[Clinical study of topotecan and cisplatin as first line chemotherapy in epithelial ovarian cancer].
OBJECTIVE
To evaluate efficacy and toxicity of topotecan and cisplatin (TP) as first line chemotherapy in epithelial ovarian cancer, and its effect on prognosis of the patients.


METHODS
Totally 94 eligible patients with pathologically verified stage II - IV epithelial ovarian cancer were enrolled into 3 groups of this clinical trial. (1) TP group: 30 patients were treated with topotecan, 0.75 mg.m(-2).d(-1), for 5 days, and cisplatin, 75 mg/m(2), on day 1. (2) Paclitaxel and carboplatin (TC) group: 31 patients were treated with paclitaxel, 135 mg/m(2), on day 1, and carboplatin, given to an area under the curve (AUC) of 5, on day 1. (3) Cyclophosphamide and cisplatin (PC) group: 33 patients were treated with cyclophosphamide, 500 mg/m(2), on day 1, cisplatin 75 mg/m(2), on day 1. Cycles were repeated every 21 - 28 days. EFFICACY of the three combination regimens were evaluated after 6 - 8 courses.


RESULTS
(1) EFFICACY: the overall response rate (ORR) in the TP group was 70%. Of the 30 patients, 8 achieved a complete response (CR) and 13 a partial response (PR). The ORR in the TC group was 77%. Of the 31 patients, 10 achieved a CR and 14 a PR. While the ORR in the PC group was 42%. Of the 33 patients, 5 achieved a CR and 9 a PR. There was no significant difference in clinical efficacy between TP group and TC group (P > 0.05). But there was a significant difference between TP group and PC group (P < 0.05). (2) Disease free survival (DFS): after median follow-up of 25 months, one-year disease free survival rate was 67% in TP group, 71% in TC group and 42% in PC group (P > 0.05). Two-year disease free survival rate was 57% in TP group, 64% in TC group and 39% in PC group (P > 0.05). (3) Overall survival (OS): One-year survival rate was 93% in TP group, 97% in TC group and 91% in PC group (P > 0.05). Two-year survival rate was 77% in TP group, 84% in TC group and 67% in PC group (P > 0.05). (4) TOXICITY: Grade III - IV myelosuppression was 60% (18/30) in TP group, 26% (8/31) in TC group and 30% (10/33) in PC group. The TP regimen had the greatest hematologic toxicity (P < 0.05). Nonhematologic toxicities were not significantly different among the three regimens (P > 0.05).


CONCLUSIONS
As first line chemotherapy in epithelial ovarian cancer, TP regimen comparable to the standard chemotherapy regimen.
Meng
Li-Hua
LH
Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Jinan, China.
Kong
Bei-Hua
BH
Zhang
You-Zhong
YZ
Yang
Xing-Sheng
XS
Wang
Li-Jie
LJ
Su
Shi-Li
SL
Jiang
Jie
J
Cui
Bao-Xia
BX
Wang
Bo
B
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D018284:Cystadenocarcinoma, Serous / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005334:Fever / Q000139:chemically induced; D005500:Follow-Up Studies; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D011379:Prognosis; D015996:Survival Rate; D019772:Topotecan / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
D019772:Topotecan; D003520:Cyclophosphamide; D016190:Carboplatin; D017239:Paclitaxel; D002945:Cisplatin