Trial Information

EARLY DETECTION OF SECOND PRIMARY LUNG CANCERS BY SPUTUM CYTOLOGY IMMUNOSTAINING

OBJECTIVES: I. Evaluate whether immunostaining of induced sputum specimens improves the
sensitivity and specificity of routine morphologic sputum surveillance to detect second
primary lung cancer in patients with previously resected nonsmall cell lung cancer. II.
Evaluate which patients are at risk of developing a second primary lung cancer by
immunostaining specimens from patients with no morphologic atypia on routine Papanicolaou
cytology. III. Make available archived sputum samples and bronchial washings for further
analysis of new antibodies and techniques. IV. Evaluate whether analysis of elevations of
relevant growth factors in bronchial lavage fluid from patients with positive immunostaining
or morphologic atypia increases the accuracy of early detection. V. Evaluate whether
quantitation of shed antigens in sputum increases the accuracy of early detection. VI.
Evaluate whether the extent of airway obstruction, as measured by the forced expiratory
volume, can predict an increased risk of developing lung cancer.

OUTLINE: Screening for Second Primary Lung Cancer. Annual sputum induction for Papanicolaou
cytology and immunostaining (using monoclonal antibodies 624H12 and 703D4), with optional
pulmonary function tests and fiberoptic bronchoscopy with bronchial washings.

PROJECTED ACCRUAL: 1,100 patients will be entered over 3 years. The sample size will be
adjusted based on the rate of positive staining in the first 100 patients. Patients followed
at uncertified centers are analyzed separately.