2021
O008/#785 A multicenter, open-label, randomized, phase 3 study to compare the efficacy and safety of lenvatinib in combination with pembrolizumab vs treatment of physician’s choice in patients with advanced endometrial cancer: study 309/keynote-775
Makker V, Colombo N, Herráez A, Santin A, Colomba E, Miller D, Fujiwara K, Pignata S, Baron-Hay S, Ray-Coquard I, Shapira R, Ushijima K, Sakata J, Yonemori K, Kim Y, Guerra E, Sanli U, Mccormack M, Huang J, Smith A. O008/#785 A multicenter, open-label, randomized, phase 3 study to compare the efficacy and safety of lenvatinib in combination with pembrolizumab vs treatment of physician’s choice in patients with advanced endometrial cancer: study 309/keynote-775. International Journal Of Gynecological Cancer 2021, 31: a4-a5. DOI: 10.1136/ijgc-2021-igcs.8.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsAdvanced endometrial cancerObjective response rateEndometrial cancerPhysician's choiceCommon treatment-emergent adverse eventsPrior platinum-based chemotherapy regimenPhase 3 study resultsPlatinum-based chemotherapy regimenPrior platinum-based chemotherapyDNA mismatch repair (MMR) statusBlinded independent central reviewPhase 1b/2 studySafety of lenvatinibKey secondary endpointMedian treatment durationAdvanced endometrial carcinomaPhase 3 studyPlatinum-based chemotherapyIndependent central reviewPlatinum-based therapyMismatch repair statusEligible ptsRECIST v1.1Adjuvant setting
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