Collaborative study for the evaluation of multiple simultaneous markers in lung cancer

The search for tumor markers suitable for use in diagnosis and management of patients with lung cancer has met with limited success because each available marker lacks sufficient sensitivity and specificity. We have begun a collaborative study to evaluate multiple simultaneous serum markers to determine whether there is a combination that will increase both sensitivity and specificity to the degree that noninvasive serologic tests might provide a means for managing patients with lung cancer. The National Cancer Institute, Bethesda, Maryland, has established a Serum Bank which can supply identical aliquots of the same serum sample to several different laboratories to perform quantitative assays for a number of markers. The results of these assays will serve as a data base to be analyzed for selection of the optimal grouping of markers for the different types of lung cancer and for evaluation of different biostatistical techniques to maximize the benefit derived by multiple marker determination. The evaluation of multiple markers will be carried out in several separate steps: (a) determination of a combination of markers that discriminate advanced lung cancer from benign lung disease; (b) demonstration of the ability of that combination to define early or localized lung cancer; (c) selection of a combination that best separates lung cancer from cancer of other sites; (d) testing of combined markers for the ability to predict response to therapy, including detection of early recurrence before clinical signs appear; and (e) evaluation of the combination(s) for effectiveness in detecting lung cancer in asymptomatic individuals. The experimental design and selection of markers will be presented and discussed.