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.

Purpose: To compare the prognosis of patients with axillary adenocarcinoma from an unknown primary (ACUPax) origin with negative MRI results and those with MRI-detected primary breast cancers. Materials and Methods: The breast MRI images of 32 patients with ACUPax without signs of primary breast cancer on mammography and ultrasound (US) were analyzed. Spot compression-magnification mammography and second-look US were performed for the area of MRI abnormality in patients with positive results; any positive findings corresponding to the MRI abnormality were confirmed by biopsy. If suspicious MRI lesions could not be localized on mammography or US, MR-guided biopsy or excision biopsy after MR-guided localization was performed. We compared the prognosis of patients with negative breast MRI with that for patients with MRI-detected primary breast cancers. Results: Primary breast cancers were confirmed in 8 (25%) patients after breast MRI. Primary breast cancers were not detected on MRI in 24 (75%) patients, including five cases of false-positive MRI results. Twenty-three patients underwent axillary lymph node dissection (ALND) followed by whole breast radiation therapy (WBRT) and chemotherapy (n=17) or subsequent chemotherapy only (n=2). Recurrence or distant metastasis did not occur during follow up in 7/8 patients with MRI-detected primary breast cancers and 22/24 patients with negative MRI results. Regional recurrence or distant metastasis did not occur in any MR-negative patient who received adjuvant chemotherapy after ALND and WBRT. Conclusion The prognoses of MR-negative patients with ACUPax who received ALND and WBRT followed by chemotherapy were as good as those of patients with MRI-detected primary breast cancers.

Purpose: Cancer antigen 15-3 (CA15-3) is a serum tumor marker for breast cancer (BC) extensively used in clinical practice. CA15-3 is non-invasive, easily available, and a costeffective tumor marker for immediate diagnosis, monitoring and prediction of BC recurrence. We hypothesized that an elevation of CA15-3 may have prognostic impact in patients with early BC with normal serum CA15-3 level. Methods: This was a retrospective cohort study, which included patients with BC who received curative surgery at a comprehensive single institution between 2000 and 2016.CA15-3 levels from 0 to 30 U/mL were considered normal, and patients who had CA15-3 > 30 U/mL, were excluded from the study. Results: The mean age of study participants (n = 11,452) was 49.3 years. The proportion of participants with elevated CA15-3 ≥ 1 standard deviation (SD) compared with the previous examination during follow-up was 23.3% (n = 2,666). During the follow-up (median followup 5.8 years), 790 patients experienced recurrence. The fully-adjusted hazard ratio (HR) for recurrence comparing participants with stable CA15-3 level to subjects with elevated CA15-3 level was 1.76 (95% confidence interval [CI], 1.52–2.03). In addition, if the CA15-3was elevated ≥ 1 SD, the risk was much higher (HR, 6.87; 95% CI, 5.81–8.11) than in patients without elevated CA15-3 ≥ 1 SD. In sensitivity analysis, the recurrence risk was consistently higher in participants with elevated CA15-3 levels than in participants without elevated CA15-3 levels. The association between elevated CA15-3 levels and incidence of recurrence was observed in all subtypes and the association was stronger in patients with N+ than in patients with N0 stage (p-value for interaction < 0.01). Conclusion The results of the present study demonstrated that elevation of CA15-3 in patients with early BC and initial normal serum CA15-3 levels has a prognostic impact.

We present our initial experience of ultrasound (US)-guided localization of clipped metastatic axillary lymph nodes (LNs) following neoadjuvant chemotherapy (NAC). We evaluated US visibility and the successful excision rate of clipped LN after NAC in 29 consecutive patients with breast cancer. US-guided localization of clipped nodes was performed in 22 patients on the day of surgery, while seven patients underwent surgery without localization. The clips were identified in all patients with residual metastatic LNs and 6 of 12 (50%) patients without residual metastatic LNs on US. Six patients without visible clips underwent US-guided localization at the presumed previous clip insertion site. The successful excision rate of 22 LNs with localization was 100% (even though 3 of them were non-sentinel LNs) and 57% (4/7) without localization. Regardless of the presence of visible residual metastatic LNs on US after NAC, successful excision of the clipped LN with US-guided localization is feasible.

Objective: This study aimed to investigate the impact of baseline values and temporal changes in body composition parameters, including skeletal muscle index (SMI) and visceral adipose tissue area (VAT), measured using serial computed tomography (CT) imaging on the prognosis of operable breast cancers in Asian patients. Materials and Methods: This study retrospectively included 627 Asian female (mean age ± standard deviation [SD], 53.6 ± 8.3 years) who underwent surgery for stage I–III breast cancer between January 2011 and September 2012. Body composition parameters, including SMI and VAT, were semi-automatically calculated on baseline abdominal CT at the time of diagnosis and follow-up CT for post-treatment surveillance. Serial changes in SMI and VAT were calculated as the delta values. Multivariable Cox regression analysis was used to evaluate the association of baseline and delta SMI and VAT values with disease-free survival. Results: Among 627 patients, 56 patients (9.2%) had breast cancer recurrence after a median of 40.5 months. The mean value ± SD of the baseline SMI and baseline VAT were 43.7 ± 5.8 cm2 /m2 and 72.0 ± 46.0 cm2 , respectively. The mean value of the delta SMI was -0.9 cm2 /m2 and the delta VAT was 0.5 cm2 . The baseline SMI and VAT were not significantly associated with disease-free survival (adjusted hazard ratio [HR], 0.983; 95% confidence interval [CI], 0.937–1.031; p = 0.475 and adjusted HR, 1.001; 95% CI, 0.995–1.006; p = 0.751, respectively). The delta SMI and VAT were also not significantly associated with disease-free survival (adjusted HR, 0.894; 95% CI, 0.766–1.043; p = 0.155 and adjusted HR, 1.001; 95% CI, 0.989–1.014; p = 0.848, respectively). Conclusion Our study revealed that baseline and early temporal changes in SMI and VAT were not independent prognostic factors regarding disease-free survival in Asian patients undergoing surgery for breast cancer.

Purpose: The GenesWell™ breast cancer test (BCT) is a recently developed multigene assay that predicts the risk of distant recurrence in patients with hormone receptor-positive (HR+) and human epidermal growth factor-2 negative (HER2−) early breast cancer (BC). The ability of this assay to predict the response to neoadjuvant chemotherapy (NACT) has not been established to date. Methods: Biopsy specimens from HR+/HER2− BC patients with axillary lymph node (LN) metastasis who underwent NACT were analyzed using the BCT score. The modified BCT score was developed and patients classified into high-and low-response groups. A total of 88 patients were available for the BCT score among the 108 eligible patients. The median followup duration was 35.9 (7.8–128.5) months. Results: Among them, 61 (65.1%) had cN1 and 53 (60.2%) had cT1 or cT2 disease. The BCT score was low in 25 (28.4%) patients and high in 63 (71.6%). Among the 50 patients with pathologic complete response or partial response, 41 (82.0%) were in the high BCT score group and 9 (18.0%) were in the low BCT score group. Among the 38 patients with stable or progressive disease, 22 (57.9%) were in the high BCT score group and 16 (42.1%) were in the low BCT score 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]). Distant metastasis-free survival was significantly different between the high- and low-response groups (p = 0.004). Conclusion We demonstrated that the BCT score predicts NACT responsiveness in HR+/ HER2− BC with LN metastasis and might help determine whether NACT should be performed. Further studies are required to validate these results.

Purpose: To evaluate the accuracy of magnetic resonance imaging (MRI)-guided breast biopsy. Methods: We retrospectively reviewed the clinical data of 111 consecutive patients referred for MRI-guided breast biopsy after mammography and breast ultrasound between May 2009 and April 2019. After excluding 37 patients without follow-up images (> 2 years), 74 patients (74 lesions) were finally included. We reviewed the histologic results of MRI-guided biopsy and subsequent surgery, post-biopsy management, and breast cancer development during followup. We investigated the false-negative rate, ductal carcinoma in situ (DCIS) underestimation, atypical ductal hyperplasia (ADH) underestimation rate, and technical failure rate of MRIguided biopsy. Results: Among 74 scheduled MRI-guided biopsies, six were canceled because biopsy was deemed unnecessary, while three failed due to technical difficulties (technical failure rate:3/68, 4.4%). MRI-guided biopsy was performed in 65 patients, of which 18 patients were diagnosed with malignant lesions, 46 with benign lesions, and one with ADH bordering on DCIS. Subsequent surgery (n = 27) showed DCIS underestimation in three cases (3/7, 43%), ADH underestimation in two cases (1/2, 50%), as well as seven concordant benign and 11 concordant malignant lesions. The overall false-negative rate was 4.3% (2/46). Thirty-eight out of 48 benign lesions were followed-up (median period, 5.8 years; interquartile range, 4.1 years) without subsequent surgery. Thirty-seven concordant benign lesions were stable (n = 27) or disappeared (n = 10); however, the size of one discordant benign lesion increased on follow-up MRI and it was diagnosed as DCIS after 1 year. Conclusion MRI-guided biopsy is an accurate method for exclusion of malignancy with a very low false-negative rate.

Purpose: To evaluate the accuracy of magnetic resonance imaging (MRI)-guided breast biopsy. Methods: We retrospectively reviewed the clinical data of 111 consecutive patients referred for MRI-guided breast biopsy after mammography and breast ultrasound between May 2009 and April 2019. After excluding 37 patients without follow-up images (> 2 years), 74 patients (74 lesions) were finally included. We reviewed the histologic results of MRI-guided biopsy and subsequent surgery, post-biopsy management, and breast cancer development during followup. We investigated the false-negative rate, ductal carcinoma in situ (DCIS) underestimation, atypical ductal hyperplasia (ADH) underestimation rate, and technical failure rate of MRIguided biopsy. Results: Among 74 scheduled MRI-guided biopsies, six were canceled because biopsy was deemed unnecessary, while three failed due to technical difficulties (technical failure rate:3/68, 4.4%). MRI-guided biopsy was performed in 65 patients, of which 18 patients were diagnosed with malignant lesions, 46 with benign lesions, and one with ADH bordering on DCIS. Subsequent surgery (n = 27) showed DCIS underestimation in three cases (3/7, 43%), ADH underestimation in two cases (1/2, 50%), as well as seven concordant benign and 11 concordant malignant lesions. The overall false-negative rate was 4.3% (2/46). Thirty-eight out of 48 benign lesions were followed-up (median period, 5.8 years; interquartile range, 4.1 years) without subsequent surgery. Thirty-seven concordant benign lesions were stable (n = 27) or disappeared (n = 10); however, the size of one discordant benign lesion increased on follow-up MRI and it was diagnosed as DCIS after 1 year. Conclusion MRI-guided biopsy is an accurate method for exclusion of malignancy with a very low false-negative rate.

Purpose: The management of patients with colorectal cancer (CRC) who have liver cirrhosis (LC) requires a thorough understanding of both diseases; however, the prognoses and postoperative outcomes of such patients remain understudied. We investigated the effect of LC on surgical and oncologic outcomes in patients with CRC, and identified prognostic factors. Methods: We analyzed 453 patients with CRC and LC (CRC-LC group), 906 with CRC only (CRC group), 906 with LC only (LC group), and 1,812 healthy subjects using health insurance claim data (2008–2013). Results: The CRC-LC group had a higher frequency of intensive care unit admission than the CRC group; there were no differences between the 2 groups in terms of early and late postoperative small bowel obstruction and incisional hernia. However, the 30-day, 60-day, and 90-day mortality rates were all significantly higher in the CRC-LC group. The higher Charlson comorbidity index (hazard ratio [HR], 1.127) and the lower socioeconomic status (HR, 0.985) were significant worse predictors of 5-year survival. Patients with underlying LC had a significantly higher HR in both the advanced CRC (HR, 1.858) and nonadvanced CRC (HR, 1.799) subgroups. However, the nonadvanced CRC subgroup showed a lower HR than the LC group (HR, 0.730). Conclusion Patients with CRC who had underlying LC had a lower survival rate than did those without LC, although the incidence rates of postoperative complications were not significantly different. The presence of LC was associated with a significantly lower survival rate regardless of CRC presence.