Efficacy and toxicity of belotecan with and without cisplatin in patients with recurrent ovarian cancer.
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.


CONCLUSIONS
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.
Nam
Eun Ji
EJ
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Women's Cancer Clinic, Yonsei University College of Medicine, Seongsan-no 250, Seodaemun-gu, Seoul, Korea.
Kim
Jae Wook
JW
Kim
Jae Hoon
JH
Kim
Sunghoon
S
Kim
Sang Wun
SW
Jang
Si Young
SY
Lee
Dae Woo
DW
Jung
Yong Wook
YW
Kim
Young Tae
YT
D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002277:Carcinoma / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D019008:Drug Resistance, Neoplasm; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality; D016879:Salvage Therapy; D016019:Survival Analysis; D016896:Treatment Outcome
D000972:Antineoplastic Agents, Phytogenic; D009944:Organoplatinum Compounds; C116963:belotecan; D002945:Cisplatin; D002166:Camptothecin