title: Phase II study of oral VP-16-213 in small cell lung cancer.
abstract: The soft, gelatin capsule of VP-16-213 (etoposide) was given orally and evaluated in a Phase II study of 56 patients with histologically confirmed small cell lung cancer. The drug was given in a dose of 200 mg/body/day orally for 5 consecutive days, and the courses were repeated every 3 to 4 weeks depending upon the individual patient recovery from myelosuppression. An overall objective response was obtained in 17 patients (30%), five previously treated (23%) and 12 untreated (35%). The median days for response after the start of treatment was 14 d (range, 5 to 64), and the median duration of response was 62 days (range, 28 to 278). The dose-limiting factor was leukopenia, while thrombocytopenia was also experienced. Gastrointestinal reactions to toxicity and alopecia were also observed, but they were not overwhelming. The study demonstrated that the VP-16-213 soft gelatin capsule given orally is effective against small cell lung cancer without clinical cross-resistance to other cytotoxic agents. Its usefulness in combination chemotherapy is thus suggested.
authors.affiliation: Second Department of Internal Medicine, Kyoto University, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Matsui
authors.forename: S
authors.initials: S
authors.lastname: Oshima
authors.forename: M
authors.initials: M
authors.lastname: Kado
authors.forename: M
authors.initials: M
authors.lastname: Nakayama
authors.forename: K
authors.initials: K
authors.lastname: Shimokata
authors.forename: S
authors.initials: S
authors.lastname: Sakai
authors.forename: F
authors.initials: F
authors.lastname: Ito
authors.forename: E
authors.initials: E
authors.lastname: Chikata
authors.forename: K
authors.initials: K
authors.lastname: Hara
authors.forename: T
authors.initials: T
authors.lastname: Kanda
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018288:Carcinoma, Small Cell / Q000188:drug therapy*; D004341:Drug Evaluation; D005047:Etoposide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged
chemical_list: D005047:Etoposide