• Gynecologic oncology · Aug 2009

    Topotecan combined with carboplatin in recurrent epithelial ovarian cancer: results of a single-institutional phase II study.

    • Heeseok Kang, Tae-Joong Kim, Yoo-Young Lee, Chel Hun Choi, Jeong-Won Lee, Duk-Soo Bae, and Byoung-Gie Kim.
    • Department of Obstetrics and Gynecology, Medical Foundation Baek-Song, Good Morning Hospital, KyungKi-Do, Republic of Korea.
    • Gynecol. Oncol. 2009 Aug 1; 114 (2): 210-4.

    ObjectiveThe aim of this trial was to investigate the efficacy and toxicity of a relative high-dose of topotecan combined with carboplatin in recurrent or persistent epithelial ovarian cancer (EOC).MethodsPatients participating in this phase II trial received topotecan at a dose of 1.0 mg/m(2)/day intravenously (IV) on days 1 to 5 in combination with carboplatin AUC 5 IV on day 5, every 21 days. The primary outcome was response rate (RR) and the toxicity. The secondary measurements were duration of response, time to progression (TTP) and overall survival (OS).ResultsFifty-nine patients entered the study and 53 were assessable for response. For this study, 260 courses of topotecan and carboplatin were given (median, 4 per patient; range, 1-8). The overall RR was 26.4%. The median duration of response and TTP were 7 and 6 months, respectively. The median OS was 19 months with a median follow-up period of 14 months. Initial platinum sensitivity and treatment free interval (TFI) >or=6 months were associated with RR and OS. In the platinum-sensitive group, RR and OS were 40.0% and 25 months, whereas in the platinum-resistant group, these were 8.7% and 11 months, respectively. Grade 4 neutropenia occurred in 40.7% of the patients, and grade 4 thrombocytopenia was seen in 32.2% with a bleeding event in two patients. Nonhematologic toxicities were mild. There were no drug-related toxic deaths.ConclusionThe relative high-dose of topotecan combined with carboplatin was feasible and produced modest activity in recurrent or persistent EOC. The RR and survival data appear promising for the initially platinum-sensitive cohort and thus this regimen may be considered for further development in this patient.

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