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本文引用的文献

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A careful reassessment of anthracycline use in curable breast cancer.对蒽环类药物在可治愈性乳腺癌治疗中的应用进行仔细重新评估。
NPJ Breast Cancer. 2021 Oct 8;7(1):134. doi: 10.1038/s41523-021-00342-5.
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Trastuzumab for early-stage, HER2-positive breast cancer: a meta-analysis of 13 864 women in seven randomised trials.曲妥珠单抗治疗早期 HER2 阳性乳腺癌:来自 7 项随机试验的 13864 名女性的荟萃分析。
Lancet Oncol. 2021 Aug;22(8):1139-1150. doi: 10.1016/S1470-2045(21)00288-6.
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Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial.曲妥珠单抗-美坦新偶联物与曲妥珠单抗联合紫杉醇用于 I 期 HER2 阳性乳腺癌(ATEMPT)的辅助治疗:一项随机临床试验。
J Clin Oncol. 2021 Jul 20;39(21):2375-2385. doi: 10.1200/JCO.20.03398. Epub 2021 Jun 2.
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Updated results from the international phase III ALTTO trial (BIG 2-06/Alliance N063D).国际 III 期 ALTTO 试验(BIG 2-06/Alliance N063D)的更新结果。
Eur J Cancer. 2021 May;148:287-296. doi: 10.1016/j.ejca.2021.01.053. Epub 2021 Mar 23.
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A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials.食品和药物管理局对生存结果的分析,将辅助紫杉醇和曲妥珠单抗试验与来自历史临床试验的外部对照进行比较。
Ann Oncol. 2020 Dec;31(12):1704-1708. doi: 10.1016/j.annonc.2020.08.2106. Epub 2020 Aug 28.
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Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up†.早期乳腺癌:ESMO 诊断、治疗及随访临床实践指南†
Ann Oncol. 2019 Aug 1;30(8):1194-1220. doi: 10.1093/annonc/mdz173.
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Seven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer.辅助紫杉醇和曲妥珠单抗治疗淋巴结阴性、人表皮生长因子受体 2 阳性乳腺癌的 7 年随访分析。
J Clin Oncol. 2019 Aug 1;37(22):1868-1875. doi: 10.1200/JCO.19.00066. Epub 2019 Apr 2.
8
The immune profile of small HER2-positive breast cancers: a secondary analysis from the APT trial.小 HER2 阳性乳腺癌的免疫特征:APT 试验的二次分析。
Ann Oncol. 2019 Apr 1;30(4):575-581. doi: 10.1093/annonc/mdz047.
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Geographical Variation in Breast Cancer Outcomes.乳腺癌治疗结果的地理差异。
Int J Environ Res Public Health. 2017 May 12;14(5):523. doi: 10.3390/ijerph14050523.
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Adjuvant Lapatinib and Trastuzumab for Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: Results From the Randomized Phase III Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization Trial.辅助性拉帕替尼和曲妥珠单抗用于早期人表皮生长因子受体2阳性乳腺癌:随机III期辅助性拉帕替尼和/或曲妥珠单抗治疗优化试验的结果
J Clin Oncol. 2016 Apr 1;34(10):1034-42. doi: 10.1200/JCO.2015.62.1797. Epub 2015 Nov 23.

接受辅助化疗和抗 HER2 治疗的 HER2 阳性早期乳腺癌小肿瘤和淋巴结阴性患者的结局——ALTTO 研究的亚分析。

Outcomes of patients with small and node-negative HER2-positive early breast cancer treated with adjuvant chemotherapy and anti-HER2 therapy-a sub-analysis of the ALTTO study.

机构信息

Institut Jules Bordet, and l'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.

Frontier Science Foundation Hellas, Athens, Greece.

出版信息

Br J Cancer. 2022 Nov;127(10):1799-1807. doi: 10.1038/s41416-022-01963-8. Epub 2022 Sep 1.

DOI:10.1038/s41416-022-01963-8
PMID:36050448
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9643324/
Abstract

BACKGROUND

Patients with small node-negative HER2-positive breast cancer are commonly treated with paclitaxel and 1 year of adjuvant trastuzumab. We performed a sub-analysis of the ALTTO trial to explore the long-term outcomes of patients with small node-negative tumours.

METHODS

The ALTTO trial randomised 8381 patients with early HER2-positive BC treated with adjuvant chemotherapy (anthracycline/taxane- or taxane/carboplatin-based), to trastuzumab (T), lapatinib (L), their sequence (T → L) or their combination (L + T). Patients with tumours ≤3 cm and node-negative were included in this sub-analysis.

RESULTS

A total of 2821 patients were analysed (median follow-up of 7 years). The median age was 52 years, and most patients had tumours ≤2 cm (64.3%). The 7-year disease-free survival (DFS) was 88.1% (95% CI: 86.7-89.3%). DFS was similar for arms T, T + L and T⟶L and significantly lower for arm L (stratified log-rank P = 0.031). The 7-year overall survival rate was 95.9% (95% CI: [95.0-96.6%) and the 7-year time-to-distant recurrence was 93.4% (95% CI: 92.3-94.4%).

CONCLUSION

With most patients treated with anthracycline-based regimens, ALTTO shows that patients with small tumours treated with trastuzumab and concomitant chemotherapy have excellent long-term outcomes, similar to those of the APT trial.

TRIAL REGISTRATION

Clinicaltrials.gov identifier NCT00490139.

摘要

背景

HER2 阳性的小淋巴结阴性乳腺癌患者通常接受紫杉醇和 1 年辅助曲妥珠单抗治疗。我们对 ALTTO 试验进行了亚组分析,以探讨小淋巴结阴性肿瘤患者的长期结局。

方法

ALTTO 试验将 8381 例接受辅助化疗(蒽环类药物/紫杉烷或紫杉烷/卡铂为基础)的早期 HER2 阳性 BC 患者随机分为曲妥珠单抗(T)、拉帕替尼(L)、序贯(T→L)或联合(L+T)治疗组。该亚组分析纳入了肿瘤≤3cm 和淋巴结阴性的患者。

结果

共分析了 2821 例患者(中位随访 7 年)。中位年龄为 52 岁,大多数患者肿瘤直径≤2cm(64.3%)。7 年无病生存率(DFS)为 88.1%(95%CI:86.7-89.3%)。T、T+L 和 T→L 组的 DFS 相似,而 L 组的 DFS 显著较低(分层对数秩检验 P=0.031)。7 年总生存率为 95.9%(95%CI:[95.0-96.6%),7 年远处复发时间为 93.4%(95%CI:92.3-94.4%)。

结论

在大多数接受蒽环类药物为基础的治疗方案的患者中,ALTTO 表明接受曲妥珠单抗和联合化疗治疗的小肿瘤患者具有极好的长期结局,与 APT 试验相似。

试验注册

Clinicaltrials.gov 标识符 NCT00490139。