Prophylactic cranial irradiation in extensive small-cell lung cancer
Prophylactic cranial irradiation in extensive small-cell lung cancer
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DOI：
10.1056/nejmoa071780
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发表时间：
2007-08-16
影响因子：
158.5
通讯作者：
Senan, Suresh
中科院分区：
文献类型：
--
作者：
Slotman, Ben;Faivre-Finn, Corinne;Senan, Suresh
背景：我们对化疗有反应的广泛性小细胞肺癌患者进行了一项预防性颅脑照射的随机试验。方法：年龄在 18 至 75 岁之间的广泛性小细胞肺癌患者被随机分配接受预防性颅脑照射（照射组）或不接受进一步治疗（对照组）。主要终点是出现症状性脑转移的时间。当存在任何提示脑转移的预定义关键症状时，对大脑进行计算机断层扫描或磁共振成像。结果：两组（每组 143 名患者）在基线特征方面非常平衡。照射组患者出现症状性脑转移的风险较低（风险比，0.27；95%置信区间[CI]，0.16至0.44；P < 0.001）。照射组1年内脑转移的累积风险为14.6%（95% CI，8.3～20.9），对照组为40.4%（95% CI，32.1～48.6）。随机分组后，辐射与中位无病生存期从 12.0 周延长至 14.7 周，中位总生存期从 5.4 个月延长至 6.7 个月相关。照射组的1年生存率为27.1%（95% CI，19.4～35.5），对照组为13.3%（95% CI，8.1～19.9）。辐射有副作用，但对全球健康状况没有临床显着影响。结论：预防性颅脑照射可降低有症状脑转移的发生率，并延长无病生存期和总生存期。
Background: We conducted a randomized trial of prophylactic cranial irradiation in patients with extensive small-cell lung cancer who had had a response to chemotherapy. Methods: Patients between the ages of 18 and 75 years with extensive small-cell lung cancer were randomly assigned to undergo prophylactic cranial irradiation (irradiation group) or receive no further therapy (control group). The primary end point was the time to symptomatic brain metastases. Computed tomography or magnetic resonance imaging of the brain was performed when any predefined key symptom suggestive of brain metastases was present. Results: The two groups (each with 143 patients) were well balanced regarding baseline characteristics. Patients in the irradiation group had a lower risk of symptomatic brain metastases (hazard ratio, 0.27; 95% confidence interval [CI], 0.16 to 0.44; P < 0.001). The cumulative risk of brain metastases within 1 year was 14.6% in the irradiation group (95% CI, 8.3 to 20.9) and 40.4% in the control group (95% CI, 32.1 to 48.6). Irradiation was associated with an increase in median disease-free survival from 12.0 weeks to 14.7 weeks and in median overall survival from 5.4 months to 6.7 months after randomization. The 1-year survival rate was 27.1% (95% CI, 19.4 to 35.5) in the irradiation group and 13.3% (95% CI, 8.1 to 19.9) in the control group. Irradiation had side effects but did not have a clinically significant effect on global health status. Conclusions: Prophylactic cranial irradiation reduces the incidence of symptomatic brain metastases and prolongs disease-free and overall survival.