Revised Overall Survival Analysis of a Phase II, Randomized, Double-Blind, Controlled Study of PROSTVAC in Men with Metastatic Castration-Resistant Prostate Cancer
Journal of Clinical Oncology(2017)
Mem Sloan Kettering Canc Ctr
Abstract
To the Editor: The article by Kantoff et al 1 described the phase II study, TBC-PRO-002, a randomized, double-blind, controlled study to evaluate the safety and efficacy of PROSTVAC-VF/TRICOM in combination with granulocyte-macrophage colony-stimulating factor in patients with androgen-independent adenocarcinoma of the prostate. This study was industry sponsored, with a collaborative research and development agreement with the National Cancer Institute (NCI). The initial sponsor, Therion Biologics, managed the study through treatment, primary end point evaluation, and 1 year of overall survival (OS) follow-up. The results were negative for progression-free survival, the primary end point. Therion went out of business in August 2006, and oversight of the PROSTVAC program reverted to the NCI. In 2008, Bavarian Nordic (BN) and the NCI established a new collaborative research and development agreement to develop PROSTVAC. BN completed OS data collection despite the negative progression-free survival results. Long-term follow-up (LTFU) results suggested improved OS for patients in the PROSTVAC-VF group compared with patients in the control group, which justified conducting a phase III study that is now fully accrued. Anticipating the planned PROSTVAC
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Key words
Metastatic Prostate Cancer,Prostate Cancer,Metastatic Cardiac Involvement
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