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晚期胃癌一线化疗后卡培他滨维持治疗的疗效和安全性
作者:肖成华  阚捷  李海燕  王新国  吴昊 
单位:青海省人民医院肿瘤内科  青海 西宁 810007 江苏省人民医院肿瘤内科  江苏 南京 210000 
关键词:胃肿瘤/药物疗法 脱氧胞苷/投药和剂量 脱氧胞苷/类似物和衍生物 抗肿瘤联合化疗方案/治疗应用 存活率 治疗结果 
DOI:R735.2;R730.53
出版年,卷(期):页码:2018,33(5):436-440
摘要:

目的 观察卡培他滨在晚期胃癌一线化疗后维持治疗的疗效和不良反应。方法 280例晚期胃癌患者经FOLFOX4方案(奥沙利铂+氟尿嘧啶+亚叶酸钙,6~9个周期)或XELOX方案(奥沙利铂+卡培他滨,4~6个周期)一线化疗后,疗效评价无疾病进展的172例患者,按照患者意愿分为维持组63例(卡培他滨维持治疗,1 000 mg/m2,每天2次,d1~14,每3周重复)和观察组109例。结果 FOLFOX4方案组和XELOX方案组的疾病控制率分别为64.4%(85/132)和65.5%(97/148),两者比较,差异无统计学意义(P=0.95)。XELOX方案的患者入维持组的比例高于FOLFOX4方案患者(P=0.009)。中位无进展生存期维持组为10.7个月(95%CI:9.6~11.8个月),观察组为7.3个月(95%CI:6.9~7.6个月,P<0.01)。中位生存期维持组优于观察组,分别为18.3个月(95%CI:17.5~19.0个月)和15.0个月(95%CI:14.5~15.5个月,P<0.01)。维持组常见不良反应为血液学和胃肠道毒性,以1~2级多见。结论 卡培他滨作为晚期胃癌一线化疗后维持治疗延长PFS和OS,耐受性良好。

Objective To evaluate the efficacy and safety of capecitabine maintenance therapy following first-line chemotherapy in patients with advanced gastric cancer. Methods This study enrolled 172 cases who were evaluated as "without disease progression" from 280 advanced gastric cancer patients after first-line chemotherapy of FOLFOX4 regimen (oxaliplatin+fluorouracil+leucovorin) for 6~9 cycles or XELOX regimen (oxaliplatin+capecitabine) for 4~6 cycles. According to patients' decision,63 cases participated in the capecitabine maintenance group (1 000 mg/m2,twice per day d1-14,every 3 weeks) and 109 cases participated in the observation group. Results The disease control rate was 64.4% (85/132) in the patients treated by FOLFOX4 regimen and 65.5%(97/148) in those treated by XELOX regimen (P=0.95). Notably,the percentage of patients in the capecitabine maintenance group was higher in those treated by XELOX regimen than that in those treated by FOLFOX4 regimen (P=0.009). In the maintenance group,the median progression free survival time was 10.7 months(95%CI:9.6-11.8 months),which was longer than that of the observation group (7.3 months,95%CI:6.9-7.6 months,P<0.01). Moreover,the median overall survival rate was also higher in the maintenance group (18.3 months,95%CI: 17.5-19.0 months),as compared with the observation group (15.0 months,95%CI:14.5-15.5 months,P<0.01). The most common adverse reactions in the maintenance group were grades 1-2 hematological and gastrointestinal toxicity. Conclusion Capecitabine maintenance therapy can prolong progression free survival and overall survival,with tolerant adverse reactions,in patients with advanced gastric cancer after first-line chemotherapy.

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