Rationale and objectives: Lung cancer is the leading cause of cancer death in the United States. Mortality outcomes have improved only modestly over the past 30 years. There is intense focus on the development of better treatments for lung cancer. Major issues include the cost and time duration of the clinical trials required to establish the utility of a drug so that it can be formally approved by regulatory agencies. In clinical settings, biomarkers that accelerate assessments of responses to treatment could benefit patients by providing earlier diagnoses of progressive disease, particularly when there are multiple options for treatment, and the effects of toxicity from one treatment tend to limit the ability to administer the next line of therapy.
Materials and methods: Quantifying longitudinal changes in tumor volumes using computed tomography could eventually become a more useful surrogate endpoint for assessing tumor responses or progression events than simple unidimensional measurements.
Results: The authors review the historical development of response measurements in lung cancer, set out the medical context for specifying volumetric imaging requirements and goals, compare volumetric technique to conventional methods, and identify the imaging profiles being pursued.
Conclusion: The Quantitative Imaging Biomarkers Alliance is investigating volumetric computed tomographic acquisition and analytic methods to increase the analytic power per subject enrolled in clinical trials to reduce the number of total subjects needed or shorten the length of time an individual needs to be followed to reliably establish drug response.