2012
LBA24 A Phase 3 Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone (DP) with or without Lenalidomide (LEN) in Patients with Castrate-Resistant Prostate Cancer (CRPC): The Mainsail Trial
Petrylak D, Fizazi K, Sternberg C, Budnik N, De Wit R, Wiechno P, Bellmunt J, Barton D, Fandi A, Jungnelius U, Li S, Vogelzang N. LBA24 A Phase 3 Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone (DP) with or without Lenalidomide (LEN) in Patients with Castrate-Resistant Prostate Cancer (CRPC): The Mainsail Trial. Annals Of Oncology 2012, 23: ixe15. DOI: 10.1016/s0923-7534(20)34329-5.Peer-Reviewed Original ResearchCastrate-resistant prostate cancerProgression-free survivalDP armOverall survivalProgressive metastatic castrate-resistant prostate cancerMetastatic castrate-resistant prostate cancerMethods Chemotherapy-naïve patientsAddition of lenalidomideLower dose intensitySafety of docetaxelSafety of lenalidomideChemotherapy-naïve patientsEarly treatment discontinuationMedian overall survivalObjective response rateECOG PS scoreFirst-line treatmentPhase 1/2 trialShorter treatment durationPhase 3Lack of benefitFebrile neutropeniaMAINSAIL trialNeutropenic sepsisPrimary endpoint
2009
Correlation of progression-free survival (PFS) and overall survival (OS) in men with metastatic castration-resistant prostate cancer (CRPC) who failed first-line chemotherapy: Results from the SPARC Trial
Halabi S, Sartor O, Petrylak D, Sternberg C, Witjes J, Noursalehi M, McKearn T, George M. Correlation of progression-free survival (PFS) and overall survival (OS) in men with metastatic castration-resistant prostate cancer (CRPC) who failed first-line chemotherapy: Results from the SPARC Trial. Journal Of Clinical Oncology 2009, 27: 5150-5150. DOI: 10.1200/jco.2009.27.15_suppl.5150.Peer-Reviewed Original ResearchProgression-free survivalCastration-resistant prostate cancerFirst-line chemotherapyOverall survivalMetastatic castration-resistant prostate cancerChemotherapy-naïve patientsDouble-blind trialDate of randomizationMedian survival timePredictors of OSProportional hazards modelType of progressionSPARC trialLine chemotherapyCRPC patientsNaïve patientsFirst progressionTau measuresProstate cancerLandmark analysisSurvival timeTreatment groupsHazards modelStratification factorsClinical relevance