Canney P, Murray E, Dixon-Hughes J, Lewsley L-A, Paul J
Department of Clinical Oncology, Beatson West of Scotland Cancer Centre, Glasgow, UK.
NHS Ayrshire & Arran, Psychological Service, Irvine, UK.
Clin Oncol (R Coll Radiol). 2015 Aug;27(8):460-4. doi: 10.1016/j.clon.2015.04.033. Epub 2015 May 11.
A high incidence of central nervous system (CNS) metastases has been reported in patients with HER2-positive tumours receiving trastuzumab therapy for metastatic breast cancer. This study tested whether prophylactic cranial irradiation (PCI) could reduce the incidence of CNS metastases in this setting. This was a prospective, randomised phase III trial. Patients were randomised 1:1 to no PCI or PCI delivered at around 6 weeks after study entry. Cognitive function was assessed prospectively. In total, 51 patients were randomised over a 3 year period; 25 received PCI and 26 did not. The cumulative incidence of CNS metastases at 2 years was 32.4% (standard error = 9.8%) on the no PCI arm and 21.0% (standard error = 8.6%) on the PCI arm; the associated hazard ratio was 0.57 (95% confidence interval 0.18-1.74; P = 0.32). There was no evidence of cognitive dysfunction in PCI patients.
据报道，接受曲妥珠单抗治疗转移性乳腺癌的HER2阳性肿瘤患者中枢神经系统（CNS）转移发生率较高。本研究检验了在此情况下预防性颅脑照射（PCI）是否能降低CNS转移的发生率。这是一项前瞻性、随机III期试验。患者按1:1随机分为不接受PCI组或在研究入组后约6周接受PCI组。对认知功能进行前瞻性评估。在3年期间共有51例患者被随机分组；25例接受PCI，26例未接受。2年时，未接受PCI组CNS转移的累积发生率为32.4%（标准误=9.8%），接受PCI组为21.0%（标准误=8.6%）；相关风险比为0.57（95%置信区间0.18 - 1.74；P = 0.32）。没有证据表明接受PCI的患者存在认知功能障碍。
