2025
Postoperative Radiotherapy ± Cetuximab for Intermediate-Risk Head and Neck Cancer.
Machtay M, Torres-Saavedra P, Thorstad W, Nguyen-Tân P, Siu L, Holsinger F, El-Naggar A, Chung C, Cmelak A, Burtness B, Bednarz G, Quon H, Breen S, Gwede C, Dicker A, Yao M, Jordan R, Dorth J, Lee N, Chan J, Dunlap N, Bar-Ad V, Stokes W, Chakravarti A, Sher D, Rao S, Harris J, Yom S, Le Q, Bar-Ad V, Bednarz G, Bowles D, Breen S, Burtness B, Chakravarti A, Chan J, Chung C, Cmelak A, Dicker A, Dorth J, Dunlap N, El-Naggar A, Gwede C, Harris J, Holsinger F, Jones C, Jordan R, Krempl G, Le Q, Lee N, Lominska C, Ma D, Machtay M, Mell L, Nguyen-Tan P, Quon H, Raben A, Rao S, Samuels S, Sher D, Siu L, Spencer S, Stokes W, Takiar V, Thorstad W, Torres-Saavedra P, Wilke C, Yao M, Yom S, Young M. Postoperative Radiotherapy ± Cetuximab for Intermediate-Risk Head and Neck Cancer. Journal Of Clinical Oncology 2025, jco2401829. PMID: 39841939, DOI: 10.1200/jco-24-01829.Peer-Reviewed Original ResearchDisease-free survivalOverall survivalToxicity ratesEpidermal growth factor receptor expressionGrowth factor receptor expressionHead and neck cancerHPV-negative diseaseIntermediate-risk cancerIntensity-modulated RTStratified log-rank testAcute toxicity ratesSecondary end pointsOral cavity cancerSquamous cell carcinomaLog-rank testHead and neckLong-term toxicityBenefit of RTFisher's exact testPostoperative RTCell carcinomaReceptor expressionNeck cancerOral cavityRadiotherapy
2024
Addition of Blinatumomab to Consolidation Therapy Among Older Newly Diagnosed Patients (pts) with BCR::ABL1 Negative B-Lineage Acute Lymphoblastic Leukemia (ALL) in the ECOG-ACRIN E1910 Randomized Phase III Trial
Podoltsev N, Sun Z, Litzow M, Paietta E, Roberts K, Zhang Y, Racevskis J, Lazarus H, Rowe J, Arber D, Wieduwilt M, Liedtke M, Bergeron J, Wood B, Zhao Y, Wu G, Chang T, Zhang W, Pratz K, Dinner S, Frey N, Gore S, Bhatnagar B, Atallah E, Uy G, Jeyakumar D, Lin T, Willman C, DeAngelo D, Patel S, Elliott M, Advani A, Tzachanis D, Vachhani P, Roy R, Sharon E, Little R, Erba H, Stone R, Mullighan C, Tallman M, Luger S, Mattison R. Addition of Blinatumomab to Consolidation Therapy Among Older Newly Diagnosed Patients (pts) with BCR::ABL1 Negative B-Lineage Acute Lymphoblastic Leukemia (ALL) in the ECOG-ACRIN E1910 Randomized Phase III Trial. Blood 2024, 144: 4211-4211. DOI: 10.1182/blood-2024-207143.Peer-Reviewed Original ResearchHematopoietic stem cell transplantationRelapse free survivalAcute lymphoblastic leukemiaWhite blood cell countOlder ptsOverall survivalBone marrowAllogeneic hematopoietic stem cell transplantationB-lineage acute lymphoblastic leukemiaRandomized phase III trialFlow cytometryMulti-color flow cytometryStratified multivariable Cox modelsIncreased treatment toxicityPeripheral blood blastsStratified log-rank testImprovement of OSHigh dose methotrexateImproved overall survivalMedian follow-upStem cell transplantationKaplan-Meier methodPhase III trialsEstimates of OSLog-rank testMDS-157 Overall Survival (OS), Clinical Benefit, and Durable Red Blood Cell (RBC) Transfusion Independence (TI) With Imetelstat in the IMerge Phase 3 Trial of RBC-Transfusion Dependent (TD) Lower-Risk Myelodysplastic Syndromes (LR-MDS)
Santini V, Komrokji R, Sekeres M, Savona M, Fenaux P, Madanat Y, Oliva E, Buckstein R, Annaášová A, Germing U, Mittelman M, Thepot S, Riggs J, Dougherty S, Berry T, Navada S, Xia Q, Sun L, Zeidan A, Platzbecker U. MDS-157 Overall Survival (OS), Clinical Benefit, and Durable Red Blood Cell (RBC) Transfusion Independence (TI) With Imetelstat in the IMerge Phase 3 Trial of RBC-Transfusion Dependent (TD) Lower-Risk Myelodysplastic Syndromes (LR-MDS). Clinical Lymphoma Myeloma & Leukemia 2024, 24: s386-s387. DOI: 10.1016/s2152-2650(24)01345-4.Peer-Reviewed Original ResearchLower-risk myelodysplastic syndromesNon-del(5q) lower-risk myelodysplastic syndromesErythropoiesis-stimulating agentsRBC-TIOverall survivalRBC-TDNon-del(5qClinical benefitRed blood cellsHemoglobin increaseRBC transfusion dependenceStratified log-rank testMedian follow-upKaplan-Meier methodLog-rank testWithdrawal of consentMedian OSOS ratesHemoglobin riseMyelodysplastic syndromeOS analysisHemoglobin levelsAssess OSPlaceboImetelstatPhase III Randomized, Placebo-Controlled Trial of Endocrine Therapy ± 1 Year of Everolimus in Patients With High-Risk, Hormone Receptor–Positive, Early-Stage Breast Cancer
Chavez-MacGregor M, Miao J, Pusztai L, Goetz M, Rastogi P, Ganz P, Mamounas E, Paik S, Bandos H, Razaq W, O'Dea A, Kaklamani V, Silber A, Flaum L, Andreopoulou E, Wendt A, Carney J, Sharma P, Gralow J, Lew D, Barlow W, Hortobagyi G. Phase III Randomized, Placebo-Controlled Trial of Endocrine Therapy ± 1 Year of Everolimus in Patients With High-Risk, Hormone Receptor–Positive, Early-Stage Breast Cancer. Journal Of Clinical Oncology 2024, 42: 3012-3021. PMID: 38833643, PMCID: PMC11565489, DOI: 10.1200/jco.23.02344.Peer-Reviewed Original ResearchInvasive disease-free survivalHormone receptor-positiveEndocrine therapyOverall survivalBreast cancerHazard ratioReceptor-positiveHigh riskSubset analysisHormone receptor-positive metastatic breast cancerRisk groupsHormone receptor-positive BCEarly-stage breast cancerStratified log-rank testProgression-free survivalEfficacy of everolimusDisease-free survivalMetastatic breast cancerPlacebo-controlled trialSecondary end pointsLog-rank testHighest grade 3Treatment completion ratesPhase IIIEverolimus arm
2023
Adjuvant Osimertinib for Resected EGFR-Mutated Stage IB-IIIA Non–Small-Cell Lung Cancer: Updated Results From the Phase III Randomized ADAURA Trial
Herbst R, Wu Y, John T, Grohe C, Majem M, Wang J, Kato T, Goldman J, Laktionov K, Kim S, Yu C, Vu H, Lu S, Lee K, Mukhametshina G, Akewanlop C, de Marinis F, Bonanno L, Domine M, Shepherd F, Urban D, Huang X, Bolanos A, Stachowiak M, Tsuboi M. Adjuvant Osimertinib for Resected EGFR-Mutated Stage IB-IIIA Non–Small-Cell Lung Cancer: Updated Results From the Phase III Randomized ADAURA Trial. Journal Of Clinical Oncology 2023, 41: 1830-1840. PMID: 36720083, PMCID: PMC10082285, DOI: 10.1200/jco.22.02186.Peer-Reviewed Original ResearchConceptsII-IIIA diseaseStage IB-IIIAAdjuvant osimertinibDFS HRDFS ratesDistant recurrenceEnd pointSafety profileLung cancerSignificant disease-free survival benefitPrimary analysisDisease-free survival benefitLong-term safety profileSmall cell lung cancerStratified log-rank testExploratory end pointsPrimary end pointSecondary end pointsConsistent safety profilePatterns of recurrenceCell lung cancerComplete tumor resectionLog-rank testADAURA trialData cutoff
2022
A phase II/III trial of chemotherapy plus cetuximab versus chemotherapy plus bevacizumab versus atezolizumab plus bevacizumab following progression on immune checkpoint inhibition in recurrent/metastatic head and neck cancers: ECOG-ACRIN EA3202.
Bhatia A, Flamand Y, Johnson J, Ishizuka J, Duan F, Tang M, Karivedu V, Subramaniam R, Burtness B. A phase II/III trial of chemotherapy plus cetuximab versus chemotherapy plus bevacizumab versus atezolizumab plus bevacizumab following progression on immune checkpoint inhibition in recurrent/metastatic head and neck cancers: ECOG-ACRIN EA3202. Journal Of Clinical Oncology 2022, 40: tps6098-tps6098. DOI: 10.1200/jco.2022.40.16_suppl.tps6098.Peer-Reviewed Original ResearchProgression-free survivalVascular endothelial growth factorM HNSCCOverall survivalPrimary endpointExperimental armControl armHigher treatment-related adverse eventsPhase II/III trialsOne-sided alpha levelRecurrent/metastatic headTreatment-related adverse eventsEffector T cell responsesMyeloid-derived suppressor cellsPhase II/IIIPhase IIStratified log-rank testEfficacy of atezolizumabPlatinum-doublet chemotherapyImmune checkpoint inhibitionFirst-line pembrolizumabAnti-tumor immunityPhase IIIDendritic cell maturationPhase III evaluationOverall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer
Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Hart L, Campone M, Petrakova K, Winer EP, Janni W, Conte P, Cameron DA, André F, Arteaga CL, Zarate JP, Chakravartty A, Taran T, Le Gac F, Serra P, O'Shaughnessy J. Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. New England Journal Of Medicine 2022, 386: 942-950. PMID: 35263519, DOI: 10.1056/nejmoa2114663.Peer-Reviewed Original ResearchConceptsAdvanced breast cancerSignificant overall survival benefitMedian overall survivalOverall survival benefitProgression-free survivalOverall survivalBreast cancerSurvival benefitHER2-negative advanced breast cancerKey secondary end pointProtocol-specified final analysisLonger progression-free survivalHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Negative advanced breast cancerStratified log-rank testFirst-line ribociclibSecondary end pointsFirst-line therapyNew safety signalsPhase 3 trialGrowth factor receptor 2Kaplan-Meier methodLog-rank testFactor receptor 2
2019
A randomized phase 3 trial of paclitaxel (P) plus carboplatin (C) versus paclitaxel plus ifosfamide (I) in chemotherapy-naive patients with stage I-IV, persistent or recurrent carcinosarcoma of the uterus or ovary: An NRG Oncology trial.
Powell M, Filiaci V, Hensley M, Huang H, Moore K, Tewari K, Copeland L, Secord A, Mutch D, Santin A, Richards W, Warshal D, Spirtos N, Disilverstro P, Ioffe O, Miller D. A randomized phase 3 trial of paclitaxel (P) plus carboplatin (C) versus paclitaxel plus ifosfamide (I) in chemotherapy-naive patients with stage I-IV, persistent or recurrent carcinosarcoma of the uterus or ovary: An NRG Oncology trial. Journal Of Clinical Oncology 2019, 37: 5500-5500. DOI: 10.1200/jco.2019.37.15_suppl.5500.Peer-Reviewed Original ResearchQuality of lifeOverall survivalEligible ptsRandomized phase 3 trialSimilar QOLStratified log-rank testAggressive epithelial malignancyNew standard regimenNRG Oncology trialsStages I-IVbChemotherapy-naive patientsPhase 3 trialLog-rank testPhase 2 activityGenitourinary hemorrhageNeurotoxicity scoresO cohortRecurrent carcinosarcomaPrimary endpointStandard regimenLonger PFSHazard ratioOptimal therapyGynecologic carcinosarcomaEpithelial malignancies
2017
Microvessel density as a prognostic marker in high-risk renal cell carcinoma.
Weiss S, Puligandla M, Jilaveanu L, Haas N, Wang X, Zito C, Boeke M, Neumeister V, Manola J, DiPaola R, Kluger H. Microvessel density as a prognostic marker in high-risk renal cell carcinoma. Journal Of Clinical Oncology 2017, 35: 4565-4565. DOI: 10.1200/jco.2017.35.15_suppl.4565.Peer-Reviewed Original ResearchHigher microvessel densityRenal cell carcinomaDisease-free survivalHigh-risk renal cell carcinomaOverall survivalMicrovessel densityTreatment armsEntire cohortCell carcinomaNephrectomy specimensGrade I/IIVascular endothelial growth factor (VEGF) pathwayStratified log-rank testEndothelial growth factor pathwayClear cell renal cell carcinomaImproved overall survivalCell renal cell carcinomaClear cell histologyShorter overall survivalLog-rank testTumor microvessel densityAbsence of necrosisGrowth factor pathwaysAdjuvant sunitinibImproved OSHealth-related quality of life (HRQoL) of pembrolizumab (pembro) vs chemotherapy (chemo) for previously treated advanced urothelial cancer (UC) in KEYNOTE-045.
De Wit R, Bajorin D, Bellmunt J, Fradet Y, Lee J, Fong L, Vogelzang N, Climent M, Petrylak D, Choueiri T, Necchi A, Gerritsen W, Gurney H, Quinn D, Culine S, Sternberg C, Mai Y, Li H, Perini R, Vaughn D. Health-related quality of life (HRQoL) of pembrolizumab (pembro) vs chemotherapy (chemo) for previously treated advanced urothelial cancer (UC) in KEYNOTE-045. Journal Of Clinical Oncology 2017, 35: 4530-4530. DOI: 10.1200/jco.2017.35.15_suppl.4530.Peer-Reviewed Original ResearchAdvanced urothelial cancerGlobal health status/QoL scoreUrothelial cancerKEYNOTE-045HRQoL instrumentsQOL scoresWk 15Cox proportional hazards modelStratified log-rank testHRQOL end pointsSecond-line therapyTreatment-related AEsHealth-related qualityLog-rank testProportional hazards modelSuperior OSBetter HRQoLHRQoL analysisStudy treatmentPembroHazards modelInvestigator's choiceRate of improvementLongitudinal data analysis modelEnd pointHealth-related quality of life (HRQoL) in the KEYNOTE-045 study of pembrolizumab versus investigator-choice chemotherapy for previously treated advanced urothelial cancer.
Vaughn D, Bellmunt J, De Wit R, Fradet Y, Lee J, Fong L, Vogelzang N, Climent M, Petrylak D, Choueiri T, Necchi A, Gerritsen W, Gurney H, Quinn D, Culine S, Sternberg C, Mai Y, Li H, Perini R, Bajorin D. Health-related quality of life (HRQoL) in the KEYNOTE-045 study of pembrolizumab versus investigator-choice chemotherapy for previously treated advanced urothelial cancer. Journal Of Clinical Oncology 2017, 35: 282-282. DOI: 10.1200/jco.2017.35.6_suppl.282.Peer-Reviewed Original ResearchGlobal health status/QoL scoreAdvanced UCKEYNOTE-045HRQoL instrumentsQOL scoresWk 15Cox proportional hazards modelStratified log-rank testAdvanced urothelial cancerHRQOL end pointsInvestigator-choice chemotherapySecond-line therapyTreatment-related AEsHealth-related qualityLog-rank testProportional hazards modelSuperior OSBetter HRQoLHRQoL analysisUrothelial cancerStudy treatmentPembroHazards modelInvestigator's choiceRate of improvement
This site is protected by hCaptcha and its Privacy Policy and Terms of Service apply