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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 肺癌是北美癌症相关死亡的主要原因。在美国和西欧，非小细胞肺癌(NSCLC)每年导致超过40万名患者死亡。对于不能切除的IIIB期和IV期NSCLC患者，常规治疗(如化疗和放射治疗)的益处微乎其微；公认的IV期患者的中位生存期(MST)在“支持性护理”组保持4-6个月，在治疗组保持6-9个月；一年生存率约为20%。美国国家癌症研究所(NCI)在其网页上引用了对52项随机临床试验的荟萃分析，这些试验显示，在接受化疗和/或放射治疗的两年内，绝对生存率提高了4%。最近的一篇论文和《新英格兰医学杂志》的一篇社论总结说，4种广泛使用的化疗方案对晚期非小细胞肺癌患者只有微乎其微的益处和严重的毒副作用，“是时候放弃化疗了。由于总体效果不佳，NCI得出结论，迫切需要更有效的治疗非小细胞肺癌的方法。 SV是一种膳食补充剂，由精选的植物和草药组成，根据科学证明的免疫增强、抗癌或抗病毒活性而精选。初步数据显示，与对照组相比，每日摄入SV可以延长晚期非小细胞肺癌(NSCLC)患者的中位生存期3倍。 这是一项随机、安慰剂对照的双盲研究，旨在确定在IIIB/IV期非小细胞肺癌患者的标准化疗方案中加入膳食补充剂(SV)是否会延长生存期。关于添加SV对肿瘤反应、毒性和生活质量的影响的信息也将被收集和分析。

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.