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575: Improving access to molecularly defined clinical trials for patients with colorectal cancer: The EORTC SPECTAcolor platform.
Title of the conference
2015 Gastrointestinal Cancers Symposium
San Francisco, USA, January 15-17, 2015
Journal of Clinical Oncology
Background: Molecular diagnostics can identify subgroups of colorectal and other cancers that are relevant for the mode of action of new anti-cancer agents. The efficient, GCP-conform and quality assured molecular screening to identify potential study patients is one of the major challenges for targeted drug development. The EORTC has implemented a new collaborative molecular screening platform in order to facilitate these next generation trials. Methods: SPECTAcolor (Screening Patients for Efficient Clinical Trial Access in advanced colorectal cancer) is a pan European network of institutions collaborating in centralized, high-throughput screening of tumor material from patients with colorectal cancer. After informed written consent, patients are screened for molecular alterations. Molecularly annotated patients can be offered so called "downstream" clinical trials. Results: Launched in September 2013, SPECTAcolor is now initiated in 19 clinical centers in 9 countries. As of 12 September 2014, 406 patients were enrolled exceeding the expected accrual target of 300 patients in the first year. Of these 406 patients, 293 patients had their tumor block shipped to the central biobank at the Dresden University Hospital for central quality and pathological review, and core analyses. Tumor samples are being additionally analyzed using next generation sequencing for 360 key cancer alterations in cooperation with the Sanger Institute (Cambridge, UK). In the first year, the blocks were analyzed for 5 baseline biomarkers. KRAS was wild type for exon 2, 3 and 4 in 151/284 pts (53%) and mutated 133 pts (47%; 114 pts in exon 2 (40%), 8 pts in exon 3, and 11 pts in exon 4). NRAS was tested in KRAS wild type pts only; mutations were found in 14 pts (4.9%; 6 pts in exon 2 and 8 pts in exon 3). BRAF mutations, all in exon 15, were found in 18 pts (7%). PI3K mutations occurred in 41 pts (15%; 13 in exon 20 and 28 in exon 9). IHC staining was showing deficient mismatch repair in 16 patients. Conclusions: SPECTAcolor is the first pan-European and EORTC screening platform. Its successful implementation proves that a logistically complex infrastructure to run next generation trials in a multinational setting is feasible.
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