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

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.