Pulsed Actinomycin D for the Treatment of Low-risk Gestational Trophoblastic Neoplasia
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摘要:
目的 探讨放线菌素D(Actinomycin D,Act-D)单日冲击疗法用于低危妊娠滋养细胞肿瘤(low-risk gestational trophoblastic neoplasia, LRGTN)患者的疗效及安全性。 方法 回顾性分析2012年1月至2015年10月北京协和医院95例接受Act-D单日冲击化疗方案治疗的LRGTN患者临床资料,对不同临床特征的疗效进行统计学分析,随诊血清人绒毛膜促性腺激素(β-human chorionic gonadotropin, β-hCG)水平评价治疗效果,并根据美国国家癌症研究所-不良事件通用术语标准评估化疗毒副反应的严重程度。 结果 95例患者中,79例经Act-D单日冲击疗法治疗后达到血清学完全缓解,完全缓解率83.2%(79/95),总疗程平均(4.4±1.3)程(1~8程),不同临床特征之间完全缓解率差异无统计学意义(P>0.05);16例患者因无效或耐药更改联合化疗方案后均达到血清学完全缓解。所有患者严重毒副反应发生率仅1.1%(1/95)。患者病情完全缓解后平均随诊(11.6±9.0)个月,3例复发,复发率3.8%。 结论 Act-D单日冲击化疗方案用于治疗LRGTN安全有效,且具备简便、耐受性好等优点,可作为LRGTN一线化疗方案。 -
关键词:
- 低危妊娠滋养细胞肿瘤 /
- 放线菌素D /
- 化疗
Abstract:Objective To investigate the efficacy and safety of pulsed Actinomycin D(Act-D) in the treatment of low-risk gestational trophoblastic neoplasia(LRGTN). Methods Clinical data of 95 patients with LRGTN who were treated with pulsed Act-D biweekly in Peking Union Medical College Hospital from January 2012 to October 2015 were analyzed retrospectively.Efficacy in patients with different clinical features were analyzed with statistical analysis. Serum β-human chorionic gonadotropin(β-hCG) were measured in follow-up during chemotherapy to assess the efficacy. The severity of side effects was evaluated according to the United States National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE). Results Among the 95 patients, 79 (83.2%) achieved serum complete remission. Their chemotherapy courses ranged from 1 to 8 courses, with the mean of (4.4±1.3)courses. There was no statistically significant difference about the complete remission rate for the different clinical characteristics (P > 0.05). Sixteen patients changed regimen because of ineffectiveness or resistance, and achieved serum complete remission after combined chemotherapy. Severe side effects rate was 1.1 % (1/95). The mean duration of follow-up was (11.6±9.0) months. Three patients got recurrence, with the recurrence rate of 3.8%. Conclusions Pulsed Act-D given biweekly was effective and well tolerated in patients with LRGTN. Because of its convenience, low cost, and good tolerance, it could be the choice of first-line chemotherapy for LRGTN. -
表 1 低危妊娠滋养细胞肿瘤常用国际化疗方案缓解率比较
化疗方案 缓解率(%) MTX 5日疗法 68[1] (0.4 mg/kg·d,最大不超过25 mg/kg·d,Ⅳ或IM,共5 d,每2周重复) MTX单日冲击疗法 49~69[2-5] (30~50 mg/m2,IM,每周重复) MTX 8日疗法 50~73.6[6] (第1、3、5、7 d MTX 1 mg/kg IM,第2、4、6、8 d叶酸0.1 mg/kg IM,每15~18天重复) Act-D单日冲击疗法 71~90[1-3, 5-6] (1.25 mg/m2,Ⅳ,每2周重复) Act-D 5日疗法 90[6] (0.5 mg/d,Ⅳ,每2周重复) MTX:氨甲蝶呤;Ⅳ:静脉滴注;IM:肌肉注射;Act-D:放线菌素D 表 2 95例低危妊娠滋养细胞肿瘤患者的临床特征
临床特征(n=95) 例数(%) 年龄(岁) <40 80(84.2) ≥40 15(15.8) 末次妊娠性质 葡萄胎 88(92.6) 非葡萄胎 7(7.4) 距前次妊娠间隔时间(月) <4 64(67.4) 4~<7 22(23.1) 7~≤12 7(7.4) >12 2(2.1) 治疗前β-hCG水平(U/L) <103 69(72.7) 103~≤104 16(16.8) 104~≤105 6(6.3) >105 4(4.2) 肿瘤最大径(cm) <3 88(92.6) 3~<5 4(4.2) ≥5 3(3.2) 临床期别 Ⅰ期 46(48.4) Ⅲ期 49(51.6) FIGO预后评分 ≤3 82(86.3) 4~6 13(13.7) 既往化疗史 无 79(83.2) 有 16(16.8) 联合手术治疗 无 89(4.2%) 有 6(2.1%) FIGO:国际妇产科联盟 表 3 影响低危妊娠滋养细胞肿瘤患者Act-D单日冲击化疗方案疗效的单因素分析
临床特征(n=95) 疗效 P值 有效[n=79(%)] 无效[n=16(%)] 年龄(岁) 0.251 <40 65(81.3) 15(18.7) ≥40 14(93.3) 1(6.7) 末次妊娠性质 0.389 葡萄胎 74(84.1) 14(15.9) 非葡萄胎 5(71.4) 2(28.6) 距前次妊娠间隔时间(月) 0.649 <4 54(84.4) 10(15.6) ≥4 25(80.6) 6(19.4) 治疗前β-hCG水平(U/L) 0.319 <103 59(85.5) 10(14.5) ≥103 20(76.9) 6(23.1) 肿瘤最大径(cm) 0.389 <3 74(84.1) 14(15.9) ≥3 5(71.4) 2(28.6) 临床期别 0.132 Ⅰ期 41(89.1) 5(10.9) Ⅲ期 38(77.6) 11(22.4) FIGO预后评分 0.880 ≤3 68(82.9) 14(17.1) 4~6 11(84.6) 2(15.4) 既往化疗史 0.091 无 68(86.1) 11(13.9) 有 11(68.8) 5(31.2) Act-D:同表 1;FIGO:同表 2 -
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