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Phase 2 study of intraperitoneal topotecan as consolidation chemotherapy in ovarian and primary peritoneal carcinoma
Author(s) -
Muntz Howard G.,
Malpass Thomas W.,
McGonigle Kathryn F.,
Robertson Mandy D.,
Weiden Paul L.
Publication year - 2008
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.23576
Subject(s) - medicine , topotecan , carboplatin , ovarian cancer , neutropenia , surgery , nausea , chemotherapy , ovarian carcinoma , phases of clinical research , gastroenterology , cancer , cisplatin
BACKGROUND. Intravenous topotecan is approved for the treatment of ovarian cancer (OC). In intraperitoneal (i.p.) topotecan studies, 20 mg/m 2 dosing was tolerable. This study evaluated the feasibility, safety, and preliminary efficacy of i.p. topotecan as consolidation chemotherapy in patients with OC or primary peritoneal cancers (PPCs). METHODS. Patients with stage III/IV ovarian or PPC in clinical complete response after surgical cytoreduction and intravenous carboplatin/paclitaxel chemotherapy who had benign findings or minimal persistent disease (≤1 cm diameter) at second‐look surgery were eligible. Intraperitoneal topotecan 20 mg/m 2 was infused once every 21 days for 4 to 6 cycles. Kaplan‐Meier estimates were used to calculate progression‐free survival (PFS) and overall survival (OS). RESULTS. Twenty patients were enrolled (18 [90%] patients had OC). Sixteen patients received 4 cycles, 3 patients received 6 cycles, and 1 patient withdrew after 1 cycle. The mean delivered dose was 18 mg/m 2 . Grade 3/4 toxicities included neutropenia and thrombocytopenia (45% for both). Grade 1/2 abdominal distension and nausea were reported in 60% and 40% of patients, respectively. Median PFS was 24 months from second‐look surgery (95% confidence intervals [CI]: ±10 months). Sixteen patients were alive and median OS was not reached at the time of data analysis. OS estimated at either 30 months from second‐look surgery, or 3 years from initial diagnosis, was 84% (95% CI, 68%‐100%). CONCLUSIONS. Consolidation i.p. topotecan is a feasible option for women withadvanced ovarian and primary peritoneal cancers. Further investigation of i.p. topotecan is warranted in this patient population. Cancer 2008. © 2008 American Cancer Society.