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晚期大肠癌SOX与FOLFOX4方案一线化疗对生存质量影响随机对照研究 被引量:10

QOF effect of S-1 plus oxaliplatin versus FOLFOX4 for first-line treatment of patients with advanced colorectal cancer:aphase Ⅱ randomized open study
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摘要 目的:分别观察替吉奥联合奥沙利铂(SOx)与FOLFOX4方案一线治疗对改善晚期大肠癌患者生存质量的影响。方法:选取2010-09—01—2012-06—01郑州市第三人民医院60例结直肠癌患者,随机分为SOX组和FOLFOX4组,每组30例。SOX组:奥沙利铂130mg/m2,静脉滴入,d1;替吉奥80~140mg/d,连续口服14d。具体剂量根据体表面积计算,体表面积〈1.25m2,80mg/d;1.25m2≤体表面积〈1.5m2,100mg/d;1.50m2≤体表面积〈1.8m2,120mg/d;体表面积≥1.8m2,140mg/d;每3周为1个周期。FOLFOX4组:奥沙利铂80mg/m2,静脉滴入,d1;亚叶酸钙200mg/m2,静脉滴入,2h,d1~d2;5-FU400mg/m2,静脉推注,d1~d2;5-FU600mg/m2持续静脉滴入22h,d1~d2;每2周重复。生存质量评价采用QLQ-CR68问卷式量表。结果:两组入组情况相似,全部60例患者均可接受评价。SOX和FOLFOX4两组总有效率分别为46.7%和36.7%,x2=0.617,P=0.432。在生存质量方面,两组均能明显改善疲倦、恶心呕吐、疼痛、排尿、胃肠道、排便问题、体质量下降和食欲下降等项评分,其中SOX组在未来看法方面也有改善。化疗后对生存质量改善的程度,SOX组在恶心呕吐、化疗反应、胃肠道、排便问题和食欲下降方面较FOLFOX4组改善更明显,P值均〈0.05。在总得分方面,化疗后SOX和FOLFOX4两组分别为(70.03±16.15)和(60.46±15.31)分,差异有统计学意义,t=2.3555,P=0.0219;其中SOX组升高(17.26±11.52)分,FOLFOX4组升高(11.53±9.78)分,差异有统计学意义,t=2.0769,P=0.0423,提示s0X组改善更明显。结论:SOX方案较FOLFOX4方案能更好改善晚期结直肠癌患者的生存质量,并且方便易用,值得进一步研究。 OBJECTIVE: To observe the effect on quality of life (QOL) in patients treated with S-1 plus oxiliplatin and FOLFOX4. METHODS: Sixty patients were ramdomly divided into SOX group and FOLFOX4 group,SOX group was given S-I plus oxalipitin,oxaliplatin was administered intravenously on d1 with 130 mg/m2, S-1 was administered orally from d1 to d14 at the following doses on the basis of body surface area(BSA) :BSA(1.25 m2 ,80 mg daily; 1.25 m2≤BSA (1.5 m2 ,100 mg daily;1. 5 m2≤BSA〈1.8 m2 ,120 mg,daily;BSA〉1. 8 m2 ,140 mg,daily;every 3 weeks as a cycle. Efficacy was evaluated at least after 2 cycles. In FOLFOX4 group oxaliplatin was administered intravenously on d1 with 80 mg/m2 ,leucovorin was given intravenously on d1 and d2 with 200 mg/m2 ,5-FU was intravenous injection on d1 and d2 with 400 mg/m2 ,and was administered intravenously 22 hours on d1 and d2 with 600 mg/m2. The assessment methods of QOF was QLQ-CR68 questionnaire. RESULTS: Patients' background and characteristics were similar, all of the 60 patients could be evaluated. The overall response rate in SOX was 46.7% and in FOLFOX4 it was 36.7% ,x2 =0. 617,P= 0. 432. In questionnaire questions such as fatigue, nausea and vomiting, gastrointestinal symptoms, pain, appetite loss,urination,defecation and weight loss were inquired, comparing the improvement of life quality between the two groups, SOX was improved more obviously in relieving of nausea and vomiting, chemotherapy toxicity,gastrointestinal symptoms, defecation,and weight loss,the P values were all less than 0.05. In total heath score,SOX(70. 03±16.15) and FOLFOX4 (60.46± 15.31) groups showed significantly better results than before chemotherapy. Furthermore, the SOX team was improved deeply before and after chemotherapy between the two groups, t= 2.076 9, P= 0. 0423. CONCLUSIONS: The present results suggest that questionnaires are useful for assessing patients' QOL with advanced CRC treated chemotherapy. Combination chemotherapy with oral fluoropyrimidine S-1 plus oxiliplatin could improve QOL better than Folfox4,we ean increase the sample size in the further research.
出处 《中华肿瘤防治杂志》 CAS 北大核心 2014年第18期1445-1450,共6页 Chinese Journal of Cancer Prevention and Treatment
基金 郑州市科技局科技攻关项目(20120835)
关键词 肠肿瘤 替吉奥 生存质量 奥沙利铂 药物疗法 intestinal neoplasms S-1 quality of life oxiliplatin drug therapy
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