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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

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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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References

  1. Mansel RE, Fallowfield L, Kissin M et al (2006) Randomized multicenter trial of sentinel node biopsy versus standard axillary treatment in operable breast cancer: the ALMANAC Trial. J Natl Cancer Inst 98(9):599–609

    Article  PubMed  Google Scholar 

  2. Krag DN, Anderson SJ, Julian TB et al (2007) Technical outcomes of sentinel-lymph node resection and conventional axillary-lymph-node dissection in patients with clinically node-negative breast cancer: results from the NSABP B-32 randomised phase III trial. Lancet Oncol 8:881–888

    Article  CAS  PubMed  Google Scholar 

  3. Shah SQ (2006) New technology of technetium-99 labeled antimony trisulfide colloid intended for sentinel lymph node imaging. Pharm Chem J 40:151

    Article  Google Scholar 

  4. Smyth DR (2006) Rapid determination of the radiochemical purity of 99mTc-antimony trisulfide colloid prepared by standard and alternative heating methods. J Nucl Med Technol. 34(3):174–178

    CAS  PubMed  Google Scholar 

  5. Fitzgibbons PL, Page DL, Weaver D et al (1999) Prognostic factors in breast cancer. College of American Pathologists consensus statement. Arch Pathol Lab Med 124:966–978

    Google Scholar 

  6. Lyman GH, Temin S, Edge SB et al (2014) American Society of Clinical Oncology Clinical Practice. Sentinel lymph node biopsy for patients with early-stage breast cancer: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol 32(13):1365–1383

    Article  PubMed  Google Scholar 

  7. Pesek S, Ashikaga T, Krag LE, Krag D (2012) The false-negative rate of sentinel node biopsy in patients with breast cancer: a meta-analysis. World J Surg 36(9):2239–2251. https://doi.org/10.1007/s00268-012-1623-z

    Article  PubMed  PubMed Central  Google Scholar 

  8. Agarwal G, Gambhir S, Kheruka S et al (2005) Low-cost sentinel node studies in breast cancer with indigenous blue dye & 99mTc-antimony colloid. J Japan Surg Soc 106:221

    Google Scholar 

  9. National Comprehensive Cancer Network. Breast Cancer (Version 1.2017). http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed 1 January 2017

  10. Parmar V, Hawaldar R, Nair NS et al (2013) Sentinel node biopsy versus low axillary sampling in women with clinically node negative operable breast cancer. Breast 22(6):1081–1086

    Article  CAS  PubMed  Google Scholar 

  11. Narui K, Ishikawa T, Kito A et al (2010) Observational study of blue dye-assisted four-node sampling for axillary staging in early breast cancer. Eur J Surg Oncol 36(8):731–736

    Article  CAS  PubMed  Google Scholar 

  12. Leong SP, Shen ZZ, Liu TJ et al (2010) Is breast cancer the same disease in Asian and Western countries? World J Surg 34(10):2308–2324. https://doi.org/10.1007/s00268-010-0683-1

    Article  PubMed  PubMed Central  Google Scholar 

  13. Agarwal G, Ramakant P, Forgach ER et al (2009) Breast cancer care in develo** countries. World J Surg 33(10):2069–2076. https://doi.org/10.1007/s00268-009-0150-z

    Article  PubMed  Google Scholar 

  14. Hinkle GH. Lymphoscintigraphy and sentinel node biopsy in the staging of cancer (Correspondence Continuing Education Courses for Nuclear Pharmacists and Nuclear Medicine Professionals, Volume 11, Lesson 6). http://pharmacyce.unm.edu/nuclear_program/freelessonfiles/Vol11Lesson6.pdf. Accessed 12 January 2017

  15. Collier BD, Palmer DW, Wilson JF et al (1983) Internal mammary lymphoscintigraphy in patients with breast cancer. Radiology 147:845–848

    Article  CAS  PubMed  Google Scholar 

  16. Agwunobi TC, Boak JL (1978) Diagnosis of malignant breast disease by axillary lymphoscintigraphy: a preliminary report. Br J Surg 65:379–383

    Article  CAS  PubMed  Google Scholar 

  17. Sadeghi R, Zakavi SR, Forghani MN et al (2010) The efficacy of Tc-99m sestamibi for sentinel node map** in breast carcinomas: comparison with Tc-99m antimony sulphide colloid. Nuclear Med Rev 13(1):1–4

    Google Scholar 

Download references

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.

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Authors and Affiliations

  1. Department of Endocrine and Breast Surgery, Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS), Raebarely Road, Lucknow, Uttar Pradesh, 226014, India

    Gaurav Agarwal, Sendhil Rajan, Sabaretnam Mayilvaganan & Anjali Mishra

  2. Department of Surgery, St. John’s Medical College, Bengaluru, Karnataka, India

    Sendhil Rajan

  3. Department of Pathology, Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS), Lucknow, Uttar Pradesh, India

    Narendra Krishnani

  4. Department of Nuclear Medicine, Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS), Lucknow, Uttar Pradesh, India

    Sanjay Gambhir

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  1. Gaurav Agarwal
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  2. Sendhil Rajan
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  3. Sabaretnam Mayilvaganan
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  5. Narendra Krishnani
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  6. Sanjay Gambhir
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Correspondence to Gaurav Agarwal.

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Gaurav Agarwal and Sendhil Rajan are joint first authors.

Awarded the BSI Best paper (podium) award at the World Congress of Surgery, Basel, Switzerland in August 2017.

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Agarwal, G., Rajan, S., Mayilvaganan, S. et al. 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. World J Surg 42, 1391–1395 (2018). https://doi.org/10.1007/s00268-018-4504-2

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  • DOI: https://doi.org/10.1007/s00268-018-4504-2

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