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阿帕替尼治疗晚期胃癌的疗效与安全性评估。

Evaluation of efficacy and safety of apatinib treatment in advanced gastric cancer.

作者信息

Yang Yang, Wu Xiuwei, Li Fanfan, Wang Nianfei, Zhang Mingjun, Sun Tong, Chen Zhendong

机构信息

Department of Medical Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei 230061, China.

出版信息

J Cancer Res Ther. 2019;15(2):365-369. doi: 10.4103/jcrt.JCRT_297_18.

DOI:10.4103/jcrt.JCRT_297_18
PMID:30964112
Abstract

AIM

We aimed to evaluate the efficacy and safety of apatinib treatment and its impact on the quality of life (QOL) of patients with advanced gastric cancer (GC) who experienced failure with at least two chemotherapeutic regimens.

MATERIALS AND METHODS

All patients received apatinib at a daily dose of 500 mg for 4 weeks per cycle until it was stopped due to disease progression, intolerable toxicity. Response Evaluation Criteria in Solid Tumors version 1.1 and Common Terminology Criteria for Adverse events 4.0 were used to assess tumor responses and toxicities, respectively. The European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-STO22 were used to assess the impact on patient's QOL.

RESULTS

Twenty-five patients were enrolled, but only 24 were evaluated for therapeutic effects. After apatinib treatment, none of the patients achieved complete response (CR), one achieved partial response (PR), and eight had stable disease (SD), resulting in a disease control rate of 37.5% (CR + PR + SD). Responses to questions regarding abdominal pain, nausea/vomiting, insomnia, constipation, and diarrhea in QLQ-C30 and abdominal pain and reflux in QLQ-STO22 were changed over the course of treatment (P < 0.05). The QOL score was elevated after three treatment cycles, but it was not considered statistically significant (P > 0.05).

CONCLUSION

Results indicated that apatinib was effective in heavily pretreated patients with advanced GC who experienced failure with two or more line chemotherapies. The toxicities were tolerable or could be clinically controlled. Apatinib treatment alleviated some of the clinical symptoms but did not improve QOL significantly.

摘要

目的

我们旨在评估阿帕替尼治疗至少接受过两种化疗方案失败的晚期胃癌(GC)患者的疗效和安全性及其对生活质量(QOL)的影响。

材料与方法

所有患者接受阿帕替尼治疗,每日剂量500mg,每周期治疗4周,直至因疾病进展、不可耐受的毒性而停药。分别采用实体瘤疗效评价标准1.1版和不良事件通用术语标准4.0版评估肿瘤反应和毒性。采用欧洲癌症研究与治疗组织QLQ-C30和QLQ-STO22评估对患者生活质量的影响。

结果

共纳入25例患者,但仅24例评估了治疗效果。阿帕替尼治疗后,无患者达到完全缓解(CR),1例达到部分缓解(PR),8例病情稳定(SD),疾病控制率为37.5%(CR+PR+SD)。在治疗过程中,QLQ-C30中关于腹痛、恶心/呕吐、失眠、便秘和腹泻以及QLQ-STO22中关于腹痛和反流的问题回答发生了变化(P<0.05)。三个治疗周期后生活质量评分升高,但未达到统计学显著差异(P>0.05)。

结论

结果表明,阿帕替尼对接受过两种或更多线化疗失败的晚期GC重度预处理患者有效。毒性可耐受或可临床控制。阿帕替尼治疗减轻了一些临床症状,但未显著改善生活质量。

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