Prospective observational study of atezolizumab plus nab-paclitaxel in patients with metastatic triple-negative breast cancer: JBCRG-C08/ATTRIBUTE.

IF 8.4 2区医学 Q1 ONCOLOGY

NPJ Breast Cancer Pub Date : 2026-06-26 DOI:10.1038/s41523-026-00997-y

Tatsunori Shimoi, Nobuhiro Shibata, Masahiro Kitada, Michiko Tsuneizumi, Mitsugu Yamamoto, Yukinori Ozaki, Yumi Fujimoto, Sayuri Akiyoshi, Naoki Hashimoto, Miki Yamaguchi, Yutaka Yamamoto, Norikazu Masuda, Hiroshi Tada, Takashi Yamanaka, Yuichiro Kikawa, Tetsuhiko Taira, Shizuka Nakagawa, Taizo Takahashi, Mari S Oba, Naoki Niikura

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引用次数: 0

Abstract

The JBCRG-C08/ATTRIBUTE (UMIN000041747) study assessed atezolizumab plus nab-paclitaxel's safety and effectiveness in a metastatic triple-negative breast cancer population, including IMpassion130-ineligible patients. The primary outcome was incidence of investigator-assessed adverse events (AEs). Safety and full analysis populations included 149 and 148 patients, respectively; 4.0% of the full analysis population had Eastern Cooperative Oncology Group performance status ≥2 and 7.4% had a history/comorbidity of autoimmune disease (AID) at baseline. AEs occurred in 96.6% of the safety analysis population; serious AEs (SAEs), in 16.8%; and immune-related AEs (irAEs), in 30.9%. irAE incidence was 45.5% in patients with a history/comorbidity of AID. Notable SAEs included pneumonitis (3.4%), diarrhoea, pyrexia, adrenal insufficiency and cardiac failure (1.3% each). Two cases of Grade 5 pneumonitis occurred. Regarding effectiveness, median progression-free survival was 5.6 months (95% confidence interval, 4.2-6.7). This first analysis found no new safety concerns with atezolizumab combination therapy, although patients with AID require careful monitoring.

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atezolizumab联合nab-紫杉醇治疗转移性三阴性乳腺癌的前瞻性观察研究：JBCRG-C08/ATTRIBUTE。

JBCRG-C08/ATTRIBUTE （UMIN000041747）研究评估了atezolizumab联合nab-紫杉醇在转移性三阴性乳腺癌人群（包括impassion130不合格患者）中的安全性和有效性。主要结局是研究者评估的不良事件（ae）的发生率。安全性和完全分析人群分别包括149例和148例患者；4.0%的全分析人群在东部肿瘤合作组的表现状态≥2,7.4%的人在基线时有自身免疫性疾病（AID）的病史/合并症。96.6%的安全性分析人群发生ae；严重ae （SAEs）占16.8%；免疫相关不良反应（irAEs）占30.9%。在有aids病史/合并症的患者中，irAE的发生率为45.5%。值得注意的SAEs包括肺炎（3.4%）、腹泻、发热、肾上腺功能不全和心力衰竭（各1.3%）。发生5级肺炎2例。关于有效性，中位无进展生存期为5.6个月（95%可信区间，4.2-6.7）。第一次分析发现，atezolizumab联合治疗没有新的安全性问题，尽管aids患者需要仔细监测。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

NPJ Breast Cancer Medicine-Pharmacology (medical)

CiteScore

10.10

自引率

1.70%

发文量

122

审稿时长

9 weeks

期刊介绍： npj Breast Cancer publishes original research articles, reviews, brief correspondence, meeting reports, editorial summaries and hypothesis generating observations which could be unexplained or preliminary findings from experiments, novel ideas, or the framing of new questions that need to be solved. Featured topics of the journal include imaging, immunotherapy, molecular classification of disease, mechanism-based therapies largely targeting signal transduction pathways, carcinogenesis including hereditary susceptibility and molecular epidemiology, survivorship issues including long-term toxicities of treatment and secondary neoplasm occurrence, the biophysics of cancer, mechanisms of metastasis and their perturbation, and studies of the tumor microenvironment.