University of Pittsburgh Cancer Center, Pittsburgh, Pennsylvania 15213, USA.
Clin Cancer Res. 2011 Jul 15;17(14):4834-43. doi: 10.1158/1078-0432.CCR-10-2962.
registHER is a prospective, observational study of 1,023 newly diagnosed HER2-positive metastatic breast cancer (MBC) patients.
Baseline characteristics of patients with and without central nervous system (CNS) metastases were compared; incidence, time to development, treatment, and survival after CNS metastases were assessed. Associations between treatment after CNS metastases and survival were evaluated.
Of the 1,012 patients who had confirmed HER2-positive tumors, 377 (37.3%) had CNS metastases. Compared with patients with no CNS metastases, those with CNS metastases were younger and more likely to have hormone receptor-negative disease and higher disease burden. Median time to CNS progression among patients without CNS disease at initial MBC diagnosis (n = 302) was 13.3 months. Treatment with trastuzumab, chemotherapy, or surgery after CNS diagnosis was each associated with a statistically significant improvement in median overall survival (OS) following diagnosis of CNS disease (unadjusted analysis: trastuzumab vs. no trastuzumab, 17.5 vs. 3.8 months; chemotherapy vs. no chemotherapy, 16.4 vs. 3.7 months; and surgery vs. no surgery, 20.3 vs. 11.3 months). Although treatment with radiotherapy seemed to prolong median OS (13.9 vs. 8.4 months), the difference was not significant (P = 0.134). Results of multivariable proportional hazards analyses confirmed the independent significant effects of trastuzumab and chemotherapy (HR = 0.33, P < 0.001; HR = 0.64, P = 0.002, respectively). The effects of surgery and radiotherapy did not reach statistical significance (P = 0.062 and P = 0.898, respectively).
For patients with HER2-positive MBC evaluated in registHER, the use of trastuzumab, chemotherapy, and surgery following CNS metastases were each associated with longer survival.
registHER 是一项针对 1023 例新诊断的 HER2 阳性转移性乳腺癌（MBC）患者的前瞻性、观察性研究。
比较了有和无中枢神经系统（CNS）转移患者的基线特征；评估了 CNS 转移后的发生率、发展时间、治疗和生存情况。评估了 CNS 转移后治疗与生存之间的关系。
在 1012 例确诊为 HER2 阳性肿瘤的患者中，有 377 例（37.3%）有 CNS 转移。与无 CNS 转移的患者相比，有 CNS 转移的患者年龄更小，更可能患有激素受体阴性疾病且疾病负担更高。在初始 MBC 诊断时无 CNS 疾病的患者中，CNS 进展的中位时间为 13.3 个月。CNS 诊断后接受曲妥珠单抗、化疗或手术治疗，与 CNS 疾病诊断后中位总生存期（OS）的统计学显著改善相关（未调整分析：曲妥珠单抗与无曲妥珠单抗治疗，17.5 个月与 3.8 个月；化疗与无化疗治疗，16.4 个月与 3.7 个月；手术与无手术治疗，20.3 个月与 11.3 个月）。尽管放射治疗似乎延长了中位 OS（13.9 个月与 8.4 个月），但差异无统计学意义（P = 0.134）。多变量比例风险分析的结果证实了曲妥珠单抗和化疗的独立显著作用（HR = 0.33，P < 0.001；HR = 0.64，P = 0.002）。手术和放疗的效果没有达到统计学意义（P = 0.062 和 P = 0.898）。
在 registHER 中评估的 HER2 阳性 MBC 患者中，CNS 转移后使用曲妥珠单抗、化疗和手术均与生存时间延长相关。
