甲磺酸阿帕替尼片联合卡培他滨片和奥沙利铂注射剂治疗晚期结直肠癌的临床研究

Clinical trial of apatinib mesylate tablets combined with capecitabine tablets and oxaliplatin injection in the treatment of advanced colorectal cancer

目的观察甲磺酸阿帕替尼片联合卡培他滨片和奥沙利铂注射剂治疗晚期结直肠癌的临床疗效及安全性。方法将66例晚期结肠癌患者随机分为对照组和试验组,每组33例。对照组予以135 mg·m^-2奥沙利铂,静脉滴注,每3周重复1次+1250 mg·m^-2卡培他滨片,bid,口服,给药2周停药1周;试验组在对照组治疗的基础上,予以甲磺酸阿帕替尼片每次0. 5 g,qd,口服。2组患者均治疗6周。比较2组患者的临床疗效、生存期,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的客观缓解率分别为69. 70%(23例/33例)和36. 36%(12例/33例),疾病控制率分别为96. 97%(32例/33例)和75. 76%(25例/33例),总生存期分别为(5. 14±0. 14)和(2. 22±0. 15)年,无进展生存期分别为(4. 16±0. 15)和(1. 41±0. 09)年,差异均有统计学意义(均P <0. 05)。2组患者的药物不良反应均以高血压、骨髓抑制、头痛、乏力、腹泻、蛋白尿次和手足综合征为主。试验组和对照组的总药物不良反应发生率分别为66. 67%和60. 61%,差异无统计学意义(P> 0. 05)。结论甲磺酸阿帕替尼片联合卡培他滨片和奥沙利铂注射剂治疗晚期结直肠癌的临床疗效较好,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of apatinib mesylate tablets combined with capecitabine tablets and oxaliplatin injection in the treatment of advanced colorectal cancer. Methods Sixty - six patients with advanced colon cancer were randomly divided into control and treatment groups with 33 cases per group. Control group was given 135 mg·m^-2oxaliplatin,intravenous infusion,once three weeks + 1250 mg·m^-2 capecitabine tablets,bid,orally with the drug was given for 2 weeks and stopped for 1 week. Treatment group was given apatinib mesylate tablets 0. 5 g per time,qd,orally,on the basis of control group. Two groups were treated for 6 weeks. The clinical efficacy, survival and adverse drug reactions were compared between two groups. Results After treatment,the main indexes of treatment and control groups were compared: the objective response rates were 69. 70%( 23 cases /33 cases) and 36. 36%( 12 cases /33 cases),the disease control rates were 96. 97%( 32 cases/33 cases) and 75. 76%( 25 cases/33 cases),the overall survival were ( 5. 14 ± 0. 14) and ( 2. 22 ± 0. 15) years,the progression - free survival were ( 4. 16 ± 0. 15) and ( 1. 41 ± 0. 09) years,and the differences were statistically significant ( all P < 0. 05). The adverse drug reactions of the two groups were mainly hypertension,myelosuppression,headache,fatigue,diarrhea,proteinuria and hand - foot syndrome. The total incidences of adverse drug reactions in the treatment and control groups were 66. 67% and 60. 61% without significant difference ( P > 0. 05). Conclusion Apatinib mesylate tablets combined with capecitabine tablets and oxaliplatin injection have a definitive clinical efficacy in the treatment of advanced colorectal cancer, without increasing the incidence of adverse drug reactions.