拓扑替康联合顺铂治疗卵巢上皮性癌的临床研究

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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75 mg/m~3,第1天;拓扑替康0.75 mg·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135 mg/m~2,第1天。(3)环磷酰胺+顺铂(PC)组:33例,给予顺铂75 mg/m~2,第1天;环磷酰胺500 mg/m~2,第1天。3组患者均以21~28 d 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%、7l%、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。 Objective To investigate the curative effect, toxicity and prognosis of topotecan combined with cisplatin (TP) in the treatment of epithelial ovarian cancer (ovarian cancer). Methods Ninety-four patients diagnosed with stage Ⅱ-Ⅳ ovarian cancer after operation were divided into three groups: (1) TP group: 30 cases given cisplatin 75 mg / m 3 on day 1; topotecan 0.75 mg · m -2 d -1, days 1 ~ 5. (2) In the paclitaxel + carboplatin (TC) group, 31 cases were treated with carboplatin dose (AUC) = 5 on day 1, paclitaxel 135 mg / m ~ 2 on day 1 . (3) Cyclophosphamide + cisplatin (PC) group: 33 cases were given cisplatin 75 mg / m ~ 2 on the first day; cyclophosphamide 500 mg / m ~ 2 on the first day. All the patients in the three groups were treated with one cycle of chemotherapy from 21 to 28 days. The curative effect was evaluated after 6 to 8 courses of treatment, and complete remission (CR) plus partial remission (PR) was effective. The efficacy, toxicity and prognosis of the three groups were compared. Results (1) The response rate of chemotherapy: CR was 8 in the TP group and 13 in the PR group, the effective rate was 70% (21/30); in the TC group, the CR was 10 and the PR was 14, the effective rate was 77% / 31). In CR group, there were 5 cases in CR group and 9 cases in PR group. The effective rate was 42% (14/33). There was no significant difference between TP group and TC group (P> 0.05). Compared with PC group, the difference was statistically significant (P <0.05). (2) Tumor-free survival rate: The median follow-up time was 25 months. The 1-year disease-free survival rates of TP, TC and PC groups were 67%, 71% and 42% , 64%, 39%. The 1-year and 2-year disease-free survival rates of each group were respectively compared with each other, the difference was not statistically significant (P> 0.05). (3) The overall survival rate: The 1-year overall survival rates of TP, TC and PC groups were 93%, 97% and 91% respectively. The 2-year overall survival rates were 77%, 84% and 67%, respectively. The 1-year and 2-year overall survival rates among the groups were not significantly different (P> 0.05). (4) Toxicity: 18 cases (60%) in TP group and 8 cases (26%) in TC group and 10 cases (30%) in PC group, respectively Compared with TC and PC group, the differences were statistically significant (P <0.05). There were no significant differences in other toxic and side effects between the three groups (P> 0.05). Conclusion As a first-line chemotherapy regimen for ovarian cancer, the TP regimen can not replace the TC regimen, but can be used as an option for clinical treatment.
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