Treatment Response Evaluation in Patients With Non-resectable Colorectal Liver Metastases A Feasibility Study

Clinical study Evaluation of oncological treatment response in patients with non-resectable colorectal liver metastases based on microscopic tissue analyses obtained by a minimal invasive technique.

Background The incidence of colorectal cancer (CRC) in Denmark is 4.200 cases and the prevalence is approximately 30.000. One in five patients will have synchronous liver metastases (CRC-LM) and a similar number will develop metachronous CRC-LM during the course of the disease.

Surgery is the cornerstone in treatment of CRC-LM with a curative intent, most often in a combination with chemotherapy. There are no randomized studies comparing surgery to chemotherapy alone, but data indicate that there is an early advantage in progression free survival when surgery is combined with chemotherapy in comparison to surgery alone, although this might not translate into an overall survival benefit. The 5 year survival rate for patients treated with liver resection is approximately 40 % and even higher in selected series. Clinical series suggest that one in four patients with CRC-LM may be resected, whereas the few population based studies report of resection rates as low as 4%. In order to improve the overall treatment of cancer patients in Denmark, the Danish Health and Medicines Authority has launched a series of National Integrated Cancer Pathways ("Kræftpakker"). A pathway for CRC-LM was issued by the end of 2008 in order to reduce processing time (e.g. faster diagnosis and quicker onset of treatment), and the compulsory use of a multidisciplinary team conference (MDT) evaluation in all patients with CRC-LM was stated in this document. Thus, all patients in Denmark with CRC-LM must be evaluated at an MDT in one of the four regional centers treating these patients (Aalborg, Aarhus, Odense or Copenhagen). However, epidemiological studies from the Region of Southern Denmark on gastro-esophageal and pancreatic cancer clearly indicate that a substantial number of patients are not getting any active treatment and/or are not even presented and evaluated on the regional MDT. This could also apply to patients with CRC-LM, and this may explain some of the differences in the reported treatment rates between population based and clinical based studies.

When the patients with CRC-LM are evaluated on the regional MDT, they will be divided into five groups based on MR/CT scans and an assessment of co-morbidity and performance status:

1. Patients with resectable liver metastases
2. Patients with potentially resectable liver metastases. These patients will need "downstaging" in order to undergo resection
3. Patients with non-resectable liver metastases.
4. Patients with disseminated extra-hepatic disease
5. Patients unfit for surgery and chemotherapy