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World Journal of Surgery

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01-05-2018 | Original Scientific Report

Prospective Randomized Trial of Use of In-House Prepared Low-Cost Radiopharmaceutical Versus Commercial Radiopharmaceutical for Sentinel Lymph Node Biopsy in Patients with Early Stage Invasive Breast Cancer

Authors: Gaurav Agarwal, Sendhil Rajan, Sabaretnam Mayilvaganan, Anjali Mishra, Narendra Krishnani, Sanjay Gambhir

Published in: World Journal of Surgery | Issue 5/2018

Abstract

Background

The current standard-of-care for surgical staging of the axilla in clinically node-negative (N0) early breast cancers is sentinel lymph node biopsy (SLNB), which requires expensive radiopharmaceuticals for efficacious results. In-house produced low-cost radiopharmaceuticals may be the solution and have shown efficacy in earlier observational/pilot studies. We compared SLNB using in-house prepared radiopharmaceutical (^99mTc-Antimony-colloid) versus commercially marketed radiopharmaceutical (^99mTc-Sulphur-colloid) in this prospective randomized study.

Study Design

78 clinically N0 early breast cancer patients (T1/2, N0 stages), undergoing primary surgery were prospectively randomized 1:1 into two groups; to receive SLNB using methylene blue, and either ^99mTc-Antimony colloid (Group-1) or ^99mTc-Sulphur colloid (Group-2). Completion axillary dissection was done in all (validation SLNB). SLNB indices were compared between the groups.

Results

The groups were comparable with regard to age, stage, tumour size, hormone receptors and HER2neu status. Cost of the in-house prepared ^99mTc-antimony colloid was 16-times lesser compared to ^99mTc-sulphur colloid. SLN identification rates (IR) in Groups 1 and 2 were 100 and 97.4% respectively, (p > 0.05). False negative rates (FNR) in Group 1 and 2 were 6.3% (1/16 patients) and 7.7% (1/13 patients), respectively, (p > 0.05). There were no major allergic reactions in either group.

Conclusion

In this prospective randomized trial on early breast cancer patients, accuracy of SLNB was comparable using in-house prepared, ^99mTc-antimony colloid and commercially marketed ^99mTc-sulphur colloid as radiopharmaceutical, while ^99mTc-antimony colloid was much cheaper than ^99mTc-sulphur colloid.

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Title: Prospective Randomized Trial of Use of In-House Prepared Low-Cost Radiopharmaceutical Versus Commercial Radiopharmaceutical for Sentinel Lymph Node Biopsy in Patients with Early Stage Invasive Breast Cancer
Authors: Gaurav Agarwal
Sendhil Rajan
Sabaretnam Mayilvaganan
Anjali Mishra
Narendra Krishnani
Sanjay Gambhir
Publication date: 01-05-2018
Publisher: Springer International Publishing
Published in: World Journal of Surgery / Issue 5/2018
Print ISSN: 0364-2313
Electronic ISSN: 1432-2323
DOI: https://doi.org/10.1007/s00268-018-4504-2

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Prospective Randomized Trial of Use of In-House Prepared Low-Cost Radiopharmaceutical Versus Commercial Radiopharmaceutical for Sentinel Lymph Node Biopsy in Patients with Early Stage Invasive Breast Cancer

Abstract

Background

Study Design

Results

Conclusion

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Study Design

Results

Conclusion

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