全脑放疗及后程三维适形放疗补量联合同期拓普替康化疗治疗肺癌脑转移的Ⅱ期临床试验

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目的 :前瞻性评价全脑放疗及后程三维适形放疗补量联合同期拓普替康化疗治疗肺癌脑转移的初步疗效及安全性。方法 :2009年3月—2012年3月,前瞻性入组肺癌脑转移全脑放疗(40 Gy/20次)及后程三维适形放疗补量(脑转移瘤数目≤3个且直径≥2 cm,补量至总剂量为56~60 Gy)联合同期拓普替康化疗(1.75 mg/m2,1次/周,共4~6次/4~6周)患者38例(同期放化疗组)。选取同期仅接受肺癌脑转移全脑放疗及后程三维适形放疗补量的38例患者作为对照(单纯放疗组)。评价疗效和不良反应。对所有患者进行随访,分析生存情况。结果 :同期放化疗组和单纯放疗组患者脑转移瘤的中位无进展生存期分别为6和3个月,1年无进展生存率分别为42.8%和11.6%,2年无进展生存率分别为21.6%和8.7%;同期放化疗组的无进展生存优于单纯放疗组(χ2=6.020,P=0.014)。同期放化疗组和单纯放疗组的中位生存期分别为13和10个月,1年生存率分别为50.8%和40.4%,2年生存率分别为37.9%和16.5%;同期放化疗组的总生存未明显优于单纯放疗组(χ2=1.811,P=0.178)。同期放化疗组和单纯放疗组的1年脑转移瘤控制率分别为75.9%和41.6%,2年脑转移瘤控制率分别为65.2%和31.2%;两组的脑转移瘤控制率差异有统计学意义(χ2=3.892,P=0.049)。同期放化疗组和单纯放疗组的1年颅外病灶控制率分别为47.8%和32.5%,2年颅外病灶控制率分别为28.7%和24.4%;两组的颅外病灶控制率差异无统计学意义(χ2=0.610,P=0.435)。两组患者的主要不良反应是骨髓抑制和胃肠反应,差异均无统计学意义(P>0.05)。结论 :与单纯放疗相比,同期放化疗可显著提高肺癌脑转移患者的无进展生存率和脑转移瘤控制率,未明显增加不良反应。 Objectives: To prospectively evaluate the efficacy and safety of total brain radiation therapy combined with three-dimensional conformal radiotherapy plus concurrent topotecan chemotherapy in the treatment of brain metastases from lung cancer. METHODS: From March 2009 to March 2012, prospective enrollment of brain brain metastases for brain metastases (40 Gy/20) and posterior three-dimensional conformal radiotherapy supplementation (number of brain metastases ≤ 3 and diameter ≥ 2 Cm, supplement to total dose of 56~60 Gy) combined with topotecan chemotherapy (1.75 mg/m2, 1 time/week, total 4~6 times/4~6 weeks), 38 cases (chemotherapy and concurrent chemotherapy group) ). A total of 38 patients with brain metastasis whole brain radiotherapy and postoperative three-dimensional conformal radiotherapy for the same period were selected as controls (radiotherapy alone). Evaluate efficacy and adverse reactions. All patients were followed up and their survival was analyzed. Results: The median progression-free survival rate of brain metastatic tumors in the concurrent chemo-radiotherapy and radiotherapy groups was 6 and 3 months, respectively. The one-year progression-free survival rates were 42.8% and 11.6%, respectively. The 2-year progression-free survival rates were respectively. It was 21.6% and 8.7%. The progression-free survival of the concurrent chemo-radiotherapy group was better than that of the radiotherapy alone group (χ2=6.020, P=0.014). The median survival time of concurrent radiotherapy and chemotherapy group and radiotherapy alone group was 13 and 10 months, respectively. The one-year survival rate was 50.8% and 40.4%, the two-year survival rate was 37.9% and 16.5%, respectively; the same period of radiotherapy and chemotherapy group Overall survival was not significantly better than that of radiotherapy alone (χ2=1.811, P=0.178). The rate of one-year brain metastasis was 75.9% and 41.6% in the concurrent chemo-radiotherapy group and radiotherapy alone group, and the rate of brain metastases was 65.2% and 31.2% in the two years. The difference in the rate of brain metastasis control between the two groups was statistical. Significance (χ2=3.892, P=0.049). The control rates of extracranial focal lesions in the concurrent radiotherapy and chemotherapy group and radiotherapy alone group were 47.8% and 32.5%, respectively. The control rates of extracranial lesions in 2 years were 28.7% and 24.4% respectively. There was no statistical difference in the control rate of extracranial lesions between the two groups. Significance (χ2=0.610, P=0.435). The main adverse reactions in both groups were myelosuppression and gastrointestinal reactions, with no statistically significant difference (P>0.05). Conclusion: Compared with radiotherapy alone, concurrent radiotherapy and chemotherapy can significantly improve the progression-free survival rate and brain metastasis control rate of patients with lung cancer brain metastasis, without significantly increasing adverse reactions.
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