4.Risk of Lymphedema After Sentinel Node Biopsy in Patients With Breast Cancer
Jinyoung BYEON ; Eunhye KANG ; Ji-Jung JUNG ; Jong-Ho CHEUN ; Kwan Sik SEO ; Hong-Kyu KIM ; Han-Byoel LEE ; Wonshik HAN ; Hyeong-Gon MOON
Journal of Breast Cancer 2024;27(5):323-333
Purpose:
Although numerous studies have identified potential risk factors for ipsilateral lymphedema development in patients with breast cancer following axillary node dissection, the risk factors for lymphedema in patients undergoing sentinel node biopsy without axillary dissection remain unclear. In this study, we aimed to determine the real-world incidence and risk factors for lymphedema in such patients.
Methods:
We conducted a single-center, retrospective review of medical records of patients with breast cancer who underwent sentinel node biopsy alone. The development cohort (5,051 patients, January 2017–December 2020) was analyzed to identify predictors of lymphedema, and a predictive model was subsequently created. A validation cohort (1,627 patients, January 2014–December 2016) was used to validate the model.
Results:
In the development cohort, 49 patients (0.9%) developed lymphedema over a median follow-up of 56 months, with most cases occurring within the first three years post-operation.Multivariate analysis revealed that a body mass index (BMI) of 30 kg/m2 or above, radiation therapy (RTx), chemotherapy, and more than three harvested lymph nodes significantly predicted lymphedema. The predictive model showed an area under the curve of 0.824 for systemic chemotherapy, with the number of harvested lymph nodes being the most significant factor. Patients were stratified into four risk groups, showing lymphedema incidences of 3.3% in the highest-risk group and 0.1% in the lowest-risk group. In the validation cohort, the incidences were 1.7% and 0.2% for the highest and lowest risk groups, respectively.
Conclusion
The lymphedema prediction model identifies RTx, chemotherapy, BMI ≥ 30 kg/m2 , and more than three harvested lymph nodes as significant risk factors. Although the overall incidence is low, the risk is notably influenced by the extent of lymph node removal and systemic therapies. The model’s high negative predictive value supports its application in designing tailored lymphedema surveillance programs for early intervention.
5.Risk of Lymphedema After Sentinel Node Biopsy in Patients With Breast Cancer
Jinyoung BYEON ; Eunhye KANG ; Ji-Jung JUNG ; Jong-Ho CHEUN ; Kwan Sik SEO ; Hong-Kyu KIM ; Han-Byoel LEE ; Wonshik HAN ; Hyeong-Gon MOON
Journal of Breast Cancer 2024;27(5):323-333
Purpose:
Although numerous studies have identified potential risk factors for ipsilateral lymphedema development in patients with breast cancer following axillary node dissection, the risk factors for lymphedema in patients undergoing sentinel node biopsy without axillary dissection remain unclear. In this study, we aimed to determine the real-world incidence and risk factors for lymphedema in such patients.
Methods:
We conducted a single-center, retrospective review of medical records of patients with breast cancer who underwent sentinel node biopsy alone. The development cohort (5,051 patients, January 2017–December 2020) was analyzed to identify predictors of lymphedema, and a predictive model was subsequently created. A validation cohort (1,627 patients, January 2014–December 2016) was used to validate the model.
Results:
In the development cohort, 49 patients (0.9%) developed lymphedema over a median follow-up of 56 months, with most cases occurring within the first three years post-operation.Multivariate analysis revealed that a body mass index (BMI) of 30 kg/m2 or above, radiation therapy (RTx), chemotherapy, and more than three harvested lymph nodes significantly predicted lymphedema. The predictive model showed an area under the curve of 0.824 for systemic chemotherapy, with the number of harvested lymph nodes being the most significant factor. Patients were stratified into four risk groups, showing lymphedema incidences of 3.3% in the highest-risk group and 0.1% in the lowest-risk group. In the validation cohort, the incidences were 1.7% and 0.2% for the highest and lowest risk groups, respectively.
Conclusion
The lymphedema prediction model identifies RTx, chemotherapy, BMI ≥ 30 kg/m2 , and more than three harvested lymph nodes as significant risk factors. Although the overall incidence is low, the risk is notably influenced by the extent of lymph node removal and systemic therapies. The model’s high negative predictive value supports its application in designing tailored lymphedema surveillance programs for early intervention.
6.Risk of Lymphedema After Sentinel Node Biopsy in Patients With Breast Cancer
Jinyoung BYEON ; Eunhye KANG ; Ji-Jung JUNG ; Jong-Ho CHEUN ; Kwan Sik SEO ; Hong-Kyu KIM ; Han-Byoel LEE ; Wonshik HAN ; Hyeong-Gon MOON
Journal of Breast Cancer 2024;27(5):323-333
Purpose:
Although numerous studies have identified potential risk factors for ipsilateral lymphedema development in patients with breast cancer following axillary node dissection, the risk factors for lymphedema in patients undergoing sentinel node biopsy without axillary dissection remain unclear. In this study, we aimed to determine the real-world incidence and risk factors for lymphedema in such patients.
Methods:
We conducted a single-center, retrospective review of medical records of patients with breast cancer who underwent sentinel node biopsy alone. The development cohort (5,051 patients, January 2017–December 2020) was analyzed to identify predictors of lymphedema, and a predictive model was subsequently created. A validation cohort (1,627 patients, January 2014–December 2016) was used to validate the model.
Results:
In the development cohort, 49 patients (0.9%) developed lymphedema over a median follow-up of 56 months, with most cases occurring within the first three years post-operation.Multivariate analysis revealed that a body mass index (BMI) of 30 kg/m2 or above, radiation therapy (RTx), chemotherapy, and more than three harvested lymph nodes significantly predicted lymphedema. The predictive model showed an area under the curve of 0.824 for systemic chemotherapy, with the number of harvested lymph nodes being the most significant factor. Patients were stratified into four risk groups, showing lymphedema incidences of 3.3% in the highest-risk group and 0.1% in the lowest-risk group. In the validation cohort, the incidences were 1.7% and 0.2% for the highest and lowest risk groups, respectively.
Conclusion
The lymphedema prediction model identifies RTx, chemotherapy, BMI ≥ 30 kg/m2 , and more than three harvested lymph nodes as significant risk factors. Although the overall incidence is low, the risk is notably influenced by the extent of lymph node removal and systemic therapies. The model’s high negative predictive value supports its application in designing tailored lymphedema surveillance programs for early intervention.
7.Selective Avoidance of Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Human Epidermal Growth Factor 2-Positive/TripleNegative Breast Cancer Patients With Excellent Response
Jai Min RYU ; Hyunjun LEE ; Wonshik HAN ; Han-Byoel LEE ; Sung Gwe AHN ; Hee Jeong KIM ; Hyung Seok PARK ; Ji Soo CHOI ; Haeyoung KIM ; Won Kyung CHO ; Jeong Eon LEE
Journal of Breast Cancer 2024;27(2):130-140
Purpose:
The Avoid Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy (ASLAN) trial aims to demonstrate the oncologic safety of omitting axillary surgery in patients with excellent response after neoadjuvant chemotherapy (NACT) for early human epidermal growth factor 2 (HER2)-positive (+)/triple-negative breast cancer (TNBC) who have undergone breast-conserving surgery (BCS) and adjuvant radiotherapy. The ASLAN trial will provide crucial information that could change the procedure in highly selected patients undergoing axillary surgery after NACT.
Methods
ASLAN is a prospective, multicenter, and single-arm surgical trial. The recruitment will be conducted among five tertiary care hospitals in the Republic of Korea. The total number of patients to be recruited will be 178, and we plan to complete patient enrollment by December 2023. The enrollment is considered among patients with HER2+ breast cancer (BC) or TNBC at clinical stage T1–3N0–1M0 who are expected to achieve breast pathological complete response (BpCR) based on a combination of radiologic imaging and physical examination after NACT. BCS was performed on eligible patients. After BCS, patients who showed BpCR were enrolled with the omission of sentinel lymph node biopsy (SLNB). The primary study endpoint upon completion of this trial is 5-year recurrence-free survival, and the secondary endpoints include the 5-year ipsilateral breast tumor recurrence interval, 5-year ipsilateral axillary recurrence interval, 5-year distant metastasis-free survival, 5-year BC-specific survival, 5-year overall survival, 5-year contralateral BC-free survival, re-operation rate according to breast biopsy after NACT, adverse events within 5 years, and quality of life.Discussion: Several clinical trials are currently underway to determine whether SLNB can be omitted after NACT in patients with HER2+ BC or TNBC that are expected to achieve pathologic complete response. The ASLAN trial is expected to provide valuable clues regarding the feasibility of omitting axillary surgery in highly selected patients.
8.Omission of Breast Surgery in Predicted Pathologic Complete Response after Neoadjuvant Systemic Therapy: A Multicenter, Single-Arm, Non-inferiority Trial
Ji-Jung JUNG ; Jong-Ho CHEUN ; Soo-Yeon KIM ; Jiwon KOH ; Jai Min RYU ; Tae-Kyung YOO ; Hee-Chul SHIN ; Sung Gwe AHN ; Seho PARK ; Woosung LIM ; Sang-Eun NAM ; Min Ho PARK ; Ku Sang KIM ; Taewoo KANG ; Jeeyeon LEE ; Hyun Jo YOUN ; Yoo Seok KIM ; Chang Ik YOON ; Hong-Kyu KIM ; Hyeong-Gon MOON ; Wonshik HAN ; Nariya CHO ; Min Kyoon KIM ; Han-Byoel LEE
Journal of Breast Cancer 2024;27(1):61-71
Purpose:
Advances in chemotherapeutic and targeted agents have increased pathologic complete response (pCR) rates after neoadjuvant systemic therapy (NST). Vacuum-assisted biopsy (VAB) has been suggested to accurately evaluate pCR. This study aims to confirm the non-inferiority of the 5-year disease-free survival of patients who omitted breast surgery when predicted to have a pCR based on breast magnetic resonance imaging (MRI) and VAB after NST, compared with patients with a pCR who had undergone breast surgery in previous studies.
Methods
The Omission of breast surgery for PredicTed pCR patients wIth MRI and vacuumassisted bIopsy in breaST cancer after neoadjuvant systemic therapy (OPTIMIST) trial is a prospective, multicenter, single-arm, non-inferiority study enrolling in 17 tertiary care hospitals in the Republic of Korea. Eligible patients must have a clip marker placed in the tumor and meet the MRI criteria suggesting complete clinical response (post-NST MRI size ≤ 1 cm and lesion-to-background signal enhancement ratio ≤ 1.6) after NST. Patients will undergo VAB, and breast surgery will be omitted for those with no residual tumor. Axillary surgery can also be omitted if the patient was clinically node-negative before and after NST and met the stringent criteria of MRI size ≤ 0.5 cm. Survival and efficacy outcomes are evaluated over five years.Discussion: This study seeks to establish evidence for the safe omission of breast surgery in exceptional responders to NST while minimizing patient burden. The trial will address concerns about potential undertreatment due to false-negative results and recurrence as well as improved patient-reported quality of life issues from the omission of surgery. Successful completion of this trial may reshape clinical practice for certain breast cancer subtypes and lead to a safe and less invasive approach for selected patients.
9.Role of Doppler US and elastography prior to biopsy to identify candidates for avoidance of surgery following neoadjuvant chemotherapy for breast cancer
Soo-Yeon KIM ; Han-Byoel LEE ; Wonshik HAN ; Su Hyun LEE ; Jung Min CHANG ; Nariya CHO
Ultrasonography 2023;42(2):323-332
Purpose:
This study aimed to evaluate the role of Doppler ultrasound (US) and elastography to identify residual breast cancer for patients showing near complete response following chemotherapy on magnetic resonance imaging (MRI).
Methods:
Between September 2016 and January 2018, 40 breast cancer patients who showed near complete response (either tumor size ≤0.5 cm or lesion-to-background parenchymal signal enhancement ratio ≤1.6) on MRI following neoadjuvant chemotherapy were prospectively enrolled. After excluding seven women who did not undergo Doppler US and elastography, 33 women (median age, 49 years; range, 32 to 67 years) were analyzed. On the day of surgery, women underwent Doppler US and elastography for tumor bed prior to US-guided core needle biopsy. Histopathologic results of biopsy and surgery were evaluated. Negative predictive value (NPV) and false negative rate (FNR) of biopsy and the combined Doppler US and elastography were analyzed, respectively.
Results:
After surgery, nine women had residual cancers and 24 women had pathologic complete response. The NPV and FNR of biopsy were 92% (24 of 26) and 22% (2 of 9), respectively. The NPV and FNR of combined Doppler US and elastography were 100% (14 of 14) and 0% (0 of 9), respectively. All of nine women with residual cancers had positive vascularity or elasticity. Two women with false-negative biopsy results, having 0.3 cm or 2.5 cm ductal carcinoma in situ at surgery, showed positive vascularity or elasticity.
Conclusion
Tumor bed showing positive vascularity or elasticity indicates residual breast cancer for patients showing near complete response on MRI following chemotherapy.
10.Residual Risk of Ipsilateral Tumor Recurrence in Patients Who Achieved Clear Lumpectomy Margins After Repeated Resection
Jong-Ho CHEUN ; Hong-Kyu KIM ; Han-Byoel LEE ; Wonshik HAN ; Hyeong-Gon MOON
Journal of Breast Cancer 2023;26(6):558-571
Purpose:
Patients with breast cancer with positive lumpectomy margins have a two-fold increased risk of ipsilateral breast tumor recurrence (IBTR). This can be the result of either technically incomplete resection or the biological characteristics of the tumor that lead to a positive margin. We hypothesized that if achieving negative margins by re-excision nullifies the IBTR risk, then the increased risk is mainly attributed to the technical incompleteness of the initial surgeries. Thus, we investigated IBTR rates in patients with breast cancer who achieved clear margins after re-excision.
Methods:
We retrospectively reviewed patients who underwent breast lumpectomy for invasive breast cancer between 2004 and 2018 at a single institution, and investigated IBTR events.
Results:
Among 5,598 patients, 793 achieved clear margins after re-excision of their initial positive margins. During the median follow-up period of 76.4 months, 121 (2.2%) patients experienced IBTR. Patients who underwent re-excision to achieve negative margin experienced significantly higher IBTR rates compared to those achieving clear margin at first lumpectomy (10-year IBTR rate: 5.3% vs. 2.6% [25 vs. 84 events]; unadjusted p = 0.031, hazard ratio, 1.61, 95% confidence interval [CI], 1.04–2.48; adjusted p = 0.030, hazard ratio, 1.69, 95% CI, 1.05–2.72). This difference was more evident in patients aged < 50 years and those with delayed IBTR. Additionally, no statistically significant differences were observed in the spatial distribution of IBTR locations.
Conclusion
Patients who underwent re-excision for initial positive margins had an increased risk of IBTR, even after achieving a final negative margin, compared to patients with negative margins initially. This increased risk of IBTR is mostly observed in young patients and delayed cases.

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