Axillary surgery versus no-axillary staging in T1N0 breast cancer: 20-year follow-up of the INT 09/98 randomized clinical trial.

IF 8.6 1区医学 Q1 SURGERY

British Journal of Surgery Pub Date : 2025-03-04 DOI:10.1093/bjs/znae311

Roberto Agresti, Marco Sandri, Giuseppe Capri, Giulia Bianchi, Tiziana Triulzi, Laura Lozza, Giovanna Trecate, Anna Trapani, Cristina Ferraris, Biagio Paolini, Sylvie Menard, Marco Greco, Secondo Folli, Elda Tagliabue

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引用次数: 0

Abstract

Background: The role of axillary surgery in breast cancer has shifted over time from a therapeutic operation to a staging method for subsequent adjuvant therapies, through the introduction of sentinel lymph node biopsy. The discovery of molecular subtypes has since questioned the necessity of axillary staging in breast cancer.

Methods: The INT09/98 randomized trial explored the omission of axillary surgery in early-stage breast cancer in patients under 65 years of age. From June 1998 to June 2003, a total of 565 T1N0 breast cancer patients were enrolled. The trial tested the non-inferiority of quadrantectomy without axillary surgery (QU) compared to quadrantectomy with axillary dissection (QUAD). The primary endpoint was overall survival (OS). Secondary endpoints included disease-free survival (DFS) and incidence/timing of axillary lymph node metastasis in the QU arm.

Results: Follow-up at 20 years showed no significant differences between the QU versus the QUAD arm. The adjusted hazard ratio for OS was 1.18 (P = 0.326) and DFS was 1.27 (P = 0.280) respectively, both within the predetermined non-inferiority limit. Axillary relapse rates in the QU arm remained low, indicating that only a subset of metastatic nodes cause recurrences if not removed. In the QU arm, patients with favourable biological features but unknown axillary node involvement did not receive adjuvant chemotherapy, without significant differences in outcomes. The axillary relapse rate with distant metastases was similar in both arms and may reflect aggressive biology of the primary tumour.

Conclusion: Avoiding axillary surgery and reducing adjuvant treatments in early breast cancer does not increase distant metastases or affect long-term survival. Axillary relapsed patients with distant metastases in both QU and QUAD arms may represent cancers with genomically determined poorer prognosis, independent of surgical intervention and adjuvant therapies.

Registration number: NCT01508546 (http://www.clinicaltrials.gov).

查看原文本刊更多论文

T1N0乳腺癌腋窝手术与非腋窝分期：INT 09/98随机临床试验的20年随访

背景：随着时间的推移，腋窝手术在乳腺癌中的作用已经从治疗性手术转变为后续辅助治疗的分期方法，通过前哨淋巴结活检的引入。分子亚型的发现对乳腺癌腋窝分期的必要性提出了质疑。方法：INT09/98随机试验探讨65岁以下早期乳腺癌患者腋部手术的遗漏。从1998年6月到2003年6月，共有565名T1N0乳腺癌患者入组。该试验检验了不加腋窝手术的四象限切除术（QU）与加腋窝清扫的四象限切除术（QUAD）的非劣效性。主要终点是总生存期（OS）。次要终点包括QU组的无病生存期（DFS）和腋窝淋巴结转移的发生率/时间。结果：20年随访显示QU组与QUAD组之间无显著差异。调整后的OS风险比为1.18 (P = 0.326)， DFS风险比为1.27 (P = 0.280)，均在预定的非劣效性限制范围内。腋窝的复发率在QU组仍然很低，这表明如果不切除，只有一小部分转移淋巴结会导致复发。在QU组中，具有良好生物学特征但未知腋窝淋巴结累及的患者未接受辅助化疗，结果无显著差异。两臂腋窝远处转移的复发率相似，可能反映了原发肿瘤的侵袭性生物学。结论：早期乳腺癌避免腋窝手术和减少辅助治疗不会增加远处转移或影响长期生存。腋窝复发的QU和QUAD手臂远处转移的患者可能代表着基因组决定的预后较差的癌症，独立于手术干预和辅助治疗。注册号：NCT01508546 （http://www.clinicaltrials.gov）。

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

British Journal of Surgery 医学-外科

CiteScore

12.70

自引率

7.30%

发文量

1102

审稿时长

1.5 months

期刊介绍： The British Journal of Surgery (BJS), incorporating the European Journal of Surgery, stands as Europe's leading peer-reviewed surgical journal. It serves as an invaluable platform for presenting high-quality clinical and laboratory-based research across a wide range of surgical topics. In addition to providing a comprehensive coverage of traditional surgical practices, BJS also showcases emerging areas in the field, such as minimally invasive therapy and interventional radiology. While the journal appeals to general surgeons, it also holds relevance for specialty surgeons and professionals working in closely related fields. By presenting cutting-edge research and advancements, BJS aims to revolutionize the way surgical knowledge is shared and contribute to the ongoing progress of the surgical community.