Page 19 - Flipbook

ARCHES: Subgroup Analysis of rPFS

Enzalutamide + ADT /
placebo + ADT
Subgroup N (E) HR (95% CI)
All patients 574 (91) / 576 (201) 0.39 (0.30, 0.50)
Age <65 years 149 (21) / 152 (58) 0.29 (0.17, 0.47)
Age ≥65 years 426 (70) / 424 (143) 0.44 (0.33, 0.58)
Geographic region – Europe 341 (55) / 344 (122) 0.42 (0.31, 0.58)
Geographic region – North America 86 (14) / 77 (29) 0.30 (0.16, 0.57)
Geographic region – rest of world 147 (22) / 155 (50) 0.40 (0.24, 0.66)
ECOG status 0 at baseline 448 (67) / 443 (146) 0.38 (0.29, 0.51)
ECOG status 1 at baseline 125 (24) / 133 (55) 0.43 (0.27, 0.70)
Gleason score at initial diagnosis <8 171 (21) / 187 (47) 0.42 (0.25, 0.70)
Gleason score at initial diagnosis ≥8 386 (65) / 373 (151) 0.36 (0.27, 0.48)
Disease localization at baseline – bone only 268 (35) / 245 (82) 0.33 (0.22, 0.49)
Disease localization at baseline – soft tissue only 51 (5) / 45 (12) 0.42 (0.15, 1.20)
Disease localization at baseline – bone and soft tissue 217 (50) / 241 (104) 0.42 (0.30, 0.60)
Baseline PSA value at or below overall median 293 (41) / 305 (96) 0.38 (0.26, 0.54)
Baseline PSA value above overall median 279 (50) / 269 (104) 0.41 (0.30, 0.58)
Low volume of disease 220 (14) / 203 (47) 0.25 (0.14, 0.46)
High volume of disease 354 (77) / 373 (154) 0.43 (0.33, 0.57)
No prior docetaxel therapy 471 (70) / 474 (166) 0.37 (0.28, 0.49)
Prior docetaxel therapy 103 (21) / 102 (35) 0.52 (0.30, 0.89)
Previous use of ADT or orchiectomy 535 (88) / 515 (179) 0.41 (0.32, 0.53)
No previous use of ADT or orchiectomy 39 (3) / 61 (22) 0.19 (0.06, 0.62)
0.0 0.5 1.0 1.5 2.0

FAVORS ENZALUTAMIDE + ADT FAVORS PLACEBO + ADT

Enzalutamide showed efficacy across all volumes of disease and regardless of
whether patients received prior docetaxel

Armstrong, Andrew J., et al. "ARCHES: a randomized, phase III study of androgen deprivation therapy with enzalutamide or placebo in men with metastatic hormone-sensitive
prostate cancer." Journal of Clinical Oncology 37.32 (2019): 2974-2986.