Second-line outcomes in metastatic colorectal cancer--raising the bar for the high jump rather than the doing the limbo.

Metastatic colorectal cancer is a significant burden to patients and healthcare systems worldwide. While outcomes have improved in the past 20 years, gains in survival in the second-line setting have been achieved at a significant monetary cost. The American Society of Clinical Oncology recently published guidelines on the definition of a clinically meaningful outcome as the measure of success of a therapy. We reviewed the FDA labels for drugs used in the second-line treatment of metastatic colorectal cancer and found that outcomes fell short of American Society of Clinical Oncology's definition of clinically meaningful. There was also variation in the methods used to determine cost-effectiveness and value of outcomes. We discuss these observations and the challenges associated with justifying payment for expensive drugs that often only achieve marginal benefits.