Orteronel for Metastatic Hormone-Sensitive Prostate Cancer: A Multicenter, Randomized, Open-Label Phase III Trial (SWOG-1216).
Archana M AgarwalCatherine M TangenMaha H A HussainShilpa GuptaMelissa PletsPrimo N LaraAndrea L HarzstarkPrzemyslaw W TwardowskiChanning J PallerDylan M ZyllaMatthew R ZibelmanEllis G LevineBruce J RothAmir GoldkornDaniel A VaenaManish KohliTony CrispinoNicholas J VogelzangIan M ThompsonDavid I QuinnPublished in: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2022)
The study did not meet the primary end point of improved OS with orteronel. The lack of correlation of PFS and PSA response with OS raises concerns over assumption of their consistent surrogacy for OS in the context of extensive postprotocol therapy in this setting.