World Journal of Surgery

, Volume 42, Issue 5, pp 1391–1395 | Cite as

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

  • Gaurav Agarwal
  • Sendhil Rajan
  • Sabaretnam Mayilvaganan
  • Anjali Mishra
  • Narendra Krishnani
  • Sanjay Gambhir
Original Scientific Report
  • 62 Downloads

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.

Notes

Acknowledgements

This prospective study was made possible with the aid of a SGPGIMS Intramural Grant. The authors would also like to acknowledge the Resident Surgeons of the Department of Endocrine and Breast Surgery, SGPGIMS, Lucknow; and Mr. Subhash Kheruka of the Department of Nuclear Medicine, SGPGIMS, Lucknow for their help.

Compliance with ethical standards

Conflict of interest

None.

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Copyright information

© Société Internationale de Chirurgie 2018

Authors and Affiliations

  1. 1.Department of Endocrine and Breast SurgerySanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)LucknowIndia
  2. 2.Department of SurgerySt. John’s Medical CollegeBengaluruIndia
  3. 3.Department of PathologySanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)LucknowIndia
  4. 4.Department of Nuclear MedicineSanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)LucknowIndia

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