Topic Abstract

Background: Clinical trials support the efficacy of the biologic therapies cetuximab and bevacizumab for the treatment of metastatic colorectal cancer, but their real-world effectiveness in diverse populations has not been well evaluated.

Objective: To evaluate the effectiveness of the biologic therapies cetuximab and bevacizumab by studying the balance of benefits and harms of adding biologic therapy to standard CRC chemotherapy regimens treatments for CRC.

Study Design: Retrospective cohort study.

Methods: Data sources include cancer registries, the Medicare program, the National Cancer Center Network (NCCN), the National Cancer Institute’s Cancer Care Outcomes Research and Surveillance Consortium (CANCORS), and a phase IV industry sponsored registry. The study will examine both survival outcomes and the incidence of serious treatment complications such as hospitalization, major bleeding episodes, heart attacks and strokes. We will measure the size of the implementation gap (Efficacy-Effectiveness between trial and non-experimental data) not only for patients with attributes similar to clinical trial participants, but also for patients who were explicitly excluded from or underrepresented in the biologic treatment trials (e.g., old age, comorbidity). This knowledge can be used to prioritize new trials, refine practice guidelines and treatment recommendations and will provide stakeholders with a comprehensive understanding of the ramifications of integrating biologic therapy into the CRC cancer treatment armamentarium.

Expected Outputs: Scientific reports

Expected Project Completion Date: Fall 2011.