CheckMate 649. Journal Of Clinical Oncology 2024, 42: 306-306. DOI: 10.1200/jco.2024.42.3_suppl.306.Peer-Reviewed Original ResearchProgression-free survivalBlinded independent central reviewCombined positive scoreObjective response ratePD-L1Overall survivalFollow-upCheckMate 649Clinically meaningful progression-free survivalPD-L1 combined positive scoreProgression-free survival benefitProgrammed death-ligand 1Dual primary endpointsHER2+ patientsDeath-ligand 1Analysis of OSIndependent central reviewLong-term efficacyFollow-up resultsEarly follow-upClinically meaningful improvementsMedian OSOS benefitPD-1Central reviewFirst-line (1L) nivolumab (NIVO) plus chemotherapy (chemo) vs chemo in patients (pts) with advanced gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma (GC/GEJC/EAC): CheckMate 649 Chinese subgroup analysis 4-year (yr) follow-up.
Shen L, Bai Y, Lin X, Li W, Wang J, Zhang X, Pan H, Bai C, Bai L, Cheng Y, Zhang J, Zhong H, Ba Y, Hu W, Xu R, Guo W, Qin S, Wang R, McCraith S, Liu T. First-line (1L) nivolumab (NIVO) plus chemotherapy (chemo) vs chemo in patients (pts) with advanced gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma (GC/GEJC/EAC): CheckMate 649 Chinese subgroup analysis 4-year (yr) follow-up. Journal Of Clinical Oncology 2024, 42: 318-318. DOI: 10.1200/jco.2024.42.3_suppl.318.Peer-Reviewed Original ResearchBlinded independent central reviewProgression-free survivalCombined positive scorePD-L1Overall survivalFollow-upCheckMate 649Safety profilePD-L1 combined positive scoreProgression-free survival benefitProgrammed death-ligand 1Clinically meaningful survival benefitStudy populationDual primary endpointsObjective response rateDeath-ligand 1Gastroesophageal junction cancerYrs of follow-upAdvanced gastric cancerIndependent central reviewOS ratesJunction cancerSurvival benefitCentral reviewFirst-line
2023
Nimotuzumab Plus Gemcitabine for K-Ras Wild-Type Locally Advanced or Metastatic Pancreatic Cancer
Qin S, Li J, Bai Y, Wang Z, Chen Z, Xu R, Xu J, Zhang H, Chen J, Yuan Y, Liu T, Yang L, Zhong H, Chen D, Shen L, Hao C, Fu D, Cheng Y, Yang J, Wang Q, Qin B, Pan H, Zhang J, Bai X, Zheng Q. Nimotuzumab Plus Gemcitabine for K-Ras Wild-Type Locally Advanced or Metastatic Pancreatic Cancer. Journal Of Clinical Oncology 2023, 41: 5163-5173. PMID: 37647576, PMCID: PMC10666986, DOI: 10.1200/jco.22.02630.Peer-Reviewed Original ResearchConceptsProgression-free survivalK-ras wild-type tumorMetastatic pancreatic cancerWild-type tumorsOverall survivalPancreatic cancerK-rasMedian progression-free survivalProgression-free survival timePhase III clinical studiesK-ras wild-typeResponse rateIncidence of adverse eventsDisease control rateSecondary end pointsIII clinical studiesPhase IIb trialMean survival timeMedian OSNimotuzumab groupImproved OSPlacebo groupClinical benefitSafety profileAdverse events
2022
Author Correction: Proteomic characterization of gastric cancer response to chemotherapy and targeted therapy reveals potential therapeutic strategies
Li Y, Xu C, Wang B, Xu F, Ma F, Qu Y, Jiang D, Li K, Feng J, Tian S, Wu X, Wang Y, Liu Y, Qin Z, Liu Y, Qin J, Song Q, Zhang X, Sujie A, Huang J, Liu T, Shen K, Zhao J, Hou Y, Ding C. Author Correction: Proteomic characterization of gastric cancer response to chemotherapy and targeted therapy reveals potential therapeutic strategies. Nature Communications 2022, 13: 6749. PMID: 36347856, PMCID: PMC9643381, DOI: 10.1038/s41467-022-34238-0.Peer-Reviewed Original Research