Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer

OBJECTIVES:

- Determine whether the presence of occult micrometastases (OM) detected by
immunohistochemistry or reverse transcriptase-polymerase chain reaction (RT-PCR) in
histologically negative lymph nodes or bone marrow is associated with poorer survival
among patients with stage I non-small cell lung cancer.

- Determine the incidence of OM in histologically negative lymph nodes and bone marrow by
immunohistochemistry (staining for cytokeratins and the CEA glycoprotein) or RT-PCR (to
detect CEA mRNA) in these patients.

- Assess the sensitivity of immunohistochemistry relative to RT-PCR for detecting OM in
these patients.

- Determine the relationship between tumor size (or T-stage) and the presence of OM
detected by immunohistochemistry or RT-PCR in these patients.

- Determine the relationship between the presence of OM and disease-free survival in
these patients.

- Determine the relationship between the site of OM and incidence of recurrence, site of
recurrence, and survival of these patients.

OUTLINE: At the time of thoracotomy and pulmonary resection, patients have samples of bone
marrow, primary tumor, and intrathoracic lymph nodes harvested. The presence of occult
metastases in bone marrow and lymph nodes is assessed using immunohistochemistry or reverse
transcriptase-polymerase chain reaction.

Patients are followed every 6 months for 5 years.

- Clinical stage I proven or suspected new non-small cell lung carcinoma T1 or T2
primary N1 or N2 lymph nodes <1cm on CT or negative mediastinoscopy

- ≥ 5 years since prior chemo or XRT; no prior mediastinal or chest XRT.

- ≥ 18 years of age

- No history of previous lung cancer or concomitant malignancy