Background: Topotecon is a specific inhibitor of topoisomerase I. It is an effective drug of small cell lung cancer. An oral formulation of topotecan is available and has just rectified to treat extensivedisease small cell lung cancer by FDA this year. The aim of this trial is to compare oral topotecan/intravenous cisplatin (TC) with intravenous etoposide/cisplatin (EP) in patients untreated small cell lung cancer.
Methods: Sixty-six patients were enrolled. Thirty patients were assigned to oral topotecan 1.4 mg*m(-2)*d(-1), from d1 to d5, with cisplatin 75 mg/m(2) on d1. Thirty-six patients were assigned to etoposide 100 mg*m(-2)*d(-1), from d1 to d3, with cisplatin 75 mg/m(2) on d1 every 21 days.
Results: Response rate was similar between groups TC, 53.3% vs EP, 60.0%. Overall survival was little different TC, 14.58 month vs EP, 12.19 months. The regimens were similarly tolerable. Grade 3/4 neutropenia and thrombocytopenia occurred more frequently with EP (42.8% vs 10.0% and 11.4% vs 3.3%, respectively), whereas grade 3/4 anaemia occurred more frequently with TC (10% vs 2.8%).
Conclusions: Oral topotecan/cisplatin provide similar efficacy and tolerability to the standard etoposide/cisplatin in patient untreated small cell lung cancer. It may provide more convenience method to intravenous treatment.