Department of Medical Oncology, Fukushima Medical University, Fukushima, Japan.
Department of Breast Oncology, National Hospital Organization Shikoku Cancer Center, Ehime, Japan.
Jpn J Clin Oncol. 2022 Oct 6;52(10):1124-1133. doi: 10.1093/jjco/hyac098.
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.
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。
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