The importance of stabilization as an endpoint in the treatment of metastatic colorectal carcinoma: recent quality of life studies.

Assessment of the effectiveness of new anticancer chemotherapies in clinical trials is usually based on the degree of objective response obtained. Response is usually defined as 'complete', when there is complete disappearance of all detectable tumor, or 'partial', when there is a 50% reduction in the sum of the products of the largest perpendicular diameters of all measurable disease, with no new lesions (Advanced Colorectal Cancer Meta-analysis Project). Both clinicians, concerned with the welfare of their patients, and healthcare administrators, keen to be assured of cost-effectiveness within their restricted budgets, see such response (along with enhanced survival) as a cardinal indicator of efficacy. Response rates are a primary influence on their decision to treat, or to sanction payment for treatment, with a particular medication. There is, however, growing evidence to suggest that stabilization of disease is also an important endpoint in chemotherapy for carcinoma, with important benefits for the patients' quality of life (QoL). We report on recent international studies on the effects of the topoisomerase I inhibitor irinotecan (Campto) as second-line treatment in patients with metastatic colorectal cancer. These confirm the value of stabilization, as well as response, in such patients, not only in bringing QoL benefits, but also in reducing length of hospitalization and hence costs.