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Validation sentinel lymph node biopsy study in cN0 axilla using low-cost dual dye technique: potential solution for resource poor settings

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Abstract

Background

Sentinel lymph node biopsy (SLNB) using radio-pharmaceutical and a blue dye is gold standard for axillary staging in clinically node-negative breast cancer. High costs and limited availability of radio-pharmaceutical and/or gamma probe are major deterrents in performing SLNB in developing countries. In this study, we evaluated feasibility of SLN identification (SLN-IR) of fluorescein-guided (FG) SLNB in combination with methylene blue dye (MBD).

Methods

This was a prospective cross-sectional non-randomized validation study in patients with clinically node-negative axilla. Patients underwent validation SLNB using fluorescein (and blue LED light) and MBD. Axillary dissection was performed irrespective of SLNB histology. SLIN-IR and False Negative Rate (FNR) were assessed for both groups.

Results

The SLNs were identified in 29 (96.6%) pre-chemotherapy patients and 23 (82%) post Neoadjuvant Chemotherapy (NACT) patients. The median number of sentinel lymph nodes identified was 3 (range of 1–5) in pre-chemotherapy patients and 1 (range of 1–3) in post NACT patients. The SLN-IR using MBD was 90%, FD was 86.7% and combined MBD FD was 96.7% in pre-chemotherapy patients. The SLN-IR using MBD was 82%, FD was 71% and combined MBD FD was 82% in in post NACT patients. The false negative rate (FNR) in pre-chemotherapy group was 8.0% (MBD), 8.3% (FD) and 7.4% (MBD + FD). The FNR in post NACT group was 8.7% (MBD), 10% (FD) and 8.7% (MBD + FD).

Conclusion

This prospective validation study showed adequate SLN-IR and FNR using low-cost dual dyes in early breast cancer patients and can be used in low resource settings. However, SLNB in post NACT axilla though viable along with a satisfactory FNR, is associated with low identification rate and needs further evaluation.

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Data availability

The datasets generated during the current study are not publicly available due to but are available from the corresponding author on reasonable request.

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Authors and Affiliations

Authors

Contributions

SKY—Conceptualization, study design, implementation, literature search, figures, data collection, data analysis, data interpretation, writing. JC—Study design, data collection, data analysis, data interpretation. DS—writing, revision and editing of manuscript. AS, AM, DBS- Revision.

Corresponding author

Correspondence to Sanjay Kumar Yadav.

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Authors declare no conflict of interest.

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. Institute ethics committee of the NSCB Medical College, Jabalpur, approved the study. Informed consent was obtained from the participants.

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Presentation: This work was presented during the golden jubilee conference of The College of Surgeons of Sri Lanka as oral presentation in November 2021

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Chavda, J., Mishra, A., Silodia, A. et al. Validation sentinel lymph node biopsy study in cN0 axilla using low-cost dual dye technique: potential solution for resource poor settings. Breast Cancer Res Treat 193, 105–110 (2022). https://doi.org/10.1007/s10549-022-06556-w

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