阿帕替尼不同起始剂量治疗晚期胃癌不良反应及疗效观察

Clinical efficacy and adverse reactions in the treatment of advanced gastric cancer with different doses of apatinib

目的探讨阿帕替尼不同起始剂量治疗晚期胃癌的不良反应及临床疗效。方法收集62例应用阿帕替尼三线治疗的晚期胃癌患者,根据随机数字法分为250 mg/d组(n=21)、500 mg/d组(n=21)和850 mg/d组(n=20)。250 mg/d组第1周剂量为250 mg/d,第2周为500 mg/d,从第3周开始为850 mg/d;500 mg/d组第1周为500 mg/d,从第2周开始为850 mg/d;850 mg/d组第1周开始即为850 mg/d。观察3组不良反应发生情况及临床疗效。结果 250 mg/d组、500 mg/d组和850 mg/d组疾病控制率分别为61.9%、52.4%和40.0%(P<0.05),症状改善率分别为80.9%、71.4%和50.0%(P<0.05),生存质量改善率分别为33.3%、28.6%和20.0%(P<0.05)。恶心、呕吐、腹痛、腹胀和腹泻等胃肠道不良反应发生率分别为19.1%、33.3%和55.0%(P<0.05)。手足综合征发生率分别为28.6%、38.1%和55.0%(P<0.05)。消化道出血发生率为4.8%、9.5%和15.0%(P<0.05)。而高血压、蛋白尿、肝肾功能异常和骨髓抑制等不良反应发生率比较,差异均无统计学意义(均P>0.05)。结论阿帕替尼小剂量递增型给药至治疗剂量可减轻不良反应,提高疗效。

Objective To study the clinical efficacy and adverse reactions in the treatment of advanced gastric cancer with different doses of apatinib. Methods Sixty-two cases of advanced gastric cancer were enrolled and randomly assigned to three groups： 250 mg/d group（ n = 21）,500 mg/d group（ n = 21） and 850 mg/d group（ n = 20）. For the 250 mg/d group,patients received 250 mg/d apatinib in the first week,500 mg/d in the second week,and 850 mg/d in the following weeks. For the 500 mg/d group,patients received 500 mg/d apatinib in the first week,and 850 mg/d in the following weeks. For the 850 mg/d group,patients received 850 mg/d apatinib through the entire process. The adverse reactions and clinical efficacy in the three groups were observed. Results For the 250 mg/d,500 mg/d,and 850 mg/d groups,the respective disease control rates（ DCR） were 61. 9%,52. 4% and 40. 0%（ P〈0. 05）,the respective symptom improvement rates were 80. 9%,71. 4% and 50. 0%（ P〈0. 05）,and the respective quality of survival rates（ Qo R）were 33. 3%,28. 6% and 20. 0%（ P〈0. 05）. Besides,the incidences of gastrointestinal reactions were 19. 1%,33. 3% and 55. 0%（ P〈0. 05）,for the 250 mg/d,500 mg/d,and 850 mg/d groups,respectively,which include symptoms as nausea,vomiting,abdominal pain,abdominal distension and diarrhea. Moreover,the respective incidences of hand-foot-syndrome（ HFS） were 28. 6%,38. 1% and 55. 0%（ P〈0. 05）,and the respective incidences of digestive tract bleeding were 4. 8%,9. 5% and 15. 0%（ P〈0. 05）,for the three groups. Nevertheless,the incidences of hypertension,proteinuria,abnormal liver and kidney function,and bone marrow suppression were not significantly different among the three groups（ all P〉0. 05）. Conclusion Apatinib treatment starting at a low dosage can reduce the incidence of adverse reactions and increase the clinical efficacy.