根治性放疗后可切除 IIIA/B 期非小细胞肺癌的心脏剂量暴露作为预后标志物：一项随机试验的二次分析。
Heart dose exposure as prognostic marker after radiotherapy for resectable stage IIIA/B non-small-cell lung cancer: secondary analysis of a randomized trial.
机构信息
Department of Radiotherapy, University of Duisburg-Essen, University Hospital Essen, Essen.
Department of Medical Oncology, West German Cancer Center, University of Duisburg-Essen, University Hospital Essen, Essen.
出版信息
Ann Oncol. 2017 May 1;28(5):1084-1089. doi: 10.1093/annonc/mdx069.
BACKGROUND
Heart exposure to ionizing irradiation can cause ischaemic heart disease. The partial heart volume receiving ≥5 Gy (heartV5) was supposed to be an independent prognostic factor for survival after radiochemotherapy for locally advanced non-small-cell lung cancer (NSCLC). But validation of the latter hypothesis is needed under the concurrent risks of lung cancer patients.
PATIENTS AND METHODS
The ESPATUE phase III trial recruited patients with potentially operable IIIA(N2)/selected IIIB NSCLC between 01/2004 and 01/2013. Cisplatin/paclitaxel induction chemotherapy was given followed by neoadjuvant radiochemotherapy (RT/CT) to 45 Gy (1.5 Gy bid/concurrent cisplatin/vinorelbine). Operable patients were randomized to definitive RT/CT(arm A) or surgery (arm B) and therefore were treated at two different total dose levels of radiotherapy. HeartV5 and mean heart dose (MHD) were obtained from the 3D radiotherapy plans, the prognostic value was analysed using multivariable proportional hazard analysis.
RESULTS
A total of 161 patients were randomized in ESPATUE, heartV5 and MHD were obtained from the 3D radiotherapy plans for 155 of these [male/female:105/50, median age 58 (33-74) years, stage IIIA/IIIB: 54/101]. Power analysis revealed a power of 80% of this dataset to detect a prognostic value of heartV5 of the size found in RTOG 0617. Multivariable analysis did not identify heartV5 as an independent prognostic factor for survival adjusting for tumour and clinical characteristics with [hazard ratio 1.005 (0.995-1.015), P = 0.30] or without lower lobe tumour location [hazard ratio 0.999 (0.986-1.012), P = 0.83]. There was no influence of heartV5 on death without tumour progression. Tumour progression, and pneumonia were the leading causes of death representing 65% and 14% of the observed deaths.
CONCLUSIONS
HeartV5 could not be validated as an independent prognostic factor for survival after neoadjuvant or definitive conformal radiochemotherapy. Tumour progression was the predominant cause of death.
REGISTER NO
Z5 - 22461/2 - 2002-017 (German Federal Office for Radiation Protection).
背景
心脏暴露于电离辐射会导致缺血性心脏病。部分心脏体积接受≥5Gy（心脏 V5）被认为是局部晚期非小细胞肺癌（NSCLC）放化疗后生存的独立预后因素。但是，在肺癌患者的并发风险下，需要验证后者的假设。
患者和方法
ESPATUE 三期试验招募了 2004 年 1 月至 2013 年 1 月间潜在可手术的 IIIA（N2）/选定的 IIIB NSCLC 患者。给予顺铂/紫杉醇诱导化疗，然后进行新辅助放化疗（RT/CT）至 45Gy（1.5Gy bid/同期顺铂/长春瑞滨）。可手术患者随机分为根治性 RT/CT（A 组）或手术（B 组），因此接受两种不同的放射治疗总剂量水平。心脏 V5 和平均心脏剂量（MHD）从 3D 放射治疗计划中获得，使用多变量比例风险分析来分析预后价值。
结果
ESPATUE 共纳入 161 例患者，其中 155 例患者的 3D 放射治疗计划中获得了心脏 V5 和 MHD[男性/女性：105/50，中位年龄 58（33-74）岁，III 期 A/III 期 B：54/101]。 功率分析显示，本数据集的功率为 80%，可以检测到 RTOG 0617 中发现的心脏 V5 的大小的预后价值。多变量分析并未将心脏 V5 确定为独立的生存预后因素，调整肿瘤和临床特征后，[风险比 1.005（0.995-1.015），P=0.30]或不包括下叶肿瘤位置[风险比 0.999（0.986-1.012），P=0.83]。心脏 V5 对无肿瘤进展的死亡没有影响。肿瘤进展和肺炎是死亡的主要原因，分别占观察到的死亡人数的 65%和 14%。
结论
心脏 V5 不能作为新辅助或根治性适形放化疗后生存的独立预后因素。肿瘤进展是死亡的主要原因。
登记号
Z5-22461/2-2002-017（德国联邦辐射防护办公室）。
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