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

doi:10.3877/cma.j.issn.1673-5250.2016.06.005

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.

Key words: Uterine cervical neoplasms, Radiotherapy, Drug therapy, Raltitrexed, Paclitaxel

表1 2组宫颈癌患者基本临床资料比较

组别	例数	年龄[岁，M(P₂₅～P₇₅)]	KPS评分[例数(%)]		体重下降[例数(%)]		肿瘤最大直径[例数(%)]
组别	例数	年龄[岁，M(P₂₅～P₇₅)]	≥70～80分	≥80分	<5%	≥5%	<4 cm	≥4 cm
RP组	40	47(39～66)	14(35.0)	26(65.0)	23(57.5)	17(42.5)	30(75.0)	10(25.0)
TP组	40	51(42～65)	17(42.5)	23(57.5)	25(62.5)	15(37.5)	28(70.0)	12(30.0)
检验值	?	Z＝－1.230	χ²＝0.475	?	χ²＝0.208	?	χ²＝0.251	?
P值	?	0.220	0.647	?	0.648	?	0.616	?
组别	例数	病理类型[例数(%)]			FIGO临床分期[例数(%)]
组别	例数	鳞癌	腺癌	鳞腺癌	Ⅱ_B	Ⅲ_A	Ⅲ_B	Ⅳ_A
RP组	40	29(72.5)	7(17.5)	4(10.0)	26(65.0)	8(20.0)	4(10.0)	2(5.0)
TP组	40	28(70.0)	9(22.5)	3(7.5)	25(57.5)	9(22.5)	3(7.5)	3(7.5)
检验值	?	χ²＝0.482			χ²＝0.421
P值	?	0.874			0.936

表1 2组宫颈癌患者基本临床资料比较

组别	例数	年龄[岁，M(P₂₅～P₇₅)]	KPS评分[例数(%)]		体重下降[例数(%)]		肿瘤最大直径[例数(%)]
组别	例数	年龄[岁，M(P₂₅～P₇₅)]	≥70～80分	≥80分	<5%	≥5%	<4 cm	≥4 cm
RP组	40	47(39～66)	14(35.0)	26(65.0)	23(57.5)	17(42.5)	30(75.0)	10(25.0)
TP组	40	51(42～65)	17(42.5)	23(57.5)	25(62.5)	15(37.5)	28(70.0)	12(30.0)
检验值	?	Z＝－1.230	χ²＝0.475	?	χ²＝0.208	?	χ²＝0.251	?
P值	?	0.220	0.647	?	0.648	?	0.616	?
组别	例数	病理类型[例数(%)]			FIGO临床分期[例数(%)]
组别	例数	鳞癌	腺癌	鳞腺癌	Ⅱ_B	Ⅲ_A	Ⅲ_B	Ⅳ_A
RP组	40	29(72.5)	7(17.5)	4(10.0)	26(65.0)	8(20.0)	4(10.0)	2(5.0)
TP组	40	28(70.0)	9(22.5)	3(7.5)	25(57.5)	9(22.5)	3(7.5)	3(7.5)
检验值	?	χ²＝0.482			χ²＝0.421
P值	?	0.874			0.936

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
组别	例数	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值	?	－	－	－	－	－	0.075	－	－	－	－	－	0.208
P值	?	－	－	－	－	－	0.785	－	－	－	－	－	0.648
组别	例数	腹泻						食欲下降
组别	例数	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值	?	－	－	－	－	－	0.503	－	－	－	－	－	0.052
P值	?	－	－	－	－	－	0.478	－	－	－	－	－	0.82
组别	例数	骨髓抑制						肝功能损害
组别	例数	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值	?	－	－	－	－	－	4.013	－	－	－	－	－	0.105
P值	?	－	－	－	－	－	0.045	－	－	－	－	－	0.745
组别	例数	皮疹						脱发
组别	例数	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值	?	－	－	－	－	－	5.591	－	－	－	－	－	20.202
P值	?	－	－	－	－	－	0.018	－	－	－	－	－	0.000
组别	例数	肌肉和关节疼痛						外周神经炎
组别	例数	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值	?	－	－	－	－	－	6.275	－	－	－	－	－	6.050
P值	?	－	－	－	－	－	0.012	－	－	－	－	－	0.014

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
组别	例数	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值	?	－	－	－	－	－	0.075	－	－	－	－	－	0.208
P值	?	－	－	－	－	－	0.785	－	－	－	－	－	0.648
组别	例数	腹泻						食欲下降
组别	例数	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值	?	－	－	－	－	－	0.503	－	－	－	－	－	0.052
P值	?	－	－	－	－	－	0.478	－	－	－	－	－	0.82
组别	例数	骨髓抑制						肝功能损害
组别	例数	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值	?	－	－	－	－	－	4.013	－	－	－	－	－	0.105
P值	?	－	－	－	－	－	0.045	－	－	－	－	－	0.745
组别	例数	皮疹						脱发
组别	例数	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值	?	－	－	－	－	－	5.591	－	－	－	－	－	20.202
P值	?	－	－	－	－	－	0.018	－	－	－	－	－	0.000
组别	例数	肌肉和关节疼痛						外周神经炎
组别	例数	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值	?	－	－	－	－	－	6.275	－	－	－	－	－	6.050
P值	?	－	－	－	－	－	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

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