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Efficacy and Toxicity of Belotecan With and Without Cisplatin in Patients With Recurrent Ovarian Cancer. September 17, 2009

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Efficacy and Toxicity of Belotecan With and Without Cisplatin in Patients With Recurrent Ovarian Cancer.

Am J Clin Oncol. 2009 Sep 10

Nam EJ, Kim JW, Kim JH, Kim S, Kim SW, Jang SY, Lee DW, Jung YW, Kim YT.
From the *Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Women’s Cancer Clinic, Yonsei University College of Medicine, Seoul, Korea; and daggerDepartment of Gynecologic Oncology, Kwandong University College of Medicine, Seoul, Korea.

OBJECTIVE: This study was performed to determine the safety and efficacy of belotecan, a new camptothecin analogue and potent topoisomerase I inhibitor, with and without platinum in patients with recurrent ovarian cancer.
METHODS: Fifty-three patients with recurrent or persistent ovarian cancer were enrolled between March 2005 and March 2008. Eligible patients received 0.5 mg/m of intravenous (IV) belotecan on days 1 to 5, every 3 weeks belotecan monotherapy (B) or 50 mg/m of IV cisplatin on day 1 plus 0.3 mg/m of IV belotecan on days 1 to 5, every 3 weeks (belotecan plus cisplatin combination therapy [BP]).

RESULTS: Of the 53 treated patients, 34 received BP and 19 received B. Thirty-four patients had platinum-sensitive (PS) disease and 19 had platinum-resistant disease. The overall response of the 53 patients was 37.7% (20/53). According to regimen, the response rate in the BP group was 47.1% (16/34) and that of the B group was 21.1% (4/19). BP had better response (66.7%, 14/21) than B (15.4%, 2/13) for PS disease (P = 0.004), but it was not superior in terms of progression-free survival (BP, 6 month; B, 7 months). Grade 3 or 4 toxicity was less common in B than in BP.

CONCLUSION: Both BP and B seems to be effective and safe regimens for patients with PS or platinum-resistant recurrent ovarian cancer. These results warrant further prospective randomized trials. Both BP and B seems to be effective and safe regimens for patients with PS or platinum-resistant recurrent ovarian cancer.

Lippincott, Williams & Wilkins