甲磺酸阿帕替尼治疗二线化疗失败后晚期胃癌疗效观察

发布时间：2018-03-07 03:14

本文选题：甲磺酸阿帕替尼　切入点：晚期胃癌　出处：《广东医学》2017年19期 　论文类型：期刊论文

【摘要】：目的观察甲磺酸阿帕替尼治疗晚期胃癌(m GC)的有效性和安全性。方法 4家三甲医院胃肠肿瘤诊治中心共入组42例具有完整病历资料的m GC患者,采用多中心、单臂、开放研究方式。治疗方案:每天口服甲磺酸阿帕替尼850 mg,顿服。28 d为1个周期,所有入组患者至少口服1周期纳入研究。每2周期进行评价,如出现3~4度不良反应,首次药物减量至750 mg/次,再次出现3~4度不良反应,再次将药物减量至500 mg/次,如不能耐受则终止治疗。研究的主要终点是无进展生存(PFS)。次要终点包括疾病控制率(DCR)、客观缓解率(ORR)、总生存期(OS)和不良反应。结果所有患者均服用1~4周期,最终42例患者纳入研究。中位PFS为4.0个月(95%CI为2.85~5.15个月)。中位OS为4.50个月(95%CI为4.03~4.97个月)。2周期后评价局部缓解(PR)4例、疾病稳定(SD)29例、疾病进展(PD)9例、DCR 78.57%、ORR 9.52%。4周期后评价完全缓解(CR)1例、PR 7例、SD 16例、PD 9例、DCR 57.14%、ORR 19.05%。常见不良反应包括继发性高血压、手足综合征、乏力、贫血、白细胞降低、血小板降低、腹泻、呕吐、皮肤黏膜改变,转氨酶升高等。因3度以上不良反应药物减量1次为9例,减量2次为4例。不良反应以继发性高血压、转氨酶升高及手足综合征为主,发生率分别为35.71%、45.24%、40.48%。发生3度以上不良反应例数最多者为继发性高血压与转氨酶升高,均为3例,发生率为7.14%,在1~4度总不良反应中的比例为20.0%。结论甲磺酸阿帕替尼治疗m GC疗效肯定,不良反应在进行积极的处理后大多数患者尚可耐受。
[Abstract]:Objective to observe the efficacy and safety of Apatinib mesylate in the treatment of advanced gastric cancer. Open study modalities. Treatment options: oral Apatinib mesylate 850 mg per day for 1 cycle per day for .28 d, all patients taking at least 1 cycle orally into the study. Evaluated every 2 cycles, if 3 or 4 degrees of adverse reactions occur, The drug was reduced to 750 mg/ for the first time, and there were 3 or 4 degrees of adverse reactions again, and the drug was reduced to 500 mg/ again. The primary endpoints of the study included disease control rate (DCR), objective remission rate (ORR), total survival time (OS) and adverse reactions. Finally, 42 patients were included in the study. The median PFS was 4.0 months, 95 CI was 2.85 ~ 5.15 months, the median OS was 4.50 months and 95 CI was 4.03 ~ 4.97 months. After the period of 9.52.4 cycles, 1 case with complete remission of CRN and 7 cases with PR were evaluated. 16 cases with PD and 9 cases with PD with DCR 57.14 ORR 19.05. The common adverse reactions included secondary hypertension, hand and foot syndrome, fatigue, anemia, leukopenia, thrombocytopenia, diarrhea, vomiting, etc. Changes of skin and mucosa, elevation of aminotransferase, etc. Because of 3 degree or more adverse reactions, 9 cases were reduced once and 4 cases were reduced twice. The main adverse reactions were secondary hypertension, elevated aminotransferase and hand and foot syndrome, and the main adverse reactions were secondary hypertension, elevated aminotransferase and hand and foot syndrome. The incidence rates were 35.71% and 45.24% respectively. The most common adverse reactions were secondary hypertension and elevated aminotransferase (3 cases). The incidence rate was 7.14, and the proportion of total adverse reactions was 20.00.Conclusion Apatinib mesylate is effective in the treatment of mGC, and most of the patients can tolerate the adverse reactions after positive treatment.
【作者单位】：南昌市第三医院肿瘤内科;江西省胸科医院肿瘤内科;江西省肿瘤医院腹部肿瘤治疗科;南昌大学第一附属医院肿瘤诊治中心;
【基金】：江西省重点研发计划项目(编号:20161BBG70010)
【分类号】：R735.2

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