¿Son todos los test genómicos iguales?

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“Tratamiento médico del cáncer en el año 2019”
Organiza:
6 , 7 y 8 d e f e b r e r o 2 0 1 9
NH Collection Eurobuilding
M A D R I D
C O O R D I N A D O R E S C I E N T Í F I C O S :
Eduardo Díaz-Rubio
Enrique Aranda Aguilar
Enrique Grande Pulido
Ana Lluch Hernández
Pedro Pérez Segura
Mariano Provencio Pulla
¿Son todos los test genómicos iguales?
tative and semi-quantitative array-based technologies.
Previous in silico comparisons of multiple gene signatures
have identified statistically significant discordance between dif-
ferent “diagnostic tests” ( 13,15– 17). However, to date, this has
been attributed to suboptimal comparisons because in the ma-
jority of studies genomic prediction scores have been estimated
from published expression profiles. It has been argued that, in
any direct comparison of validated diagnostic genomic assays,
a high level of concordance could and should be obtained (14).
In the current study, we performed such a direct comparison,
each commercial assay was performed as prescribed by the rel-
evant manufacturer (although the AQUA-IHC4 assay sed TMAs
for convenience). What is striking is that, among five tests with
robust independent technical and clinical validation as predic-
tors of residual risk (MammaPrint, Oncotype DX, Prosigna, IHC4,
and IHC4-AQUA) and three that measure a recognized risk fac-
tor (molecular subtype), there is marked disagreement across
all tests. Indeed, for all tests the level of agre ment was
Risk tool Total
Nottingham Prognostic Index, median (range) 4.6 (2.8–8.2)
"3.4, No. (%) 12 (4.0)
>3.4– "5.4, No. (%) 226 (74.8)
>5.4, No. (%) 64 (21.2)
PREDICT 10-year overall survival, median (range), %
Endocrine therapy only 77.0 (25.1–94.6)
Chemotherapy and endocrine therapy 82.6 (39.8–95.9)
Additional benefit of chemotherapy 5.5 (1.2–25.8)
Adjuvant! 10-year risk overall survival, median (range), %
Endocrine therapy only 68.6 (25.4–90.4)
Chemotherapy and endocrine therapy 76.4 (31.0–93.6)
Additional benefit of chemotherapy 6.8 (1.2–25.8)
Adjuvant! 10-year relapse-free survival, median (range), %
Endocrine therapy only 60.5 (22.0–82.1)
Chemotherapy and endocrine therapy 72.9 (29.1–89.4)
Additional benefit of chemotherapy 10.5 (2.7–33.3)
Table 3. Risk categorization by each test
Risk group Oncotype DX* No. (%) MammaPrint† No. (%) Prosigna No. (%) IHC4 No. (%) IHC4-AQUA‡ No. (%)
No. of patients (%) 301 (99.7) 298 (98.9) 299 (99.0) 257 (85.1) 271 (89.7)
Low risk 163 (54.2) 183 (61.4) 108 (36.1) 62 (24.1) 87 (32.1)
Intermediate risk 84 (27.9) – 88 (29.4)
Mid risk – – –
High risk 54 (17.9) 115 (38.6) 103 (34.5) 72 (28.0) (18.1)
*Oncotype DX is divided into three risk groups, with intermediate defined as recurrence score 18-25 for the current analysis.
†MammaPrint divides tumors into two risk groups only.
‡IHC4-AQUA divides tumors into four risk groups: low, low-mid (here called intermediate), mid and high (combined as high risk).
ARTICLE
108/9/djw050/2499553 by guest on 01 February 2019