| HERTAX (n = 101)[1] | JO17360 (n = 112)[2] | SAKK 22/99 (n = 175)[3] | |
| Treatment schema | Tr + Doc (comb) versus Tr → Doc (seq) | Tr + Doc (comb) versus Tr → Tr + Doc (seq) | Tr + chemo (comb) versus Tr → Tr + chemo (seq) |
| Line of treatment | First line | First line | First, second, or third line |
| Median first PFS during Tr monotherapy | 3.9 mo | 3.7 mo | 3.7 mo |
| Median PFS or TTP following both Tr and chemo | PFS 9.4 mo (comb) versus PFS 9.9 mo (seq) | PFS 14.6 mo (comb) versus PFS 12.4 mo (seq) | TTP 10.3 mo (comb) versus TTP 12.2 mo (seq) |
| RECIST RR following both Tr and chemo | 58 (comb) versus 38% (seq) | 67.9 (comb) versus 47.2% (seq) | Not reported |
| Median OS | 30.5 mo (comb) versus 19.7 mo (seq) | Not reached, but HR 2.72 with p = 0.04 in favor of comb | 36.3 mo (comb) versus 35.6 mo (seq) |
| Trial caveats | Tr was not continued along with docetaxel in the sequential arm | Study closed early due to presumption of inferiority of sequential arm at interim analysis | Accrual over 13 years; many censored patients due to off protocol endocrine therapy added; study design changed during conduct; chemo regimens not reported |
