卡培他滨维持治疗晚期胃癌的疗效和安全性研究

目的：观察卡培他滨维持治疗晚期胃癌的疗效和安全性.方法：收集48例一线化疗方案以氟尿嘧啶类药物为基础治疗后获益的晚期胃癌患者,设卡培他滨维持治疗组（n=25）和观察组（n=23）,维持组予以卡培他滨1.0 g/m^2 bid第1～14天,休息7d,21d为1个周期,至疾病进展或不能耐受不良反应停药.观察组仅随诊,定期复查.观察维持治疗组的近期疗效和安全性,比较两组无进展生存期的差异.结果：25例卡培他滨维持治疗患者,共完成148个周期化疗,其中5例患者因不良反应停药,余均口服至病情进展,中位治疗周期为6周期.维持治疗疗效分析：5例患者达到PR,16例SD,4例PD.维持治疗有效率为20％,疾病控制率为84％.维持治疗组的中位无进展生存期为8.2个月,观察组的中位无进展生存期为6.1个月（P＜0.05）.维持治疗组的主要不良反应为手足综合症和血液学毒性,但程度较轻,主要为Ⅰ～Ⅱ级,Ⅲ级发生率为28％,无Ⅳ级不良反应发生,耐受性好.结论：一线化疗方案以氟尿嘧啶类药物为基础治疗后获益的晚期胃癌患者,予以卡培他滨维持治疗可延长无进展生存期,不良反应可耐受.

Efficacy and safety of capecitabine in the maintenance therapy of advanced gastric carcinoma

AIM：To explore the efficacy and safety of capecitabine in the maintenance therapy of advanced gastric carcinoma.METHODS：All 48 patients with advanced gastric cancer after response to fluorouracil-based chemotherapy as a first-line were divided into two groups,the maintenance therapy group （n=25） was administered capecitabine at a dose of 1 000 mg/m2,twice daily for 14 days,followed by a 7-day rest period,21 days for 1 cycles,until disease progressed or can not tolerate the toxicities withdrawal.The control group （n=23） administered with regular clinical observations until disease progressed.The efficacy and safety of maintenance therapy group were observed,the difference between two groups of progression-free survival was compared.RESULTS：25 cases of capecitabine maintenance therapy patients,a total of 148 cycles of chemotherapy,including 5 cases of patients with adverse effects due to withdrawal,were treated until disease progressed,the median cycle for 6 cycles.There were 5 PR,16 SD and 4 PD.The objective response rate of capecitabine maintenance therapy group was 20%,disease control rate was 84%.Maintenance therapy group,the median progression-free survival was 8.2 months,the observation group,the median progression-free survival was 6.1 months,P=0.05,there was significant difference between two groups.The most common adverse effects in the maintenance therapy group was hand-foot syndrome and hematological toxicity,but to a lesser degree,mainly for Ⅰ-Ⅱ degree,Ⅲ incidence rate was 28%,good tolerance.CONCLUSION：First-line chemotherapy regimen to fluoropyrimidine-based therapy benefit to patients with advanced gastric cancer,capecitabine as maintenance therapy can prolong progression-free survival,toxicity can be tolerated.