A phase II study of two topotecan regimens evaluated in recurrent @entity902 -sensitive XXXX : a Gynecologic Oncology Group Study (GOG 146Q).

@entity1 @entity43 @entity137 @entity3012 @entity1398 @entity902
OBJECTIVE: To evaluate the efficacy and safety of topotecan in @entity1 with recurrent @entity43 . METHODS: A randomized phase II analysis of @entity902 -sensitive @entity1 with measurable disease was performed independently assessing intravenous topotecan 1.25 mg/m2 daily 5 every 21 days (regimen I) and topotecan 4.0 mg/m2/day on days 1, 8, and 15 of a 28-day cycle (regimen II). All @entity1 were treated until disease progression, unmanageable @entity137 , or @entity1 refusal. Insufficient accrual related to regimen I resulted in a redesign of the study as a single arm phase II trial assessing only regimen II. More complete efficacy data is presented for regimen II as enrollment on regimen I was insufficient for some analyses. RESULTS: A total of 81 @entity1 were enrolled. One @entity1 was ineligible. Fifteen @entity1 received regimen I, while 65 @entity1 were treated with regimen II. The response rate on regimen I (daily 5) was 27% (90% CI: 10-51%) and 12% (90% CI: 6-21%) on regimen II (weekly). The median PFS and @entity3012 were 4.8 and 27.8 months, respectively, for regimen II. Grade 3/4 @entity1398 rate was 93% with daily 5 dosing and 28% for weekly treatment. @entity1398 was very low in both groups. CONCLUSION: The weekly regimen of topotecan appeared less active but resulted in less @entity137 than the daily regimen in @entity902 -sensitive recurrent @entity43 @entity1 .
