[Efficacy and safety of Xiaoaiping combined with chemotherapy in the treatment of advanced esophageal cancer]
- PMID: 28635236
- DOI: 10.3760/cma.j.issn.0253-3766.2017.06.010
[Efficacy and safety of Xiaoaiping combined with chemotherapy in the treatment of advanced esophageal cancer]
Abstract
Objective: To evaluate the efficacy and safety of Xiaoaiping combined with chemotherapy in the treatment of advanced esophageal cancer. Methods: This is a multi-center, randomized, open label and parallel controlled study. A total of 124 advanced esophageal cancer patients with Karnofsky Performance Status (KPS) score ≥60 and expected survival time≥3 months were enrolled. We adopted design and divided the patients into study and control group. The patients in study group received Xiaoaiping combined with S-1 and cisplatin. The control group received S-1 and cisplatin. Each group included 62 patients and 21 days as a treatment cycle. The efficacy and adverse events in patients of the two groups were observed and compared. Results: 57 patients in the study group and 55 in the control group were included in efficacy assessment. The response rate was 54.4% and 34.5% in the study group and control group, respectively(P<0.05). Disease control rates were 86.0% and 69.1%, respectively(P<0.05). The median progression-free survival (PFS) was 7.97 in the study group and 6.43 months in the control group(P<0.05). The median overall survival(OS) was 12.93 in the study group and 10.93 months in the control group(P<0.05). The most common adverse events in the two groups were nausea and vomiting, thrombocytopenia, anemia, neutropenia, liver damage, pigmentation, oral mucositis, renal impairment and diarrhea. The incidences of nausea, vomiting, thrombocytopenia, leukopenia, neutropenia and diarrhea in the study group were significantly higher than those in the control group(P<0.05). Conclusion: Xiaoaiping combined with S-1 and cisplatin significantly increased response rate, and prolongedpatients' survival in patients with advanced esophageal cancer.
目的： 探讨消癌平注射液联合化疗治疗中晚期食管癌的疗效和安全性。 方法： 选取临床确诊的中晚期食管癌、KPS评分≥60分，预计生存时间≥3个月的患者124例，采取多中心、随机、开放、平行对照试验设计，将患者分为试验组和对照组，每组62例，试验组接受消癌平注射液联合替吉奥＋顺铂化疗方案，对照组单用替吉奥＋顺铂化疗方案，21 d为1个治疗周期，观察两组患者的疗效和不良反应。 结果： 试验组和对照组可评价临床疗效的患者分别为57例和55例。试验组和对照组患者的有效率分别为54.4%和34.5%，疾病控制率分别为86.0%和69.1%，试验组患者的有效率和疾病控制率均明显高于对照组，差异有统计学意义(均P<0.05)。试验组和对照组患者的中位无进展生存时间分别为7.97和6.43个月，差异有统计学意义(P＝0.033)；试验组和对照组患者的中位总生存时间分别为12.93和10.93个月，差异有统计学意义(P＝0.023)。两组患者常见的不良反应为恶心呕吐、血小板减少、血红蛋白减少、中性粒细胞减少、白细胞减少、肝功能损害、色素沉着、口腔黏膜炎、肾功能损害和腹泻等，其中试验组患者恶心呕吐、血小板减少、白细胞减少、中性粒细胞减少和腹泻的发生率明显低于对照组，差异有统计学意义(均P<0.05)。 结论： 消癌平注射液联合替吉奥＋顺铂化疗方案治疗中晚期食管癌患者，可明显提高近期疗效，延长患者的生存时间，降低化疗不良反应，给患者带来临床收益。.
Keywords: Drug therapy; Esophageal neoplasms; S-1; Xiaoaiping injection.
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