塞来昔布联合化疗对转移性或术后复发性晚期胃癌的疗效及药物不良反应

Efficacy and adverse drug reactions of celecoxib combined with chemotherapy in the treatment of metastatic or recurrent advanced gastric cancer

摘要:

目的 分析塞来昔布联合化疗治疗转移性或术后复发性胃癌的疗效和安全性。方法 收集2010年9月至2016年12月转移性或术后复发性胃癌患者，分为塞来昔布+化疗组和单纯化疗组，治疗6个周期。比较两组患者间临床资料、无进展生存期（PFS）、总生存期（OS）的差异，并进一步分析COX-2阳性亚组的生存情况，评价药物安全性。结果 共纳入患者176例，塞来昔布+化疗组89例，单纯化疗组87例。两组患者客观缓解率、疾病控制率比较，差异均无统计学意义（P>0.05）。两组患者中位OS（P=0.59）和中位PFS（P=0.734）比较，差异均无统计学意义。塞来昔布+化疗组COX-2阳性患者中位OS为14个月，单纯化疗组COX-2阳性患者为10个月，差异有统计学意义（P=0.010）；塞来昔布+化疗组COX-2阳性患者中位PFS为7.5个月，单纯化疗组COX-2阳性患者为5个月，差异有统计学意义（P<0.001）。两组患者的药物不良反应均以恶心最为常见，但差异无统计学意义。结论 塞来昔布联合化疗可延长COX-2阳性晚期胃癌患者的OS和PFS，且不增加药物不良反应。

Abstract:

Objective To analyze the efficacy and safety of celecoxib combined with chemotherapy in the treatment of metastatic or postoperative recurrent gastric cancer.Methods Patients with metastatic or postoperative recurrent gastric cancer were recruited between September 2010 and December 2016, and they were divided into celecoxib + chemotherapy group and chemotherapy alone group. All patients had 6 cycles of treatment. The clinical data, progression-free survival (PFS) and overall survival (OS) were compared between the two groups. The COX-2 positive subgroup was further analyzed and the drug safety was evaluated.Results A total of 176 patients were included in this study, 89 in celecoxib + chemotherapy group and 87 in chemotherapy alone group. There were no significant differences in total effective rate and disease control rate between the two groups (P>0.05). There were yet no significant differences in median OS (P=0.59) and median PFS (P=0.734) between the two groups (P>0.05). The median OS of COX-2 positive patients in celecoxib + chemotherapy group (14 months) were longer than that of COX-2 positive patients in chemotherapy alone group (10 months) (P=0.010). The median PFS of COX-2 positive patients in celecoxib + chemotherapy group (7.5 months) were also longer than that of COX-2 positive patients in chemotherapy alone group (5 months) (P<0.001). Nausea was the most common adverse drug reactions in the two groups, but there was no statistical difference in the incidence between the two groups.Conclusion Celecoxib combined with chemotherapy can prolong the OS and PFS of patients with COX-2 positive advanced gastric cancer, but not increase the adverse drug reactions.