Treatment Group Treatment Group Treatment Group Treatment Group
Durability of Response Sirolimus only (N=4) Siro + Steroids (N=15) VCR only (N=5) VCR + Steroids (N=19) *p-value (steroid groups only)
Persistent disease 3 months from start of therapy, n (%) 0 (0%) 2 (13.3%) 5 (100%) 19 (100%) 0.2
Persistent disease 6 months from start of therapy, n (%) 0 (0%) 3 (20%) 0 (0%) 1 (5.3%) 0.3
Time to persistent disease from start of therapy (days), median [IQR] 1631.5 [977.3, 2285.8) 257.5 [123.3, 551] NA 407.5 [286.8, 528.3] 0.8
Persistent disease requiring change in treatment agent, n (%) 1 (25%) 3 (20%) 0 (0%) 1 (5.3%) 0.3
Persistent disease requiring continuation of current therapy, n (%) 2 (50%) 4 (26.7%) 0 (0%) 0 (0%) 0.029
Recurrent disease 3 months from start of therapy, n (%) 0 (0%) 1 (6.7%) 1 (20%) 0 (0%) 0.4
Recurrent disease 6 months from start of therapy, n (%) 0 (0%) 1 (6.7%) 1 (20%) 0 (0%) 0.4
Time to recurrent disease from start of therapy (days), median [IQR] 1915.5 [1509.8, 2321.3] 430.5 [268.5,637.8] 379 [193.5, 646] 231 [231, 231] 0.8
Recurrent disease requiring change in treatment agent, n (%) 1 (25%) 3 (20%) 2 (40%) 0 (0%) 0.076
Recurrent disease requiring re-initiation of prior therapy, n (%) 1 (25%) 4 (26.7%) 1 (20%) 2 (10.5%) 0.4
Progressive disease 3 months from start of therapy, n (%) 0 (0%) 1 (6.7%) 0 (0%) 0 (0%) 0.4
Progressive disease 6 months from start of therapy, n (%) 0 (0%) 1 (6.7%) 0 (0%) 0 (0%) 0.4
Time to progressive disease from start of therapy (days), median [IQR] 730 [730, 730] 1700 [1700, 1700] NA 553 [387, 719] 0.7
Progressive disease requiring change in treatment agent, n (%) 0 (0%) 1 (6.7%) 0 (0%) 1 (5.3%) >0.9
Progressive disease requiring re-initiation of prior therapy, n (%) 1 (25%) 0 (0%) 0 (0%) 1 (5.3%) >0.9