吉非替尼不联合放射治疗日本发生脑转移的EGFR突变肺腺癌患者的二期临床试验
BACKGROUND: Brain metastases (BM) are a common in patients with lung cancer. Although whole-brain radiation therapy (WBRT) is the standard therapy, it may have a risk of decline in cognitive function of patients. In this study, we evaluated the efficacy of gefitinib alone without radiation therapy for the treatment of patients with BM from lung adenocarcinoma.
MATERIALS AND METHODS: Eligible patients had BM from lung adenocarcinoma with epidermal growth factor receptor (EGFR) mutations. Gefitinib was given at 250mg orally once a day until tumor progression or unacceptable toxicity.
RESULTS: Forty-one patients were enrolled. The response rate was 87.8%. No patient experienced grade ≥4 toxicity. The median progression-free survival time was 14.5 months (95% CI, 10.2-18.3 months), and the median overall survival time was 21.9 months (95% CI, 18.5-30.3 months). In compared with L858R, exon 19 deletion was associated with better outcome of patients after treatment with gefitinib in both progression-free (p=0.003) and overall survival (p=0.025).
CONCLUSION: Favorable response of BM to gefitinib even without irradiation was demonstrated. Exon 19 deletion was both a predictive and prognostic marker of patients with BM treated by gefitinib.
结论:对于发生脑转移的EGFR突变肺腺癌患者,即使不联合应用放射治疗,吉非替尼治疗也可以获得良好的缓解。外显子19是脑转移患者接受吉非替尼治疗的预后提示因子。
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