Successful Implementation of SPECTAcolor, the First Pan-European and EORTC Screening Platform, Proves that a Logistically Complex Infrastructure to Run Next Generation Trials in a Multinational Setting is Feasible

Over 500 patients in and availability of high quality biological materials

Screening Patients for Efficient Clinical Trial Access in advanced colorectal cancer's (SPECTAcolor) successful start has demonstrated its viability to facilitate next generation cancer clinical trials. It has been successfully implemented across 19 clinical centres located in nine European countries and has recruited over 500 patients since its launch in September 2013. The observed frequency of mutations is similar to that observed in previous colorectal cancer clinical trials.

In addition, pathological review and core analyses of tumour blocks shipped to the central biobank at Dresden University Hospital for central quality, deemed over 98% of the samples were adequate. Tumour samples are also analysed by Next Generation Sequencing for 360 key cancer genes in cooperation with the Sanger Institute (Cambridge, UK). After informed written consent, patients are screened for molecular alterations. Molecularly annotated patients can be offered so called “downstream” clinical trials.

The results were presented by SPECTAcolor’s coordinator Dr. Gunnar Folprecht of the Dresden University Hospital at the 2015 Gastrointestinal Cancers Symposium held 15-17 January 2015 in San Francisco. This successful implementation is evidence that a logistically complex infrastructure to run next generation trials in a multinational setting is feasible.

Improving access to molecularly defined clinical trials for patients with colorectal cancer

Treatments for patients with cancer are becoming increasingly tailored to the molecular characteristics of the particular patient and disease. Consequently, molecularly characterising a patient's tumour is now a prerequisite for them to access the appropriate clinical trial for their particular cancer type. Assessing their tumours, however, is more easily said than done, because the required testing is beyond the scope of most hospitals. 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 European Organisation for Research and Treatment of Cancer (EORTC) built a collaborative molecular screening platform, SPECTAcolor, which provides the necessary infrastructure to screen adult patients with advanced-stage colorectal cancer for mutations in colorectal cancer biomarkers. 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 tumour block shipped to the central biobank.

A preliminary analysis of biological materials for five baseline cancer biomarkers showed:

  • KRAS was wild type for exon 2, 3 and 4 in 151 of 284 patients (53%) and mutated in 133 patients (47%); 114 patients in exon 2 (40%), 8 patients in exon 3, and 11 patients in exon 4.
  • NRAS was tested in KRAS wild type patients only and mutations were found in 14 patients (4,9%); 6 patients in exon 2 and 8 patients in exon 3.
  • BRAF mutations, all in exon 15, were found in 18 patients (7%).
  • PI3K mutations occurred in 41 patients (15%), 13 in exon 20 and 28 in exon 9.
  • Immunohistochemistry staining was showing deficient mismatch repair in 16 patients.

SPECTAcolor provides an excellent opportunity for molecular-oriented clinical trials in Europe based on innovative and high-quality partnership models with the pharmaceutical industry. It is supported by a unique partnership between the EORTC Charitable Trust and the Corporate Social Responsibility Program of Alliance Boots.