Development and Validation of Prediction Models for Sentinel Lymph Node Status Indicating Postmastectomy Radiotherapy in Breast Cancer: a Population-Based Study of 18 185 Women

Abstract

Background: Postmastectomy radiotherapy (PMRT) impairs the outcome of immediate breast reconstruction (IBR) in patients with breast cancer, and the sentinel lymph node (SLN) status is crucial in evaluating the need for PMRT. This study aimed to develop models to preoperatively predict the risk for SLN metastasis indicating the need for PMRT. Methods: Women diagnosed with clinically node-negative (cN0) T1-T2 breast cancer from January 2014 to December 2017 were identified within the Swedish National Quality Register for Breast Cancer. Nomograms for nodal prediction based on preoperatively accessible patient and tumor characteristics were developed using adaptive LASSO logistic regression. The prediction of ≥1 and >2 SLN macrometastases (macro-SLNMs) adheres to the current guidelines on use of PMRT and reflects the exclusion criteria in ongoing clinical trials aiming to de-escalate locoregional radiotherapy in patients with 1-2 macro-SLNMs, respectively. Predictive performance was evaluated using area under the receiver operating characteristic curve (AUC) and calibration plots. Results: Overall, 18 185 women were grouped into training (n =13 656) and validation (n = 4529) cohorts. The well-calibrated nomograms predicting ≥1 and >2 macro-SLNMs displayed AUCs of 0.708 and 0.740, respectively, upon validation. By using the nomogram for ≥1 macro-SLNMs, the risk could be updated from the pre-test population prevalence 13% to the post-test range 2%-75%. Conclusion: Nomograms based on routine patient and tumor characteristics could be used for prediction of SLN status that would indicate PMRT need and assist the decision-making on IBR for patients with cN0 breast cancer.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This study was funded by The Governmental Funding of Clinical Research within the National Health Service (ALF), Swedish Research Council, Erling Persson Foundation, and Per-Eric and Ulla Schyberg's Foundation. The funding sources had no role in the study design, analyses, data interpretation, writing of the manuscript, or the decision to submit the manuscript.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study was approved by the Swedish Ethical Review Authority.

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Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

The data sets generated and analyzed in the present study are available from the corresponding author upon reasonable request.

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