The trial from an alternate universe.
Top Line: Does post-prostatectomy mitoxantrone + prednisone with androgen therapy (ADT) improve outcomes in men with high-risk prostate cancer?
The Study: We know what you’re thinking: “but we don’t even give ADT alone after prostatectomy.” But Dr. D’Amico was just recovering from the bump on the head that sparked the idea for his risk classification scheme when SWOG S9921 was dreamt up in the late 90s. Nearly 1K men were enrolled after radical prostatectomy with: pT3b-4 or N1, Gleason score (GS) at least 8, GS 7 with positive margins or PSA > 10, or preop PSA > 15. In addition, everybody had to have an undetectable postop PSA. They were then randomized to the experimental arm of 2 years of ADT or the experimental-er arm of ADT with mitoxantrone + prednisone. History lesson: Mitoxantrone cross-links DNA and inhibits topoisomerase II, and at the time it was used in metastatic prostate cancer. The trial was stopped early due to an unexpected number of secondary acute myeloid leukemias in the mitoxantrone arm, and there were no differences in survival outcomes between arms.
Bottom Line: It’s hard to draw a clear line from this study, but outcomes were generally good so postop ADT may one day upgrade from salvage to adjuvant status. | Hussain, J Clin Oncol 2018
The Study: We know what you’re thinking: “but we don’t even give ADT alone after prostatectomy.” But Dr. D’Amico was just recovering from the bump on the head that sparked the idea for his risk classification scheme when SWOG S9921 was dreamt up in the late 90s. Nearly 1K men were enrolled after radical prostatectomy with: pT3b-4 or N1, Gleason score (GS) at least 8, GS 7 with positive margins or PSA > 10, or preop PSA > 15. In addition, everybody had to have an undetectable postop PSA. They were then randomized to the experimental arm of 2 years of ADT or the experimental-er arm of ADT with mitoxantrone + prednisone. History lesson: Mitoxantrone cross-links DNA and inhibits topoisomerase II, and at the time it was used in metastatic prostate cancer. The trial was stopped early due to an unexpected number of secondary acute myeloid leukemias in the mitoxantrone arm, and there were no differences in survival outcomes between arms.
Bottom Line: It’s hard to draw a clear line from this study, but outcomes were generally good so postop ADT may one day upgrade from salvage to adjuvant status. | Hussain, J Clin Oncol 2018
Comments
Post a Comment