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Study objective : To determine whether monoclonal antibody (Mab) detection of tumor-associated antigen expressed on sputum epithelial cells precedes clinical presentation of second primary lung cancer. Design Setting/Participants : Eleven oncology centers collaborate in the accrual of 1,000 patients with stage I non-small cell lung cancer (NSCLC) who had undergone resection. The Mabs examined in this study (624H12, 703D4) detect two promising oncofetal/differentiation markers (ie, a difucosylated Lewis X and a 31-Kd glycoprotein antigen). Interventions : Induced sputum specimens are evaluated for quality, then are Papanicolaou and immunostained by independent central laboratories at enrollment and annually thereafter. The predictive value of Mab markers is compared with routine morphologic study for detection of second primary lung cancer during an anticipated 3 years of accrual and 1 year of follow-up. Measurements and results : Five hundred eighty of an anticipated 1,000 patients have been accrued on schedule. Patients are primarily white (88.6%), former smokers (75.9%), men (55.6%), with a median age of 66.7, and joined the study at an average of 3.7 years following resection of a stage 1 NSCLC (34.4% squamous, 43.6% adenocarcinoma). Central laboratories found less dysplasia and more unsatisfactory specimens (27.3%) than do the accrual institution laboratories. Immunostaining identifies more suspicious cells than does morphologic study. However, only two second primary lung cancers (eight total deaths) have occurred to date. Conclusions : Halfway through the accrual, we describe the study design and preliminary observations. This study illustrates rational selection of carcinogenesis markers by linkage of marker expression on preneoplastic specimens with subsequent expression on tumor tissue.

To determine the role of transbronchial needle aspiration (TBNA) in the diagnosis of peripheral pulmonary lesions, TBNA was performed in 20 patients who had unexplained nodules (15) or masses (five) and no endobronchial abnormality. The TBNA cytopathology was positive for malignancy in 11 patients, and provided the only diagnostic specimen in seven. The TBNA yield was significantly higher than that of forceps biopsy or bronchial brushing, either alone or in combination (p less than 0.05). The procedure was complicated by pneumothorax in one patient. Transbronchial needle aspiration is diagnostically useful and safe for evaluation of the peripheral pulmonary nodule.

A comparison was made of the efficacy of pleural needle biopsy and pleural-fluid cytopathology in the diagnosis of pleural tumor in a group of 271 patients. A malignant tumor involving the pleura was present in 95 cases. Needle biopsy alone provided a diagnosis of tumor in 53 instances, and cytopathologic preparations were diagnostic in 69 patients. A diagnosis was established on either the biopsy or cytopathology, or both, in 86 cases (90 percent). These results indicate the value of using both biopsy and fluid cytology in the evaluation of pleural effusion, which often is due to involvement of the pleura by malignant neoplasm.

Thirty-two consecutive patients with mediastinal lesions suggestive of bronchogenic carcinoma underwent transbronchial needle aspiration. Eighteen of 20 patients (90 percent) with proved bronchogenic carcinoma had malignant cytology specimens or tissue fragments. Of 12 patients with normal cytology specimens, six were subsequently proved to have nonneoplastic disease. Transbronchial needle aspiration appears to offer a sensitive and specific alternative to more invasive surgical techniques used in the diagnosis of malignancies with mediastinal involvement

C ytologic examination of sputum has long been used in the diagnosis of bronchogenic carcinoma. Tumors of the segmental and larger bronchi may shed cells detectable in the sputum for many months prior to becoming symptomatic or radiographically apparent.’ During this period of their development, standard endoscopic techniques have frequently proven inadequate to localize the lesion with sufficient accuracy to permit definitive therapy.2 As increasing emphasis is being placed on early diagnosis and as sputum cytology becomes more widely used, we can expect an increasing need to evaluate patients whose diagnosis of cancer is based solely on sputum cytology. It is the purpose of this paper to summarize the endoscopic techniques and observations we have found useful in discovering the source of malignant cells found in the sputum of patients whose tumor site cannot otherwise be located. This work was performed at The Johns Hopkins Hospital as one aspect of a screening study designed to identify, localize and treat lung cancer discovered in a working population of cigarette smoking men over age 45 years.