29 / 40
Panitumumab en primera linea:
Evidencia en combinación con
FOLFOX / FOLFIRI
EPAR Vectibix
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000741/WC500187313.pdf(accessed 23-04-18)
CI: confidence Interval; NA: Not applicable; NE: Not estimable; ORR: Overall response rate; PFS: progression-free
survival; OS: Overall survival
2006314
PLANET
20050203
Pmab+FOLFIRI Pmab+FOLFIRI Pmab+FOLFOX Pmab+FOLFOX
Total number of subjects enrolled per
treatment arm
154
39
38
593
Overall
RAS
ascertainment rate
93%
83%
90%
Number of subjects with wild-type RAS
status
69
26
27
259
ORR, %
58.8
73.1
77.8
58.7
PFS
Median months (95% CI)
11.2
(7.6, 14.8)
14.8
(7.1, 18.7)
12.8
(6.2, 22.0)
10.1
(9.3, 12.0)
Hazard ratio vs. control arm (95% CI)
NA
0.86
(0.47, 1.56)
0.72
(0.58, 0.90)
OS
Median OS, months (95% CI)
NE
45.8
(32.8, 51.5)
39.0
(26.5, NE)
26.0
(21.7, 30.4)
Hazard ratio vs. control arm (95% CI)
NA
0.97
(0.41, 2.28)
0.78
(0.62, 0.99)