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Validation of a clinical prognostic model in Chinese patients with metastatic and advanced pretreated non-small cell lung cancer treated with gefitinib.

机译:吉非替尼治疗的中国转移性和晚期非小细胞肺癌患者临床预后模型的验证。

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A clinical prognostic model derived from BR.21 trial was established by Florescu et al., which helped to identify a small group of patients with non-small cell lung cancer (NSCLC) who might be less likely to benefit from erlotinib therapy. Whether the prognostic model derived from Caucasian patients treated with erlotinib will be applied to Asian patients treated with gefitinib is still an open question. We reviewed a multi-center clinical trial of Chinese patients with NSCLC treated with gefitinib. The data were collected and analyzed according to the prognostic model reported by Florescu et al. One hundred and nineteen patients were included in the validation study. Twenty-eight patients, 61 patients, 27 patients, and 3 patients were classified into the Low Risk (LR) group, Intermediate Low Risk (ILR) group, Intermediate High Risk/High Risk (IHR/HR) group, respectively. The median overall survival of LR group was not reached, ILR and IHR/HR group was 8.9 months and 4.5 months, respectively. There was a significant difference in overall survival between LR group versus ILR group and IHR/HR group (P = 0.0003 and 0.0001, respectively). While IHR/HR group appeared to have less survival benefit than ILR group, the difference was not statistically significant (P = 0.148). The result has shown a similar effect as that seen by Florescu et al. in differentiating patient risk groups. Our study provides the potential evidence that the prognostic model might be applied to Asian patients with NSCLC treated with gefitinib and helps clinicians to select patients for gefitinib therapy and stratify patients within second-line clinical trials.
机译:Florescu等人建立了源自BR.21试验的临床预后模型,该模型有助于确定一小部分非小细胞肺癌(NSCLC)患者,这些患者可能不太可能受益于厄洛替尼治疗。是否将从厄洛替尼治疗的白种人患者获得的预后模型应用于吉非替尼治疗的亚洲患者仍是一个悬而未决的问题。我们回顾了吉非替尼治疗的中国非小细胞肺癌患者的多中心临床试验。根据Florescu等人报道的预后模型收集和分析数据。验证研究包括119例患者。分别将28例患者,61例患者,27例患者和3例患者分为低风险(LR)组,中低风险(ILR)组,中高风险/高风险(IHR / HR)组。 LR组的中位总生存期未达到,ILR和IHR / HR组分别为8.9个月和4.5个月。 LR组与ILR组和IHR / HR组之间的总生存率存在显着差异(分别为P = 0.0003和0.0001)。虽然IHR / HR组的生存获益似乎比ILR组少,但差异无统计学意义(P = 0.148)。结果显示出与Florescu等人所见相似的效果。在区分患者风险组中。我们的研究提供了潜在的证据,表明该预后模型可能适用于吉非替尼治疗的亚洲NSCLC患者,并有助于临床医生选择吉非替尼治疗的患者并在二线临床试验中对患者进行分层。

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