Key clinical point: In high-risk patients with prostate cancer undergoing radical prostatectomy, adjuvant chemotherapy with docetaxel and prednisone fails to extend overall progression-free survival (PFS); but shows potential benefit in those with higher pathologic stage and Gleason grade of 7 or less.
Major finding: Adjuvant chemotherapy showed no statistical difference in PFS vs. standard of care (55.5 vs. 42.2 months; adjusted hazard ratio [aHR], 0.80; P = .18). PFS was significantly longer with adjuvant chemotherapy in patients with tumor stage pT3b or higher (47.2 vs 29.2 months; aHR, 0.54; P = .022) and Gleason score of 7 or less (81.8 vs. 36.8 months; aHR, 0.65; P = .046).
Study details: A phase 3 study of 298 high-risk patients with localized prostate adenocarcinoma, randomly assigned to either chemotherapy (docetaxel + prednisone) or standard of care.
Disclosures: This study was supported by the Department of Veterans Affairs, Cooperative Studies Program.
“Numerous studies over the last several years have led to the introduction of systemic therapy earlier in the treatment course for patients with metastatic disease. Collectively, these findings have led to studies designed to test whether adjuvant systemic chemotherapy may result in clinical benefits. Lin et al. describe a phase III randomized clinical study in patients who underwent prostatectomy and were randomized to 6 cycles of adjuvant docetaxel versus standard of care. Unfortunately, the study was ended early due to poor accrual, leading to an underpowered study as a little less than half of the planned patients were accrued. While there was no difference observed for the primary endpoint, progression-free survival (PFS), prespecified subgroup analyses did reveal benefits with regard to PFS in patients with tumor stage > T3b and, interestingly, Gleason score < 7. These findings suggest that an adequately powered study may yet reveal benefits to adjuvant approaches.”
Mark Klein, MD
Lin DW et al. Eur Urol. 2020 Jan 7. doi: 10.1016/j.eururo.2019.12.020.