The need to tailor the omission of axillary lymph node dissection to patients with good prognosis and sentinel node micro-metastases
- PMID: 36127853
- PMCID: PMC9972015
- DOI: 10.1002/cam4.5257
The need to tailor the omission of axillary lymph node dissection to patients with good prognosis and sentinel node micro-metastases
Abstract
Background: Results of IBCSG-23-01-trial which included breast cancer patients with involved sentinel nodes (SN) by isolated-tumor-cells or micro-metastases supported the non-inferiority of completion axillary-lymph-node-dissection (cALND) omission. However, current data are considered insufficient to avoid cALND for all patients with SN-micro-metastases.
Methods: To investigate the impact of cALND omission on disease-free-survival (DFS) and overall survival (OS), we analyzed a cohort of 1421 patients <75 years old with SN-micro-metastases who underwent breast conservative surgery (BCS). We used inverse probability of treatment weighting (IPTW) to obtain adjusted Kaplan-Meier estimators representing the experience in the analysis cohort, based on whether all or none had been subject to cALND omission.
Results: Weighted log-rank tests comparing adjusted Kaplan-Meier survival curves showed significant differences in OS (p-value = 0.002) and borderline significant differences in DFS (p-value = 0.090) between cALND omission versus cALND. Cox's regression using stabilized IPTW evidenced an average increase in the risk of death associated with cALND omission (HR = 2.77, CI95% = 1.36-5.66). Subgroup analyses suggest that the rates of recurrence and death associated with cALND omission increase substantially after a large period of time in the half sample of women less likely to miss cALND.
Conclusions: Using IPTW to estimate the causal treatment effect of cALND in a large retrospective cohort, we concluded cALND omission is associated with an increased risk of recurrence and death in women of <75 years old treated by BCS in the absence of a large consensus in favor of omitting cALND. These results are particularly contributive for patients treated by BCS where cALND omission rates increase over time.
Trial registration: ClinicalTrials.gov NCT03461172.
Keywords: adjusted Kaplan-Meier estimator; axillary lymph node dissection; breast cancer; micro-metastasis; sentinel node.
© 2022 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.
Conflict of interest statement
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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References
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- Giuliano AE, Ballman KV, McCall L, et al. Effect of axillary dissection vs no axillary dissection on 10‐year overall survival among women with invasive breast cancer and sentinel node metastasis: the ACOSOG Z0011 (Alliance) randomized clinical trial. Jama. 2017;318(10):918‐926. doi:10.1001/jama.2017.11470 - DOI - PMC - PubMed
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- Galimberti V, Cole BF, Viale G, et al. Axillary dissection versus no axillary dissection in patients with breast cancer and sentinel‐node micrometastases (IBCSG 23‐01): 10‐year follow‐up of a randomised, controlled phase 3 trial. Lancet Oncol. 2018;19(10):1385‐1393. - PubMed
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