Clinical and technical validation of a genomic classifier (ColoPrint) for predicting outcome of stage II colon cancer patients Josep Tabernero, Vall d’Hebron University Hospital, Barcelona, Spain and Victor Moreno 2 , Robert Rosenberg 3 , Ulrich Nitsche 3 , Thomas Hoffmann-Bachleitner 4 , Giovanni Lanza 5 , Jeroen van Akker 6 , Paul Roepman 6 , Iris Simon 6 , Ramon Salazar 2 2 IDIBELL, Institut Català d'Oncologia, L'Hospitalet de Llobregat, Spain; 3 Department of Surgery, Klinikum rechts der Isar,T echnische University Munich, Munich, Germany; 4 Department of Surgery, Medical University of Vienna, Vienna, Austria; 5 Istituto di Anatomia e Istologia Patologica, University di Ferrara, Ferrara, Italy; 6 Agendia BV, Amsterdam, Netherlands and Agendia Inc. , Irvine, CA, US
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Clinical and technical validation of a genomic classifier (ColoPrint) for predicting outcome of stage II colon cancer patients Josep Tabernero, Vall d’Hebron.
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Clinical and technical validation of a genomic classifier (ColoPrint) for predicting outcome of stage II colon cancer
patients
Josep Tabernero, Vall d’Hebron University Hospital, Barcelona, Spain
and Victor Moreno2, Robert Rosenberg3, Ulrich Nitsche3, Thomas Hoffmann-Bachleitner4, Giovanni Lanza5, Jeroen van Akker6, Paul Roepman6, Iris Simon6, Ramon Salazar2
2IDIBELL, Institut Català d'Oncologia, L'Hospitalet de Llobregat, Spain; 3Department of Surgery, Klinikum rechts der Isar,T echnische University Munich, Munich, Germany;
4Department of Surgery, Medical University of Vienna, Vienna, Austria; 5Istituto di Anatomia e Istologia Patologica, University di Ferrara, Ferrara, Italy;
6Agendia BV, Amsterdam, Netherlands and Agendia Inc. , Irvine, CA, US
ASCO recommendation• “direct evidence from randomized controlled trials does not support the
routine use of adjuvant chemotherapy for patients with stage II colon cancer.• Features associated with an increased risk of recurrence include inadequate
lymph node sampling, T4 disease, perforation and a poorly differentiated histology
NCCN guidelines • consider 5FU or clinical trial or observation for low risk patients (T3, no high risk
features)• Consider 5FU/oxaliplatin or clinical trial or observation for high risk patients• High risk features: T4, less than 12 LN assessed, perforation, obstructions,
positive margins, high grade, lymphatic/vascular invasion
Guidelines for Risk Assessment
Whole Genome Array
Training Set (stage I-IV) (n=188) Netherlands Cancer Institute, Leiden Medical Center, Slotervaart
Selection of Final 18-Gene Set & Algorithm
Clinical Validation Study 1 (stage I-III)Institut Catala d’Oncologia Barcelona (J Clin Oncol. 2011;29:17-24)
Standardization of Analytical Methods
In-silico Validation Study (stage I-III) public datasets (n=322)
Dev
elop
men
tVa
lidati
on o
f Col
oPrin
t
Clinical Validation Study 2 (stage II)Munich Hospital Rechts der Isar (J Clin Oncol 28:15s (abstract 3513)
Clinical Validation Study 3 (stage II)Vall d’Hebron, MedUni Vienna, University of Ferrara
PARSC Prospective Study (stage II + III) - ongoingUS, Asian, and European Center (N ~600 stage II)
Clinical Validation Study 4 (stage II-III)MD Anderson (ongoing)
Stag
e II
pool
ed a
naly
sis
STAGE II PATIENTS (N=320)
Pooled Analysis
Variable
Total
ColoPrint
Low High p-value
N=320 % N=209 % N=111 %
Median Age 68.4 67.3 69.3 0.583
Age > 70 No 195 60.9 130 62.2 65 58.6 0.525 Yes 125 39.1 79 37.8 46 41.4
Localization Left 144 56.9 92 55.1 52 60.5 0.413 Right 109 43.1 75 44.9 34 39.5