Daily clinical practice of fresh tumour tissue freezing and gene expression profiling; logistics pilot study preceding the MINDACT trial.
OBJECTIVE
The 70-gene prognosis-signature is a prognostic tool for early breast cancer analysis. In addition to scientific evidence, implementation of the signature in clinical trials and daily practice requires logistical feasibility. The aim of our study was to test logistics for gene expression profiling on fresh frozen tumour tissue in the preparation for the prospective, multinational Microarray In Node-negative Disease may Avoid ChemoTherapy (MINDACT) trial.


METHODS
Sixty-four patients were included in six European hospitals. Fresh frozen tumour samples were shipped on dry ice to Agendia B.V., where RNA was isolated and subsequently hybridised on the 70-gene prognosis-signature (MammaPrint).


RESULTS
Tumour samples were obtained in 60 of 64 patients. Among the 60 samples, 11 contained insufficient tumour cells (<50%) and three contained insufficient RNA quality. All 46 samples eligible for genomic profiling were successfully hybridised, and the results were reported on average within 4-5d.


CONCLUSIONS
Gene expression profiling on fresh frozen tissue is feasible in daily clinical practice.
Mook
S
S
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Division of Pathology and Surgical Oncology, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands.
Bonnefoi
H
H
Geneva University Hospitals, Geneva, Switzerland.
Pruneri
G
G
European Institute of Oncology, University of Milan, Milan, Italy.
Larsimont
D
D
Institute Jules Bordet, Brussels, Belgium.
Jaskiewicz
J
J
Medical University of Gdansk, Gdansk, Poland.
Sabadell
M D
MD
Vall d'Hebron University Hospital, Barcelona, Spain.
MacGrogan
G
G
Institute Bergonié, Bordeaux, France.
Van't Veer
L J
LJ
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Division of Pathology and Surgical Oncology, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands; Agendia B.V., Amsterdam, The Netherlands.
Cardoso
F
F
Institute Jules Bordet, Brussels, Belgium.
Rutgers
E J
EJ
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Division of Pathology and Surgical Oncology, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands. Electronic address: e.rutgers@nki.nl.
D000368:Aged; D014408:Biomarkers, Tumor / Q000235:genetics*; D001943:Breast Neoplasms / Q000235:genetics / Q000473:pathology; D018270:Carcinoma, Ductal, Breast / Q000235:genetics / Q000473:pathology; D002986:Clinical Trials as Topic; D015925:Cryopreservation / Q000379:methods / Q000592:standards*; D005060:Europe; D005240:Feasibility Studies; D005260:Female; D020869:Gene Expression Profiling; D006801:Humans; D016015:Logistic Models; D008875:Middle Aged; D020411:Oligonucleotide Array Sequence Analysis; D010865:Pilot Projects; D013048:Specimen Handling / Q000379:methods / Q000592:standards*
D014408:Biomarkers, Tumor