EFFECTS OF A DIETARY SUPPLEMENT ON NON-SMALL CELL LUNG CANCER PATIENTS

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 肺癌是北美癌症相关死亡的主要原因。 非小细胞肺癌（NSCLC）在美国和西欧每年导致超过40万患者死亡。 常规治疗如化疗和放疗对不能切除的IIIB期和IV期NSCLC患者的获益甚微; IV期患者普遍接受的中位生存期（MST）在“支持性治疗”组保持在4-6个月，在治疗组保持在6-9个月;一年生存率约为20%。 美国国家癌症研究所（NCI）在其网页上引用了一项对52项随机临床试验的荟萃分析，该分析显示，化疗和/或放疗的2年绝对生存率为4%。 最近的一篇论文和《新英格兰医学杂志》的一篇编辑评论得出结论，4种广泛使用的化疗方案对晚期NSCLC患者仅提供边际获益，并伴有严重毒性，“是时候从化疗中走出来了。 由于总体结果不佳，NCI得出结论，迫切需要更有效的NSCLC治疗方法。 SV是一种膳食补充剂，由精选的植物和草药组成，这些植物和草药是根据其科学证明的免疫增强，抗癌或抗病毒活性而选择的。 初步数据显示，与对照组相比，每日摄入SV可使晚期非小细胞肺癌（NSCLC）患者的中位生存时间延长3倍。 这是一项随机、安慰剂对照、双盲研究，旨在确定在IIIB/IV期NSCLC患者的标准化疗方案中添加膳食补充剂（SV）是否会延长生存期。还将收集和分析关于添加SV对肿瘤缓解、毒性和生活质量的影响的信息。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Carcinoma of the lung is the leading cause of cancer related deaths in North America. Non-small Cell Lung Cancer (NSCLC) causes the death of more than 400,000 patients annually in the US and Western Europe. The benefit of conventional therapies, such as chemotherapy and radiotherapy, for unresectable stage IIIB and IV NSCLC patients is marginal; the generally accepted median survival time (MST) of stage IV patients has remained 4-6 months in the "Supportive Care" group and 6-9 months in the treatment group; the one-year survival is about 20%. National Cancer Institute (NCI) quoted in its Web page a meta-analysis of 52 randomized clinical trials that showed an absolute survival benefit of 4% at 2 years with chemotherapy and/or radiotherapy. A recent paper and an Editorial comment of New Engl J Med concluded that 4 widely used chemotherapy regimens offer only marginal benefits with severe toxicities for advanced NSCLC patients and "It is time to move on from chemotherapy. Because of the poor overall results, NCI concludes that More Effective Treatments for NSCLC Are Urgently Needed. SV is a dietary supplement consisting of selected botanicals and herbs chosen for their scientifically documented immune-potentiating, anticancer, or antiviral activity. Preliminary data have shown that daily ingestion of SV can prolong the median survival time 3-fold over the control group of advanced non-small cell lung cancer (NSCLC) patients. This is a randomized, placebo-controlled, double-blind study designed to determine if adding a dietary supplement, (SV) to a standard chemotherapy regimen in patients with Stage IIIB/IV NSCLC will prolong survival. Information about the effects of the addition of SV on tumor response, toxicities and quality of life will also be collected and analyzed.