TY - JOUR
T1 - Gene signature evaluation as a prognostic tool
T2 - Challenges in the design of the MINDACT trial
AU - Bogaerts, Jan
AU - Cardoso, Fatima
AU - Buyse, Marc
AU - Braga, Sofia
AU - Loi, Sherene
AU - Harrison, Jillian A.
AU - Bines, Jacques
AU - Mook, Stella
AU - Decker, Nuria
AU - Ravdin, Peter
AU - Therasse, Patrick
AU - Rutgers, Emiel
AU - van't Veer, Laura J.
AU - Piccart, Martine
PY - 2006/10
Y1 - 2006/10
N2 - This Review describes the work conducted by the TRANSBIG consortium in the development of the MINDACT (Microarray In Node negative Disease may Avoid ChemoTherapy) trial. The goal of the trial is to provide definitive evidence regarding the clinical relevance of the 70-gene prognosis signature, and to assess the performance of this signature compared with that of traditional prognostic indicators for assigning adjuvant chemotherapy to patients with node-negative breast cancer. We outline the background work and the key questions in node-negative early-stage breast cancer, and then focus on the MINDACT trial design and statistical considerations. The challenges inherent in this trial in terms of logistics, implementation and interpretation of the results are also discussed. We hope that this article will trigger further discussion about the difficulties of setting up and analyzing trials aimed at establishing the worth of new methods for better selection of patients for cancer treatment.
AB - This Review describes the work conducted by the TRANSBIG consortium in the development of the MINDACT (Microarray In Node negative Disease may Avoid ChemoTherapy) trial. The goal of the trial is to provide definitive evidence regarding the clinical relevance of the 70-gene prognosis signature, and to assess the performance of this signature compared with that of traditional prognostic indicators for assigning adjuvant chemotherapy to patients with node-negative breast cancer. We outline the background work and the key questions in node-negative early-stage breast cancer, and then focus on the MINDACT trial design and statistical considerations. The challenges inherent in this trial in terms of logistics, implementation and interpretation of the results are also discussed. We hope that this article will trigger further discussion about the difficulties of setting up and analyzing trials aimed at establishing the worth of new methods for better selection of patients for cancer treatment.
UR - http://www.scopus.com/inward/record.url?scp=33750601244&partnerID=8YFLogxK
U2 - 10.1038/ncponc0591
DO - 10.1038/ncponc0591
M3 - Review article
C2 - 17019432
AN - SCOPUS:33750601244
SN - 1743-4254
VL - 3
SP - 540
EP - 551
JO - Nature clinical practice oncology
JF - Nature clinical practice oncology
IS - 10
ER -