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JCO：III期肺癌手术、放化疗等根治性治疗后真的还需要预防性颅脑放疗吗？

2018年05月23日

作者：南南和北北

来源：桓兴医讯

美国《临床肿瘤学杂志》2018年5月22日在线先发——在III期根治性治疗的非小细胞肺癌中预防性颅脑照射与随诊观察的对比：一项随机III期NVALT-11/DLCRG-02研究

Dirk De Ruysscher, Anne-Marie C. Dingemans, John Praag, Jose Belderbos, Caroline Tissing-Tan, Judith Herder...Show More

目的

目前这项研究旨在了解，在以根治为目的进行治疗的III期非小细胞肺癌（NSCLC）患者中，预防性颅脑照射（PCI）是否会降低有症状脑转移的发生率。

患者与方法

用对比剂增强CT或核磁成像进行分期，将III期非小细胞肺癌患者在同步/序贯放化疗+/-手术后随机分组，一组进行随诊观察，另一组进行预防性颅脑照射（PCI）。主要终点为24个月时出现的有症状脑转移情况，有症状脑转移的判定为一种或多种提示有脑转移主要症状且核磁成像或CT证实存在脑转移，脑转移的主要症状有颅内压升高、头疼、恶性呕吐、认知或情感障碍、癫痫、局灶性神经症状。次要终点为不良反应、生存率、生活质量、生活质量调整生存期、医疗花费。

结果

2009-2015年，将175名患者随机分组：87名接受预防性颅脑照射（PCI）、88名只进行随诊观察。中位随访时间为48.5个月（95%CI，39-54个月）。预防性颅脑照射组86名患者中有6名（7.0%）出现有症状性脑转移、对照组88名患者中有24名（27.2%）（P=0.001）。预防性颅脑照射将有症状性脑转移的出现时间明显延长（风险比，0.23；[95%CI，0.09-0.56]；P=0.0012）。两组出现脑转移的中位时间均未到。两组间总生存率没有明显差异。预防性颅脑照射组1、2级记忆障碍（26/86对比7/88名患者）和认知障碍（16/86对比3/88名患者）明显增加。只在预防性颅脑照射3个月时生活质量有下降，随后与随诊观察组相近。

结论

预防性颅脑照射明显降低了出现有症状性脑转移患者的比例，但有低级别毒副作用的增加。ProphylacticCranial Irradiation Versus Observation in Radically Treated Stage IIINon–Small-Cell Lung Cancer: A Randomized Phase III NVALT-11/DLCRG-02 Study

Dirk De Ruysscher, Anne-Marie C. Dingemans, John Praag,Jose Belderbos, Caroline Tissing-Tan, Judith Herder...Show More

Purpose

The purpose of the current study wasto investigate whether prophylactic cranial irradiation (PCI) reduces theincidence of symptomatic brain metastases in patients with stage IIInon–small-cell lung cancer (NSCLC) treated with curative intention.

Patients and Methods

Patients with stage III NSCLC—stagedwith a contrast-enhanced brain computed tomography or magnetic resonanceimaging—were randomly assigned to either observation or PCI afterconcurrent/sequential chemoradiotherapy with or without surgery. The primaryend point—development of symptomatic brain metastases at 24 months—was definedas one or a combination of key symptoms that suggest brain metastases—signs ofincreased intracranial pressure, headache, nausea and vomiting, cognitive oraffective disturbances, seizures, and focal neurologic symptoms—and magneticresonance imaging or computed tomography demonstrating the existence of brainmetastasis. Adverse effects, survival, quality of life, quality-adjustedsurvival, and health care costs were secondary end points.

Results

Between 2009 and 2015, 175 patientswere randomly assigned: 87 received PCI and 88 underwent observation only.Median follow-up was 48.5 months (95% CI, 39 to 54 months). Six (7.0%) of 86patients in the PCI group and 24 (27.2%) of 88 patients in the control grouphad symptomatic brain metastases (P = .001). PCI significantly increasedthe time to develop symptomatic brain metastases (hazard ratio, 0.23; [95% CI,0.09 to 0.56]; P = .0012). Median time to develop brain metastases wasnot reached in either arm. Overall survival was not significantly differentbetween both arms. Grade 1 and 2 memory impairment (26 of 86 v seven of88 patients) and cognitive disturbance (16 of 86 v three of 88 patients)were significantly increased in the PCI arm. Quality of life was only decreased3 months post-PCI and was similar to the observation arm thereafter.

Conclusion

PCI significantly decreased theproportion of patients who developed symptomatic brain metastases with anincrease of low-grade toxicity.