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