Table 5.
Field testing of the ESMO-MCBS for the treatment of advanced prostate cancer at the Medical University of Vienna
| Analysed treatment | Setting | Primary EP | PFS control | PFS gain | PFS HR | OS control | OS gain | OS HR | Adjustment/remark | MCBS | MCBS-FT |
|---|---|---|---|---|---|---|---|---|---|---|---|
| ADT±early docetaxel (CHAARTED) Sweeney et al71 |
Metastatic hormone sensitive | OS | 11.7 m | 8.5 m | 0.61 (0.51 to 0.72) | 44.0 m | 13.6 m | 0.61 (0.47 to 0.80) | No QOL assessment | NA | 4 |
| SOC vs SOC+docetaxel vs SOC+zoledronic acid vs SOC+docetaxel+zoledronic Acid (STAMPEDE) James et al72 |
High risk locally advanced or metastatic | OS | – – – |
– – – |
– – – |
71.0 m | 10.0 m NR 5.0 m |
0.78 (0.66 to 0.93) 0.94 (0.79 to 1.11) 0.82 (0.69 to 0.97) |
Multiarm, multistage design | NA NA NA |
4 – 4 |
| Docetaxel+prednisone vs mitoxantrone+prednisone* Tannock et al73 |
Castration refractory | OS | – | – | – | 16.5 m | 2.4 m | 0.76 (0.62 to 0.94) | QOL improved | 3 | NA |
| Enzalutamide vs placebo (PREVAIL)* Beer et al74 |
Castration-refractory pre-docetaxel | PFS, OS | 3.2 m | >12 m | 0.19 (0.15 to 0.23) | 30.2 m | 2.2 m | 0.71, (0.60 to 0.84) | QOL improved | 3 | NA |
| Standard non-CT or RT±radium-223 (ALSYMPCA)* Parker et al75 |
Castration refractory and bone pain/lesions | OS | – | – | – | 11.3 m | 3.6 m | 0.70 (0.55 to 0.88) | QOL improved | 5 | NA |
| Prednisone±abiraterone* De Bono et al76 |
Castration refractory after docetaxel | OS | – | – | – | 10.9 m | 3.9 m | 0.65 (0.54 to 0.77) | 4 | NA | |
| Enzalutamide vs placebo (AFFIRM)* Scher et al77 |
Castration refractory after docetaxel | OS | – | – | – | 13.6 m | 4.8 m | 0.63 (0.53 to 0.75) | QOL improved | 4 | NA |
| Cabazitaxel+prednisone vs mitoxantrone+prednisone (TROPIC)* De Bono et al78 |
Castration refractory after docetaxel | OS | – | – | – | 12.7 m | 2.4 m | 0.70 (0.59 to 0.83) | 2 | NA |
*Adapted according to Cherny et al.8
ADT, androgen deprivation treatment; CT, chemotherapy; EP, end point; ESMO-MCBS, European Society for Medical Oncology Magnitude of Clinical Benefit Scale; FT, field testing; m, months; NA, not applicable; NR, not reached; OS, overall survival; PFS, progression-free survival; QOL, quality of life; RT, radiotherapy; SOC, standard of care.