Astragalus polysaccharide injection integrated with vinorelbine and cisplatin for patients with advanced non-small cell lung cancer: effects on quality of life and survival
Astragalus polysaccharide injection integrated with vinorelbine and cisplatin for patients with advanced non-small cell lung cancer: effects on quality of life and survival
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DOI：
10.1007/s12032-011-0068-9
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发表时间：
2012-09-01
期刊：
影响因子：
3.4
通讯作者：
Wang, Xiao-Hong
中科院分区：
文献类型：
--
作者：
Guo, Li;Bai, Shu-Ping;Wang, Xiao-Hong
目前，以铂类药物为基础的双药方案是晚期非小细胞肺癌（NSCLC）患者的标准治疗方案。然而，化疗引起的副作用仍然是一个重要的临床问题。黄芪多糖（Astragalus polysaccharide，APS）是从黄芪（astragalus membranaceus）中分离得到的一种多糖，是一种常用的中药复方。据报道，APS可增加肿瘤反应，稳定和改善体能状态，并降低化疗毒性。我们设计了这项试验，以确定APS注射液联合长春瑞滨和顺铂（VC）是否能改善晚期NSCLC患者的生活质量。次要目的是肿瘤缓解、毒性和生存结果。2008年5月至2010年3月，136例经组织学或细胞学证实的NSCLC患者入组本研究。患者随机接受VC（VC组）或VC联合APS（VC-APS组）。VC-APS组的客观缓解率为42.64%，VC组为36.76%，差异无统计学意义（P = 0.483）。VC-APS组和VC组的中位生存时间分别为10.7和10.2个月（P = 0.76），1年生存率分别为35.3%和32.4%（P = 0.717）。治疗3个周期后，两组患者的总体生活质量（P = 0.003）、身体功能（P = 0.01）、疲劳（P < 0.001）、恶心呕吐（P <0.001）、疼痛（P = 0.007）和食欲不振（P = 0.023）差异有统计学意义。综上所述，我们已经证明，APS联合VC治疗与单独VC相比，可显著改善晚期NSCLC患者的生活质量。
A platinum-based two-drug regimen is currently the standard of care for patients with advanced non-small-cell lung cancer (NSCLC). However, chemotherapy-induced side effects still remain a significant clinical problem. Astragalus polysaccharide (APS) is a polysaccharide isolated from the radix of astragalus membranaceus, a commonly used herbal compound in traditional Chinese medicine. APS was reported to increase tumor response, stabilize and improve performance status, and reduce chemotherapy toxicity. We designed this trial to determine whether APS injection integrated with vinorelbine and cisplatin (VC) offered an improved QOL over VC for patients with advanced NSCLC. Secondary objectives were tumor response, toxicity, and survival results. One hundred thirty-six patients with histologically or cytologically confirmed NSCLC were enrolled in this study from May 2008 to March 2010. Patients were randomized to receive either VC (VC arm) or VC combined with APS (VC-APS arm). The objective response rate of was 42.64% in the VC-APS arm and 36.76% in the VC arm. The difference was not statistically significant (P = 0.483). Median survival time was 10.7 and 10.2 months (P = 0.76) in VC- APS arm and VC arm, with 1-year survival rates of 35.3 and 32.4% (P = 0.717), respectively. After 3 cycles of treatment, there were significant differences in the overall patient QOL (P = 0.003), physical function (P = 0.01), fatigue (P < 0.001), nausea and vomiting (P < 0.001), pain (P = 0.007), and loss of appetite (P = 0.023) between the two study groups. In summary, we have proved that the treatment of APS integrated with VC had significantly improved QOL in patients with advanced NSCLC compared with VC alone.