The EORTC 10041/BIG 03-04 MINDACT trial is feasible: Results of the pilot phase

Rutgers, Emiel J.; Piccart‐Gebhart, Martine; Bogaerts, Jan; Delaloge, Suzette; Veer, Laura van ‘t; Rubio, Isabel T.; Viale, Giuseppe; Thompson, Alastair; Passalacqua, Rodolfo; Nitz, Ulrike; Vindevoghel, A.; Pierga, Jean Yves; Ravdin, Peter M.; Werutsky, Gustavo; Cardoso, Fátima

doi:10.1016/j.ejca.2011.09.016

Cited by 95 publications

(67 citation statements)

References 30 publications

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“…[26][27][28] Currently, the MINDACT trial is being conducted and the first results are expected by the end of this calendar year, which will further assess the predictive capacity of the 70-GS in a randomized prospective setting. 9 In the present study, i.e., in patients who were treated within the indicated area for gene expression profiles characterized as having a fairly good prognosis, it was the prognostic value of the 70-GS that was used to discern a group of patients with such good outcome that no substantial benefit was to be expected of adjuvant CT. The observed effect in the present study is not attributable to a hitherto unproven predictive value of the 70-GS.…”

Section: Discussionmentioning

confidence: 89%

“…Between February 2007 and July 2011, the 70-GS became available in the Netherlands and was offered to patients enrolled in the Microarray in Node-Negative Disease May Avoid Chemotherapy (MINDACT) trial. 9 In this trial patients were randomized between administration of adjuvant CT based on the gene signature or conventional prognostic clinicopathological factors.…”

Section: Methodsmentioning

confidence: 99%

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Using a gene expression signature when controversy exists regarding the indication for adjuvant systemic treatment reduces the proportion of patients receiving adjuvant chemotherapy: a nationwide study

Kuijer

Bommel

Drukker

et al. 2016

Genetics in Medicine

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Methods:Patients within a national guideline directed indication area for 70-GS use who were surgically treated between November 2011 and April 2013 were selected from the Netherlands Cancer Registry database. The effect of 70-GS use on the administration of CT was evaluated in guideline-and age-delineated subgroups addressing potential effect of bias by linear mixed-effect modeling and instrumental variable (IV) analyses.Results: A total of 2,043 patients within the indicated area for 70-GS use were included, of whom 298 received a 70-GS. Without use of the 70-GS, 45% of patients received CT. The 70-GS use was associated with a 9.5% decrease in CT administration (95% confidence interval (CI): −15.7 to −3.3%) in linear mixed-effect model analyses and IV analyses showed similar results (−9.9%; 95% CI: −19.3 to −0.4). Conclusion:In patients in whom the Dutch national guidelines suggest the use of a gene-expression profile, 70-GS use is associated with a 10% decrease in the administration of adjuvant CT. Genet Med advance online publication 19 November 2015

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Section: Discussionmentioning

confidence: 89%

Section: Methodsmentioning

confidence: 99%

Using a gene expression signature when controversy exists regarding the indication for adjuvant systemic treatment reduces the proportion of patients receiving adjuvant chemotherapy: a nationwide study

Kuijer

Bommel

Drukker

et al. 2016

Genetics in Medicine

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“…Retrospective studies informed the development of the products. Ongoing prospective trials will show whether the prognostic value is confirmed (Rutgers et al 2011). The introduction of new products with insufficient evidence of clinical utility should be carefully monitored in order to obtain additional information regarding the usefulness and performance of the test in that specific setting.…”

Section: Discerning Tests With and Without Clinical Utilitymentioning

confidence: 99%

The challenge of implementing genetic tests with clinical utility while avoiding unsound applications

Cornel

Borry

2012

J Community Genet

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“…When presenting the results of the pilot phase of the trial in 2010, the TRANSBIG team announced that the principal finding, to date, was that such a trial could actually be carried out in real-world conditions (Rutgers et al, 2010).…”

Section: The Tailorx and Mindact Trialsmentioning

confidence: 99%

Cancer clinical trials in the era of genomic signatures: Biomedical innovation, clinical utility, and regulatory-scientific hybrids

et al. 2011

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The paper examines two large-scale, North-American and European clinical trials designed to validate two commercially available genomic tumor signatures that predict a patient's risk of breast cancer recurrence and response to chemotherapy. The paper builds on empirical evidence from the two trials to explore the emergence of diverse regulatoryscientific hybrids, i.e. configurations of genomic practice and bioclinical work that depend on linkages between technical, commercial, patient, clinical, and legal interests and institutions. The development of the genomic signatures for each trial -Oncotype DX and MammaPrint -has followed quite different routes. Oncotype began as a commercial platform: the company that produced it did not discover a signature but rather constructed it by asking users at every step what clinical question they wanted the signature to answer and what data would be credible in that regard. The test has been designed to minimally disrupt existing clinical workflows. MammaPrint, on the other hand, began as a breast cancer signature: the researchers who discovered it, at the Netherlands Cancer Institute (NKI), established a company to commercialize it as a test after the fact. MammaPrint requires a change in pathologists' routines. Thus, while these two trials signify a new departure for clinical cancer trials on a number of levels -they both incorporate new models of interaction between biotech companies and public research, and they both aim to establish the clinical relevance of genomic markersthey also embody different socio-technical scripts: one attempts to accommodate established routines, while the other openly challenges prevailing evidential hierarchies and existing biomedical configurations.

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The EORTC 10041/BIG 03-04 MINDACT trial is feasible: Results of the pilot phase

Cited by 95 publications

References 30 publications

Using a gene expression signature when controversy exists regarding the indication for adjuvant systemic treatment reduces the proportion of patients receiving adjuvant chemotherapy: a nationwide study

Using a gene expression signature when controversy exists regarding the indication for adjuvant systemic treatment reduces the proportion of patients receiving adjuvant chemotherapy: a nationwide study

The challenge of implementing genetic tests with clinical utility while avoiding unsound applications

Cancer clinical trials in the era of genomic signatures: Biomedical innovation, clinical utility, and regulatory-scientific hybrids

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