氯喹联合含顺铂化疗方案一线治疗HER-2阴性晚期胃癌的临床研究

Clinical study of chloroquine in combination with cisplatin⁃based regimen as the first⁃line treatment for HER⁃2 negative advanced gastric cancer

目的探讨氯喹联合含顺铂双药化疗方案一线治疗人表皮生长因子受体2(HER-2)晚期阴性胃癌的疗效与安全性。方法收集2015年1月至2018年6月HER-2阴性晚期胃癌患者41例。在顺铂联合氟尿啶啶类双药化疗的基础上,加用磷酸氯喹(250 mg/天口服,d1~d14),观察近期疗效、总生存时间(OS)、无进展生存时间(PFS)和不良反应。结果 41例患者中,接受顺铂联合氟尿嘧啶方案7例、联合卡培他滨方案24例、联合替吉奥方案10例。41例患者均可进行疗效评价,获CR 1例、PR 21例、SD 16例和PD 3例,有效率为53.7%,疾病控制率为92.7%。全组中位随访18.4个月,中位OS为12.9(95%CI:11.6~14.1)个月,中位PFS为7.3(95%CI:6.2~8.4)个月。联合氟尿嘧啶、卡培他滨和替吉奥组的中位OS分别为12.3 (95%CI:9.2~15.4)个月、13.6 (95%CI:11.6~15.6)个月和9.6 (95%CI:4.0~15.1)个月,组间差异无统计学意义(P=0.189)。不良反应主要为恶心(80.5%)、呕吐(78.0%)、白细胞减少(41.5%)、嗜睡(39.0%)、手足综合征(22.0%)和皮疹(22.0%),以1~2级为主。结论氯喹联合化疗一线治疗HER-2阴性晚期胃癌疗效较好,安全性可控,值得临床进一步研究和探索。

Objective To evaluate the efficacy and safety of chloroquine combined with cisplatin-based regimen as the firstline treatment for human epidermal receptor-2(HER-2)negative advanced gastric cancer.Methods Forty-one advanced gastric cancer patients with negative HER-2 were enrolled from January 2015 to June 2018.All of them received the therapy of chloroquine phosphate(250 mg/d oral administration,d1-d14)combined with cisplatin and fluorouracil/capecitabine/S-1 regimen.The short-term efficacy,overall survival(OS),progression-free survival(PFS),as well as adverse effects were analyzed.Results Among the 41 patients,there were 7 cases received cisplatin+fluorouracil regimen,24 cases received cisplatin+capecitabine regimen,and 10 cases received cisplatin+S-1 regimen.There were 1 patients of CR,21 of PR,16 of SD and 3 of PD.The response rate was 53.7%,and the disease control rate was 92.7%.The median OS and PFS was 12.9(95%CI:11.6-14.1)months and 7.3(95%CI:6.2-8.4)months,respectively.The median OS was 12.3(95%CI:9.2-15.4)months,13.6(95%CI:11.6-15.6)months and 9.6(95%CI:4.0-15.1)months in cisplatin+fluorouracil group,cisplatin+capecitabine group and cisplatin+S-1 group,and there was no significant difference among them(P=0.189).The most common adverse events were nausea(80.5%),vomiting(78.0%),leucopenia(41.5%),drowsiness(39.0%),hand foot syndrome(22.0%)and rash(22.0%),and most of them were of grade 1-2.Conclusion Chloroquine combined with cisplatin-based chemotherapy as the first-line treatment for HER-2 negative advanced gastric cancer has good efficacy and controllable safety,which is worthy of further clinical exploration.