拓扑替康联合顺铂治疗卵巢上皮性癌的临床研究

目的 探讨拓扑替康联合顺铂（TP）治疗卵巢上皮性癌（卵巢癌）的疗效、毒副反应及预后。方法 将手术后经病理检查确诊为Ⅱ～Ⅳ期卵巢癌的94例患者分为3组：（1）TP组：30例,给予顺铂75mg／m^2,第1天;拓扑替康0．75mg·m^-2·d^-1,第1～5天。（2）紫杉醇＋卡铂（TC）组：31例,卡铂剂量按（血浆浓度-时间）曲线下面积（AUC）=5给予,第1天;紫杉醇135mg／m^2,第1天。（3）环磷酰胺＋顺铂（PC）组：33例,给予顺铂75mg／m^2,第1天;环磷酰胺500mg／m^2,第1天。3组患者均以21～28d为1个化疗周期,6～8个疗程后评价疗效,完全缓解（CR）加部分缓解（PR）为有效。比较3组患者的疗效、毒副反应及预后。结果 （1）化疗反应率：TP组CR为8例,PR为13例,有效率为70％（21／30）;TC组CR为10例,PR为14例,有效率为77％（24／31）;PC组CR为5例,PR为9例,有效率为42％（14／33）。TP组有效率与TC组相比,差异无统计学意义（P〉0．05）;与PC组相比,差异则有统计学意义（P〈0．05）。（2）无瘤生存率：中位随访时间25个月,TP、TC、PC组患者1年无瘤生存率分别为67％、71％、42％;2年无瘤生存率分别为57％、64％、39％。各组间1年及2年无瘤生存率分别比较,差异均无统计学意义（P〉0．05）。（3）总生存率：TP、TC、PC组1年总生存率分别为93％、97％、91％;2年总生存率分别为77％、84％、67％。各组间1年及2年总生存率分别比较,差异均无统计学意义（P〉0．05）。（4）毒副反应：发生Ⅲ～Ⅳ度骨髓抑制的患者,TP组为18例（60％）,TC组为8例（26％）,PC组为10例（30％）,TP组分别与TC、PC组比较,差异均有统计学意义（P〈0．05）;其他毒副反应,3组间比较,差异均无统计学意义（P〉0．05）。结论 作为卵巢癌的一线化疗方案,TP方案虽不能取代TC方案,但可作为临床治疗的一种选择。

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.