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Evidence-Based Oncology January/February

From Bench to Bedside: Promising Colon Cancer Clinical Trials

Jill M. Comeau, PharmD, BCOP; and Brice Labruzzo Mohundro, PharmD, BCACP
Similar to most malignancies, the future of colon cancer research is focused on targeted and personalized therapy, with VEGF being the most commonly targeted pathway in current clinical trials. With the utilization of targeted therapy, the focus of treatment becomes the identification of patients who will benefit from this therapy. This is already seen in current practices, with the use of KRAS testing becoming the standard of care prior to initiating treatment for mCRC and utilization of EGFR inhibitors. Other pathways which are utilized or have been studied in other malignancies are also being studied in CRC, including HDAC, c-MET, and PARP. Along with traditional chemotherapy agents, new agents NKTR-102, EZN-2208, and ThermoDox are being created to improve the pharmacokinetics and delivery of the drug, which will hopefully improve both clinical benefit and patient tolerability. Immunomodulatory pathways, previously not found to be beneficial, have shown some promise in phase I and II trials. Currently, the main concern from a managed care perspective is the cost-benefit ratio of these medications. With 2 new agents approved in 2012, with only a 1.4-month OS benefit, the question that arises is the cost, both economic and quality of life. Past pharmacoeconomic studies have looked at the use of currently approved targeted therapies and the incremental cost-effectiveness ratio (ICER) per discounted life-year. Based upon 2008 Medicare reimbursements, the ICER in $/year, or the cost of saving a life-year, with targeted therapies (bevacizumab or cetuximab) added to conventional chemotherapy, was $170,896 per year compared with $102,336 per year for conventional chemotherapy. 54 With the approval of more targeted therapies, pharmacoeconomic studies are pivotal in assessing the effects on future healthcare costs. Future QOL studies would be also useful to demonstrate if the response or small survival gains are worth the toxicities, especially in non-curable diseases like CRC.

Author Affiliations: University of Louisiana at Monroe College of Pharmacy– Shreveport Campus (JMC), Shreveport, LA; University of Louisiana at Monroe College of Pharmacy–Baton Rouge Campus (BLM), Baton Rouge, LA.

Funding Source: None.

Author Disclosures: The authors (JMC, BLM) report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

Authorship Information: Concept and design (JMC, BLM); acquisition of data (JMC, BLM); analysis and interpretation of data (JMC, BLM); drafting of the manuscript (JMC, BLM); critical revision of the manuscript for important intellectual content (JMC, BLM); and administrative, technical, or logistic support (JMC, BLM).

Address correspondence to: Jill M. Comeau, PharmD, BCOP, Assistant Professor, University of Louisiana at Monroe College of Pharmacy–Shreveport Campus, 1725 Claiborne Ave, Shreveport, LA 71103. E-mail:
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