[A phase II study of NK171 (etoposide)]

A phase II study of NK171 (etoposide), a semisynthetic derivative of podophyllotoxin, was carried out in patients with primary lung cancer at 46 institutes throughout Japan. Out of 198 patients registered for the study, 130 were judged eligible by the committee for extramural review and the response rate was 13.8% (18/130). The response rates were 17.4% (15/86) by i.v. administration and 6.8% (3/44) by oral administration. In the case of i.v. administration, the response was observed only for small cell carcinoma and the response rate was 32.6% (15/46). In the case of oral administration, the response rates were 16.7% (1/6) for squamous cell carcinoma, 12.5% (1/8) for adenocarcinoma and 3.4% (1/29) for small carcinoma. As a hematological toxicity, leukopenia (less than 3,000/mm3) was observed in 66.7% and 35.3% of cases treated, for i.v. and oral administration, respectively. With regard to the clinical picture, alopecia was observed at high incidences of 73-82% in the cases of both i.v. and oral administration.