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Evidence summaries

Sentinel Lymph Node Biopsy in Early-Stage Breast Cancer

The incidence of axillary metastases in patients with negative sentinel node biopsy appears to be low. Level of evidence: "B"

A systematic review 1 including 69 studies with a total of 8059 subjects was abstracted in DARE. Lymphatic mapping with sentinel lymph node (SLN) biopsy is used widely to reduce the complications associated with complete axillary lymph node dissection in patients with low-risk breast carcinoma. The proportion of patients who had successfully mapped SLNs ranged from 41% to 100%, with over 50% of studies reporting a rate < 90%. The false-negative rate (FNR) ranged from 0% to 29%, averaging 7.3% overall.

In a randomized trial 2 (n=516) comparing sentinel node biopsy (+ evacuation if sentinel node was positive) (group 1) with sentinel node biopsy followed by evacuation (group 2), axillary metastases were found during surgery in 92 patients in group 1 and 82 patients in group 2. The false negative rate in group 2 was 8.8% (axillary metastases were found at evacuation in 8 patients in whom sentinel node biopsy was negative). During a median follow-up of 46 months, there were no clinical axillary recurrences in either group.

According to 8 observational studies 3 4 5 6 7 8 9 10 with a median follow-up of 3 - 5 years, the rate of axillary recurrence was about 0.3%.

In a prospective, multicenter, randomized phase III trial 11, patients with cN0 early breast cancer or extensive/high-grade ductal carcinoma in situ planned for standard radioactive-labeled colloid lymphoscintigraphy (LSG) with subsequent SLN biopsy (SNLB) were randomly assigned 1:1 to receive SLNB either with knowledge of the LSG findings or without. Modified intention-to-treat analysis (n = 1163) showed a mean number of histologically detected SLNs of 2.21 with LSG and 2.26 without LSG (difference 0.05; stratified 95% CI -0.18 to infinity), thus establishing noninferiority of omitting preoperative LSG. Secondary end points displayed no statistically significant differences.

A meta-analysis 12 assessing the use of SLNB following neoadjuvant chemotherapy (NAC) in patients presenting with clinically positive lymph nodes included 3398 patients. The pooled estimate of the FNR was 13% and that of the identification rate was 91%. The adjusted axillary pathological complete response rate was 47%. A trend toward significance was observed with only clinical stage N1 (cN1) disease whereby clinical stage N1 was associated with an increased axillary pathological complete response rate when compared to N2 or N3 disease (P = .06).

Comment: The quality of evidence is downgraded by imprecise results (few events in randomized trials). The skill of the operator appears to influence the sensitivity of sentinel node biopsy in detecting axillary metastases.

    References

    • Kim T, Giuliano AE, Lyman GH. Lymphatic mapping and sentinel lymph node biopsy in early-stage breast carcinoma: a metaanalysis. Cancer 2006 Jan 1;106(1):4-16. [PubMed][DARE]
    • Veronesi U, Paganelli G, Viale G, Luini A, Zurrida S, Galimberti V, Intra M, Veronesi P, Robertson C, Maisonneuve P, Renne G, De Cicco C, De Lucia F, Gennari R. A randomized comparison of sentinel-node biopsy with routine axillary dissection in breast cancer. N Engl J Med 2003 Aug 7;349(6):546-53. [PubMed]
    • Blanchard DK, Donohue JH, Reynolds C, Grant CS. Relapse and morbidity in patients undergoing sentinel lymph node biopsy alone or with axillary dissection for breast cancer. Arch Surg 2003 May;138(5):482-7; discussion 487-8. [PubMed]
    • Kokke MC, Jannink I, Barneveld PC, van der Linden JC, Gelderman WA, Wissing JC, Bosscha K. Incidence of axillary recurrence in 113 sentinel node negative breast cancer patients: a 3-year follow-up study. Eur J Surg Oncol 2005 Apr;31(3):221-5. [PubMed]
    • Langer I, Marti WR, Guller U, Moch H, Harder F, Oertli D, Zuber M. Axillary recurrence rate in breast cancer patients with negative sentinel lymph node (SLN) or SLN micrometastases: prospective analysis of 150 patients after SLN biopsy. Ann Surg 2005 Jan;241(1):152-8. [PubMed]
    • Naik AM, Fey J, Gemignani M, Heerdt A, Montgomery L, Petrek J, Port E, Sacchini V, Sclafani L, VanZee K, Wagman R, Borgen PI, Cody HS 3rd. The risk of axillary relapse after sentinel lymph node biopsy for breast cancer is comparable with that of axillary lymph node dissection: a follow-up study of 4008 procedures. Ann Surg 2004 Sep;240(3):462-8; discussion 468-71. [PubMed]
    • Reitsamer R, Peintinger F, Prokop E, Rettenbacher L, Menzel C. 200 Sentinel lymph node biopsies without axillary lymph node dissection -- no axillary recurrences after a 3-year follow-up. Br J Cancer 2004 Apr 19;90(8):1551-4. [PubMed]
    • Torrenga H, Fabry H, van der Sijp JR, van Diest PJ, Pijpers R, Meijer S. Omitting axillary lymph node dissection in sentinel node negative breast cancer patients is safe: a long term follow-up analysis. J Surg Oncol 2004 Oct 1;88(1):4-7; discussion 7-8. [PubMed]
    • Veronesi U, Galimberti V, Mariani L, Gatti G, Paganelli G, Viale G, Zurrida S, Veronesi P, Intra M, Gennari R, Rita Vento A, Luini A, Tullii M, Bassani G, Rotmensz N. Sentinel node biopsy in breast cancer: early results in 953 patients with negative sentinel node biopsy and no axillary dissection. Eur J Cancer 2005 Jan;41(2):231-7. [PubMed]
    • Zavagno G, Carcoforo P, Franchini Z, Renier M, Barutta L, De Salvo GL, Maravegias K, Capitanio G, Nitti D, Lise M. Axillary recurrence after negative sentinel lymph node biopsy without axillary dissection: a study on 479 breast cancer patients. Eur J Surg Oncol 2005 Sep;31(7):715-20. [PubMed]
    • Kuemmel S, Holtschmidt J, Gerber B et al. Prospective, Multicenter, Randomized Phase III Trial Evaluating the Impact of Lymphoscintigraphy as Part of Sentinel Node Biopsy in Early Breast Cancer: SenSzi (GBG80) Trial. J Clin Oncol 2019;37(17):1490-1498.[PubMed]
    • El Hage Chehade H, Headon H, El Tokhy O et al. Is sentinel lymph node biopsy a viable alternative to complete axillary dissection following neoadjuvant chemotherapy in women with node-positive breast cancer at diagnosis? An updated meta-analysis involving 3,398 patients. Am J Surg 2016;212(5):969-981.[PubMed]

Primary/Secondary Keywords