Almac Diagnostics today announced details of a global multi-centre collaborative lung cancer study with leading research organisations in the USA, Canada, Asia and Europe, which, according to Professor Paul Harkin, has the “potential to benefit many thousands of patients worldwide”. The study is led by Dr Dean Fennell, Cancer Research UK clinician scientist and senior lecturer in thoracic medical oncology at Queen's University, Belfast. The study, managed in partnership with Almac Diagnostics, will utilise over 1,500 non-small cell lung cancer (NSCLC) tumour samples from 15 research centres.
The aim of the study is to generate a gene expression signature that will allow clinicians to stratify patients with early NSCLC (stages I and II) into those who will relapse after surgery and those who will have disease-free survival with surgery alone. This gene signature will form the basis of a clinical test to identify patients at high risk of lung cancer recurrence after surgery, and who may therefore benefit from adjuvant treatment.
The study will utilise Almac’s unique Cancer DSA™ technology, a proprietary microarray platform designed to measure gene expression in archived FFPE (formalin fixed paraffin embedded) tissue. This microarray platform identifies tens of thousands of transcripts that are specific to lung cancer and not available on conventional commercial arrays.
The use of FFPE tissue samples will enable Almac to retrospectively generate and validate this powerful prognostic test. This has clear clinical utility, as frozen tissue is not routinely collected during surgery.
To date, most prognostic gene expression signatures have been developed using relatively small numbers of samples. The benefit of being able to access large numbers of archive samples retrospectively is the ability to identify molecular sub types, which are likely to influence patient’s prognosis.
Professor Paul Harkin, president and managing director of Almac Diagnostics, explained: “This is the largest transcriptional study of its type and has the potential to benefit many thousands of patients worldwide. Our microarray technology means we can now access a wide range of genetic material, previously not available through commercial array analysis, in order to validate prognostic tests. This fits in with Almac’s vision to be the global leader in the provision of translational genomic based solutions for the advancement of patient care”.
Dr. Dean A. Fennell, the academic lead on the study from the centre for cancer research and cell biology at Queen’s, added: “Lung cancer is a global health burden and it accounts for around 30% of cancer deaths in the USA and Europe. Prognosis following diagnosis of NSCLC, the most common form of the disease in 80% of patients, remains abysmal with an overall five-year survival of only 10-15%, a figure that has not changed in decades.”
“However,” Dr Fennell continues, “one fifth of patients have early stage NSCLC that is potentially curable following surgery, which results in five-year survival rate of 40-82%, depending on the tumour size and the degree of local invasion. While it is now accepted that the use of adjuvant chemotherapy reduces the risk of recurrence in a minority of patients, no routinely used molecular test exists to select those patients at a high risk of recurrence. This large scale gene expression study will generate the first such test capable of identifying patients with high risk NSCLC. It is anticipated that submission to international regulatory bodies for approval will occur by 2010 to enable its routine implementation in the clinic.”
Professor Giorgio Scagliotti, department of clinical and biological sciences at the University of Turin and a leading world expert on lung cancer, said: “Potentially this study will generate data easily applicable to clinical practice and will hopefully lead to a much better treatment optimisation for our patients."
Collaborators in the study include Queen’s University, Belfast, University of Turin, St. James Hospital, Dublin University of Texas MD Anderson Cancer Centre, Royal Brompton and Harefield Hospital London and Saccomanno Research Institute at St. Mary’s Hospital and Medical Center, Grand Junction, Colorado, and Guy’s and St Thomas NHS Foundation Trust.
