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Retrospectively validating the results of the ACOSOG Z0011 trial in a large Asian Z0011-eligible cohort

  • Jiwoong Jung
  • Wonshik Han
  • Eun Sook Lee
  • So-Youn Jung
  • Jai Hong Han
  • Dong-Young Noh
  • Yumi Kim
  • Hee Jun Choi
  • Jeong Eon Lee
  • Seok Jin Nam
  • Jong Won Lee
  • Hee Jeong Kim
  • Eunhae Um
  • Joo Heung Kim
  • Seho Park
  • Young Up ChoEmail author
Clinical trial
  • 29 Downloads

Abstract

Purpose

The Z0011 trial demonstrated that axillary dissection (ALND) could be omitted during breast-conserving therapy for cT1-2N0 breast cancers with 1–2 metastatic SLNs. However, that result has not been validated in a larger cohort and the significance of the small number of SLNs remains unclear. This study aimed to validate the Z0011 results within an Asian Z0011-eligible cohort and determine whether the number of sentinel lymph nodes (SLNs) influenced the Z0011-based outcomes.

Methods

Data from Asian patients who fulfilled the Z0011 criteria were collected from five hospitals. Disease recurrence (DR) was compared between patients who underwent ALND or SLN dissection (SLND) alone. Propensity-score matching was performed to reduce the effects of potential selection biases.

Results

During 2010–2016, 1750 Asian patients had 1–2 SLN metastases and fulfilled the Z0011 criteria. These patients included 707 cases treated using SLND alone (40%) and 967 patients with ≤ 2 SLNs (55%). Ninety-five patients (5.4%) experienced DR at a median interval of 50 months, although the rates of DR were similar in the ALND and SLND groups. The adjusted hazard ratios for DR after ALND omission were 0.95 (95% CI 0.55–1.64) among the entire cohort and 0.83 (95% CI 0.34–2.03) among patients with ≤ 2 SLNs.

Conclusions

In this Asian Z0011-eligible cohort, ALND omission did not increase risk of DR, even among patients with ≤ 2 SLNs. Therefore, the Z0011 strategy might be safely applied in Asia, and a small number of SLNs did not significantly influence this strategy.

Keywords

Axillary lymph node dissection Breast cancer Sentinel lymph node biopsy 

Notes

Acknowledgements

The authors would like to express their appreciation for the statistical supports from Medical Research Collaborating Center in Seoul National University Hospital.

Funding

This research was supported by a Grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (Grant Nos. HI14C3405 and HI14C1277).

Compliance with ethical standards

Conflict of interest

The authors declare that no actual or potential conflict of interest exists.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the Ethical Standards of the Institutional and/or National Research Committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Supplementary material

10549_2019_5157_MOESM1_ESM.doc (293 kb)
Supplementary material 1 (DOC 293 KB)

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  • Jiwoong Jung
    • 1
  • Wonshik Han
    • 2
  • Eun Sook Lee
    • 3
  • So-Youn Jung
    • 3
  • Jai Hong Han
    • 3
  • Dong-Young Noh
    • 2
  • Yumi Kim
    • 2
  • Hee Jun Choi
    • 4
  • Jeong Eon Lee
    • 4
  • Seok Jin Nam
    • 4
  • Jong Won Lee
    • 5
  • Hee Jeong Kim
    • 5
  • Eunhae Um
    • 6
  • Joo Heung Kim
    • 7
  • Seho Park
    • 8
  • Young Up Cho
    • 8
    Email author
  1. 1.Department of SurgerySeoul Medical CenterSeoulKorea
  2. 2.Department of SurgerySeoul National University College of MedicineSeoulKorea
  3. 3.Center for Breast Cancer, Research Institute and HospitalNational Cancer CenterGoyangKorea
  4. 4.Division of Breast Surgery, Department of Surgery, Samsung Medical CenterSungkyunkwan University School of MedicineSeoulKorea
  5. 5.Division of Breast Surgery, Department of Surgery, Asan Medical CenterUniversity of Ulsan College of MedicineSeoulKorea
  6. 6.Department of Surgery, Ilsan Paik HospitalUniversity of InjeGoyangKorea
  7. 7.Department of SurgeryNational Health Insurance Service Ilsan HospitalGoyangKorea
  8. 8.Department of Surgery, Severance HospitalYonsei University College of MedicineSeoulRepublic of Korea

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