Early Phase II Study of Oral Administration of Etoposide for 21 Consecutive days in Patients with Non-small-cell Lung Cancer

: An early phase II clinical study was done to investigate the activity and the safety of oral administration of etoposide for 21 consecutive days in patients with non-small-cell lung cancer. An interim analysis was done after registration of 24 cases. One case was a dropout because of an insufficient administration period (4 days). The other 23 cases were complete: they comprised 9 cases of adenocarcinoma, 13 cases of squamous cell carcinoma, and 1 case of large cell carcinoma. Prior therapy had not been given in two cases. The doses used were 50 mg/person/day in 12 cases and 75 mg/person/day in 11 cases. The response observed was one case of at 50 mg/person/day to stage IV squamous cell carcinoma, 17 cases were no change, 5 cases were progressing disease, and giving a response rate of 4.3% in complete cases. Considering those results, we decided that it would be difficult to achieve a 20% response rate by the end of this study, and therefore the study was terminated. The side effects of the regimen were tolerable. In conclusion, etoposide was not active against non-small-cell lung cancer at the dosage and schedule employed. Further investigation is required to obtain a more effective form of therapy.