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Kanglaite injection plus platinum-based chemotherapy for stage III/IV non-small cell lung cancer: A meta-analysis of 27 RCTs.

康莱特注射液联合铂类化疗治疗 ⅲ/ⅳ 期非小细胞肺癌: 27 项rct的荟萃分析。

  • 影响因子:4.09
  • DOI:10.1016/j.phymed.2019.153154
  • 作者列表:"Huang X","Wang J","Lin W","Zhang N","Du J","Long Z","Yang Y","Zheng B","Zhong F","Wu Q","Ma W
  • 发表时间:2020-02-01
Abstract

BACKGROUND:Kanglaite injection (KLT) is a broad-spectrum anti-tumor drug, which is extracted from the seeds of the Chinese medicinal herb Coix lacryma-jobi, and has been widely used for the treatment of advanced lung cancer. PURPOSE:To evaluate the combined effects of Kanglaite injection plus platinum-based chemotherapy (PBC) on patients with stage III/IV non-small cell lung cancer (NSCLC). STUDY DESIGN:A systematic review and meta-analysis of randomized clinical trials (RCTs). MATERIALS AND METHODS:Twelve databases were searched from their inceptions until July 05, 2019. All the RCTs comparing the efficacy and safety of Kanglaite injection plus PBC versus PBC alone were selected. Analyses were performed using Review Manager 5.3, Comprehensive Meta-Analysis 3.0 and Trial Sequential Analysis (TSA). Disease control rate (DCR) was defined as the primary endpoint, objective response rate (ORR), survival rate, quality of life (QOL), cellular immunity function, and toxicities were defined as the secondary endpoints. RESULTS:Twenty-seven RCTs recruiting 2,243 patients with stage III/IV NSCLC were included. The results showed that, compared with PBC alone, Kanglaite injection plus PBC improved DCR (RR = 1.20, 95% CI 1.15-1.26, p < 0.00001), ORR (RR = 1.45, 95% CI 1.31-1.60, p < 0.00001), 1-year survival rate (RR = 1.20, 95% CI 1.02-1.43, p = 0.03), QOL (RR = 1.32, 95% CI 1.25-1.40, p < 0.00001), CD4+T cells (WMD = 4.86, 95% CI 4.00-5.73, p < 0.00001), CD4+/CD8+ ratio (WMD = 0.19, 95% CI 0.07-0.31, p < 0.002), and reduced severe toxicities by 59% (RR = 0.41, 95% CI 0.33-0.51, p < 0.00001). Most results were robust and the quality of evidence was from moderate to low. CONCLUSIONS:Kanglaite injection in combination with PBC showed significantly higher efficacy than PBC alone in the treatment of stage III/IV NSCLC. Moreover, the combination therapy can improve cellular immunity and attenuate the severe toxicities caused by chemotherapy. However, high-quality RCTs are warranted to further assess the effects of the combined therapy.

摘要

背景: 康莱特注射液是从中药薏苡仁中提取的一种广谱抗肿瘤药物,并已广泛用于晚期肺癌的治疗。 目的: 评价康莱特注射液联合铂类化疗 (PBC) 治疗 ⅲ/ⅳ 期非小细胞肺癌 (NSCLC) 的疗效。 研究设计: 随机临床试验 (RCTs) 的系统评价和荟萃分析。 材料和方法: 从 12 个数据库中检索到 2019 年 7 月 5 日。选择比较康莱特注射液联合PBC与单纯PBC疗效和安全性的所有rct。使用Review Manager 5.3,全面荟萃分析 3.0 和试验序贯分析 (TSA) 进行分析。疾病控制率 (DCR) 定义为主要终点、客观缓解率 (ORR) 、生存率、生活质量 (QOL) 、细胞免疫功能、和毒性被定义为次要终点。 结果: 纳入了 27 项rct,招募了 2,243 例III/IV期NSCLC患者。结果显示,与单纯PBC相比,康莱特注射液联合PBC改善DCR (RR = 1.20,95% CI 1.15-1.26,p <0.00001),ORR (RR = 1.45,95% CI 1.31-1.60,p <0.00001) 、 1 年生存率 (RR = 1.20,95% CI 1.02-1.43,p = 0.03) 、QOL (RR = 1.32,95% CI 1.25-1.40,p <0.00001),CD4 + T细胞 (WMD = 4.86,95% CI 4.00-5.73,p <0.00001),CD4 +/CD8 + 比值 (WMD = 0.19,95% CI 0.07-0.31,p <0.002),严重毒性降低 59% (RR = 0.41,95% CI 0.33-0.51,P <0.00001)。大多数结果是稳健的,证据质量从中等到低。 结论: 康莱特注射液联合PBC治疗 ⅲ/ⅳ 期NSCLC的疗效明显优于单纯PBC。此外,联合治疗可以提高细胞免疫,减轻化疗引起的严重毒性。然而,需要高质量的rct来进一步评估联合治疗的效果。

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DOI:10.1002/ijc.32532
作者列表:["Hata A","Nakajima T","Matsusaka K","Fukuyo M","Morimoto J","Yamamoto T","Sakairi Y","Rahmutulla B","Ota S","Wada H","Suzuki H","Matsubara H","Yoshino I","Kaneda A"]

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DOI:10.1002/ijc.32530
作者列表:["Zhang L","Yang Y","Chai L","Bu H","Yang Y","Huang H","Ran J","Zhu Y","Li L","Chen F","Li W"]

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肺肿瘤方向

肺肿瘤,又叫支气管肺癌,是常见的恶性肿瘤之一。肺肿瘤的治疗为包括手术、中药、放疗、化疗及免疫等多学科的综合治疗。

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