¿Son todos los test genómicos iguales?

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1 )
“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?
QUA), Agendia (MammaPrint/Blueprint) and Stratifyer
aTyper). Results from individual tests were collated at
wick Clinical Trials Unit (CTU) for analysis.
cal Analysis
prelim was designed to recruit 300 patients to enable
pa value for agreement between tests to be estimated
od accuracy. Assuming 70% of patients would be as-
o no chemotherapy by the test and the true kappa value
(14), this would provide a lower 95% confidence limit of
ese numbers were also sufficient to allow for the as-
proportion of patients assigned to no chemotherapy to
m 55% to 80% (lower confidence limit for kappa varied
4 to 0.72, respectively).
proportion of tumors assigned to risk groups and/or sub-
as determined. The kappa coefficient and associated
fidence interval (CI) was used to assess agreement be-
sts. The predicted benefits of endocrine therapy with or
chemotherapy individualized to patients were esti-
sing two nomograms, Adjuvant! (version 8, without cor-
for HER2 status) ( 20) and PREDICT (21– 23). A
riable logistic regression model using stepwise elimina-
s performed to determine factors predicting discordant
o explore the post hoc hypothesis that individual tests
ore likely to agree at the extremes of their ranges, two-
scatterplots for the tests that provide risk scores and
nt charts for the categorization of tumors were con-
(24). Statistical analyses were performed using the SAS
al package (version 9.3; SAS Institute Inc., Cary, NC) and
n 3.0.3 ( 25). All statistical tests were two-sided, and a P
less than .05 was considered statistically significant.
MammaPrint for four patients, and from BluePrint for seven pa-
Table 1. Characteristics of the 302 patients
Characteristic Total
Age, median (range), y 58 (40–78)
Menopausal status of participant, No. (%)
Pre/perimenopausal 97 (32.1)
Postmenopausal 205 (67.9)
Number of involved nodes, No. (%)
None 57 (18.9)
1-3 192 (63.6)
4-9 42 (13.9)
Positive sentinel node biopsy without clearance surgery 11 (3.6)
Histological grade, No. (%)
1 19 (6.3)
2 201 (66.6)
3
Largest tumor size, median (range), mm
!30 No. (%) 172 (57.0)
>30 No. (%) 130 (43.0)
Lymphovascular invasion reported, No. (%)
No 169 (56.0)
Yes 122 (40.4)
Not known 11 (3.6)
Tumor type, No. (%)
Ductal 214 (70.9)
Lobular 65 (21.5)
Tubular/cribriform 2 (0.7)
Mucinous 4 (1.3)
Micropapillary 1 (0.3)
Mixed 16 (5.3)
y¼ year
J. M. S. Bartlett et al. | 3 f 9
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