Phase II study of oral VP-16-213 in small cell lung cancer

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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.