2022
Advances in antibody-drug conjugates for gynecologic malignancies
Tymon-Rosario J, Gorman M, Richardson D, Washington C, Santin A. Advances in antibody-drug conjugates for gynecologic malignancies. Current Opinion In Obstetrics & Gynecology 2022, 35: 6-14. PMID: 36484278, DOI: 10.1097/gco.0000000000000838.Peer-Reviewed Original ResearchConceptsAntibody-drug conjugatesOvarian cancer patientsGynecologic malignanciesCancer patientsPlatinum-resistant ovarian cancer patientsUse of ADCsOngoing phase 3 trialsRecurrent ovarian cancer patientsNovel antibody-drug conjugateReceptor-targeting antibodiesPhase 3 trialProgression-free survivalFirst U.S. FoodOngoing clinical trialsHER2/neuPersonalized cancer careTisotumab vedotinPrimary endpointCervical cancerGynecologic cancerCancer careClinical trialsMultiple tumorsCurrent evidenceDrug AdministrationLenvatinib plus Pembrolizumab for Advanced Endometrial Cancer
Makker V, Colombo N, Casado Herráez A, Santin AD, Colomba E, Miller DS, Fujiwara K, Pignata S, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Ushijima K, Sakata J, Yonemori K, Kim YM, Guerra EM, Sanli UA, McCormack MM, Smith AD, Keefe S, Bird S, Dutta L, Orlowski RJ, Lorusso D. Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer. New England Journal Of Medicine 2022, 386: 437-448. PMID: 35045221, DOI: 10.1056/nejmoa2108330.Peer-Reviewed Original ResearchConceptsAdvanced endometrial cancerProgression-free survivalEndometrial cancerOverall survivalMedian progression-free survivalPlatinum-based chemotherapy regimenLonger progression-free survivalEnd pointBlinded independent central reviewMedian overall survivalPrimary end pointPhase 3 trialResponse Evaluation CriteriaPlatinum-based chemotherapyIndependent central reviewChemotherapy regimenAdverse eventsStandard therapyCentral reviewPembrolizumabGrade 3LenvatinibChemotherapyPhysician's choicePatients
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
2018
GOG 3016/ENGOT-cx9: An open-label, multi-national, randomized, phase 3 trial of cemiplimab, an anti-PD-1, versus investigator's choice (IC) chemotherapy in ≥2 line recurrent or metastatic cervical cancer.
Tewari K, Vergote I, Oaknin A, Alvarez E, Chase D, Gaillard S, Lheureux S, Rischin D, Santin A, Feng M, Mathias M, Fury M, Lowy I, Monk B. GOG 3016/ENGOT-cx9: An open-label, multi-national, randomized, phase 3 trial of cemiplimab, an anti-PD-1, versus investigator's choice (IC) chemotherapy in ≥2 line recurrent or metastatic cervical cancer. Journal Of Clinical Oncology 2018, 36: tps5600-tps5600. DOI: 10.1200/jco.2018.36.15_suppl.tps5600.Peer-Reviewed Original Research