低剂量阿帕替尼治疗晚期胃癌疗效及安全性分析

Efficacy and safety of low-dose apatinib in the treatment of advanced gastric cancer

目的回顾性分析低剂量阿帕替尼治疗晚期胃癌的临床疗效及不良反应。方法收集51例应用阿帕替尼治疗三线及三线以上晚期胃癌患者,早餐后口服500 mg/d,观察不良反应,定期复查评价疗效,随访记录生存时间。结果 CR患者0例,PR患者4例(6.67%),SD患者18例(35.29%),PD患者29例(56.87%),ORR为7.84%(4/51),DCR为43.13%(22/51)。单因素分析ECOG PS评分0～1分患者有效率高于2分患者(P=0.001),合并手足综合征、高血压和蛋白尿,其治疗有效率高于无相应不良反应者(均P<0.05),多因素Logistic回归分析显示:ECOG PS、合并手足综合征、高血压是疗效独立预测因素(均P<0.05)。患者m PFS 3.43个月(95%CI,3.19～3.68),m OS4.36个月(95%CI 3.84～4.90),亚组分析显示:DCR组mOS显著长于PD组(6.32个月vs 2.90个月,P<0.05)。结论低剂量阿帕替尼(500 mg/d)治疗三线及三线以上晚期胃癌疗效确切,安全性良好,不良反应可控。

Objective To retrospectively analyze the clinical efficacy and adverse reactions of low-dose apatinib in the treatment of advanced gastric cancer. Methods 51 patients with third-line or more advanced gastric cancer were treated with apatinib, oral 500mg/d after breakfast. Adverse reactions were observed, and the efficacy was evaluated regularly. The survival time was followed up. Results There was 0 patient with CR, 4 patients with pulmonary disease (6.67%), 18 patients with SD (35.29%) and 29 patients with PD (56.87%). The percentage of ORR and DCR was 7.84%(4/51) and 43.13%(22/51). Univariate analysis showed that the efficacy was higher in ECOG PS score 0-1 points patients than that in patients with more than 2 points (P=0.001). And the efficacy was higher in patients combined with hand-foot syndrome, hypertension and proteinuria in patients with no corresponding adverse reactions(all P<0.05). Multivariate Logistic regression analysis showed that ECOG PS, combined with hand-foot syndrome and hypertension were independent predictors of efficacy (all P<0.05). The mPFS and the mOS of patients was 3.43 months (95% CI, 3.19 to 3.68) and 4.36 months(95% CI 3.84 to 4.90). Subgroup analysis showed that mOS was significantly longer in the DCR group than that in the PD group (6.32 months vs 2.90 months, P<0.05). Conclusion Low-dose apafitinib (500 mg/d) is effective in the treatment of third-line or more advanced gastric cancer, with good safety and controllable adverse reactions.