We monitored the plasma elastase:alpha 1-proteinase inhibitor complexes during chemotherapy for cancer and investigated the relationship between the elastase burden and the onset of adult respiratory distress syndrome (ARDS) in 20 patients with primary lung cancer who received combination chemotherapy; 15 normal nonsmokers served as controls. Of the 20 patients, 6 developed pneumonia, and 6 developed ARDS. We measured peripheral WBCs, C-reactive protein (CRP), plasma elastase:alpha 1-proteinase inhibitor complex (complex), and the ratio of complex/WBC during chemotherapy for cancer. In patients who did not experience complications during combination chemotherapy, WBC counts changed, but levels of complex were normal. In patients who developed pneumonia, levels of complex were abnormally high during the WBC nadir, and the complex/WBC count increased along with the level of CRP. In patients who developed ARDS during chemotherapy for cancer, levels of complex were abnormally high immediately after chemotherapy and remained high after the onset of ARDS. In addition, complex/WBC counts and CRP levels increased at the onset of ARDS. The maximum complex concentration was significantly higher in patients with pneumonia (414.3 +/- 57.2 ng/ml) and ARDS (683.2 +/- 72.8 ng/ml), compared with normal nonsmokers (130.2 +/- 5.5 ng/ml; p < 0.01) and patients who did not develop complications (211.5 +/- 23.3 ng/ml; p < 0.01). The maximum complex/WBC count was also significantly higher in patients with pneumonia (0.56 +/- 0.12) and ARDS (1.03 +/- 0.27), compared with normal nonsmokers (0.03 +/- 0.002; p < 0.01) and patients without complications (0.09 +/- 0.01; p < 0.01). These findings suggested a possible correlation between increased levels of complex and the onset of ARDS.