Search

Introduction Adding pertuzumab(P) on trastuzumab(H) with cytotoxic chemotherapy increased pathologic complete response (pCR) of early or locally advanced HER2 positive breast cancer (EBC) with neoadjuvant chemotherapy. Since 63.6% of pCR rate has been reported from TRYPHAENA trial, TCHP regimen has been used as a standard of neoadjuvant treatment regimen for patients with HER2 positive EBC. However, this regimen has profound toxicities in terms of myelosuppression, neurotoxicity, and etc. Furthermore we still need more information on clinical outcomes and toxicities with this regimen. Therefore, we report real world experience of EBC patients treated with neoadjuvant TCHP followed by curative surgery. Methods We retrospectively reviewed electronic medical record of EBC patients who received neoadjuvant TCHP. Information which we gathered included patients’ and tumor characteristics at the time of diagnosis, details of neoadjuvant chemotherapy, pathologic assessment of tumor response to neoadjuvant TCHP and recurrence free survival after curative surgery. pCR was defined as absence of residual invasive cancer on pathologic evaluation of the resected breast specimen and all sampled regional lymph nodes (ypT0/isN0). Results Between February 2016 and August 2019, 447 patients were treated with neoadjuvant TCHP followed by curative surgery. Median age at BC diagnosis was 56. In clinical stage, stage II was 54.6% and 45.4% of stage III and hormone receptor (HR) positive BC was 48.3%. Most commonly reported adverse event(AE) was mucositis (84%) followed by diarrhea (77%). In terms of Grade 3 AE, anorexia(6%), diarrhea(2%) were frequently observed and 9(2%) of febrile neutropenia occurred despite of prophylactic use of peg-filgrastim. Forty percent of patients experienced dose reduction due to AEs. Of 447 patients, 29% of patients underwent total mastectomy and 71% of breast conserving surgery. In terms of clinical outcome, pCR rate was 64%; 77% of HR negative BCs and 50% of HR positive BCs. Among baseline characteristics, high nuclear grade, high histologic grade, HR stats affected to pCR status (Ps Key words: neoadjuvant chemotherapy, HER2+ breast cancer, pertuzumab, pathologic complete response Citation Format: Ji-Yeon Kim, Seok Jin Nam, Seok Won Kim, Jonghan Yu, Byung Joo Chae, Se Kyung Lee, Jai Min Ryu, Jin Seok Ahn, Young-Hyuck Im, Yeon Hee Park. Real Would Evidence (RWE) of neoadjuvant docetaxel/carboplatin/trastuzumab/pertuzumab (TCHP) in patients with HER2 positive early or locally advanced breast cancer treated Single institutional experience [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS10-38.

Background The aim of this study was to examine the accuracy of radiologic complete response (rCR) in predicting pathologic complete response (pCR), and determine whether rCR is a predictor of favorable survival outcomes. Materials and methods We retrospectively reviewed breast cancer patients treated with neoadjuvant chemotherapy (NAC) followed by surgery from September 2007 to June 2016. Breast lesions and axillary nodes were measured by MRI and categorized into either disappeared (breast rCR) or residual disease (breast non-rCR) and either normalized (axillary rCR) or abnormal findings (axillary non-rCR) in the axillary nodes. Correlation between rCR and pCR were compared using Cohen’s Kappa statistics, and the recurrence-free survival (RFS) and overall survival (OS) rates were calculated by the Kaplan-Meier method. Results Out of the 1017 eligible patients, 287 (28.2%) achieved breast pCR, 165 (16.2%) achieved breast rCR, 529 (52.0%) had axillary pCR, and 274 (26.9%) achieved axillary rCR. The correlation between a breast rCR and pCR showed a Cohen’s Kappa value of 0.459, and between axillary rCR and pCR, the value was 0.384. During a median follow-up time of 48.0 months, the 5-year RFS rates were 90.6% for breast rCR, and 69.2% for breast non-rCR. The 5-year RFS rates were 82.3% for axillary rCR, and 68.8% for axillary non-rCR. Patients without breast rCR had a 2.4-fold significant increase in the risk of recurrence (p = 0.004) compared to patients with breast rCR. Conclusion Although rCR correlated with pCR by only moderate to fair degrees, breast rCR was a strong predictor for a favorable RFS outcome.

To examine the association between obesity measured by body mass index (BMI) and waist circumference (WC) according to menopausal status in Korean women. We identified 6,467,388 women, using the Korean National Health Insurance System Cohort. Cox-proportional hazard models were used to generate adjusted hazard ratios (aHRs) and 95% confidence intervals (CIs) for breast cancer risk in relation to BMI and WC. In postmenopausal women, the risk of breast cancer increased with BMI. Compared to women with a BMI of 18.5–23 kg/m two, the risk of invasive breast cancer was lower in patients with BMI

Objective The aim of this study was to present the results of early experience of RANSM. Background Robot-assisted nipple-sparing mastectomy (RANSM) improves cosmetic outcomes over conventional nipple-sparing mastectomy (CNSM). However, data on the feasibility and safety of the RANSM are limited. Methods Patients who underwent RANSM with immediate breast reconstruction (IBR) as part of the Korea Robot-Endoscopy & Minimal Access Breast Surgery Study Group (KoREa-BSG) from November 2016 to January 2020 were enrolled. Clinicopathologic characteristics, perioperative complications, and operation time were collected. Results Overall, 73 women underwent 82 RANSM procedures conducted by 11 breast surgeons at eight institutions. The median patient age was 45.0 years old (20-66 years), and 52 (63.4%) patients were premenopausal. Invasive breast cancer was noted in 55 cases (40 cases were stage I, 11 cases were stage II, and four cases were stage III, respectively) and ductal carcinoma in-situ was recorded in 20 cases. Of those, three patients with BRCA1/2 mutation carriers underwent contralateral risk-reducing RANSM. The median length of hospitalization was 11.7 days (5.0-24.0 days). The incision location was the mid-axillary line and the median incision length was 46.3 mm (30.0-60.0 mm). Median total operation time, median total mastectomy time, and median reconstruction time was 322.0 minutes (163.0-796.0 minutes), 190.8 minutes (97.5-325.0 minutes), and 133.6 minutes (45.0-689.0 minutes). Only two cases (2.5%) required re-operation. Nipple ischemia was found in nine cases (10.9%) but only one case (1.2%) required nipple excision given that eight cases (9.7%) resolved spontaneously. Skin ischemia was observed in five cases (6.1%) and only two (2.4%) cases needed skin excision whereas three cases (3.6%) resolved spontaneously. There was no conversion to open surgery or cases of mortality. The mean time for mastectomy among surgeons who performed more than 10 cases was 182.3 minutes (± 53.7, minutes) and 195.4 minutes (± 50.4, minutes). Conclusion This was the first report of RANSM conducted in the KoREa-BSG. RANSM is technically feasible and acceptable with a short learning curve. Further prospective research to evaluate surgical and oncologic outcomes is needed.

PurposeRecent studies revealed the BRCA1 c.5339T>C, p.Leu1780Pro variant (L1780P) is highly suggested as a likely pathogenic. The aim of this study was to evaluate clinicopathologic features of L1780P with breast cancer (BC) using multicenter data from Korea to reinforce the evidence as a pathogenic mutation and to compare L1780P and other BRCA1/2mutations using Korean Hereditary Breast Cancer (KOHBRA) study data.Materials and MethodsThe data of 54 BC patients with L1780P variant from 10 institutions were collected and the clinicopathologic characteristics of the patients were reviewed. The hereditary breast and/or ovarian cancer–related characteristics of the L1780P variant were compared to those of BC patients in the KOHBRA study.ResultsThe median age of all patients was 38 years, and 75.9% of cases showed triple-negative breast cancer. Comparison of cases with L1780P to carriers from the KOHBRA study revealed that the L1780P patients group was more likely to have family history (FHx) of ovarian cancer (OC) (24.1% vs. 19.6% vs. 11.2%, p < 0.001 and p=0.001) and a personal history of OC (16.7% vs. 2.9% vs. 1.3%, p=0.003 and p=0.001) without significant difference in FHx of BC and bilateral BC. The cumulative risk of contralateral BC at 10 years after diagnosis was 31.9%, while the cumulative risk of OC at 50 years of age was 20.0%. Patients with L1780P showed similar features with BRCA1 carriers and showed higher penetrance of OC than patients with other BRCA1 mutations.ConclusionL1780P should be considered as a pathogenic mutation. Risk-reducing salpingo-oophorectomy is highly recommended for women with L1780P.

We hypothesized that a deep-learning algorithm using HE images might be capable of predicting the benefits of adjuvant chemotherapy in cancer patients. HE slides were retrospectively collected from 1343 de-identified breast cancer patients at the Samsung Medical Center and used to develop the Lunit SCOPE algorithm. Lunit SCOPE was trained to predict the recurrence using the 21-gene assay (Oncotype DX) and histological parameters. The risk prediction model predicted the Oncotype DX score 25 and the recurrence survival of the prognosis validation cohort and TCGA cohorts. The most important predictive variable was the mitotic cells in the cancer epithelium. Of the 363 patients who did not receive adjuvant therapy, 104 predicted high risk had a significantly lower survival rate. The top-300 genes highly correlated with the predicted risk were enriched for cell cycle, nuclear division, and cell division. From the Oncotype DX genes, the predicted risk was positively correlated with proliferation-associated genes and negatively correlated with prognostic genes from the estrogen category. An integrative analysis using Lunit SCOPE predicted the risk of cancer recurrence and the early-stage hormone receptor-positive breast cancer patients who would benefit from adjuvant chemotherapy.

The purpose of this study was to evaluate pathologic lymph node metastasis in breast cancer with cytology-proven axillary metastasis. This study was designed prospectively. We performed axillary lymph node dissections (ALND) after lymphatic mapping by near-infrared (NIR) fluorescence imaging with Indocyanine Green (ICG). We evaluated 72 breast cancer patients with cytology-proven axillary metastasis by curative surgery at the Samsung Medical Center between May of 2016 and December of 2017. Among the 72 patients with cytology-proven axillary metastasis, 14 of 39 patients (35.9%) with one or two sentinel lymph nodes containing metastases were metastasized to post-sentinel lymph node. Thirteen of fourteen patients had additional non-sentinel lymph node metastases, seven of thirteen patients also had additional level II lymph node metastases, and one patient had only one additional level II lymph node metastasis. Of T1 or T2 stage patients, 10 of 33 patients (30.3%) with one or two sentinel lymph nodes containing metastases were metastasized to post-sentinel lymph node. Even in patients without SLN metastasis, 50% of the patients had at least three LN metastases, and 40% in the T1 or T2 stage patients. Sentinel lymph node biopsy without ALND might be not safe for patients with cytology-proven axillary metastasis.

Background: Most of breast cancer patients survive for a long-term period. The existing assessment of survivors’ prognosis has had some limitations in breast cancer because it is based on an evaluation at the time of diagnosis. Conditional survival reflects change over time after diagnosis and treatment of cancer. Conditional disease-free survival (CDFS) and conditional overall survival (COS) can provide more accurate prognosis to breast cancer patients. In this study, we aimed to determine 5-years CDFS and COS according to disease-free period after diagnosis and treatment of breast cancer in Korea. Method: We retrospectively reviewed clinical data of 5664 patients aged 16 to 86 who underwent curative surgery for breast cancer between January 2000 and December 2008 at Samsung Medical Center, a single tertiary hospital in Korea. The CDFS and COS rates were based on cumulative DFS and OS estimates up to 15 years using the Kaplan-Meier method. Results: At baseline, each 5-years DFS and OS were 88.0% and 93.8%. For patients who kept disease free status from 1 to 9 years after surgery, the 5-years CDFS rates were calculated as 88.7%, 90.7%, 91.6%, 91.1%, 91.5%, 91.0%, 89.5%, 86.1% and 86.1%, respectively. The 5-year COS rates of the patients who had survived from 1 to 9 years after surgical treatment were calculated as 92.6%, 92.1%, 91.2%, 91.0%, 89.4%, 85.6%, 80.7%, 75.3%, and 73.0%, respectively. Conclusion: Our study showed that 5-years CDFS and COS for most patients who have breast cancer in Korea seemed to be good prognosis for a long time. However, cancer recurrence tended to occur after a long period postoperatively. Further study is required to identify risk factors associated with recurrence after several years in Korean breast cancer patients. Citation Format: Jee Hyun Ahn, Seok Jin Nam, Seok Won Kim, Jeong Eon Lee, Byung-Joo Chae, Se Kyung Lee, Jai Min Ryu, Jonghan Yu. The 5-years conditional disease free survival and overal survival for breast cancer patients in Korea [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-08-25.

Objective Demands for genetic counseling with BRCA1/2 examination have markedly increased. Accordingly, the incidence of uninformative results on BRCA1/2 mutation status has also increased. Because most patients examined for BRCA1/2 mutation have a high risk of hereditary breast and/or ovarian cancer, many patients suffer psychological distress even when the BRCA1/2 result is negative. We compared oncological outcomes between BRCA1/2-negative breast cancer with high risk of hereditary breast and/or ovarian cancer and sporadic breast cancer without risk of hereditary breast and/or ovarian cancer. Methods The criteria for high risk for hereditary breast and/or ovarian cancer were defined as family history of breast and/or ovarian cancer in first- or second-degree relative, early onset breast cancer at Results All matching variables were successfully matched. Median follow-up duration was 57.8 months. There was no significant difference between the groups in disease-free survival (log-rank P = 0.197); however, the study group showed significantly better overall survival and breast cancer-specific survival (both P Conclusions BRCA1/2-negative breast cancer patients who had hereditary breast and/or ovarian cancer risk factors showed similar disease-free survival and better overall survival and breast cancer-specific survival compared with those with sporadic breast cancer without hereditary breast and/or ovarian cancer risk factors.

Many breast cancer patients receive sentinel lymph node biopsy after neoadjuvant chemotherapy (NAC). We evaluated the axillary pathologic complete response (pCR) in relation to achievement of breast pCR. We evaluated 1044 patients who were diagnosed with invasive breast cancer and were treated with NAC followed by curative surgery at the Samsung Medical Center between January 2008 and December 2016. The pathologic node-positive rates in breast pCR patients were compared for different breast cancer subtypes and clinical nodal stages. Axillary pCR was achieved in 51.9% of the patients after NAC. In this case, the axillary pCR was associated with a biologic subtype (P

We hypothesized that a deep-learning algorithm using HE images might be capable of predicting the benefits of adjuvant chemotherapy in cancer patients. HE slides were retrospectively collected from 1343 de-identified breast cancer patients at the Samsung Medical Center and used to develop the Lunit SCOPE algorithm. Lunit SCOPE was trained to predict the recurrence using the 21-gene assay (Oncotype DX) and histological parameters. The risk prediction model predicted the Oncotype DX score > 25 and the recurrence survival of the prognosis validation cohort and TCGA cohorts. The most important predictive variable was the mitotic cells in the cancer epithelium. Of the 363 patients who did not receive adjuvant therapy, 104 predicted high risk had a significantly lower survival rate. The top-300 genes highly correlated with the predicted risk were enriched for cell cycle, nuclear division, and cell division. From the Oncotype DX genes, the predicted risk was positively correlated with proliferation-associated genes and negatively correlated with prognostic genes from the estrogen category. An integrative analysis using Lunit SCOPE predicted the risk of cancer recurrence and the early-stage hormone receptor-positive breast cancer patients who would benefit from adjuvant chemotherapy.

Purpose Double heterozygosity (DH) for BRCA1 and BRCA2 variant is very rare with only a few cases reported, and most those in Caucasians. In this article, we present seven unrelated cases of DH for BRCA1/2 identified from a single institution in Korea, and describe the characteristics and phenotype of DH individuals compared to those with a single BRCA variant.Materials and Methods This study included 27,678 patients diagnosed with breast cancer and surgically treated at Samsung Medical Center (SMC) between January 2008 and June 2020. In total, 4,215 high-risk breast cancer patients were tested for the BRCA1/2 genes, and electronic medical records from 456 cases with pathogenic/likely pathogenic variants (PVs/LPVs) were reviewed.ResultsA younger mean age at diagnosis was associated with DH than a single variant of BRCA1/2. More triple-negative breast cancer (TNBC) and higher nuclear and histologic grade cancer occurred with DH than BRCA2 variant. All 7 cases of DH were unrelated, and their mutation combinations were different. There were no Ashkenazi founder variants detected.ConclusionWe suggest that patients with DH for BRCA1/2 variants develop breast cancer at a younger age, but the histopathologic features are similar to those of BRCA1.

Purpose Little is known about the impact of financial toxicity in disease-free breast cancer survivors. We aim to validate the COmprehensive Score for financial Toxicity in Korean (COST-K) and evaluate financial toxicity among disease-free breast cancer survivors.Materials and Methods We conducted linguistic validation following a standardized methodology recommended by Functional Assessment of Chronic Illness Therapy multilingual translation (FACITtrans). For psychometric validation, we conducted a cross-sectional survey with 4,297 disease-free breast cancer survivors at a tertiary hospital in Seoul, Korea between November 2018 and April 2019. Survivors were asked to complete the COST-K and European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) questionnaires. The test-retest reliability, internal consistency, and validity of the COST-K were assessed using standard scale construction techniques.Results The COST-K demonstrated good internal consistency, with a Cronbach’s α of 0.81. The test-retest analysis revealed an intraclass correlation coefficient of 0.78. The COST-K had moderate correlation (r=–0.60) with the financial difficulty item of the EORTC QLQ-C30 and week correlation with the items on acute and chronic symptom burdens (nausea/vomiting, –0.18; constipation, –0.14; diarrhea, –0.14), showing good convergent and divergent validity. The median COST-K was 27 (range, 0 to 44; mean±standard deivation [SD], 27.1±7.5) and about 30% and 5% of cancer survivors experienced mild and severe financial toxicity, respectively. Younger age, lower education, lower household income was associated with higher financial toxicity.Conclusion The COST-K is a valid and reliable instrument for measuring financial toxicity in disease-free breast cancer survivors. Considering its impact on the health-related quality of life, more studies need to be conducted to evaluate financial toxicity in cancer survivors and design interventions.

Decision to undergo risk-reducing mastectomy (RRM) needs to consider several factors, including patient’s preference, surgeon’s preference, family history, and genetic predisposition. The aim of this study was to examine whether preoperative diagnosis of BRCA1/2 mutation status could influence surgical decision-making in newly diagnosed breast cancer patients. We retrospectively reviewed ipsilateral breast cancer patients with BRCA1/2 mutation who underwent primary surgery between January 2008 and November 2019 at a single institution in Korea. Of 344 eligible patients, 140 (40.7%) patients were aware of their mutation status ‘prior to surgery’, while 204 (59.3%) did not. Contralateral RRM rate was significantly higher in the group with BRCA1/2 mutation status identified ‘prior to surgery’ compared to the group with mutation status identified ‘after surgery’ [45.0% (63/140) vs. 2.0% (4/204)] (p BRCA1/2 testing (p p BRCA1/2 mutation status identified prior to surgery. Although not statistically significant, higher incidence of developing contralateral breast cancer for BRCA1/2 mutation carriers who underwent ipsilateral surgery-only compared to those who underwent contralateral RRM was observed [12.1% (95% CI: 7.7–17.7%)] (p = 0.1618). Preoperative diagnosis of BRCA1/2 mutation could impact surgical decision-making for breast cancer patients to undergo risk-reducing surgery at the time of initial surgery.

Background Since April 2015, the Korean National Health Insurance (NHI) has reimbursed breast cancer patients, approximately 50% of the cost of the breast reconstruction (BR) procedure. We aimed to investigate NHI reimbursement policy influence on the rate of immediate BR (IBR) following total mastectomy (TM). Methods We retrospectively analyzed breast cancer data between April 2011 and June 2016. We divided patients who underwent IBR following TM for primary breast cancer into “uninsured” and “insured” groups using their NHI statuses at the time of surgery. Univariate analyses determined the insurance influence on the decision to undergo IBR. Results Of 2,897 breast cancer patients, fewer uninsured patients (n = 625) underwent IBR compared with those insured (n = 325) (30.0% vs. 39.8%, P < 0.001). Uninsured patients were younger than those insured (median age [range], 43 [38–48] vs. 45 [40–50] years; P < 0.001). Pathologic breast cancer stage did not differ between the groups (P = 0.383). More insured patients underwent neoadjuvant chemotherapy (P = 0.011), adjuvant radiotherapy (P < 0.001), and IBR with tissue expander insertion (P = 0.005) compared with those uninsured. Conclusion IBR rate in patients undergoing TM increased after NHI reimbursement., Graphical Abstract

BackgroundEndocrine therapy is administered to hormone-positive breast cancer patients to prevent distant metastasis. It is important to evaluate the risk of recurrence and to determine which patients are viable candidates for such treatment because hormone therapy has side effects that can include postmenopausal symptoms. The Clinical Treatment Score post–five years (CTS5), a simple tool for identifying candidates for endocrine therapy, was recently introduced; however, CTS5 only has been applied in validation studies with postmenopausal women. We aimed to validate CTS5 among premenopausal breast cancer patients.MethodsWe identified patients treated between 1994 and 2014 at Samsung Medical Center in Seoul, Korea, and followed their treatment outcomes for more than 60 months after surgery using clinicopathologic parameters. According to menopausal status, we divided the study population into two groups: pre- and postmenopausal women. After calculating CTS5 values based on some parameters, we stratified the rate of late distant recurrence (DR) and analyzed the correlation between CTS5 value and late DR by risk.ResultsAmong 16,904 patients treated surgically for breast cancer, 2,605 with hormone receptor–positive breast cancer who received endocrine therapy were included. Of these, 1,749 (67.14%) patients were premenopausal women, and the median age was 44.00 years. When categorizing study participants according to CTS5-related risk for late DR, 86.79% were categorized as low risk, 5.95% were categorized as intermediate risk, and 7.26% were categorized as high risk. The annual rate of DR was 1.41% for those in the present study and was similar between pre- and postmenopausal participants (1.40 vs. 1.42). Distant metastasis-free survival was not different between the two groups (hazard ratio: 0.817, 95% confidence interval [CI]: 0.547–1.221). The area under the receiver operating characteristic curve at 10 years for premenopausal and postmenopausal patients was 61.75 (95% CI: 52.97–70.53) and 72.71 (95% CIs: 63.30–82.12), respectively.ConclusionsAlthough CTS5 was able to predict late DR, it should be applied with caution in premenopausal women. A CTS5 calculator for premenopausal women might be needed to not underestimate the risk of recurrence in Korea.

The GenesWell™ BCT (BCT score) is a recently developed multigene assay that predicts the risk of distant recurrence in patients with hormone receptor-positive (HR+) and HER2 negative (HER2-) early breast cancer (BC). The ability of the assay to predict the response to neoadjuvant chemotherapy (NACT) has not been established to date. Biopsy specimens of HR+/HER2- BC patients with axillary lymph node (LN) metastasis who underwent NACT were analyzed using the BCT score. The modified breast cancer test (BCT) score was developed and classified into high-and low-response groups. A total of 88 patients were available for the BCT score among 108 eligible patients. The median follow-up duration was 35.9 (7.8-128.5) months. Among these, 61 (65.1%) had cN1 and 53 (60.2%) had cT1 or T2. The BCT score was low in 25 (28.4%) patients and high in 63 (71.6%) patients. Among 50 patients with pathologic complete response or partial response, 41 (82.0%) were in the high-response group, and 9 (18.0%) were in the low-response group. Among 38 patients with stable disease or progressive disease, 22 (57.9%) patients were in the high-response group, and 16 (42.1%) were in the low-response group (p = 0.025). Ki-67 before NACT was a significant factor for predicting tumor response (p = 0.006; 3.81 [1.50-10.16]). The BCT score showed a significant response to NACT (p = 0.016; 4.18 [1.34–14.28]). A significant difference was found in distant metastasis-free survival between the high and low response groups (p = 0.004). We demonstrated that the BCT score predicts NACT responsiveness of HR+/HER2- BC with LN metastasis and might help determine whether to undergo NACT or not. Further studies are warranted to validate these findings.

Background Increasing rates of breast cancer screening have been associated with an increasing frequency of non-palpable breast lesions detection. Preoperative breast lesion localization is essential for optimizing excision accuracy. This study aimed to evaluate the efficacy and safety of indocyanine green (ICG) hyaluronic acid injection as a novel mixture for localization. Methods We performed a prospective clinical trial with female patients who underwent surgery for non-palpable breast lesions. All patients were sequentially assigned to the control group (localization with activated charcoal), Test Group 1 (ICG-hyaluronic acid mixture 0.1 mL), or Test Group 2 (ICG-hyaluronic acid mixture 0.2 mL) by 1:1:1 ratio. Results A total of 44 patients were eligible for this study (Control Group = 14, Test Group 1 = 15, Test Group 2 = 15 patients). Fibroadenoma (n = 17, 38.6%) accounted for the largest proportion of diagnoses, and five patients (11.4%) were diagnosed with malignancies. There were no statistically significant differences in baseline characteristics among the three groups. The marking rate was over 86% in all groups, with no significant intergroup differences. Skin pigmentation was only observed in the control group. The mean accuracy of resection (the greatest diameter of the excised specimen divided by the greatest diameter of the preoperative lesion as observed using ultrasonography, with values closer to 1 reflecting a higher accuracy) was 3.7 in the control group, 2.2 in Test Group 1, and 2.1 in Test Group 2 (p = 0.037 between Controls and Test Group 1, p = 0.744 between Test Group 1 and Test Group 2, and p = 0.026 between Controls and Test Group 2). Conclusion ICG-hyaluronic acid injection is a novel method that was shown to accurately localize non-palpable breast lesions and was associated with no skin pigmentation. Further research is required to apply this method to malignant breast lesions. Trial registration “A Multicenter Open-label, Parallel, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of LuminoMark™ Inj. (Conc. for Fluorescence) Localization in Patients with Non-palpable Breast Lesions” was prospectively registered as a trial (ClinicalTrials. gov Identifier: NCT03743259, date of registration: May 29, 2018, https://clinicaltrials.gov/ct2/show/NCT03743259)

Purpose The purpose of this study was to investigate risk factors for post-metastasis overall survival (PMOS), and to analyze the effect of early detection of distant metastases before symptoms occur on survival in breast cancer patients under intensive surveillance.Methods A total of 7,840 patients underwent surgery for breast cancer from January 2010 to December 2014 at Samsung Medical Center; of these, we retrospectively studied 316 metastatic breast cancer patients. The patients were divided into two groups based on method of metastases detection, routine surveillance without symptoms (asymptomatic group) or follow-up for new-onset symptoms (symptomatic group).Results Multivariate analysis of PMOS showed that the patients with multiple metastases had a 1.872 fold risk of PMOS (p = 0.011) compared to the patients with bone metastasis only. The hazard ratio for the symptomatic group was higher than that for the asymptomatic group (p < 0.001). When patients were stratified by tumor subtype, patients who were HR-positive and asymptomatic on diagnosis of distant metastasis had a better prognosis than those who were HR-positive and symptomatic on diagnosis. However, patients who were HER2-positive showed no significant survival difference between two groups.Conclusion Breast cancer patients who were diagnosed with distant metastasis after symptoms occurred had a poorer prognosis than patients who were diagnosed before symptoms had developed. It is important to follow up patients regularly for symptoms related to distant metastases. Our findings validate the need for intensive surveillance, suggesting reconsideration of the guidelines for metastases screening in breast cancer patients.

Background Immediate breast reconstruction with tissue expander in breast cancer patients who were expected to receive adjuvant therapy, such as chemotherapy or radiotherapy, has been a topic of debate. Postoperative complications from tissue expander procedures can delay the timing of adjuvant treatment and subsequently increase the probability of recurrence. The purpose of this study was to identify the impact of chemotherapy and radiotherapy on postoperative complications in patients who underwent immediate reconstruction (IR) using tissue expander. Methods We conducted a retrospective study of 1081 breast cancer patients who underwent mastectomy and IR using tissue expander insertion between 2012 and 2017 in Samsung Medical Center. The patients were divided into two groups based on complications (complication group vs. no complication group). Complication group was regarded to have surgical removal or conservative treatment based on clinical findings such as infection, capsular contracture, seroma, hematoma, rupture, malposition, tissue viability, or cosmetic problem. The complication group had 59 patients (5.5%) and the no complication group had 1022 patients (94.5%). Results In univariate analysis, adjuvant radiotherapy and adjuvant chemotherapy were significantly associated with postoperative complications. In multivariate analysis, however, only higher pathologic N stage was significantly associated with postoperative complications (p p = 0.775) or radiotherapy (p = 0.825) were not risk factors for postoperative complications. Conclusions IR with tissue expander after mastectomy may be a treatment option even when the patients are expected to receive adjuvant chemotherapy or radiotherapy. These results will aid patients who are concerned about the complications of IR caused by chemotherapy or radiotherapy determine whether or not to have IR. Trial registration Patients were selected and registered retrospectively, and medical records were evaluated.

Purpose Restricted shoulder motion is a major morbidity associated with a lower quality of life and disability after axillary lymph node dissection (ALND) in patients with breast cancer. This study sought to evaluate the antiadhesive effect of a poloxamer-based thermosensitive sol-gel (PTAS) agent after ALND. Methods We designed a double-blind, multicenter randomized controlled study to evaluate the clinical efficacy and safety of PTAS in reducing upper-limb dysfunction after ALND. The primary outcome was the change in the range of motion (ROM) of the shoulder before surgery and 4 weeks after ALND (early postoperative period). Secondary outcomes were shoulder ROM at six months, axillary web syndrome, and lymphedema (late postoperative period). Results A total of 170 patients with planned ALND were randomly assigned to one of 2 groups (poloxamer and control) and 15 patients were excluded. In the poloxamer group (n = 76), PTAS was applied to the surface of the operative field after ALND. ALND was performed without the use of poloxamer in the control group (n = 79). Relative to the control group, the poloxamer group had significantly lower early postoperative restrictions in total shoulder ROM at four weeks (-30.04 ± 27.76 vs. -42.59 ± 36.79; p = 0.0236). In particular, the poloxamer group showed greater reductions in horizontal abduction at four weeks (-3.92 ± 9.80 vs. -10.25 ± 15.42; p = 0.0050). The ROM of the shoulder at 24 weeks, axillary web syndrome, and lymphedema were not significantly different between the two groups. No adverse effects were observed in either group. Conclusion We suggest that poloxamer might improve the early postoperative shoulder ROM in patients with breast cancer who have undergone ALND. Trial registration ClinicalTrials.gov Identifier: NCT02967146.

IMPORTANCE: The potential association between breast implant–related anaplastic large cell lymphoma (BIA-ALCL) and implant texture has raised concerns about the additional unexpected adverse effects of textured implants, including potentially adverse outcomes for other cancers. In addition to the risk of developing BIA-ALCL, breast cancer survivors may worry about whether the type of implant inserted is associated with recurrence of their original cancer—an issue for which little evidence currently exists. OBJECTIVE: To evaluate the oncologic outcomes of breast cancer according to the surface type of implants used for reconstruction and to identify the independent factors associated with breast cancer recurrence and survival, including implant surface type. DESIGN, SETTING, AND PARTICIPANTS: This cohort study was conducted at Samsung Medical Center, a single tertiary referral center in Seoul, South Korea. Patients with breast cancer who underwent total mastectomy and immediate 2-stage tissue expander/implant reconstruction between January 1, 2011, and December 31, 2016, were identified from a prospectively maintained database. Patients were categorized into 2 groups according to the surface type of implant used for their reconstruction (smooth or textured implant). These patients were followed up for at least 2 years after insertion of the implant. Data analysis was performed from February 15, 2020, to March 5, 2020. EXPOSURES: Use of smooth implants vs textured implants at the second-stage operation. MAIN OUTCOMES AND MEASURES: The main outcomes of interest were local and regional recurrence-free survival (LRRFS) and disease-free survival (DFS) rates. Cumulative incidence of oncologic events in the smooth implant and textured implant groups and their respective hazard ratios (HRs) were collected and updated regularly. RESULTS: In total, 650 patients (all women, with a mean [SD] age of 43.5 [7.4] years), representing 687 cases, met the inclusion criteria and were followed up for a median (range) duration of 52 (31-106) months. Of the 687 cases, 274 (39.9%) received a smooth implant and 413 (60.1%) received a textured implant. Patients in these 2 surface texture groups had similar characteristics, including tumor staging (stage I: 102 [37.2%] vs 173 [41.9%]; stage II: 93 [33.9%] vs 119 [28.8%]; stage III: 14 [5.1%] vs 20 [4.8%]; P = .50) and rates of adjuvant radiotherapy (42 [15.3%] vs 49 [11.9%]; P = .19) and chemotherapy (113 [41.2%] vs 171 [41.4%]; P = .97). The 5-year LRRFS was 96.7%, and the 5-year DFS was 95.2%. Compared with the use of a smooth implant, textured implant use was statistically significantly associated with lower DFS, and this difference remained significant after adjusting for estrogen receptor (ER) status and tumor stage (HR, 3.054; 95% CI, 1.158-8.051; P = .02). Similar statistically significant associations were observed on multivariable analysis of patients with ER-positive cancer (HR, 3.130; 95% CI, 1.053-9.307; P = .04) and those with invasive cancer (HR, 3.044; 95% CI, 1.152-8.039; P = .03). The association of textured implant use with recurrence (lower DFS) was more prominent in cases with late-stage (stage II or III) tumor (HR, 8.874; 95% CI, 1.146-68.748; P = .04). The LRRFS did not differ statistically significantly according to implant surface texture. CONCLUSIONS AND RELEVANCE: This cohort study found that use of textured implants in reconstruction appears to be associated with recurrence of breast cancer. Further investigation is required to verify these results.

Numerous studies have shown that vitamins reduce the risk of cancers, but the relationship between serum vitamin levels and breast cancer is still controversial. In this study, we evaluated serum levels of vitamins in Korean patients with benign breast disease or breast cancer and investigated their associations with clinical and laboratory parameters. Concentrations of vitamin A, D, and E, together with homocysteine and methylmalonic acid as biomarkers of vitamin B12 deficiency, were measured by high-performance liquid chromatography (HPLC) or liquid chromatography with tandem mass spectrometry (LC-MS/MS) in the serum of 104 breast cancer patients, 62 benign breast disease patients, and 75 healthy Korean females. We further assessed possible associations between vitamin levels and breast cancer subtypes, the presence of lymph node metastasis, and tumor stages. Serum concentrations of vitamins A and E were significantly lower in breast cancer patients and in benign breast disease patients than in healthy controls. Severe vitamin D deficiency was more prevalent in breast cancer patients than in healthy controls. Vitamin D level was significantly lower in breast cancer patients with estrogen receptor-negative or triple-negative subtypes than in those with other subtypes. Further research with a larger study population is required to elucidate the role of vitamins in breast cancer.

Introduction Tumor metastasis is a major clinical challenge accounting for the vast majority of cancer related deaths.In previous studies, prediction of distant metastasis was based on subtypes,clinical status and sometimes gene expression were used however clinical application was difficult. In this study, we develop the easy to use prediction tool for distant metastasis using clinical characteristics and gene profiles which came from CancerSCANTM, Next Generation Sequencing based targeted-sequencing platform designed at Samsung Medical Center(SMC). Methods We performed a retrospective chart review of 326 breast cancer patients who underwent surgery and CancerSCAN TM between Jan 2001 and Dec 2014 at SMC. Median follow up period was 83 months (Range 1˜190). Cancer scanTM cover 381 genes but 27 genes and 34 occasions (loss of function, mutation or copy number variation) were selected for analysis through gradient boosting and Wilcoxon Signed rank test. Azure Machine Learning is a cloud service that enables the execution of machine learning processes.This was accomplished using the steps of (1) edit the data, (2) split the data, (3) train the model, (4) score the model, and (5) evaluate the model. We split the modeling data into training and testing sets using a randomized 50–50 split. Two-class Decision Forest method was used. After deploying the Azure ML predictive model as a web service, we used a Representational State Transfer application programming interface to send data and obtained predictions in real-time. Results No distant metastasis group and distant metastasis group consisted of 267 and 59 patients, respectively. HR-/HER2+ and 50 years old and over patients were higher in metastasis group (p-value = 0.003 and p-value = 0.000). Nuclear grade 3 and N2,3 were higher in metastasis group (p-value = 0.010 and p-value = 0.000, p-value = 0.001 respectively). Stage III was also higher in metastasis group (p-value = 0.000). Among 59 patients with distantmetastasis, multiple sites metastasis was 21 cases (35.6%) and then lung metastasis was 19 cases (32.2%). In the 21 cases of multiple sites metastasis, triple sites was 6 cases (28.6%) and double sites was 15 cases (71.4%). PIK3CA mutation was the most frequent gene variation in all patients (34.5% of no metastasis group and 27.1% of metastasis group) but there was no difference between two groups(p-value = 0.278). BRCA 1 loss of function and BRCA2 loss of function were more frequent in metastasis group than no metastasis group(p-value = 0.033 and p-value = 0.024, respectively) but total counts was too small. We assessed the area under the curve (AUC) of the receiver operating characteristic (ROC) curve for predictive value. The AUC of ROC curve was 1.000 and also accuracy, precision, recall were 1.000. In addition, we conducted internal validation using 83 patients during 2015. When we applied a 0.5 threshold value with our predictive model, true negative was 81 and true positive was 2 among 83 patients. Finally, the accuracy of validation was 1.000. Conclusion Our predicted model could represent a useful and easy-to-access tool for the selection of patients with distant metastasis. After additional evaluation with large data and external validation, worldwide use of our model could be expected. Citation Format: Kim I, Choi HJ, Ryu JM, Lee SK, Yu JH, Kim SW, Nam SJ, Seo SW, Lee JE. A predictive model for distant metastasis in breast cancer patients using machine learning [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P2-08-52.

Background: There are many factors that might contribute to the delay of surgery in patients with breast cancer. Previous studies investigate the influence of delay of surgery, but they reported inconsistent results. The purpose of this study was to evaluate the impact of time of surgery on prognosis of breast cancer. Methods: We performed a retrospective review of the patients with breast cancer, who received surgery between 1992 and 2009, by using data from Korea Breast Cancer Society Registry. Kaplan-Meier survival analysis and Cox regression model were used to evaluate the impact of time to surgery in breast cancer and subgroup analyses were performed for each disease stage and molecular subtype. Result: A total 14727 patients were included for analysis. Delay of surgery more than 31 days was associated with worse survival for breast cancer [hazard ratio (HR) = 2.16; 95% confidence interval (CI), 1.936-2.408, p Conclusion: Surgical delay of more than 31 days were independent risk factors for worse outcome of breast cancer in each molecular subtype and breast cancer group except stage 0 and I. Although preoperative evaluation is required, surgical delay should be shortened to enhance survival of breast cancer, especially in patients with tumor size more than 2cm or presence of lymph node metastasis. Citation Format: Kim J-M, Choi HJ, Kim I, Ryu JM, Yu J, Lee JE, Kim SW, Nam SJ, Lee SK. The impact of time interval between diagnosis and surgery in each type and stage of breast cancer [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P2-08-29.

A recent study conducted at the University of Tennessee Medical Center using a large dataset from the National Cancer Database (NCDB) reported the use of nomograms for predicting Oncotype DX™ (ODX) scores with clinicopathologic data. We reviewed the data of 218 patients who underwent the ODX test at a single institution in Korea to confirm that nomograms can accurately predict ODX score groups using our data, which differ from those of the NCDB in terms of ethnicity. The concordance index (c-index) of nomograms was much lower than that of the University of Tennessee Medical Center for high- and low-risk groups of commercial ODX and Trial Assigning Individualized Options for Treatment values. Although the nomogram for predicting ODX scores was based on a large dataset, it could not be generalized to patients in Asia. Further studies using large datasets of patients from different ethnicities should be performed to develop a nomogram applicable to patients worldwide.

Purpose The American Joint Committee on Cancer (AJCC) recently released the breast cancer staging system, 8th edition, which included additional four biologic factors. However, there has been no external validation of the prognostic value of the new stages with different population-based databases. Methods To validate the prognostic value of the new staging system in the Asian population, with a focus on Korean patients with breast cancer, we performed a retrospective study with data from the Korean Breast Cancer Society that included 24,014 patients with invasive ductal or lobular carcinoma who underwent surgery between January 2009 and January 2012 in Korea. The proportional differences were evaluated between the anatomic staging system (AJCC 7th edition) and the prognostic staging system (AJCC 8th edition, December 2017 published version). Comparisons of overall survival (OS) and disease-free survival (DFS) with Kaplan-Meier graphs and hazard ratios were also performed. Results Our analysis included 24,014 patients (median age, 50 years; range, 20-91 years). Stage I, II, and III disease accounted for 47.6%, 43.5%, and 8.9%, respectively, of anatomic stages and 61.8%, 27.6%, and 10.8%, respectively, of clinical prognostic stages. A total of 6,272 cases (26.1%) were upstaged, 4,656 (19.4%) were downstaged, and 13,086 (54.5%) remained unchanged. OS and DFS decreased in the order from prognostic stages IA to IIIC but did not change among the anatomic stage groups. Conclusion Our data suggests that the prognostic staging system provides superior prognostic value to the anatomic staging system in Korean patients with breast cancer.

Purpose The 21 gene expression assay, Oncotype DX (ODX) is costly (the current estimated cost is ˜$4000), and were tested in only approximately one-third of breast cancer patients who meet the inclusion criteria in the United States. Recent study of University of Tennessee Medical Center reported a novel nomogram for prediction of ODX recurrence score using clinico-pathologic data, which was based on a large dataset from the National Cancer Data Base (NCDB). The purpose of this study was to confirm that the nomogram could predict ODX score group accurately with Korean data, which is different from the NCDB in terms of ethnicity. Methods A retrospective review was performed with 218 patients who received breast-conserving surgery or mastectomy at Samsung Medical Center and were tested with the ODX from April 2011 to January 2017. An online nomogram calculator, provided by the University of Tennessee Medical Center on their website was used in order to calculate the probability of a low-risk or a high-risk ODX score for each patient. The cut-off value for predictive accuracy of the nomogram was set same as the original study. Results With the cut-off value as 90% for inspection of the commercial ODX score, high-risk group showed 33.3% positive predictive value (PPV) and low-risk group showed 68.7%. With the cut-off value as 86% for TAILORx score, PPV was 66.7% for high-risk group, and 38.9% for low-risk group. The sensitivity of the nomogram for the low-risk group commercial ODX score was 96.8%, and 33.3% for the TAILORx score. For the high-risk group, sensitivity was 20% for the commercial ODX score, and 16.7% for the TAILORx score. Conclusions Although the nomogram for prediction of ODX score was based on a large dataset of NCDB, it could not be generalized to patients in Asia. Further studies based on large data from different ethnicities should be performed to develop the nomogram for patients worldwide. Citation Format: Kim J-M, Ryu JM, Kim I, Choi HJ, Nam SJ, Kim SW, Yu J, Lee SK, Lee JE. The accuracy of nomograms based on large dataset using clinico-pathologic variables for prediction of oncotype DX breast cancer recurrence score [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P5-11-01.

Purpose We evaluated the concordance between core needle biopsy (CNB) and surgical specimens on examining intrinsic biological subtypes and receptor status, and determined the accuracy of CNB as a basic diagnostic method. Methods We analyzed breast cancer patients with paired CNB and surgical specimen samples during 2014. We used monoclonal antibodies for nuclear staining, and estrogen receptor (ER) and progesterone receptor (PR) status evaluation. A positive test was defined as staining greater than or equal to 1% of tumor cells. Human epidermal growth factor receptor 2 (HER2) was graded by immunohistochemistry and scored as 0 to 3+ according to the recommendations of the American Society of Clinical Oncology/College of American Pathologists. Ki-67 immunostaining was performed using the monoclonal antibody Ki-67, and the results were divided at 10% intervals. The cutoff value for high Ki-67 was defined as 20%. Concordance analysis of ER, PR, HER2, Ki-67, and five intrinsic biological subtypes was performed on CNB and surgical specimens. Statistical analysis for concordance was calculated using κ-tests. Results We found very good agreement for ER and PR with a concordance of 96.7% for ER (κ=0.903), and 94.3% for PR (κ=0.870). HER2 and Ki-67 showed concordance rates of 84.8% (κ=0.684) and 83.5% (κ=0.647), respectively, which were interpreted as good agreement. Five subgroups analysis showed 85.8% agreement and κ-value of 0.786, also indicating good agreement. Conclusion CNB showed high diagnostic accuracy compared with surgical specimens, and good agreement for ER, PR, HER2, and Ki-67. Our findings reaffirmed the recommendation of CNB as an initial procedure for breast cancer diagnosis, and the assessment of receptor status and intrinsic biological subtypes to determine further treatment plans.

Numerous studies have demonstrated that breast cancer in young women (BCY) has unfavorable prognostic features and more unfavorable subtypes. However, few studies have evaluated the effect of subtype disparities on breast cancer prognosis by age, especially for BCY. We analyzed breast cancer mortality stratified by tumor subtype according to age among patients younger than 50 years. Data from the Korean Breast Cancer Society Registry for patients diagnosed with invasive breast cancer when aged less than 50 years between 2003 and 2010 were reviewed retrospectively. We identified 30,793 patients with breast cancer who were eligible for analysis. Of these, 793 (2.6%) were aged 20–29 and 8926 (28.8%) were aged 30–39. Median follow-up duration was 84 months. Mean age was 42.4 years. Patients in their 20s were more likely to have cancer of advanced stage and higher nuclear grade, present with lymphovascular invasion, and have unfavorable subtypes. Patients in the 20s group showed worse prognosis. In multivariate analysis for overall survival (OS), the hazard ratio (HR) for patients in the 20s group was higher than that for the 30s and 40s groups, and patients with triple-negative breast cancer (TNBC) showed higher HR than patients with HER-2 or luminal subtype (all p

Purpose We describe a rationale for the re-classification of the BRCA1 c.5539T>C (L1780P) variant using a clinical evidence. Methods A retrospective review was conducted to identify all patients with breast or ovarian cancer and the L1780P variant between 2002 and 2015 at a single institution. Results We identified the BRCA1/2 genetic mutation test results of 1223 breast cancer patients and 174 patients with ovarian cancer. Of the 160 BRCA 1/2 variant unknown significance, 16 (10.0%) patients were identified as having the L1780P variant. Among them, 10 had breast cancer, 4 had ovarian cancer, and 2 had both breast and ovarian cancer. Thirteen (81.3%) patients with this variant had family histories of breast or ovarian cancer. Two (16.7%) also had comorbid ovarian cancer. Two patients with this variant showed that co-segregation of the disease in multiple family members and family histories of breast and ovarian cancer. This variant was found to be either absent or at extremely low frequency in general population databases. Conclusion The L1780P variant might confer to “Likely pathogenic” according to a clinical evidence and the ACMG standards and guidelines. A nation-wide or global survey and a functional analysis are needed to confirm the pathogenicity of the L1780P variant.

Background: Conditional disease-free survival (CDFS) reflects changes over time. Because traditional disease-free survival (DFS) is estimated from the date of diagnosis, it is limited in the ability to predict risk of recurrence in patients who have been disease free. In this study, we determined CDFS of breast cancer patients and estimated the prognostic factors for DFS. Method: We retrospectively reviewed clinical data of 7587 consecutive patients who underwent curative surgery for breast cancer between January 2004 and December 2013 at Samsung Medical Center. Univariate and multivariate analyses were performed to identify risk factors for DFS, which was computed using the Kaplan–Meier method. CDFS rates were based on cumulative DFS estimates. Results: Median follow-up duration was 20.44 months. Three-year DFS was 93.46 percent at baseline. Three-year CDFS survival estimates for patients who had been disease free for 1, 2, 3, 4 and 5 years after treatment were calculated as 92.84, 92.37, 93.03, 89.41, and 79.64 percent, respectively. Three-year CDFS increased continuously each year after 1 year of DFS in hormone receptor (HR)-negative patients but decreased each year in HR-positive patients. Conclusion: In HR-positive patients who are disease free after 3 years, continuous care including surveillance and metastases workup should be considered, although this is not recommended in the current guidelines. On the other hand, the social costs may be reduced in HR-negative patients by extending the surveillance interval. Further studies are needed to identify indicators of DFS prognosis in breast cancer patients.Background: Conditional disease-free survival (CDFS) reflects changes over time. Because traditional disease-free survival (DFS) is estimated from the date of diagnosis, it is limited in the ability to predict risk of recurrence in patients who have been disease free. In this study, we determined CDFS of breast cancer patients and estimated the prognostic factors for DFS. Method: We retrospectively reviewed clinical data of 7587 consecutive patients who underwent curative surgery for breast cancer between January 2004 and December 2013 at Samsung Medical Center. Univariate and multivariate analyses were performed to identify risk factors for DFS, which was computed using the Kaplan–Meier method. CDFS rates were based on cumulative DFS estimates. Results: Median follow-up duration was 20.44 months. Three-year DFS was 93.46 percent at baseline. Three-year CDFS survival estimates for patients who had been disease free for 1, 2, 3, 4 and 5 years after treatment were calculated as 92.84, 92.37, 93.03, 89.41, and 79.64 percent, respectively. Three-year CDFS increased continuously each year after 1 year of DFS in hormone receptor (HR)-negative patients but decreased each year in HR-positive patients. Conclusion: In HR-positive patients who are disease free after 3 years, continuous care including surveillance and metastases workup should be considered, although this is not recommended in the current guidelines. On the other hand, the social costs may be reduced in HR-negative patients by extending the surveillance interval. Further studies are needed to identify indicators of DFS prognosis in breast cancer patients. Citation Format: Paik H-J, Lee SK, Park S, Ryu JM, Kim I, Bae SY, Yu J, Lee JE, Kim SW, Nam SJ. Conditional disease-free survival among patients with breast cancer [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P5-13-07.

Introduction: Although the indication for total mastectomy (TM) with immediate breast reconstruction (IBR) has been expanded, IBR after neoadjuvant chemotherapy (NACT) is still controversy. We assumed that TM with IBR after NACT is feasible surgical treatment in breast cancer patients. Methods: A retrospective review of breast cancer patients who underwent TM with IBR after NACT between 2008 and 2015 at a single center was conducted. These cases were matched by 1:5 to patients who underwent mastectomy alone after NACT. Matching variables included age, clinical T and N staging before NACT, response to NACT, and pathologic staging after NACT. Pathological stage was followed by seventh American Joint Committee on Cancer (AJCC) classification. Results: Overall, 31 patients were identified in the TM with IBR group (Study group) and 85 patients (Control group) were matched. In the study group, 13 (41.9%) patients underwent nipple-sparing mastectomy (NSM) and 18 (58.1%) underwent skin-sparing mastectomy (SSM). Median follow-up duration was 29.2 (7-31) and 38.8 (11-85) months for the study and control group, respectively. Median age was 37.0 (26-57) and 40.0 (24-56) years for the study and control group, respectively. The clinicopathologic characteristics of both groups are summarized in Table1. Disease-free survival (p=0.520), local recurrence-free survival (p=0.610), distant metastasis-free survival (p=0.795), and over survival (p=0.971) did not differ significantly between two groups. Conclusion: TM with IBR after NACT is feasible surgical treatment option in breast cancer patients. Clinicopathologic characteristicsVariablesControl group (n=85)Study group (n=31)p-valueAge, years (matching variables) 0.890≤3515 (17.7)9 (29.0) 36-5061 (71.8)21 (67.7) 51≥9 (10.6)1 (3.2) BMI, m2/kg 0.13025≤62 (72.9)28 (90.3) 26-3018 (21.2)2 (6.5) 30>5 (5.9)1 (3.2) Histology 0.326Ductal carcinoma in situ2 (2.4)3 (9.7) Invasive ductal carcinoma74 (87.1)28 (90.3) Invasive lobular carcinoma2 (2.4)0 (0) Others7 (8.2)0 (0) Multiplicity 0.063yes19 (22.6)12 (40.0) no65 (77.4)18 (60.0) Lymphovascular invasion 0.161yes33 (39.3)17 (54.8) no51 (60.7)14 (45.2) Nuclear grade 0.317Low10 (11.9)1 (3.3) Intermediate27 (32.1)14 (46.7) High47 (56.0)15 (24.2) Pathologic T stage (matching variable) 0.154T17 (8.2)6 (19.4) T229 (34.1)15 (48.4) T331 (36.5)4 (12.9) T418 (21.2)6 (19.4) Pathologic N stage (matching variable) 0.494N036 (42.4)13 (41.9) N123 (27.1)13 (41.9) N216 (18.8)4 (12.9) N310 (11.8)1 (3.2) Estrogen receptor 0.608positive49 (57.7)15 (48.4) negative36 (42.4)16 (51.6) Progesterone receptor 0.291positive40 (47.1)10 (32.3) negative45 (52.9)21 (67.7) HER2 status 0.345amplification29 (34.1)10 (32.3) not amplification56 (65.9)21 (67.7) Clinical T-stage (matching variable) 0.897cT12 (2.4)1 (3.2) cT231 (36.5)12 (38.7) cT346 (54.1)16 (51.6) cT46 (7.1)2 (6.5) Clinical N stage (matching variable) 0.947cN03 (3.5)1 (3.2) cN120 (23.5)10 (32.3) cN236 (42.4)10 (32.3) cN326 (30.6)10 (32.3) Response (matching variable) 1.000Partial response64 (75.3)27 (29.7) Stable disease21 (24.7)4 (12.9) Citation Format: Ryu JM, Lee JE, Kim SW, Yu J, Rayzah M, Lee SK, Mansoor A, Bae SY, Park S, Paik H-J, Kim I, Bang SI, Jeon BJ, Mun G-H, Pyon J-K. Oncologic outcomes of immediate breast reconstruction after neoadjuvant chemotherapy in breast cancer patients: A matched case control study [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P3-14-12.

Background We evaluated the feasibility and prognostic effect in axillary recurrence or survival of sentinel lymph node biopsy (SLNB) in patients with cytology-proven, node-positive breast cancer after neoadjuvant chemotherapy (NAC). Methods This is a retrospective study of 329 patients who were diagnosed with invasive breast cancer and axillary lymph nodes (ALN) metastasis and treated with NAC followed by curative surgery at Samsung Medical Center between January 2007 and December 2013. We analyzed and compared outcomes including prognoses and survival rates among all groups. Results The median age at the time of surgery was 44.4 years. The median follow-up time was 37 months (range, 1-91 months). The sentinel lymph node (SLN) identification rate was 96.7% (117 of 121 patients). The median number of retrieved SLNs was 4.0 (range, 1-7), and 57 patients had negative SLNs on frozen-section analysis. The false negative rate of SLNB after NAC was 7.8% (5 of 64 patients). In survival analysis, there was no difference in the overall survival (P = .2) and the regional recurrence-free survival (P = .297) among Groups 1, 2, and 4. Conclusion SLNB may be feasible after NAC for node-positive breast cancer and may help reduce surgical morbidity by avoiding the need for standard axillary lymph node dissection in some patients. We suggest that future studies with a large number of patients and a longer follow-up period are necessary to support the use of SLN surgery as an alternative to axillary lymph node dissection in this patient population.

Tumor size and number of lymph node (LN) metastases are well known as the most important prognostic factors of breast cancer. We hypothesized that very small breast cancers with LN metastasis represent a progressive biologic behavior and evaluated tumor size stratified by LN metastasis. Data between 1990 and 2010 were obtained retrospectively from the Korean Breast Cancer Society Registry with inclusion criteria of female, non-metastatic, unilateral, and T1/2 breast cancer. We collected the following variables: age at surgery, tumor size, number of LN metastases, nuclear grade (NG), lymphovascular invasion (LVI), estrogen receptor status, progesterone receptor status, and epidermal growth factor receptor-2 status. Patient characteristics were compared by means of independent t-tests for continuous variables and the Chi-square or Fisher's exact test for categorical variables. Kaplan-Meier curves, with corresponding results of log-rank tests, were constructed for breast cancer-specific survival (BCSS). Five- and eight-year breast cancer-specific mortality (BCSM) was obtained in groups of 300 patients, followed by smoothing according to the confidence interval using the lowess method. We identified 39,826 breast cancer patients who met the inclusion criteria. Among them, 1433 (3.6 %) patients died due to breast cancer. The median follow-up duration was 63.4 (3-255) months. In the multivariate analysis, age at surgery, NG, LVI, subtype, and tumor size-nodal interactions were independently associated with BCSM. The N1 group had lower BCSS for T1a than T1b. The N2+ group also had lower BCSS for T1b than T1c or T2. In the N1 group of tumors smaller than 10 mm, 5- and 8-year BCSM decreased with larger tumor size. Patients with very small tumors with LN metastasis have decreased BCSM according to increase tumor size. Small tumors with LN metastasis could have aggressive biological behavior.

Purpose Tumor size and lymph node metastasis are important factors that contribute to the progression of breast cancer. We aimed to analyze the relationship between tumor size and lymph node metastasis molecular subtype and examine the effects of nodal metastasis on overall survival (OS). Methods We retrospectively reviewed the data of 16,552 patients who underwent breast surgery in Samsung Medical Center between 2000 and 2015. Information on tumor size (largest diameter of the invasive component), number of positive lymph nodes, and molecular subtype were obtained. We constructed a linear regression model to evaluate the relationship between tumor size and lymph node metastasis. To determine the effect of nodal metastasis on OS, we performed a Cox proportional regression analysis with Np/T (number of metastatic lymph nodes [n]/tumor size [cm]). Results This study included 12,007 patients with a median follow-up of 62 months. The linear regression coefficients were 1.043 for luminal A, 1.024 for luminal B, 0.656 for HER2, and 0.435 for triple-negative breast cancer (TNBC) subtypes. No significant difference was observed in the coefficients between the luminal A and B subtypes (p = 0.797), while all other coefficients showed significant difference. After adjusting for other risk factors, the hazard ratio (HR) of Np/T for each subtype was significant for OS: luminal A (HR, 1.134; 95% confidence interval [CI], 1.097–1.171; p < 0.001), luminal B (HR, 1.049; 95% CI, 1.013–1.086; p = 0.007), HER2 (HR, 1.069; 95% CI, 1.014–1.126; p = 0.013), and TNBC (HR, 1.038; 95% CI, 1.01–1.067; p = 0.008). Conclusion The incidence of lymph node metastasis differed according to molecular subtype. Luminal types have higher incidence of nodal metastasis than HER2 and TNBC. The HR of Np/T was highest in luminal A subtypes and lowest in TNBC subtypes.

Purpose The Breast Imaging Reporting and Data System (BI-RADS) is a systematic and standardized scheme of the radiological findings of breast. However, there were different BI-RADS categories between breast cancers as the clinical characteristics in previous studies. We analyzed the association of BI-RADS categories with the clinicopathological characteristics and prognosis of breast cancer. Methods A total of 44,184 patients with invasive breast cancers assigned to BI-RADS category 3, 4, or 5 in preoperative mammography or ultrasonography were analyzed retrospectively using large-scale data from the Korean Breast Cancer Society registration system. The difference in the clinicopathological factors and prognoses according to the BI-RADS categories (BI-RADS 3–4 and BI-RADS 5) were compared between the mammography and ultrasonography groups. Comparisons of the clinicopathological factors in both groups were made using logistic regression analysis, while the prognoses were based on the breast cancer-specific survival using the Kaplan-Meier method and Cox proportional hazards model. Results The factors associated with BI-RADS were T stage, N stage, palpability, histology grade, and lymphovascular invasion in the mammography group; and N stage, palpability, histology grade, and lymphovascular invasion in the ultrasonography group. In the survival analysis, there were significant differences in the breast cancer-specific survival of the BI-RADS category groups in both of the mammography (hazard ratio [HR], 3.366; P < 0.001) and ultrasonography (HR, 2.877; P < 0.001) groups. Conclusion In this study, the BI-RADS categories of preoperative mammography and ultrasonography of patients with invasive breast cancer were associated with prognosis and could be an important factor in making treatment decisions.

Purpose Li-Fraumeni syndrome (LFS) is a rare autosomal cancer syndrome caused by a germline mutation in the TP53 gene. Breast cancer in LFS patients is of various subtypes; however, limited data are available on the clinicopathological features of these subtypes and their appropriate treatments. This study aimed to review the clinical features and treatments for breast cancer in South Korean patients with germline TP53 mutations. Methods Data on the clinicopathological features and treatment of all breast cancer patients with LFS were collected retrospectively from the available database of 4 tertiary hospitals in the Republic of Korea. Results Twenty-one breast cancer cases in 12 unrelated women with confirmed germline TP53 mutations were included in the study. The median age at diagnosis was 33.5 years. The histopathological diagnosis included invasive ductal carcinoma (n = 16), ductal carcinoma in situ (n = 3), and malignant phyllodes tumor (n = 2). While 42% and 31% of the cases were positive for estrogen and progesterone receptors, respectively, 52.6% were human epidermal growth factor receptor 2 (HER2) positive, and 21% were triple-negative. The treatments included mastectomy (52%) and breast-conserving surgery (38%). Five patients underwent radiotherapy (RT). The median follow-up period was 87.5 (8-222) months. There were 3 ipsilateral and 4 contralateral breast recurrences during the follow-up, and 8 patients developed new primary cancers. In the post-RT subgroup, there were 2 ipsilateral and 2 contralateral breast recurrences in 1 patient, and 4 patients had a new primary cancer. Conclusion As reported in other countries, breast cancer in LFS patients in South Korea had an early onset and were predominantly but not exclusively positive for HER2. A multidisciplinary approach with adherence to the treatment guidelines, considering mastectomy, and avoiding RT is encouraged to prevent RT-associated sequelae in LFS patients.

The relationships between serum levels of trace elements and breast cancer remain relatively unknown. In this study, we investigate serum levels of seven trace elements in Korean breast cancer patients compared to controls without breast cancer. Serum trace element levels were determined using inductively coupled plasma mass spectrometry in Korean breast cancer patients before initiation of breast cancer treatment. Korean females without breast cancer served as a control group. Trace element levels were measured in the discovery cohort (n = 287) and were validated in an independent cohort (n = 142). We further investigated possible associations between trace element levels and the presence of lymph node metastasis, distant metastasis, or triple-negative breast cancer among breast cancer patients in subgroup analyses. Serum manganese and molybdenum levels were significantly higher (p &lt, 0.05) in breast cancer patients than in controls. Serum copper levels were significantly higher in breast cancer patients with distant metastasis, while selenium levels were significantly lower. Other trace elements were neither significantly different between breast cancer patients and controls nor between subgroups of breast cancer patients. Our study provides insights about the potential roles and impacts of trace elements through an assessment of the associations between trace elements and breast cancer.

Triple-negative breast cancer (TNBC) accounts for 10–20% of all diagnosed BCs and it is enriched in BRCA1 mutation. Guidelines for Western countries suggest that BRCA 1/2 genetic testing should be done for patients with TNBC diagnosed less than 60 years, but there is lack of evidence supporting genetic testing in Asian populations. We determined the prevalence of germline BRCA 1/2 mutations among unselected Korean patients with TNBC and analyzed oncologic outcomes. From among 1628 women with TNBC who underwent surgery at Samsung Medical Center (SMC) between Jul 2008 and Jan 2016, 999 samples were available in the SMC biobank for testing germline BRCA 1/2 mutations using next-generation DNA sequencing. Overall, 131 Korean patients (13.1%) had BRCA 1/2 mutations: 97 (9.7%) were in BRCA 1, and 35 (3.5%) were in BRCA 2. One patient had both BRCA 1 and BRCA 2 mutations. Overall, 68 distinct pathologic or likely pathogenic variants (43 BRCA1 and 25 BRCA2) were found. Among those diagnosed at ≤ 60 years, the prevalence of BRCA 1/2 mutation was 14.5%. The mean age of diagnosis of BRCA1/2 mutation carriers was significantly younger than that of non-carriers (45.6 vs. 50.1 years, p

Purpose Many patients with cytology proven node-positive breast cancer receive a neoadjuvant chemotherapy (NAC) treatment. We developed a nomogram to predict the breast and axillary pathologic complete responses (pCR) in patients with a cytologically proven axillary node positive breast cancer with NAC. Methods We selected 995 patients who were diagnosed with an invasive breast cancer and axillary lymph nodes metastasis, and who were treated with NAC followed by a curative surgery at the Samsung Medical Center between January 2007 and December 2014. The baseline patient and tumor characteristics, chemotherapy regimen, and tumor and nodal responses were thoroughly analyzed and reviewed. A nomogram was developed using a binary logistic regression model with a cross validation. Results Axillary pCR was achieved in 47.3% and breast pCR was achieved in 24.3% of the patients after NAC. In this case, the both pCR was associated with an initial clinical tumor stage, negative progesterone receptor status, positive human epidermal growth factor receptor 2 status, and clinical radiologic nodal responses. A nomogram was developed based on the clinical and statistically significant predictors. It had good discrimination performance (area under the curve [AUC], 0.868; 95% confidence interval, 0.84-0.89) and calibration fit as noted in that case. The cross validation had an average AUC 0.853 (0.837-0.869). Conclusion Our nomogram might help to predict breast and axillary pCRs after NAC in patients with an initially node-positive breast cancer. Minimal surgery might be acceptable in patients for whom the nomogram indicates a high probability of achieving pCRs.

Beginning in 2018, biomarkers including estrogen receptor (ER) status were incorporated in the 8th AJCC staging system. ER expression levels were not considered in these changes. We hypothesized that the levels of ER expression could affect the prognosis of breast cancer. A retrospective review was conducted to identify all female patients with invasive breast cancer between 2003 and 2012. ER negative (group I), weakly ER-positive (group II), and strongly ER-positive (group III) were defined as Allred total scores of 0–2, 3–5, and 6–8, respectively. We examined a multigene panel, designated the BCT score, which is a newly developed prognostic model for predicting the risk of a distant metastasis. Among the 4949 patients enrolled in this study, 1310 (26.5%), 361 (7.3%), and 3277 (66.2%) were categorized as group I, II, and III, respectively. Median F/U duration was 57.8 months. Compared to group III, patients in group II were younger, had larger tumors, and were also more likely to have PR-negative tumors, HER-2 amplification, high Ki-67, and high nuclear grade. Between group II and III, there was a significant difference in OS (P = 0.0764, 0.909, and 0.010, respectively). After adjusting for additional factors that may affect OS, the HR for OS showed higher in group II than in group III. The baseline median BCT score indicated that lower ER expression was associated with significantly higher BCT score (P

Background Oncotype DX(ODX) is a 21-gene breast cancer recurrence score(RS) assay that aids in decision-making for chemotherapy in early-stage hormone receptor-positive(HR+)breast cancer. We developed a prediction tool using machine learning for high- or low-risk ODX criteria (i.e., RS 25 for high-risk). Methods We performed a retrospective review of 301 breast cancer patients who underwent surgery between April 2011 and July 2017 and then an ODX test at Samsung Medical Center in Seoul, Korea. Among them, 208 cases were defined as the modeling group and 76 cases were defined as the validation group. We built a supervised machine learning classification model using the Azure ML platform. Results For the high RS group, accuracy was 0.903 through Two-class Decision Jungle method in test set. For the low RS group, the accuracy was 0.726 when the Two-class Neural Network method was applied. The AUC of the ROC curve was 0.917 in the high RS group and 0.744 in the low RS group in test set. In addition, we conducted an internal validation using 76 patients who underwent ODX testing between January 2017 and July 2017. The accuracy of validation was 0.880 in the high RS group and 0.790 in the low RS group. Conclusion We developed a predictive model using machine learning that could represent a useful and easy-to-access tool for the selection of high ODX RS patients. After additional evaluation with large data and external validation, worldwide use of our model could be expected.

Purpose The results of the Suppression of Ovarian Function Trial (SOFT) and the Tamoxifen and Exemestane Trial (TEXT) showed that ovarian function suppression (OFS) in premenopausal early breast cancer patients improves disease control. However, mood swings after OFS is one of the chief complaints to make patients stop undergoing endocrine therapy. Studies about complications of OFS in breast cancer patients are not established well. We designed this randomized controlled trial to evaluate psychological functioning of patients after undergoing adjuvant OFS by goserelin. Patients and Methods We randomly assigned 64 premenopausal women with hormone receptor positive early breast cancer to the tamoxifen or tamoxifen plus goserelin group for a period of 1 year. Participants were screened for depression and generalized anxiety disorder using Hamilton Rating Scale for Depression (HAMD), Hamilton Rating Scale for Anxiety (HAM-A), Anxiety Sensitivity Index (ASI) and Albany panic and phobia questionnaire (APPQ) at baseline, 6 months and 12 months. Brain-derived Neurotrophic Factor (BDNF) levels were measured, as well. The results were analyzed by using a linear mixed model and a generalized linear mixed model. Results Thirty two patients were distributed in each group, equally. Linear mixed-mixed model analyses revealed that, compared with HAM-A scores of each group at baseline, HAM-A scores at 12 months showed increments (p=0.0078). Among HAM-A questions, Questions for intellectual, sensory and autonomic status were scored significantly high at 12 months (p=0.0018, p=0.0132, p=0.0006). Platelet BDNF levels reported a statistically significant rise at 12 months (p=0.0006). There was no significant time-by-study group effect in all scales. Conclusion Compared with the patients without OFS, patients with Goserelin showed no difference in anxiety or depression scales. Thought the levels of anxiety of each group at 12 months were increased, they do not indicate medical interventions. Patients with increased levels of BDNF at 12 months are expected to have good recovery from anxious and depressive symptoms. Citation Format: Yi HW, Nam SJ, Kim SW, Lee JE, Lee SK, Bae SY, Park S, Paik H-J, Ryu JM. Depression and anxiety after adjuvant ovarian function suppression in premenopausal breast cancer patients. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P1-11-01.

The first aim of our study was to evaluate surgical decision-making by BRCA mutation carriers with breast cancer based on the timing of knowledge of their BRCA mutation status. The second aim was to evaluate breast cancer outcome following surgical treatment. This was a retrospective study of 164 patients diagnosed with invasive breast cancer, tested for BRCA mutation, and treated with primary surgery between 2004 and 2015 at Samsung Medical Center in Seoul, Korea. We reviewed types of surgery and timing of the BRCA test result. We compared surgical decision- making of BRCA carriers with breast cancer based on the timing of knowledge of their BRCA mutation status. Only 15 (9.1%) patients knew their BRCA test results before their surgery, and 149 (90.9%) knew the results after surgery. In patients with unilateral cancer, there was a significant difference between groups whose BRCA mutation status known before surgery and groups whose BRCA status unknown before surgery regarding the choice of surgery (p = 0.017). No significant difference was observed across surgery types of risk of ipsilateral breast tumor recurrence (p = 0.765) and contralateral breast cancer (p = 0.69). Genetic diagnosis before surgery has an impact on surgical decision choosing unilateral mastectomy or bilateral mastectomy in BRCA mutation carriers with breast cancer. Knowledge about BRCA mutation status after initial surgery led to additional surgeries for patients with BCS. Thus, providing genetic counseling and genetic testing before surgical choice and developing treatment strategies for patients with a high risk of breast cancer are important.

Luminal A breast cancer has a much better prognosis than other subtypes, with a low risk of local or regional recurrence. However, there is controversy around under- versus overtreatment with regard to adjuvant treatment of node-positive, luminal A breast cancer. The purpose of this study was to identify whether adjuvant systemic chemotherapy has any benefit in node-positive, luminal A breast cancer and to evaluate feasibility of endocrine therapy without chemotherapy in this group. This was a retrospective study of 11,025 patients who were surgically treated for invasive breast cancer at Samsung Medical Center between January 2004 and December 2013. Luminal A subtype was defined as ER+, HER2-, and Ki-67 < 14%. We compared AC based (AC: doxorubicin or epirubicin, plus cyclophosphamide) adjuvant chemotherapy versus endocrine therapy without chemotherapy in patients with node-positive, luminal A breast cancer. We performed 1: n matching, with a maximum n of 8 on endocrine therapy group (n = 50) to chemotherapy group (n = 642). The median age of the patients in each group at the time of surgery was 58.3 ± 9.5 years in the chemotherapy group and 58.7 ± 11.7 in the endocrine therapy only group. The median follow-up time was 51.9 months (range, 1–125 months). In multivariable analysis, omission of adjuvant chemotherapy in luminal A cancer had no influence on OS and DFS. Axillary lymph node metastasis and progesterone receptor (PR) status were significantly different between the endocrine therapy alone group and the chemotherapy group in terms of OS. Nuclear grade, PR status, and adjuvant radiotherapy were significantly different between the endocrine therapy alone group and the chemotherapy group with regard to DFS. In survival analysis, there were no differences in OS (P = .137) and DFS (P = .225) between the 2 groups. Adjuvant chemotherapy could provide little benefit to postmenopausal patients with luminal A, node-positive breast cancer, and endocrine therapy alone may help reduce morbidity. Future studies with a large number of patients and longer follow-up time are necessary to determine whether chemotherapy might be avoided in this patient population.

Axillary lymph node (ALN) status is an important prognostic factor for breast cancer patients. With increasing numbers of patients undergoing neoadjuvant chemotherapy (NAC), issues concerning sentinel lymph node biopsy (SLNB) after NAC have emerged.We analyzed the clinicopathologic features and developed a nomogram to predict the possibility of nonsentinel lymph node (NSLN) metastases in patients with positive SLNs after NAC. A retrospective medical record review was performed of 140 patients who had had clinically positive ALNs at presentation, had a positive SLN after NAC on subsequent SLNB, and undergone axillary lymph node dissection (ALND) from 2008 to 2014.On multivariate stepwise logistic regression analysis, pathologic T stage, lymphovascular invasion, SLN metastasis size, and number of positive SLN metastases were independent predictors for NSLN metastases (P .05). The NAC nomogram was based on these 4 variables. A receiver operating characteristic curve was plotted, and the area under the curve (AUC) was 0.791 for the NAC nomogram. In the internal validation of performance, the AUCs for the training and test sets were 0.801 and 0.760, respectively. The nomogram was validated in an external patient cohort, with an AUC of 0.705.The Samsung Medical Center NAC nomogram was developed to predict the likelihood of additional positive NSLNs. The Samsung Medical Center NAC nomogram could provide information to surgeons regarding whether to perform additional ALND when the permanent biopsy revealed positive findings, although the intraoperative SLNB findings were negative.

Purpose Although metastasis occurs in 1 or 2 sentinel lymph nodes (SLNs), axillary lymph node dissection (ALND) has been widely not performed. For axillary staging and management, the necessity of intraoperative frozen section analysis of SLN has been controversial. The aim of this study is to evaluate the validity and benefit of SLN analysis by permanent section alone in clinically negative lymph node breast cancer patients. Methods We conducted a retrospective study of 283 cases with negative node clinical findings between July 2018 and August 2019 in Samsung Medical Center. Clinical nodal stage was evaluated by physical examination, breast ultrasonography, breast magnetic resonance imaging, and chest computerized tomography. The cases were divided into 2 groups; the permanent group had 151 cases (53.4%) and the frozen group had 132 cases (46.6%). We retrospectively analyzed the differences in the number of metastatic lymph nodes and rates of performed ALND between the 2 groups. Results Baseline and clinicopathologic characteristics between the 2 groups were well balanced. Three cases in the permanent group and 6 cases in the frozen group underwent additional or immediate ALND. The rates of ALND between the 2 groups were not significantly different (P = 0.312). The cased of 78.9% and 89.5% with metastatic lymph nodes in permanent and frozen groups were in the pathologic N1 stage, respectively. Conclusion SLNs analysis by permanent section alone may be performed in clinically negative axillary node breast cancer patients. Our findings can help to avoid unnecessary intraoperative frozen section analysis.