Phase 2 study of intraperitoneal topotecan as consolidation chemotherapy in ovarian and primary peritoneal carcinoma

摘要: BACKGROUND. Intravenous topotecan is approved for the treatment of ovarian cancer (OC). In intraperitoneal (i.p.) studies, 20 mg/m2 dosing was tolerable. This study evaluated feasibility, safety, and preliminary efficacy i.p. as consolidation chemotherapy in patients with OC or primary peritoneal cancers (PPCs). METHODS. Patients stage III/IV PPC clinical complete response after surgical cytoreduction intravenous carboplatin/paclitaxel who had benign findings minimal persistent disease (≤1 cm diameter) at second-look surgery were eligible. Intraperitoneal infused once every 21 days 4 to 6 cycles. Kaplan-Meier estimates used calculate progression-free survival (PFS) overall (OS). RESULTS. Twenty enrolled (18 [90%] OC). Sixteen received cycles, 3 1 patient withdrew cycle. The mean delivered dose 18 mg/m2. Grade 3/4 toxicities included neutropenia thrombocytopenia (45% both). 1/2 abdominal distension nausea reported 60% 40% patients, respectively. Median PFS 24 months from (95% confidence intervals [CI]: ±10 months). alive median OS not reached time data analysis. estimated either 30 surgery, years initial diagnosis, 84% CI, 68%-100%). CONCLUSIONS. Consolidation a feasible option women withadvanced cancers. Further investigation warranted this population. Cancer 2008. © 2008 American Society.