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在一项 III 期随机对照研究中,对早期三阴性乳腺癌患者进行了亚组分析,这些患者接受了新辅助阿替利珠单抗或安慰剂联合nab-紫杉醇和基于蒽环类化疗的治疗(IMpassion031)。

Subgroup analysis of Japanese patients in a phase III randomized, controlled study of neoadjuvant atezolizumab or placebo, combined with nab-paclitaxel and anthracycline-based chemotherapy in early triple-negative breast cancer (IMpassion031).

机构信息

Department of Medical Oncology, Fukushima Medical University, Fukushima, Japan.

Department of Breast Oncology, National Hospital Organization Shikoku Cancer Center, Ehime, Japan.

出版信息

Jpn J Clin Oncol. 2022 Oct 6;52(10):1124-1133. doi: 10.1093/jjco/hyac098.


DOI:10.1093/jjco/hyac098
PMID:35750038
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9538755/
Abstract

BACKGROUND: In the global phase III IMpassion031 study, neoadjuvant atezolizumab plus nab-paclitaxel/anthracycline-based chemotherapy improved pathological complete response in patients with early stage triple-negative breast cancer. Here, we report primary analysis results from a subgroup of Japanese patients. METHODS: Patients with histologically documented, previously untreated, stage cT2-cT4, cN0-cN3, cM0 triple-negative breast cancer were randomized 1:1 to receive intravenous atezolizumab 840 mg or placebo every 2 weeks in combination with chemotherapy consisting of nab-paclitaxel intravenous 125 mg/m2 once a week, followed by doxorubicin intravenous 60 mg/m2 and cyclophosphamide intravenous 600 mg/m2 every 2 weeks. Patients then underwent surgery. Pathological complete response (ypT0/is ypN0) in the intention-to-treat and PD-L1-positive (≥1% PD-L1-expressing tumor-infiltrating immune cells) populations were co-primary endpoints. RESULTS: This subanalysis (data cutoff: 3 April 2020) included 36 patients from Japan (intention-to-treat; atezolizumab arm, n = 17; placebo arm, n = 19). Pathological complete response occurred in 41% (n = 7; 95% confidence interval, 18-67) of patients in the atezolizumab arm and 37% (n = 7; 95% confidence interval, 16-62) in the placebo arm. In the PD-L1-positive population, pathological complete response occurred in 50% (n = 5; 95% confidence interval, 19-81) of patients in the atezolizumab arm and 45% (n = 5; 95% confidence interval, 17-77) in the placebo arm. Treatment-related grade 3-4 adverse events occurred in 71% and 68% of patients in the respective arms. CONCLUSION: Atezolizumab added to neoadjuvant chemotherapy numerically improved pathological complete response versus placebo in this small exploratory analysis of Japanese patients with early stage triple-negative breast cancer, a trend directionally consistent with the global study results. No new safety signals were identified.

摘要

背景:在全球 III 期 IMpassion031 研究中,新辅助阿替利珠单抗联合 nab-紫杉醇/蒽环类化疗可提高早期三阴性乳腺癌患者的病理完全缓解率。在此,我们报告了日本患者亚组的初步分析结果。

方法:组织学确诊、未经治疗的 cT2-cT4、cN0-cN3、cM0 期三阴性乳腺癌患者按 1:1 随机分配,接受静脉注射阿替利珠单抗 840mg 或安慰剂,每 2 周 1 次,联合 nab-紫杉醇静脉滴注 125mg/m2,每周 1 次,随后给予多柔比星静脉滴注 60mg/m2 和环磷酰胺静脉滴注 600mg/m2,每 2 周 1 次。患者随后接受手术。在意向治疗人群和 PD-L1 阳性(≥1%表达肿瘤浸润免疫细胞的 PD-L1)人群中,主要终点是病理完全缓解(ypT0/is ypN0)。

结果:本亚分析(数据截止日期:2020 年 4 月 3 日)纳入了来自日本的 36 例患者(意向治疗;阿替利珠单抗组,n=17;安慰剂组,n=19)。阿替利珠单抗组的病理完全缓解率为 41%(n=7;95%置信区间,18-67),安慰剂组为 37%(n=7;95%置信区间,16-62)。在 PD-L1 阳性人群中,阿替利珠单抗组的病理完全缓解率为 50%(n=5;95%置信区间,19-81),安慰剂组为 45%(n=5;95%置信区间,17-77)。阿替利珠单抗组和安慰剂组分别有 71%和 68%的患者发生治疗相关 3-4 级不良事件。

结论:在这项对日本早期三阴性乳腺癌患者的小型探索性分析中,与安慰剂相比,阿替利珠单抗联合新辅助化疗在数值上提高了病理完全缓解率,与全球研究结果的趋势方向一致。未发现新的安全性信号。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0fe2/9538755/71a474aebbf8/hyac098f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0fe2/9538755/75bf0b231d26/hyac098f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0fe2/9538755/71a474aebbf8/hyac098f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0fe2/9538755/75bf0b231d26/hyac098f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0fe2/9538755/71a474aebbf8/hyac098f2.jpg

相似文献

[1]
Subgroup analysis of Japanese patients in a phase III randomized, controlled study of neoadjuvant atezolizumab or placebo, combined with nab-paclitaxel and anthracycline-based chemotherapy in early triple-negative breast cancer (IMpassion031).

Jpn J Clin Oncol. 2022-10-6

[2]
Neoadjuvant atezolizumab in combination with sequential nab-paclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy in patients with early-stage triple-negative breast cancer (IMpassion031): a randomised, double-blind, phase 3 trial.

Lancet. 2020-9-20

[3]
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[4]
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[5]
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[6]
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J Clin Oncol. 2022-9-1

[7]
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[8]
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[10]
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引用本文的文献

[1]
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Front Immunol. 2024

[2]
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Cancers (Basel). 2024-10-13

本文引用的文献

[1]
Clinicopathological Characteristics and Treatment Strategies of Triple-Negative Breast Cancer Patients With a Survival Longer than 5 Years.

Front Oncol. 2021-2-1

[2]
IMpower132: Atezolizumab plus platinum-based chemotherapy vs chemotherapy for advanced NSCLC in Japanese patients.

Cancer Sci. 2021-4

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Neoadjuvant atezolizumab in combination with sequential nab-paclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy in patients with early-stage triple-negative breast cancer (IMpassion031): a randomised, double-blind, phase 3 trial.

Lancet. 2020-9-20

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Different treatment efficacies and side effects of cytotoxic chemotherapy.

J Thorac Dis. 2020-7

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Breast Cancer. 2020-5

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Cancers (Basel). 2020-3-29

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N Engl J Med. 2020-2-27

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Ann Oncol. 2020-4

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Subgroup analysis of Japanese patients in a Phase 3 study of atezolizumab in advanced triple-negative breast cancer (IMpassion130).

Jpn J Clin Oncol. 2019-12-27

[10]
Racial differences in characteristics and prognoses between Asian and white patients with nonsmall cell lung cancer receiving atezolizumab: An ancillary analysis of the POPLAR and OAK studies.

Int J Cancer. 2020-6-1

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