Table 3. Clinical characteristics of patients with a confirmed ⩾50% PSA decrease.
| Max. PSA decline (%) | 95.6% | 84.5% | 79.4% | 78.6% | 77.2% | 57% |
|---|---|---|---|---|---|---|
| Dose of daily Dex (mg) |
0.5 |
0.5 |
0.5 |
0.5 |
1a |
0.5 |
|
Clinical characteristics at steroid switch | ||||||
| Age (years) | 73.1 | 81.8 | 61 | 62.5 | 63.6 | 73 |
| ECOG PS on Switch | 1 | 0 | 1 | 1 | 0 | 0 |
| Hb (g dl−1) | 10 | 12.4 | 14.4 | 13.7 | 12.8 | 13.6 |
| Alk Phos (IU l−1) | 2238 | 100 | 57 | 85 | NA | 53 |
| LDH (IU l−1) | 418 | 214 | 171 | 169 | NA | 242 |
| Albumin (g dl−1) | 36 | 42 | 37 | 34 | NA | 36 |
| Metastases |
Bone |
Bone, LN |
LN |
Bone, LN |
Bone |
LN, Pulm |
|
Response to steroid switch | ||||||
| Baseline PSA before switch (ng ml−1) | 1084 | 2689 | 9.7 | 210 | 37.7 | 15 |
| PSA nadir on switch | 48 | 418 | 1.9 | 45 | 8.5 | 6.5 |
| Duration of treatment Abi+Dex (m) | 12.2 (Ong) | 6.5 (Ong) | 5.7 | 13.9 | 5.5 (Ong) | 5.8 |
| Time to PSA nadir on Abi+Dex (m) | 3.6 | 4.7 | 1.8 | 6.2 | 4.5 | 1.5 |
| Time to PSA Progression on Abi+Dex (m) |
8.7 |
3.6 |
3.6 |
8.7 |
6.4 |
4.9 |
|
Treatment before switch | ||||||
| Duration of treatment AA+Pred (m) | 4.8 | 4.8 | 22.1 | 14.9 | 6.7 | 6.4 |
| Max. PSA decline on AA+Pred | 78% | 27% | 99% | 38% | 84% | 48% |
| Previous single agent Dex (m) | Yes (59.9) | Yes (15.3) | No | Yes (3.5) | No | Yes (4.9) |
| Time from previous single agent Dex (m) | 28.1 | 15.6 | — | 45.8 | — | 6.4 |
| Max. PSA decline on Previous single agent Dex | 97% | 27% | — | 38% | — | 71% |
| Previous CT lines | 1 | 1 | 1 | 1 | 1 | 2 |
Abbreviations: Alk Phos=Alkaline Phosphatase; CT=chemotherapy; Dex=dexamethasone; Hb=haemoglobin; LDH=Lactate dehydrogenase; LN=lymph nodes; m=months; NR=not reached; Ong=ongoing; PSA=prostate-specific antigen; Pulm=pulmonary metastases; yr=years.
a
Intially on Dexamethasone 2 mg OD, tapered to 1 mg over 2 weeks and kept on 1 mg OD throughout the study.