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- W2598774811 abstract "5035 Background: CTC enumeration is a biomarker associated with clinical outcomes in patients (pts) with mCRPC. CTC count at baseline (BL) and post-treatment is prognostic for survival. Enzalutamide (ENZA) was approved for post-chemotherapy CRPC based on the overall survival (OS) benefit (AFFIRM trial). In this trial, CTC enumeration was embedded as a biomarker endpoint. Methods: AFFIRM was a phase 3 study (N = 1199; NCT00974311) randomizing men who received ≤ 2 docetaxel-based chemotherapy regimens to ENZA 160 mg/day or placebo (PBO) (2:1). CTC samples were collected at sites selected for logistics and investigator interest. Conversion rate was defined as a decline from ≥ 5 (unfavorable) to < 5 (favorable) CTCs/7.5 mL of blood from BL to best post-BL result. Results: BL CTCs were obtained from 447 of 1199 pts at 89 of 156 study sites; BL demographics and disease history were similar to pts in whom samples were not collected. 382 pts had both BL and post-BL counts; OS, rPFS and select disease characteristics for pts with CTC data are shown in the table. Conversion from unfavorable to favorable CTC counts was observed in 61 of 127 pts (48%; 95% CI 39%-57%) treated with ENZA compared to 6 of 62 pts (9.7%; 95% CI 3.6%-20%) with PBO (p < 0.0001). Progression from favorable to unfavorable counts occurred in 18% of ENZA pts compared to 44% with PBO. Conclusions: Unfavourable baseline CTC counts were associated with higher PSA and greater disease burden. The higher rate of conversion from unfavorable to favorable and lower conversion from favorable to unfavorable for ENZA relative to placebo was consistent with observed OS benefit. Clinical trial information: NCT00974311. Baseline CTC < 5 ENZA n = 131 CTC < 5 PBO n = 62 CTC ≥ 5 ENZA n = 127 CTC ≥ 5 PBO n = 62 Median Age 69 70 70 70 ECOG = 0 71 (54%) 29 (47%) 36 (28%) 20 (32%) Brief Fatigue Inventory = 0 62 (52%) 19 (34%) 38 (33%) 21 (36%) Median PSA (ng/mL) 68 55 241 211 Median Hemoglobin (g/L) 124 126 114 115 Median Alk Phosphatase (U/L) 85 87 178 147 Median LDH (U/L) 185 190 236 242 Bone Mets >20 22 (17%) 11 (18%) 74 (58%) 36 (58%) OS Not reached 19.5 m 13.6 m 10.7 m HR (95% CI) 0.52 (0.28-0.98) 0.78 (0.51-1.17) rPFS 11.0 m 2.8 m 5.8 m 2.8 m HR (95% CI) 0.23 (0.16-0.35) 0.38 (0.26-0.54)" @default.
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- W2598774811 date "2015-05-20" @default.
- W2598774811 modified "2023-10-03" @default.
- W2598774811 title "Circulating tumor cell (CTC) enumeration in men with metastatic castration-resistant prostate cancer (mCRPC) treated with enzalutamide post-chemotherapy (phase 3 AFFIRM study)." @default.
- W2598774811 doi "https://doi.org/10.1200/jco.2015.33.15_suppl.5035" @default.
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