New data support 'potentially practice-changing' approach to sentinel lymph node biopsy
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Key takeaways:
- Certain groups of women with early-stage breast cancer may not benefit from sentinel lymph node biopsy.
- Retrospective study results of real-world conditions support similar findings from a previous trial.
Sentinel lymph node biopsy may be omitted in certain patients with early-stage breast cancer, according to findings presented at American Society of Breast Surgeons Annual Meeting.
Sentinel lymph node biopsy (SLND) did not impact disease recurrence or metastasis in women with cT1N0 hormone receptor-positive, HER2-negative breast cancer and a negative axillary ultrasound, which closely matched results published last year from the Sentinel Node vs. Observation After Axillary Ultra-Sound (SOUND) trial, the methods of which this study investigated in a real-world setting.
The SOUND trial examined the necessity of SLNB — considered standard care for determining axillary node stage — in patients with early-stage breast cancer and a negative axillary ultrasound.
“Given the similarity of our population to [patients in the SOUND trial], our findings support thoughtful integration of these results into clinical practice,” Andreas Giannakou, MD, breast surgery fellow at Brigham and Women’s Hospital, Massachusetts General Hospital and Dana-Farber Cancer Institute, said in a press release.
The SOUND trial — which randomly assigned more than 1,400 women to receive SLNB or no axillary surgery — showed noninferiority for omitting SLND in 5-year distant disease-free survival.
“In current practice, nodal status remains a critical factor for adjuvant systemic therapy decisions in patients who are premenopausal and in those with HER2-positive and triple-negative breast cancer,” Giannakou said during a press briefing.
Methodology
Giannakou and colleagues investigated the general applicability of the SOUND trial’s findings with a retrospective study, building their study cohort from a prospectively maintained database, Giannakou said.
They included women with cT1N0 hormone receptor-positive, HER2-negative breast cancer and a negative axillary ultrasound treated between 2016 and 2023. These patients would have been eligible for participation in the SOUND trial.
Researchers then compared the treatment characteristics of their study cohort with the SLND arm of the SOUND trial.
The study population consisted of 312 patients (median age, 57 years). It included 199 postmenopausal women with a median tumor size of 1.3 cm; 32.7% had grade 1, 50.6% had grade 2 and 16.7% had grade 3 disease.
Results and next steps
The analysis showed 87.8% of patients had no positive nodes, a higher rate than the SOUND trial (84.6%).
Patients with one to three positive nodes accounted for 11.2% of the cohort (vs. 13.1% in the SOUND trial), and those with four or more made up 0.9% (vs. 0.6% in the SOUND trial).
Most individuals in both studies received only hormone therapy as adjuvant treatment (80.1% in the retrospective group; 77.5% in the SOUND trial).
In the retrospective study, 10.3% of patients received no adjuvant therapy (vs. 2.4% in the SOUND trial), whereas 2.9% had chemotherapy (vs. 6.9% in the SOUND trial).
Giannakou and colleagues’ retrospective analysis found 1.3% of patients had locoregional recurrence (vs. 1.7% in the SOUND trial) and 0.3% had distant metastasis (vs. 1.8% in the SOUND trial).
“Our follow-up was shorter than the SOUND trial, yet with similar patient characteristics and disease burden overall,” Giannakou said. "We would expect those oncologic outcomes to remain excellent over time.”
In postmenopausal women, the analysis found 89% to be node negative and just 5.5% of those received chemotherapy. For the node-positive group, 14.3% went on to chemotherapy.
The results prompted Giannkou’s institution to implement the “omission of surgical staging of the axilla in postmenopausal patients with hormone-positive, HER2-negative breast cancer,” he said.
“Like every important study that is potentially practice changing, people should implement these findings with caution, and breast surgery is a field that is very multi-disciplinary,” he added. “All disciplines, including radiation oncology, medical oncology, colleagues should discuss and come up with a criteria of selection of patients that all agree and feel comfortable applying those findings. We need to start cautiously, and then in a year or 2 from now we’ll have prospective data from actual real-world experience, and we can expand the criteria of inclusion.”
References:
- Applying SOUND trial results in the real world: New study identifies appropriate patients in a multi-disciplinary clinical practice (press release). Available at: https://www.breastsurgeons.org/meeting/2024/docs/ASBrS-2024-Press-Release-SOUND-Trial-Giannakou.pdf. Published April 11, 2024. Accessed April 11, 2024.
- Gentilini OD, et al. JAMA Oncol. 2023;doi:10.1001/jamaoncol.2023.3759.
- Giannakou A, et al. Presented at: The American Society of Breast Surgeons Annual Meeting press briefing; April 3, 2024; virtual.
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Giannakou A, et al. Presented at: American Society of Breast Surgeons Annual Meeting press briefing; April 3, 2024; virtual.
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