Abstract: Objective  To observe the clinical efficacy and safety of erlotinib plus temozolomide for recurrence/progression patients with epidermal growth factor receptor (EGFR) gene mutation in nonsmall cell lung cancer (NSCLC) with brain metastases after whole brain radiotherapy. Methods  A total of 68 EGFR gene mutation NSCLC patients with brain metastases of intracranial recurrence/progression after whole brain radiotherapy were selected from August 2013 to June 2018 in Baoji Central Hospital of Shaanxi Province and Xintai People′s Hospital of Shandong Province. All the patients were randomly divided into erlotinib group and combined treatment group (erlotinib combined with temozolomide) using random number table method. The patients in erlotinib group (34 cases) were treated with oral erlotinib 150 mg/d until progression or unacceptable adverse reaction, and the patients in combined treatment group (34 cases) were given erlotinib and oral temozolomide 150 mg/(m2·d) for 1-5 day, every 28 days was a cycle, temozolamide for 6 cycles. Comparison was made on curative effects and occurrence condition of adverse reactions between the two groups. Results  The overall response rates in the erlotinib group and combined treatment group were 11.8% (4/34) and 32.4% (11/34) respectively, and the disease control rates in the two groups were 35.3% (12/34) and 64.7% (22/34) respectively, with significant differences (χ2=4.191, P=0.041; χ2=5.882, P=0.015). The median progression-free survival in the erlotinib group and combined treatment group were 3.22 months and 5.29 months respectively, and the median overall survival in the two groups were 5.60 months and 7.90 months respectively, with significant differences (χ2=9.269, P=0.002; χ2=11.005, P=0.001). The incidence of nausea and vomiting in combined treatment group was significantly higher than that in erlotinib group ［67.6% (23/34) vs. 14.7% (5/34)］, with a significant difference (χ2=19.671, P＜0.001), but there were no significant differences in the incidences of other adverse reactions (all P＞0.05). The patients in the two groups had no more than grade Ⅲ of adverse reactions. Conclusion  The curative effect of erlotinib combined with temozolomide is better in the treatment of recurrence/progression patients with EGFR gene mutation in NSCLC with brain metastases after whole brain radiotherapy, with mild adverse reactions and good patients′ tolerance.

Key words: Carcinoma, non-small-cell lung, Neoplasm metastasis, Radiotherapy, Erlotinib, Temozolomide