晚期非小细胞肺癌患者参与III期化疗试验的资格。
Eligibility of patients with advanced non-small cell lung cancer for phase III chemotherapy trials.
作者信息
Vardy Janette, Dadasovich Ryan, Beale Philip, Boyer Michael, Clarke Stephen J
机构信息
Sydney Cancer Centre, Concord Repatriation General Hospital and Royal Prince Alfred Hospital, Sydney, NSW, Australia.
出版信息
BMC Cancer. 2009 Apr 29;9:130. doi: 10.1186/1471-2407-9-130.
BACKGROUND
Evidence that chemotherapy improves survival and quality of life in patients with stage IIIB & IV non small cell lung cancer (NSCLC) is based on large randomized controlled trials. The purpose of this study was to determine eligibility of patients with advanced NSCLC for major chemotherapy trials.
METHODS
Physicians treating stage IIIB/IV NSCLC at Sydney Cancer Centre assessed patient eligibility for the E1594, SWOG9509 and TAX326 trials for patients presenting from October 2001 to December 2002. A review of the centre's registry was used to obtain missing data.
RESULTS
199 patients with advanced NSCLC were registered during the 14-month period. Characteristics of 100 patients were defined prospectively, 85 retrospectively: 77% males, median age 68 (range 32-88), 64% stage IV disease. Only 35% met trial eligibility for E1594 and 28% for SWOG9509 and TAX326. Common reasons for ineligibility were: co-morbidities 75(40%); ECOG Performance Status >or=2 72(39%); symptomatic brain metastasis 15(8%); and previous cancers 21(11%). Many patients were ineligible by more than one criterion.
CONCLUSION
The majority of patients with advanced NSCLC were ineligible for the large chemotherapy trials. The applicability of trial results to advanced lung cancer populations may be limited. Future trials should be conducted in a more representative population.
背景
化疗可改善ⅢB期和Ⅳ期非小细胞肺癌（NSCLC）患者生存率及生活质量的证据基于大型随机对照试验。本研究旨在确定晚期NSCLC患者是否符合大型化疗试验的入组标准。
方法
悉尼癌症中心治疗ⅢB/Ⅳ期NSCLC的医生对2001年10月至2002年12月期间就诊的患者进行评估，判断其是否符合E1594、SWOG9509和TAX326试验的入组标准。通过查阅该中心的登记资料获取缺失数据。
结果
在14个月期间共登记了199例晚期NSCLC患者。前瞻性确定了100例患者的特征，回顾性确定了85例患者的特征：男性占77%，中位年龄68岁（范围32 - 88岁），64%为Ⅳ期疾病。只有35%的患者符合E1594试验的入组标准，28%的患者符合SWOG9509和TAX326试验的入组标准。不符合入组标准的常见原因包括：合并症75例（40%）；东部肿瘤协作组（ECOG）体能状态≥2级72例（39%）；有症状的脑转移15例（8%）；既往有癌症史21例（11%）。许多患者因不止一项标准而不符合入组要求。
结论
大多数晚期NSCLC患者不符合大型化疗试验的入组标准。试验结果对晚期肺癌人群的适用性可能有限。未来的试验应在更具代表性的人群中进行。
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