A total of 116 patients with
small cell lung cancer were randomized to receive either:
cyclophosphamide, 750 mg/m2,
doxorubicin, 50 mg/m2, and
vincristine, 2 mg iv (Regimen A), or the same drugs plus
etoposide, 100 mg/m2 iv daily for 2 days (
Regimen B) every 3 weeks. Complete responders received whole-brain
radiation therapy. The overall response rates were 50% for Regimen A and 65% for
Regimen B (P less than 0.05). The complete response rates were 18% for Regimen A and 44% for
Regimen B (P less than 0.01). For patients with limited disease, the complete responders were 35% on Regimen A and 52% on
Regimen B (P = 0.26); for those with extensive disease, the complete responders were 0% on Regimen A and 35% on
Regimen B (P = 0.002). The median survival for complete responders was 17 months on Regimen A and 20 months on
Regimen B. The difference is not statistically significant. Toxicity was tolerable for both groups; however, it was greater for the
etoposide arm. We conclude that although
etoposide improves the overall response rates in patients with
small cell lung cancer, especially those with extensive disease, the addition of this
drug does not lead to improved survival.