Sentinel Lymph Node Biopsy With or Without Use of Preoperative Lymphoscintigraphy in Early Breast Cancer
In a German/Swiss phase III trial (SenSzi [GBG80]) reported in the Journal of Clinical Oncology, Kuemmel et al found that preoperative lymphoscintigraphy was not associated with an increased number of histologically detected sentinel lymph nodes with sentinel lymph node biopsy in women with early breast cancer.
Study Details
The multicenter study, conducted between May 2014 and October 2015, included 1,163 patients (modified intent-to-treat population) with cN0 early breast cancer or extensive/high-grade ductal carcinoma in situ planned for standard radioactive-labeled colloid lymphoscintigraphy with subsequent sentinel lymph node biopsy. They were randomly assigned to receive sentinel lymph node biopsy either with (n = 585) or without (n = 578) knowledge of the lymphoscintigraphy findings. The primary endpoint was the mean number of histologically detected sentinel lymph nodes per patient. To establish noninferiority of omitting preoperative lymphoscintigraphy, the stratified one-sided 95% confidence interval (CI) for the difference (without lymphoscintigraphy minus with lymphoscintigraphy) in the mean number of histologically detected sentinel lymph nodes had to be greater than –0.27 (10% noninferiority margin).
Performance With vs Without Lymphoscintigraphy
The mean number of histologically detected sentinel lymph nodes was 2.21 in the lymphoscintigraphy group and 2.26 in the group without lymphoscintigraphy (difference = 0.05, stratified 95% CI = –0.18 to infinity), demonstrating noninferiority of omitting preoperative lymphoscintigraphy. Rates of node-positive disease identified by sentinel lymph node biopsy were 22.1% without lymphoscintigraphy vs 21.6% with lymphoscintigraphy (odds ratio [OR] = 1.033, P = .842). Among patients with ≥ 1 positive sentinel lymph node, completion axillary lymph node dissection was performed in 34.4% without lymphoscintigraphy vs 32.8% with lymphoscintigraphy (OR = 1.072, P = .792).
The investigators concluded, “We show that sentinel lymph node biopsy is equally effective irrespective of the surgeon’s knowledge of preoperative lymphoscintigraphy results. Sentinel lymph node biopsy without lymphoscintigraphy will speed up the preoperative workflow and reduce cost.”
Sherko Kuemmel, PhD, of the Interdisciplinary Breast Unit, Kliniken Essen-Mitte, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was funded by the German Breast Group. For full disclosures of the study authors, visit jco.ascopubs.org.
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