The comparison of CAP chemotherapy and radiotherapy to radiotherapy alone for resected lung cancer with positive margin or involved highest sampled paratracheal node (stage IIIA). LCSG 791.

This study was conducted to determine the effect of adjuvant chemotherapy on locally advanced resected non-small cell lung cancer. Anatomic eligibility requirements were either positive resection margins or tumor involvement of the highest sampled mediastinal lymph node. One hundred seventy-two patients were randomized to receive either postoperative thoracic irradiation alone or together with six cycles of CAP chemotherapy (cyclophosphamide, doxorubicin, and cisplatin). The chemotherapy arm showed significantly longer recurrence-free survival (p = 0.004). This benefit accrued to patients with both nonsquamous (p = 0.01) and squamous (p = 0.08) cell carcinoma. At 1 year following randomization, there was a 14% difference in survival favoring the chemotherapy arm. Chemotherapy significantly reduced distant metastases. Median survival was 20 months for the chemotherapy arm and 13 months for the radiotherapy alone arm. The 2-year survival rate for the entire study population was 35%. Toxic reactions were primarily predictable hematologic, GI, and alopecia toxicity expected from CAP. Esophagitis was not a significant problem.