Table 2.
Phase III mCSPC.
| DOCETAXEL + ADT vs. ADT |
Abiraterone + prednisone + ADT vs. ADT |
||||
|---|---|---|---|---|---|
| GETUG-15 [8], [9] | CHAARTED [11], [12] | STAMPEDE [13], [34] | STAMPEDE [21] | LATITUDE [20] | |
| Period of inclusion | 10/2004–12/2008 | 07/2006–11/2012 | 10/2005–03/2013 | 11/2011–01/2014 | 02/2013–12/2014 |
| n | 385 | 790 | 2962 (M0/M1) | 1917 (M0/M1) | 1199 |
| ECOG, PS | |||||
| 0 | 357 (98%) | 549 (69.5%) | 662 (72%) ADT arm | 1489 (77.7%) | |
| 1–2 | 9 (2%) | 241 (30.5%) | 225 (28%) ADT arm | 428 (22%) | NA |
| Metastatic at diagnosis | 71% (272) | 73% (575) | 61% (1817) | 49% (941) | 100% (1199) |
| Burden of metastases | |||||
| HVD | 48% (183) | 65% (513) | NA | NA | 100% (1199) |
| LVD | 52% (202) | 35% (277) | NA | NA | 0 |
| Gleason Score ≥8 | 56% | 61.2% | 64% ADT arm | 75% | 98% |
| Number of cycles of Docetaxel/median duration of abiraterone + p | 9 | 6 | 6 + prednisone 10 mg/day |
23.7 months | NA |
| Median follow-up (months) | 84 | 54 | 43 | 40 | 30.4 |
| Median OS (months) ADT/ADT + D (or abiraterone + prednisone) | 48.6/62.1 HR 0.88 (0.68–1.14) |
47.2/57.6 HR: 0.73 (0.59–0.89) |
45/60 HR: 0.76 (0,62–0,92) |
3-year survival 76%/83% HR: 0.63 (0.52–0.76) |
34.7/NR HR: 0.62 (0.51–0.76) |
| Median OS HVD (months) ADT/ADT + D | 35.1/39.8 HR: 0.78 (0.56–1.09) |
34.4/51.2 HR: 0.63 (0.50–0.79) |
NA | NA | 34.7/NR HR: 0.62 (0.51–0.76) |
| Median OS LVD (months) ADT/ADT + D | 83.4/NR HR: 1.02 (0.67–1.55) |
NR/63.5 HR: 1.04 (0.70–1.55) |
NA | NA | NA |
| Median PFS (months) ADT/ADT + D (or abiraterone + prednisone) | 12.9/22.9 HR: 0.67 (0.54–0.84) |
11.7/19.4 HR: 0.61 (0.52–0.73) |
M1: HR: 0.61 (0.53–0.71) | 3-year failure-free survival 45%/75% HR: 0.29 [0.25–0.34] | radiographic PFS 14.8/33.0 HR: 0.47 (0.39–0.55) |
ADT, androgen deprivation therapy; D, docetaxel; HR, hazard ratio; HVD, high volume disease (for CHAARTED and GETUG-15 were defined as visceral metastases or 4 or more bone metastases with >1 bone lesion beyond pelvis or axis, for Latitude patients were considered high risk if they met at least two of the following requirements: Gleason score of at least 8, presence of at least three lesions on a bone scan, or presence of measurable visceral metastasis); LVD, low volume disease; mCRPC, metastatic castrate-resistant prostate cancer; NA, not applicable; NR, not reached; OS, overall survival; PFS, progression free survival; PS, performance status; P, prednisone; M0, no metastatic; M1, metastatic.