IV topotecan (TOPT) in patients (Pts) who relapse following platinum(P)/paclitaxel(TX) treatment: subset analysis of a phase III trial

A comparison of oral and IV topotecan (TOPT) was made using a randomised ph ase III study. From this study, a subset of patients were taken from the IV arm of the study, who had failed first line treatment with platinum and pa clitaxel as combination therapy (TX/P). This subset was compared to those o ther IV patients who had received first line therapy with a regimen other t han platinum with paclitaxel (non-TX/P). Demographically there were no subs tantial differences between the populations being compared. Those patients who had received TX/P as first line therapy had a response rate at least as good (22.2%) as those patients who had received non-TX/P (18.2%), and tole rability was comparable. Therefore single agent TOPT 1.5mg/m(2) daily shoul d be considered as second line treatment for patients who had failed TX/P(t he accepted standard).