Study population, baseline tumor load and survival data, response
Study cohort | Validation cohort | Total | ||||
Female | Male | Female | Male | |||
Study population | ||||||
# Patients | n | 29 | 41 | 32 | 38 | 140 |
Age stage IV (year) | Mean±SD | 62±14 | 65±17 | 60±14 | 62±19 | 63±16 |
Age further progression (year) | Mean±SD | 65±13 | 68±15 | 62±15 | 61±20 | 64±16 |
Age death (year) | Mean±SD | 65±14 | 71±15 | 63±16 | 62±23 | 66±17 |
Mutation present | n | 15 | 19 | 20 | 19 | 73 |
BRAF | n | 12 | 16 | 17 | 16 | 61 |
cKIT | n | 1 | 1 | 2 | ||
NRAS | n | 3 | 3 | 2 | 2 | 10 |
Lab results at stage IV | ||||||
LDH | U/L (max 250) | 370.52 | 291.44 | 349.79 | 321.59 | 328.74 |
s-100β | µg/L (max 0.1) | 1.8 | 2.03 | 0.67 | 1.42 | 1.52 |
Tumor load and survival | ||||||
Sum of lesions at stage IV | n | 163 | 214 | 178 | 219 | 774 |
Sum of follow-up WBCT | n | 225 | 371 | 308 | 387 | 1291 |
Sum of timepoint evaluations | n | 1436 | 1865 | 1474 | 1758 | 6533 |
Progression-free survival (d) | Median (IQR) | 284 (174–333) | 262 (180–294) | 543 (260–622) | 236 (174–299) | 275 (180–360) |
Responder | Median (IQR) | 304 (128–363) | 270 (160–294) | 620 (587–834) | 257 (210–293) | 269 (134–308) |
Non-responder | Median (IQR) | 281 (177–309) | 257 (210–293) | 281 (177–309) | 240 (200–302) | 278 (216–494) |
Median overall survival (day) | Median (IQR) | 551 (249–1156) | 761 (351–1280) | 1093 (449–1544) | 848 (350–1232) | 771 (339–1270) |
Responder | Median (IQR) | 815 (368–1267) | 808 (534–1246) | 1151 (823–1720) | 1295 (279–1385) | 889 (368–1222) |
Non-responder | Median (IQR) | 492 (215–776) | 752 (317–1346) | 705 (334–1230) | 771 (452–1158) | 760 (297–1284) |
Responder | n | 15 | 25 | 17 | 24 | 81 |
Complete response (CR) | n | 5 | 6 | 9 | 7 | 27 |
Partial response (PR) | n | 8 | 17 | 6 | 14 | 45 |
Stable disease (SD) | n | 2 | 2 | 2 | 3 | 9 |
Non-responder | ||||||
Progressive disease (PD) | n | 14 | 16 | 12 | 17 | 59 |
Lesion response | ||||||
Responder | n | 119 | 80 | 63 | 125 | 387 |
CR | n | 95 | 53 | 21 | 43 | 212 |
PR | n | 19 | 17 | 30 | 47 | 113 |
SD | n | 5 | 10 | 12 | 35 | 62 |
Non-responder | ||||||
PD | n | 95 | 97 | 77 | 110 | 379 |
LDH, lactate dehydrogenase; WBCT, whole-body CT.