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表皮生长因子受体突变型肺腺癌脑转移日本患者单独使用吉非替尼而不进行放射治疗的 II 期试验。

Phase II trial of gefitinib alone without radiation therapy for Japanese patients with brain metastases from EGFR-mutant lung adenocarcinoma.

机构信息

Divisions of Neurological Surgery, Chiba Cancer Center, Chiba, Japan.

出版信息

Lung Cancer. 2013 Nov;82(2):282-7. doi: 10.1016/j.lungcan.2013.08.016. Epub 2013 Aug 28.

DOI:10.1016/j.lungcan.2013.08.016
PMID:24021541
Abstract

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 250 mg 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.

摘要

背景

脑转移(BM)是肺癌患者的常见病症。虽然全脑放疗(WBRT)是标准疗法,但它可能会导致患者认知功能下降的风险。在这项研究中,我们评估了单独使用吉非替尼而不进行放疗治疗肺腺癌脑转移患者的疗效。

材料与方法

符合条件的患者患有肺腺癌脑转移且存在表皮生长因子受体(EGFR)突变。吉非替尼的剂量为 250mg,口服,每天一次,直至肿瘤进展或出现不可接受的毒性。

结果

共纳入 41 名患者。有效率为 87.8%。没有患者出现≥4 级毒性。无进展生存期的中位数为 14.5 个月(95%可信区间,10.2-18.3 个月),总生存期的中位数为 21.9 个月(95%可信区间,18.5-30.3 个月)。与 L858R 相比,19 号外显子缺失与吉非替尼治疗后患者的无进展生存(p=0.003)和总生存(p=0.025)结果更好相关。

结论

即使未进行放疗,吉非替尼对 BM 也有良好的反应。19 号外显子缺失是 BM 患者接受吉非替尼治疗的预测和预后标志物。

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