Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026
Phase II Clinical Study of Adebrelimab and Bevacizumab Combined With Cisplatin/Carboplatin in Patients With Triple-Negative Breast Cancer With Brain Metastases (ABC Study).
СтатьяКлиническое исследование II фазыНазвание и аннотация: Перевод в очереди
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Li Ting, Zhou Teng, Wang Biyun, Tao Zhonghua, Zhao Mingchuan, Wang Leiping, Jin Juan, Zhao Yannan, Gong Chengcheng, Cao Jun, Miao Haotao, Peng Wenxia, Wang Jianfei, Jin Min, Hu Xichun, Zhang Jian
Аннотация
PURPOSE: Brain metastases (BMs) of triple-negative breast cancer (TNBC) are lethal, often associated with a limited life span and lack of effective antitumor agents. Here we reported a triple combination therapy consisting of adebrelimab, bevacizumab, and cisplatin/carboplatin in BMs of TNBC.
METHODS: This phase II clinical trial involved patients with TNBC with active BMs. Participants were administered with adebrelimab, bevacizumab, and cisplatin/carboplatin until disease progression or unacceptable toxic effects. The primary end point was the objective response rate in CNS (CNS-ORR) according to the Response Assessment in Neuro-Oncology BMs criteria, and the secondary end points included the clinical benefit rate in CNS (CNS-CBR), progression-free survival (PFS), overall survival (OS), the first progression site, and safety.
RESULTS: A total of 35 patients were enrolled and treated, and the median lines of previous treatment were 2 (range, 0-4). The confirmed CNS-ORR was 77.1% (27/35, 95% CI, 59.9 to 89.6), and the CNS-CBR was 80.0% (28/35, 95% CI, 63.1 to 91.6). The median overall PFS was 8.3 months (95% CI, 5.8 to 11.5), whereas the median CNS-PFS was 10.3 months (95% CI, 7.4 to 14.3) and the median OS was 21.1 months (95% CI, 13.2 to not reached). Among the 28 patients who progressed, progression was intracranial-only in 32.1% (9/28) patients, extracranial-only in 35.7% (10/28) patients, and both in 32.1% (9/28) patients. The incidence of grade ≥3 treatment-related adverse events was 65.7% (23/35). Treatment-related serious adverse events occurred in five patients (14.3%), and no treatment-related deaths were reported.
CONCLUSION: The combination of adebrelimab, bevacizumab, and cisplatin/carboplatin was the first regimen to demonstrate promising intracranial antitumor activity and prolonged PFS and CNS-PFS, along with a manageable safety profile, warranting further investigation.
METHODS: This phase II clinical trial involved patients with TNBC with active BMs. Participants were administered with adebrelimab, bevacizumab, and cisplatin/carboplatin until disease progression or unacceptable toxic effects. The primary end point was the objective response rate in CNS (CNS-ORR) according to the Response Assessment in Neuro-Oncology BMs criteria, and the secondary end points included the clinical benefit rate in CNS (CNS-CBR), progression-free survival (PFS), overall survival (OS), the first progression site, and safety.
RESULTS: A total of 35 patients were enrolled and treated, and the median lines of previous treatment were 2 (range, 0-4). The confirmed CNS-ORR was 77.1% (27/35, 95% CI, 59.9 to 89.6), and the CNS-CBR was 80.0% (28/35, 95% CI, 63.1 to 91.6). The median overall PFS was 8.3 months (95% CI, 5.8 to 11.5), whereas the median CNS-PFS was 10.3 months (95% CI, 7.4 to 14.3) and the median OS was 21.1 months (95% CI, 13.2 to not reached). Among the 28 patients who progressed, progression was intracranial-only in 32.1% (9/28) patients, extracranial-only in 35.7% (10/28) patients, and both in 32.1% (9/28) patients. The incidence of grade ≥3 treatment-related adverse events was 65.7% (23/35). Treatment-related serious adverse events occurred in five patients (14.3%), and no treatment-related deaths were reported.
CONCLUSION: The combination of adebrelimab, bevacizumab, and cisplatin/carboplatin was the first regimen to demonstrate promising intracranial antitumor activity and prolonged PFS and CNS-PFS, along with a manageable safety profile, warranting further investigation.