Phase III Comparison of Prophylactic Cranial Irradiation Versus Observation in Patients With Locally Advanced Non-Small-Cell Lung Cancer: Primary Analysis of Radiation Therapy Oncology Group Study RTOG 0214
Phase III Comparison of Prophylactic Cranial Irradiation Versus Observation in Patients With Locally Advanced Non-Small-Cell Lung Cancer: Primary Analysis of Radiation Therapy Oncology Group Study RTOG 0214
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DOI：
10.1200/jco.2010.29.1609
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发表时间：
2011-01-20
影响因子：
45.3
通讯作者：
Choy, Hak
中科院分区：
文献类型：
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作者：
Gore, Elizabeth M.;Bae, Kyounghwa;Choy, Hak
本研究旨在探讨预防性颅脑照射(PCI)能否提高局部晚期非小细胞肺癌(LA-NSCLC)的生存率。参与者按分期(IIIA V IIIB)、组织学(非鳞癌与鳞癌)和治疗(手术与非手术)进行分层，并随机分配到经皮冠状动脉介入治疗或观察组。经皮冠状动脉介入治疗分15次进行，每次30Gy.研究的主要终点是总体生存期(OS)。次要终点是无病生存期(DFS)、神经认知功能(NCF)和生活质量。对OS和DFS采用Kaplan-Meier和LOG-RANK分析。采用Logistic回归模型评价脑转移的发生率。结果1,058例患者共发生脑转移356例。由于进展缓慢，这项研究提前结束；356名患者中有340人符合条件。1年OS(P=0.86；75.6%vs76.9%)与1年DFS(P=0.11；56.4%vs51.2%)无显著差异。观察与经皮冠状动脉介入治疗的风险比为1.03(95%可信区间，0.77比1.36)。两组1年BM率差异有统计学意义(P=0.004；PCIv观察组分别为7.7%和18.0%)。观察组患者发生BM的可能性是对照组的2.52倍(未调整的优势比，2.52；95%CI，1.32~4.80)。结论对于治疗后无疾病进展的III期患者，经皮冠状动脉介入治疗可降低BM的发生率，但不能改善OS或DFS。
PurposeThis study was conducted to determine if prophylactic cranial irradiation (PCI) improves survival in locally advanced non-small-cell lung cancer (LA-NSCLC).Patients and MethodsPatients with stage III NSCLC without disease progression after treatment with surgery and/or radiation therapy (RT) with or without chemotherapy were eligible. Participants were stratified by stage (IIIA v IIIB), histology (nonsquamous v squamous), and therapy (surgery v none) and were randomly assigned to PCI or observation. PCI was delivered to 30 Gy in 15 fractions. The primary end point of the study was overall survival (OS). Secondary end points were disease-free survival (DFS), neurocognitive function (NCF), and quality of life. Kaplan-Meier and log-rank analyses were used for OS and DFS. The incidence of brain metastasis (BM) was evaluated with the logistic regression model.ResultsOverall, 356 patients were accrued of the targeted 1,058. The study was closed early because of slow accrual; 340 of the 356 patients were eligible. The 1-year OS (P = .86; 75.6% v 76.9% for PCI v observation) and 1-year DFS (P = .11; 56.4% v 51.2% for PCI v observation) were not significantly different. The hazard ratio for observation versus PCI was 1.03 (95% CI, 0.77 to 1.36). The 1-year rates of BM were significantly different (P = .004; 7.7% v 18.0% for PCI v observation). Patients in the observation arm were 2.52 times more likely to develop BM than those in the PCI arm (unadjusted odds ratio, 2.52; 95% CI, 1.32 to 4.80).ConclusionIn patients with stage III disease without progression of disease after therapy, PCI decreased the rate of BM but did not improve OS or DFS.