2022
Randomized Phase III Trial of Paclitaxel and Carboplatin Versus Paclitaxel and Ifosfamide in Patients With Carcinosarcoma of the Uterus or Ovary: An NRG Oncology Trial
Powell MA, Filiaci VL, Hensley ML, Huang HQ, Moore KN, Tewari KS, Copeland LJ, Secord AA, Mutch DG, Santin A, Warshal DP, Spirtos NM, DiSilvestro PA, Ioffe OB, Miller DS. Randomized Phase III Trial of Paclitaxel and Carboplatin Versus Paclitaxel and Ifosfamide in Patients With Carcinosarcoma of the Uterus or Ovary: An NRG Oncology Trial. Journal Of Clinical Oncology 2022, 40: 968-977. PMID: 35007153, PMCID: PMC8937015, DOI: 10.1200/jco.21.02050.Peer-Reviewed Original ResearchConceptsProgression-free survivalUterine carcinosarcomaOvarian carcinosarcomaEligible patientsHazard ratioMore patientsPC armMedian progression-free survivalRandomized phase III trialNRG Oncology trialsPhase III trialsPI armsGenitourinary hemorrhageHematologic toxicityMedian OSIII trialsLonger OSStandard treatmentGreater death rateStage IIINoninferiority designOncology trialsPatientsStage IStage IV
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