替莫唑胺联合放疗在非小细胞肺癌脑转移中的临床研究

Clinical Research of Temozolomide Combined with Radiotherapy in the Treatment of Brain Metastasis in Patients with Non-small Cell Lung Cancer

目的:探讨替莫唑胺联合放疗在非小细胞肺癌脑转移治疗中的疗效、安全性及对总生存期的影响。方法:42例非小细胞肺癌脑转移的患者随机分为替莫唑胺联合放疗组与单纯放疗组:替莫唑胺联合放疗组给予替莫唑胺(75mg·m-2·d-1)联合4周总剂量40Gy常规头部放疗(2Gy,5d/周);单纯放疗组仅予40Gy常规头部放疗。替莫唑胺联合放疗组放疗结束后继续给予6周期替莫唑胺(第1周期150mg·m-2·d-1;第2～6周期200mg·m-2·d-1),连续服用5d,28d为1周期。结果:替莫唑胺联合放疗组与单纯放疗组的客观有效率分别为75%、64%(P=0.017),差异有统计学意义;中性粒细胞减少发生率分别为40%、27%(P=0.019),血小板减少发生率分别为10%、5%(P=0.045),血红蛋白降低发生率分别为25%、18%(P=0.024),差异均有统计学意义;总生存期分别为9.2、7.9个月,差异无统计学意义(P=0.449)。结论:替莫唑胺联合放疗治疗非小细胞肺癌脑转移安全、有效。

OBJECTIVE： To investigate the therapeutic efficacy and safety of temozolomide combined with radiotherapy in the treatment of brain metastasis in patients with non-small cell lung cancer and its effect on overall survival time. METHODS： 42 brain metastases patients with non-small cell lung cancer were randomized into temozolomide combined with radiotherapy group and radiotherapy group： Temozolomide combined with radiotherapy group was given temozolomide 75 mg·m-2·d-1 and conventional head radiotherapy of a total dose of 40 Gy fractionated （2 Gy, 5 d/week） for 4 weeks while radiotherapy group was given radiotherapy of a total dose of 40 Gy alone. Temozolomide combined with radiotherapy group received temozolomide therapy （first cycle： 150 mg·m-2·d-1;second to the sixth cycles：200 mg·m-2·d-1） for 5 days every 28 days for an additional six cycles. RESULTS： The objective response rates of temozolomide combined with radiotherapy group and radiotherapy group were 75% and 64%（P=0.017）, there was significant difference. The incidence rates of neutropenia in two groups were 40% and 27%（P=0.019）, those of thrombocytopenia was 10% and 5%（P=0.045） and those of hemochrome decreasing were 25% and 18%（P=0.024）, respectively. There were significant differences. Overall survival time of two groups were 9.2 and 7.9, there was no significant difference （P=0.449）. CONCLUSION： Temozolomide combined with radiotherapy is safe and effective in the treatment of brain metastasis in patients with non-small cell lung cancer.