Controlled clinical trial of prophylactic cranial irradiation for patients with small-cell lung cancer in complete remission
Controlled clinical trial of prophylactic cranial irradiation for patients with small-cell lung cancer in complete remission
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DOI：
10.1016/s0169-5002(98)00056-7
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发表时间：
1998-09-01
期刊：
影响因子：
5.3
通讯作者：
Arriagada, R
中科院分区：
文献类型：
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作者：
Laplanche, A;Monnet, I;Arriagada, R
我们对 211 名完全缓解 (CR) 的小细胞肺癌患者进行了一项随机临床试验。该试验的目的是评估预防性颅脑照射（PCI）对总体生存率的影响。符合条件的患者被随机分配接受 PCI（100 名患者）或不接受 PCI（111 名患者）。每个中心都可以使用自己的 PCI 方案，只要总剂量在 24-30 Gy 范围内，并且在 3 周内交付且剂量为 3 Gy 或更少。平均随访时间为 5 年。两组之间的生存曲线没有显着差异（P = 0.25）。 PCI 组的 4 年总体生存率（95% 置信区间）为 22% [15-32%]，而对照组为 16% [10-25%]。与对照组相比，PCI 组的相对死亡风险为 0.84 (95% CI = [0.62-1.13])。 PCI组脑转移发生率较低，但差异无统计学意义（P=0.14）。 PCI 组的 4 年累积脑转移率为 44% [32-57%]，而对照组为 51% [38-63%]。总之，在这项必须提前结束的研究中，脑转移的发生率和生存率没有发现显着差异。 (C) 1998 Elsevier Science Ireland Ltd. 保留所有权利。
We conducted a randomised clinical trial on 211 patients with small-cell lung cancer in complete remission (CR). The aim of this trial was to evaluate the effect of prophylactic cranial irradiation (PCI) on overall survival. Eligible patients were randomly assigned to receive either PCI (100 patients) or no PCI (111 patients). Each centre was allowed to use its own PCI protocol as long as the total dose was within the range of 24-30 Gy and delivered in less than 3 weeks with fractions of 3 Gy or less. The mean follow-up is 5 years. The survival curves do not differ significantly (P = 0.25) between the two groups. The 4-year overall survival rate (95% confidence interval) is 22% [15-32%] in the PCI group versus 16% [10-25%] in the control group. The relative risk of death in the PCI group compared to the control group is 0.84 (95% CI = [0.62-1.13]). The incidence of brain metastasis is lower in the PCI group, but the difference is not statistically significant (P = 0.14). The 4-year cumulative rate of brain metastasis is 44% [32-57%] in the PCI group compared to 51% [38-63%] in the control group. In conclusion, in this study, which had to be closed prematurely, no significant difference was found in terms of the incidence of brain metastases nor in survival. (C) 1998 Elsevier Science Ireland Ltd. All rights reserved.