IV期乳腺癌脑磁共振成像监测的II期试验

Phase II Trial of Brain MRI Surveillance in Stage IV Breast Cancer.

作者信息

Ahmed Kamran A, Kim Youngchul, Armaghani Avan J, Arrington John A, Costa Ricardo L, Czerniecki Brian J, Diaz Roberto, Dowell Robin A, Extermann Martine, Forsyth Peter A, Lee Kimberley T, Loftus Loretta, Mills Matthew N, Phuoc Vania H, Rosa Marilin, Soliman Hatem H, Sam Christine S, Washington Iman R, Soyano Aixa E, Han Hyo S

机构信息

Department of Radiation Oncology, Moffitt Cancer Center.

Department of Biostatistics and Bioinformatics, Moffitt Cancer Center.

出版信息

Neuro Oncol. 2025 Jan 24. doi: 10.1093/neuonc/noaf018.

DOI:10.1093/neuonc/noaf018

PMID:39851040

Abstract

BACKGROUND

Screening of asymptomatic stage IV breast cancer with brain MRIs is currently not recommended by National Comprehensive Cancer Network (NCCN) Guidelines. The incidence of asymptomatic brain metastasis is not well documented.

METHODS

The study is designed as a single arm, phase II trial, with the goal of investigating surveillance brain MRIs in neurologically asymptomatic patients with metastatic breast cancer. Breast cancer patients were classified into triple negative (TN), HER2+, and hormone receptor (HR)+/HER2-. Patients underwent a surveillance brain MRI and a second brain MRI at 6 months if the baseline MRI was negative. Asymptomatic, stage IV breast cancer patients, ECOG ≤2, and life expectancy ≥6 months were eligible. The primary objective was to determine the frequency of asymptomatic brain metastasis in metastatic breast cancer. Clinical trial information: NCT05115474.

RESULTS

A total of 101 patients completed the surveillance brain MRI including 40 HR+/HER2-, 33 HER2+, and 28 TN patients. The overall frequency of brain metastasis on initial surveillance brain MRI was 14% (n=14) with rates of 18%, 15%, and 10% in TN, HER2+, and HR+/HER2- patients, respectively. Following the 6-month MRI, the cumulative rates of brain metastasis increased to 25% in TN, 24% in HER2+, and 23% in HR+/HER2- patients.

CONCLUSIONS

The highest frequency of brain metastases at baseline was in TN and HER2+ breast cancer. Following the 6-month MRI, the cumulative frequency was approximately a quarter across all subtypes. These results warrant confirmatory trials to refine brain MRI surveillance recommendations for neurologically asymptomatic stage IV breast cancer.

摘要

背景

美国国立综合癌症网络（NCCN）指南目前不建议对无症状的IV期乳腺癌患者进行脑部磁共振成像（MRI）筛查。无症状脑转移的发生率尚无充分记录。

方法

本研究设计为单臂II期试验，目的是调查神经功能无症状的转移性乳腺癌患者的脑部MRI监测情况。乳腺癌患者分为三阴性（TN）、人表皮生长因子受体2（HER2）阳性和激素受体（HR）阳性/HER2阴性。患者接受一次脑部MRI监测，若基线MRI为阴性，则在6个月时进行第二次脑部MRI检查。符合条件的患者为无症状的IV期乳腺癌患者，东部肿瘤协作组（ECOG）体能状态评分≤2且预期寿命≥6个月。主要目的是确定转移性乳腺癌中无症状脑转移的频率。临床试验信息：NCT05115474。

结果

共有101例患者完成了脑部MRI监测，其中包括40例HR阳性/HER2阴性、33例HER2阳性和28例TN患者。初次脑部MRI监测时脑转移的总体发生率为14%（n = 14），TN、HER2阳性和HR阳性/HER2阴性患者的发生率分别为18%、15%和10%。在6个月的MRI检查后，TN患者脑转移的累积发生率增至25%，HER2阳性患者为24%，HR阳性/HER2阴性患者为23%。