拓扑替康和顺铂作为上皮性卵巢癌一线化疗的临床研究
[Clinical study of topotecan and cisplatin as first line chemotherapy in epithelial ovarian cancer].
作者信息
Meng Li-Hua, Kong Bei-Hua, Zhang You-Zhong, Yang Xing-Sheng, Wang Li-Jie, Su Shi-Li, Jiang Jie, Cui Bao-Xia, Wang Bo
机构信息
Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Jinan, China.
出版信息
Zhonghua Fu Chan Ke Za Zhi. 2007 Oct;42(10):683-7.
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.
目的
评估拓扑替康联合顺铂（TP）作为上皮性卵巢癌一线化疗方案的疗效和毒性，及其对患者预后的影响。
方法
94例经病理证实为Ⅱ - Ⅳ期上皮性卵巢癌的合格患者被纳入本临床试验的3组。（1）TP组：30例患者接受拓扑替康治疗，剂量为0.75mg·m⁻²·d⁻¹，连用5天，顺铂75mg/m²，于第1天给药。（2）紫杉醇联合卡铂（TC）组：31例患者于第1天接受紫杉醇治疗，剂量为135mg/m²，卡铂给予曲线下面积（AUC）为5，于第1天给药。（3）环磷酰胺联合顺铂（PC）组：33例患者于第1天接受环磷酰胺治疗，剂量为500mg/m²，顺铂75mg/m²，于第1天给药。每21 - 28天重复1个周期。6 - 8个疗程后评估三种联合方案的疗效。
结果
（1）疗效：TP组的总缓解率（ORR）为70%。30例患者中，8例达到完全缓解（CR），13例达到部分缓解（PR）。TC组的ORR为77%。31例患者中，10例达到CR，14例达到PR。而PC组的ORR为42%。33例患者中，5例达到CR，9例达到PR。TP组与TC组的临床疗效无显著差异（P > 0.05）。但TP组与PC组之间存在显著差异（P < 0.05）。（2）无病生存期（DFS）：中位随访25个月后，TP组1年无病生存率为67%，TC组为71%，PC组为42%（P > 0.05）。TP组2年无病生存率为57%，TC组为64%，PC组为39%（P > 0.05）。（3）总生存期（OS）：TP组1年生存率为93%，TC组为97%，PC组为91%（P > 0.05）。TP组2年生存率为77%，TC组为84%，PC组为67%（P > 0.05）。（4）毒性：TP组Ⅲ - Ⅳ度骨髓抑制为60%（18/30），TC组为26%（8/з1），PC组为30%（10/33）。TP方案的血液学毒性最大（P < 0.05）。三种方案的非血液学毒性无显著差异（P > 0.05）。
结论
作为上皮性卵巢癌一线化疗方案，TP方案与标准化疗方案相当。
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