目的：研究卡培他滨联合顺铂(XP方案)一线治疗HER2阴性的晚期胃癌后给予卡培他滨维持化疗的疗效及安全性。方法：82例初治的HER2阴性的晚期胃癌患者一线方案采用XP方案。每2周期化疗后进行疗效评价。最多6个周期化疗后疗效评价为无疾病进展的患者共59例，随机分为两组(A，B组)，A组(n=30)给予卡培他滨单药维持化疗(1 000 mg/m2，2次/d，d1~14，3周为1周期)，持续至疾病进展或患者出现不能耐受的毒副作用为止。B组(n=29)仅接受定期随访观察。结果：82例患者共接收416周期的初始化疗，经初始化疗后均可评价疗效，总有效率(response rate，RR)为48.78%，疾病控制率(disease control rate，DCR)为71.95%。A组RR和DCR分别为26.67%，76.67%，均高于B组(RR和DCR分别为0.00%，37.93%，P<0.05)。维持化疗组中位疾病进展时间(time to progress，TTP)7.9个月较B组5.3个月延长(P<0.05)。A组和B组中位总生存期(overall survival，OS)分别为14.8，13.2个月，差异无统计学意义(P>0.05)。维持化疗期间主要不良反应有骨髓抑制、恶心呕吐、腹泻、周围神经毒性、黏膜炎、手足综合征等，经对症治疗后均有好转，无治疗相关性死亡。结论：XP方案一线治疗HER2阴性的晚期胃癌后单药卡培他滨维持，可提高有效率、疾病控制率，延长疾病进展时间，且不良反应轻，值得进一步研究和临床推广应用。
Efficacy and safety of capecitabine maintenance therapy after first-line capecitabine plus cisplatin chemotherapy in patients with HER-2 negative advanced gastric cancer
Objective: To investigate the efficacy and safety of capecitabine maintenance therapy after the first-line capecitabine plus cisplatin (XP regimen) chemotherapy for patients with HER-2 negative advanced gastric cancer. Methods: A total of 82 chemotherapy-naive patients with HER-2 negative advanced gastric cancer were recruited into this study. They were treated with first-line XP regimen, with 21 days as a cycle. The efficacy was evaluated after two cycles of chemotherapy. A maximum six-cycle dosage was given. A total of 59 patients who responded to the therapy were randomly assigned to either group A or B. In group A, 30 patients were given with capecitabine maintenance therapy (1 000 mg/m2, bid, d1–14, q3w) until disease progression or intolerable toxicity. In group B, 29 patients were treated with clinical observation. Results: A total of 416 cycles of the chemotherapy were completed in 59 patients. All patients were evaluated for the therapeutic efficacy. The response rate (RR) and disease control rate (DCR) were 48.78% and 71.95% in the patients. The RR and DCR were 26.67% and 76.67% in group A, and 0.00% and 37.93% in group B, respectively (P<0.05). The median time to progression was longer in group A (7.9 months) than in group B (5.3 months) (P<0.05). The median overall survival time was 14.8 and 13.2 months in group A and B, respectively (P>0.05). The most common adverse events include myelosuppression, nausea/vomiting, diarrhea, peripheral neurotoxicity, mucositis and hand-foot syndrome. No treatment-related death was found. Conclusion: Capecitabine plus cisplatin with subsequent capecitabine maintenance therapy can increase the RR and DCR, prolong the median time to progression in HER-2 negative advanced gastric cancer, with good tolerance and safety.