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中华妇幼临床医学杂志(电子版) ›› 2016, Vol. 12 ›› Issue (06) : 644 -650. doi: 10.3877/cma.j.issn.1673-5250.2016.06.005

所属专题: 文献

论著

雷替曲塞联合顺铂同步放化疗治疗中晚期宫颈癌
谢小妹1, 李向阳1,(), 殷海涛1, 张一帆1, 刘凌1, 卜祥兆1, 孙凌飞1, 管峦1   
  1. 1. 221009江苏,东南大学医学院附属徐州市中心医院放疗科
  • 收稿日期:2016-05-07 修回日期:2016-11-09 出版日期:2016-12-01
  • 通信作者: 李向阳

Concurrent chemoradiatherapy with raltitrexed and cisplatin in the treatment of moderate and advanced cervical cancer

Xiaomei Xie1, Xiangyang Li1,(), Haitao Yin1, Yifan Zhang1, Ling Liu1, Xiangzhao Bu1, Lingfei Sun1, Luan Guan1   

  1. 1. Department of Radiation Oncology, Xuzhou Central Hospital, Affiliated to School of Medicine, Southeast University, Xuzhou 221009, Jiangsu Province, China
  • Received:2016-05-07 Revised:2016-11-09 Published:2016-12-01
  • Corresponding author: Xiangyang Li
  • About author:
    Corresponding author: Li Xiangyang, Email:
引用本文:

谢小妹, 李向阳, 殷海涛, 张一帆, 刘凌, 卜祥兆, 孙凌飞, 管峦. 雷替曲塞联合顺铂同步放化疗治疗中晚期宫颈癌[J/OL]. 中华妇幼临床医学杂志(电子版), 2016, 12(06): 644-650.

Xiaomei Xie, Xiangyang Li, Haitao Yin, Yifan Zhang, Ling Liu, Xiangzhao Bu, Lingfei Sun, Luan Guan. Concurrent chemoradiatherapy with raltitrexed and cisplatin in the treatment of moderate and advanced cervical cancer[J/OL]. Chinese Journal of Obstetrics & Gynecology and Pediatrics(Electronic Edition), 2016, 12(06): 644-650.

目的

探讨雷替曲塞联合顺铂同步放化疗,治疗中晚期宫颈癌的临床疗效和安全性。

方法

选择2011年1月至2012年12月,东南大学医学院附属徐州市中心医院放疗科收治的80例中晚期宫颈癌患者为研究对象。采用信封法,将其随机分为RP组(n=40,接受雷替曲塞联合顺铂同步放化疗方案治疗)与TP组(n=40,接受紫杉醇联合顺铂同步放化疗方案治疗)。RP组具体化疗方案为:雷替曲塞3 mg/m2,静脉滴注15 min,d1;顺铂60 mg/m2,静脉滴注60 min,d1。TP组具体化疗方案为:紫杉醇135 mg/m2,静脉滴注180 min,d1;顺铂60 mg/m2,静脉滴注60 min,d2。统计学比较2组患者治疗有效率、不良反应率、总生存(OS)率及无病生存(DFS)率。本研究经过本院伦理委员会审核通过,所有患者均签署知情同意书。

结果

①2组患者的年龄、Karnofsky行为状态(KPS)评分、体重下降百分比、肿瘤最大直径、病理类型、国际妇产科联盟(FIGO)临床分期等基本临床资料比较,差异均无统计学意义(P>0.05)。②RP组和TP组治疗有效率分别为92.5%(38/40)与90.0%(36/40),二者比较,差异无统计学意义(χ2=0.734,P=0.675)。③RP组骨髓抑制、皮疹、脱发、肌肉和关节酸痛、外周神经炎发生率分别为62.5%(25/40)、12.5%(5/40)、30.0%(12/40)、5.0%(2/40)、10.0%(4/40),均分别显著低于TP组的82.5%(33/40)、35.0%(14/40)、80.0%(32/40)、25.0%(10/40)、32.5%(13/40),并且差异均有统计学意义(χ2=4.013,P=0.045;χ2=5.591,P=0.018;χ2=20.202,P<0.001;χ2=6.275,P=0.012;χ2=6.050,P=0.014)。2组患者恶心、呕吐、腹泻、食欲下降、肝功能损害发生率比较,差异均无统计学意义(P>0.05)。④2组患者OS曲线、DFS曲线分别比较,差异无统计学意义(χ2=0.930,P=0.330;χ2=0.780,P=0.380)。

结论

雷替曲塞联合顺铂同步放化疗,治疗中晚期宫颈癌安全、有效,其疗效与紫杉醇联合顺铂同步放化疗疗效相近,但导致的不良反应更少。

Objective

To investigate the efficacy and safety of concurrent chemoradiatherapy with raltitrexed and cisplatin in treatment of patients with moderate and advanced cervical cancer.

Methods

From January 2011 to December 2012, a total of 80 patients with moderate and advanced cervical cancer were selected as research subjects and they were randomly assigned to RP group (n=40, received concurrent chemoradiatherapy with raltitrexed and cisplatin treatment) and TP group (n=40, received concurrent chemoradiatherapy with paclitaxel and cisplatin treatment) by envelope method. The chemotherapy regimen of RP group was as follows: raltitrexed 3 mg/m2 intravenous drip 15 min on day 1, and cisplatin 60 mg/m2 intravenous drip 60 min on day 1. The chemotherapy regimen of TP group was as follows: paclitaxel 135 mg/m2 intravenous drip 180 min on day 1, and cisplatin 60 mg/m2 intravenous drip 60 min on day 2. The effective rate, adverse reactions rate, and overall survival (OS) rate and disease free survival (DFS) rate were observed and compared by statistical methods between two groups. This study was approved by the ethics committee of our hospital, and all patients signed the informed consent.

Results

①There were no significant differences between two groups in the age, Karnofsky performance status (KPS) score, body weight loss ratio, the maximum diameter of tumor, pathological type, Federation International of Gynecology and Obstetrics (FIGO) stage (P>0.05). ②The effective rates in RP group and TP group were 92.5% (38/40) and 90% (36/40), respectively, and there was no significant difference between them (χ2=0.734, P=0.675). ③The incidences of myelosuppression, rash, alopecia, muscle and joint pain, peripheral neuritis in RP group were 62.5% (25/40), 12.5% (5/40), 30.0% (12/40), 5.0% (2/40), 10.0% (4/40), respectively, and they were significantly lower than those in TP group 82.5% (33/40), 35.0% (14/40), 80.0% (32/40), 25.0% (10/40), 32.5% (13/40), respectively, and all the differences were statistically significant (χ2=4.013, P=0.045; χ2=5.591, P=0.018; χ2=20.202, P<0.001; χ2=6.275, P=0.012; χ2=6.050, P=0.014). There were no significant differences between two groups in gastrointestinal toxicity and liver dysfunction (P>0.05). ④There were no significant differences between two groups in OS curve and DFS curve (χ2=0.930, P=0.330; χ2=0.780, P=0.380).

Conclusions

Concurrent chemoradiatherapy with raltitrexed and cisplatin in the treatment of moderate and advanced cervical cancer is safe and effective. Its effect is similar to the effect of concurrent chemoradiatherapy with paclitaxel and cisplatin, and resulting in less adverse reactions.

表1 2组宫颈癌患者基本临床资料比较
表2 2组宫颈癌患者不良反应发生情况比较[例数(%)]
组别 例数 恶心 呕吐
1级 2级 3级 4级 5级 合计 1级 2级 3级 4级 5级 合计
RP组 40 9(22.5) 23(57.5) 7(17.5) 1(2.5) 0(0) 31(77.5) 25(62.5) 9(22.5) 6(15.0) 1(2.5) 0(0) 15(37.5)
TP组 40 8(20.0) 24(60.0) 7(17.5) 1(2.5) 0(0) 32(80.0) 23(57.5) 9(22.5) 7(17.5) 1(2.5) 0(0) 17(42.5)
χ2 ? 0.075 0.208
P ? 0.785 0.648
组别 例数 腹泻 食欲下降
1级 2级 3级 4级 5级 合计 1级 2级 3级 4级 5级 合计
RP组 40 25(62.5) 9(22.5) 5(12.5) 1(2.5) 0(0) 15(37.5) 17(42.5) 16(40.0) 7(17.5) 0(0) 0(0) 23(57.5)
TP组 40 28(70.0) 8(20.0) 4(10.0) 0(0) 0(0) 12(30.0) 16(40.0) 17(42.5) 7(17.5) 1(2.5) 0(0) 24(60.0)
χ2 ? 0.503 0.052
P ? 0.478 0.82
组别 例数 骨髓抑制 肝功能损害
1级 2级 3级 4级 5级 合计 1级 2级 3级 4级 5级 合计
RP组 40 15(37.5) 13(32.5) 11(27.5) 4(10.0) 0(0) 25(62.5) 35(87.5) 5(12.5) 1(2.5) 0(0) 0(0) 5(12.5)
TP组 40 7(17.5) 13(32.5) 12(30.0) 7(17.5) 1(2.5) 33(82.5) 34(85.0) 6(15.0) 1(2.5) 0(0) 0(0) 6(15.0)
χ2 ? 4.013 0.105
P ? 0.045 0.745
组别 例数 皮疹 脱发
1级 2级 3级 4级 5级 合计 1级 2级 3级 4级 5级 合计
RP组 40 35(87.5) 4(10.0) 1(2.5) 0(0) 0(0) 5(12.5) 28(70.0) 12(30.0) 0(0) 0(0) 0(0) 12(30.0)
TP组 40 26(65.0) 8(20.0) 4(10.0) 2(5.0) 0(0) 14(35.0) 8(20.0) 15(37.5) 17(42.5) 0(0) 0(0) 32(80.0)
χ2 ? 5.591 20.202
P ? 0.018 0.000
组别 例数 肌肉和关节疼痛 外周神经炎
1级 2级 3级 4级 5级 合计 1级 2级 3级 4级 5级 合计
RP组 40 38(95.0) 1(2.5) 1(2.5) 0(0) 0(0) 2(5.0) 36(90.0) 2(5.0) 2(5.0) 0(0) 0(0) 4(10.0)
TP组 40 30(75.0) 6(15.0) 4(10.0) 0(0) 0(0) 10(25.0) 27(67.5) 6(15.0) 5(12.5) 2(5.0) 0(0) 13(32.5)
χ2 ? 6.275 6.050
P ? 0.012 0.014
图1 2组宫颈癌患者总生存曲线比较
图2 2组宫颈癌患者无病生存曲线比较
[1]
Kim TE, Park BJ, Kwack HS, et al. Outcomes and prognostic factors of cervical cancer after concurrent chemoradiation[J]. J Obstet Gynaecol Res,2012,38(11):1315-1320.
[2]
Lee TS, Kang SB, Kim YT, et al. Chemoradiation with paclitaxel and carboplatin in high-risk cervical cancer patients after radical hysterectomy: a Korean Gynecologic Oncology Group study[J]. Int J Radiat Oncol Biol Phys,2013,86(2):304-310.
[3]
Nagai Y, Toita T, Wakayama A, et al. Concurrent chemoradiotherapy with paclitaxel and cisplatin for adenocarcinoma of the cervix[J]. Anticancer Res,2012,32(4):1475-1479.
[4]
Kelly C, Bhuva N, Harrison M, et al. Use of raltitrexed as an alternative to 5-fluorouracil and capecitabine in cancer patients with cardiac history[J]. Eur J Cancer,2013,49(10):2303-2310.
[5]
Li XY, Liu L, Xie XM, et al. The role of raltitrexed/cisplatin with concurrent radiation therapy in treating advanced cervical cancer[J]. Eur Rev Med Pharmacol Sci,2014,18(22):3491-3496.
[6]
卜祥兆,刘凌,周云. 子宫颈癌外照射范围的临床探讨[J]. 中华放射肿瘤学杂志,2010,19(3):221-222.
[7]
Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors[J]. J Natl Cancer Inst, 2000, 92(3): 205-216.
[8]
Ishitsuka R, Miyazaki J, Ichioka D, et al. Impact of acute kidney injury defined by CTCAE v4.0 during first course of cisplatin-based chemotherapy on treatment outcomes in advanced urothelial cancer patients[J/OL]. Clin Exp Nephrol, (2016-08-26)[2016-09-28].

URL    
[9]
Torre LA, Bray F, Siegel RL, et al. Global cancer statistics, 2012[J]. CA Cancer J Clin, 2015, 65(2):87-108.
[10]
阳志军,陈艳丽,李力,等. 不同治疗模式对ⅡB期宫颈癌患者预后和生活质量的影响[J]. 肿瘤防治研究,2014, 41(9):1021-1025.
[11]
Chemoradiotherapy for Cervical Cancer Meta-analysis Collaboration (CCCMAC). Reducing uncertainties about the effects of chemoradiotherapy for cervical cancer: individual patient data meta-analysis[J]. Cochrane Database Syst Rev,2010, 1:CD008285.
[12]
Avallone A, Di Gennaro E, Silvestro L, et al. Targeting thymidylate synthase in colorectal cancer: critical re-evaluation and emerging therapeutic role of raltitrexed[J]. Expert Opin Drug Saf, 2014, 13(1): 113-129.
[13]
Zhao C, Fan L, Qi F, et al. Raltitrexed plus oxaliplatin-based transarterial chemoembolization in patients with unresectable hepatocellular carcinoma[J]. Anticancer Drugs,2016,27(7):689-694.
[14]
Ransom D, Wilson K, Fournier M, et al. Final results of Australasian Gastrointestinal Trials Group ARCTIC study: an audit of raltitrexed for patients with cardiac toxicity induced by fluoropyrimidines[J]. Ann Oncol,2014,25(1):117-121.
[15]
Gaafar P, Sallam YA, Shafik HE, et al. Impact of New Chemotherapeutic agents on the outcome of Egyptian patients with advanced malignant pleural mesothelioma[J]. Gulf J Oncolog,2014,1(16):56-63.
[16]
Barni S, Ghidini A, Coinu A, et al. A systematic review of raltitrexed-based first-line chemotherapy in advanced colorectal cancer[J]. Anticancer Drugs,2014,25(10):1122-1128.
[17]
Wilson KS, Fitzgerald CA, Barnett JB, et al. Adjuvant therapy with raltitrexed in patients with colorectal cancer intolerant of 5-fluorouracil: British Columbia Cancer Agency experience[J]. Cancer Invest,2007,25(8):711-714.
[18]
Judson I, Maughan T, Beale P, et al. Effects of impaired renal function on the pharmacokinetics of raltitrexed (Tomudex ZD1694)[J]. Br J Cancer,1998,78(9):1188-1193.
[19]
ZalcbergJ. Overview of the tolerability of 'Tomudex' (raltitrexed): collective clinical experience in advanced colorectal cancer[J]. Anticancer Drugs,1997,8(Suppl 2):S17-S22.
[20]
Cocconi G, Cunningham D, Van Cutsem E, et al. Open, randomized, multicenter trial of raltitrexed versus fluorouracil plus high-dose leucovorin in patients with advanced colorectal cancer. Tomudex Colorectal Cancer Study Group[J]. J Clin Oncol,1998,16(9):2943-2952.
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