低剂量阿帕替尼治疗晚期恶性肿瘤的安全性及有效性分析  

Safety and efficacy analysis of low-dose apatinib in treatment of advanced malignant tumors

作　　者：宋东[1] 杨晓玲[1] 冯慧晶[1] 杨雪晶[1] 张俊萍[1] Song Dong;Yang Xiaoling;Feng Huijing;Yang Xuejing;Zhang Junping(Department of Medical Oncology,Shanxi Academy of Medical Sciences,Shanxi Dayi Hospital,Taiyuan 030032,China)

机构地区：[1]山西医学科学院山西大医院肿瘤内科,太原030032

出　　处：《肿瘤研究与临床》2019年第7期469-473,共5页Cancer Research and Clinic

摘　　要：目的探讨低剂量阿帕替尼治疗晚期恶性肿瘤的安全性及有效性。方法回顾性分析2015年3月至2018年3月山西大医院收治的54例初治或经多线治疗失败后给予250mg(29例)和500mg(25例)两种不同低剂量阿帕替尼治疗的晚期恶性肿瘤患者的临床资料,其中胃癌15例,肺癌11例,卵巢癌9例,肝癌7例,软组织肉瘤6例,食管癌3例,黑色素瘤2例,腹膜癌1例。分析其客观有效率(ORR)、疾病控制率(DCR)、无进展生存(PFS)和总生存(OS),评估其疗效和相关不良反应。结果54例患者均可评价不良反应,非血液学药物相关不良反应以高血压、手足皮肤反应、蛋白尿最为常见,血液学药物相关不良反应以白细胞减少、血小板减少最为常见,所有患者耐受性均较好。250mg剂量组患者药物相关不良反应发生率低于500mg剂量组,其中Ⅰ~Ⅱ级高血压发生率两组差异有统计学意义(χ2=6.268,P=0.012)。近期疗效:250mg与500mg剂量组患者ORR分别为6.9%(2/29)和12.0%(3/25),DCR分别为41.4%(12/29)和52.0%(13/25),500mg剂量组均优于250mg剂量组,但差异均无统计学意义(ORR:χ2=0.416,P=0.519;DCR:χ2=0.609,P=0.435)。远期疗效:500mg剂量组与250mg剂量组患者中位PFS时间分别为3.9个月和3.6个月,中位OS时间分别为7.8个月和7.6个月,500mg剂量组均优于250mg剂量组,但差异均无统计学意义(PFS:χ2=0.472,P=0.492;OS:χ2=0.261,P=0.609)。结论低剂量阿帕替尼可用于治疗晚期恶性肿瘤,患者药物相关不良反应小,疗效确切,易耐受,便于长期服用,是晚期恶性肿瘤治疗的选择之一。Objective To investigate the safety and efficacy of low-dose apatinib in treatment of advanced malignant tumors. Methods The clinical data of 54 patients with advanced malignant tumors who were admitted to Shanxi Dayi Hospital from March 2015 to March 2018 were analyzed retrospectively. These patients were treated with apatinib at doses of 250 mg (29 cases) and 500 mg (25 cases) after initial treatment or failure of multi-line treatment. There were 15 cases of gastric cancer, 11 cases of lung cancer, 9 cases of ovarian cancer, 7 cases of liver cancer, 6 cases of soft tissue sarcoma, 3 cases of esophageal cancer, 2 cases of melanoma, and 1 case of peritoneal cancer. The objective response rate (ORR), disease control rate (DCR), progress free survival (PFS) and overall survival (OS) were analyzed, and the efficacy and related adverse reactions were evaluated. Results The adverse reactions of 54 patients could be evaluated. Non-hematological drug-related adverse reactions were most common with hypertension, hand-foot skin reaction and proteinuria, while hematologic drug-related adverse reactions were most common with leukopenia and thrombocytopenia. All patients were well tolerated. The incidence of drug-related adverse reactions in the 250 mg dose group was lower than that in the 500 mg dose group, and the incidence of grade Ⅰ-Ⅱ hypertension between the two groups was statistically different (χ 2=6.268, P=0.012). Short-term efficacy: ORR of the patients in the 250 mg and 500 mg dose groups was 6.9%(2/29) and 12.0%(3/25), respectively;DCR was 41.4%(12/29) and 52.0%(13/25), respectively;and the 500 mg dose group was superior to the 250 mg dose group, but the differences were not statistically significant (ORR:χ2=0.416, P=0.519;DCR:χ2=0.609, P=0.435). Long-term efficacy: the 500 mg dose group had a slight advantage over the 250 mg dose group in both median PFS time (3.9 months vs. 3.6 months) and median OS time (7.8 months vs. 7.6 months), but the differences were not statistically significant (PFS:χ2=0.472, P

关 键 词：恶性肿瘤 阿帕替尼 低剂量 不良反应 

分 类 号：R730.5[医药卫生—肿瘤]