Efficacy & Accuracy: Latest clinical evidence
SLNB – accurate for multicentric breast cancer
• «…SLN biopsy in multicentric breast cancer seems feasible and accurate and should therefore be considered in patients with multicentric breast cancer and clinically negative axilla…» 1
Patent Blue V detects SLN when other techniques fail
• «…The use of BPV is recommended in patients who have unsuccessful SLN detection utilizing the radioactive tracer in order to improve the detection rate…»
• «…There is merit in the use of Patent Blue in a combined technique, which could outweigh concerns about allergic reactions…»
• «…BPV enabled the detection of SLN when use of scintigraphy and GP failed and retention of its use in a combined technique is recommended…» 2
SLNB procedure is equally effective with pa or pt injection
• «…This study strongly validates the PA injection technique given the high detection rate (99.1%) of SLN and the high concordance (95.6%) between blue dye and the radiotracer, as well as higher significant ex and in vivo counts, improving SLN probe detection…» 3
Patent Blue V endorsed by international clinical practices guidelines
Europe
«…There are two current techniques used to identify the sentinel node(s): Radiopharmaceutical, technetium sulfur colloid, and isosulfan blue dye (used in the United States) Technetium-labeled albumin and Patent blue dye (used in Europe)…» 4
«…Dyes cause the blue colouring as they pass slowly through the sentinel node. Isosulfan blue is of greater use in the United States, and Patent blue V in Europe…» 5
UK
«…Increasingly sentinel lymph node biopsy (SLNB) is the preferred method for staging the axilla in early breast cancer (NICE Guidelines 2009). In the UK the SLN is successfully localized in 99% of patients using a combined technique of radioactive (TcM99m) labelled nanocolloid and 2 mls of diluted Patent V blue dye injected into the breast (NEW START Programme). SLNB using the dual localisation protocol is now being used for other tumours, notably melanoma, penile, testicular, cervical and head and neck cancers…» 6
France
«…Le traceur utilisé est un colorant, un radio isotope ou les 2. L’injection du colorant (bleu patenté, bleu isosulfan ou bleu de méthylène) a lieu au bloc opératoire après induction de l’anesthésie, une dizaine de minutes avant l’incision…» 7
[The tracer is either a dye, a radiopharmaceutical or both. The dye (Patent Blue, isosulfan blue or methylene blue) is injected in an operating room under anaesthesia, approximately ten minutes before incision…]
Safety data: Less than 1% side effects
Review of adverse reactions in the NEW START program & ALMANAC trial 8
• 7,917 patients who underwent sentinel lymph node biopsy for breast carcinoma using Patent Blue V in combination with 99m Tc-albumin colloid
• Objective: Review the adverse reactions of Patent Blue V
• Results: «…72 of 7 917 (0.9%) patients experienced adverse reactions…»
• Conclusion: «...allergic potential of Patent Blue V dye compares favourably with isosulfan blue. Severe anaphylaxis is rare…»
Reduced morbidity & Improved quality of life
Randomized multicenter trial: ALMANAC trial 9
• 1,031 patients
• Objective: Compare quality-of-life outcomes between patients who received SLNB with Patent Blue V (n=515) vs. patients who received standard axillary treatment (n=516)
• Results: Lymphedema, sensory deficit, intercostobrachial nerve damage reported less frequently in the group who received SLNB (p≤0.001)
• Conclusion: «…Sentinel lymph node biopsy is associated with reduced arm morbidity and better quality of life… and should be the treatment of choice for patients who have early-stage breast cancer…»
Features & Benefits
Visualizer
• Clear identification and localization of sentinel lymph nodes 5 mins after injection 10
• High identification rate 11
Convenient
• Participate to reduce morbidity
• Improve quality of life 9,12
User-friendly
• Subcutaneous injection
• No obligation to dilute 10,13
Product Information
The site is not country specific and may vary from the approved product information in the country where you are located. Please refer to the local prescribing information and Summary of Product Characteristics (SmPC). Some products mentioned in this website may not be registered, nor commercially available in all countries. Please contact your local Guerbet representative.
Bibliography
1. Van la Parra RFD et al., A prospective validation study of sentinel lymph node biopsy in multicentric breast cancer: SMMaC trial. Eur J Surg Oncol. 2014 Oct;40(10):1250-5.
2. Elmadahm AA et al. Identification of the sentinel lymph node in the SNAC-1 trial. ANZ J Surg. 2015 Jan;85(1-2):58-63.
3. Rodier JF et al. Prospective multicentric randomized study comparing periareolar and peritumoral injection of radiotra¬cer and blue dye for the detection of sentinel lymph node in breast sparing procedures: FRANSENODE trial. J Clin Oncol. 2007 Aug 20;25(24):3664-9.
4. Schwartz GF. Clinical practice guidelines for the use of axillary sentinel lymph node biopsy in carcinoma of the breast: current update. Breast J. Mar-Apr 2004;10(2):85-8.
5. Vidal-Sicart S & Olmos RV. Review article: sentinel node mapping for breast cancer: current situation. J Oncol. 2012;2012:361341.
6. Association of Breast Surgery at BASO. Association of Breast Surgery Guidelines Use of Blue dye for SLNB, 2009.
7. HAS. Note de cadrage. Place de la technique du ganglion sentinelle dans la stratégie diagnostique de l’envahissement ganglionnaire d’un cancer du sein à un stade précoce. 2011. p21.
8. Barthelmes L et al. Adverse reactions to Patent Blue V dye – The NEW START and ALMANAC experience. Eur J Surg Oncol. 2010 Apr;36(4):399-403..
9. Mansel RE et al., Randomized multi-center trial of sentinel node biopsy vs standard axilliary treatment in operable cancer: the ALMANAC trial. J Natl Cancer Inst. 2006 May 3;98(9):599-609.
10. Nos C et al. sentinel lymph node detection for breast cancer: which patients are best suited for the Patent Blue dye only method of identification? Ann Surg Oncol. 2001 Jun;8(5):438-43.
11. Peek MC et al. Is blue dye still required during sentinel lymph node biopsy for breast cancer. Ecancermedicalscience. 2016 Sep 19;10:674.
12. Classe JM et al. Cost comparison of axillary sentinel lymph node detection and axillary lymphadenectomy in early breast cancer. A national study based on a prospective multi-institutional series of 985 patients ‘on behalf of the Group of Surgeons from the French Unicancer Federation. Ann Oncol. 2012 May; 23(5): 1170–1177.
13. Nos C et al. Macroscopic quality control improves the reliability of blue dye-only sentinel lymph node biopsy in breast cancer. Ann Surg Oncol. 2003 Jun;10(5):525-30.