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ABSTRACT: To evaluate the efficacies of gefitinib plus radiotherapy in the treatment of brain metastases in non-small-cell lung carcinoma (NSCLC) patients. A retrospective analysis was conducted for 161 NSCLC patients with brain metastases treated in Xinqiao Hospital from January 2001 to January 2010. And 38 patients aged 38 - 77 years old received the combined regimen of gefitinib plus radiotherapy. It consisted of synchronically practicing general or stereotactic brain radiotherapy and an oral intake of gefitinib (250 mg, QD for at least 8 consecutive weeks). The efficacies and toxicity were evaluated at Week 12 after the initial treatment. A total of 123 patients aged 37 - 76 years old undergoing whole brain or stereotactic radiotherapy were used as control. χ(2) test between two groups was carried out to evaluate the objective response rate (ORR), disease control rate (DCR), brain metastasis related symptoms and III-IV degree of toxicity. Non-parametric rank tests were performed to compare the U.S. Eastern Cooperative Oncology Group (ECOG) performance status score between two groups. In the combination therapy group, the levels of ORR and DCR were significantly higher than those in the conventional treatment group (31.6%, 78.9% vs 15.4%, 60.2%). The differences were statistically significant (χ(2) = 4.859, P = 0.027 and χ(2) = 4.479, P = 0.034); significant difference existed in brain metastasis-related symptoms between two groups (χ(2) = 4.612, P = 0.037); the ECOG scores were evaluated in the combination therapy group. And they were as follows: 0 - 1 (n = 18), 2 (n = 11), 3 - 4 (n = 9) at pre-treatment vs 0 - 1 (n = 27), 2 (n = 6), 3 - 4 (n = 5) at post-treatment. The ECOG score significantly improved after treatment (Z = -2.012, P = 0.044). Regarding the III-IV degree of toxicity, the combination therapy group had 4 patients with acne-like rash and it was significantly higher than that in the conventional therapy group (n = 0) (P = 0.003). But no difference existed in the occurrence of fatigue, nausea, vomiting, diarrhea and myelosuppression. The combined regimen of gefitinib plus radiotherapy can improve the therapeutic efficacies of brain metastases and enhance the quality-of-life in NSCLC patients, side effects are tolerable.