Risk stratification system for groups with a low, intermediate, and high risk of subsequent distant metastasis and death following isolated locoregional recurrence of breast cancer.

PURPOSE: This study aimed to identify prognostic factors for long-term outcomes among patients with isolated locoregional recurrence (ILRR) of breast cancer as their first failure event. Many prognostic tools have been developed to inform systemic treatment choices in the adjuvant setting, but tools for predicting post-ILRR prognosis are scarce. METHODS: A total of 495 patients who experienced ILRR after primary surgery at the Asan Medical Center between 1989 and 2008 were included. All patient information and tumor characteristics at the initial surgery were retrieved from our retrospectively collected database, and ILRRs were categorized as local recurrence or regional recurrence (RR). Distant metastasis-free survival (DMFS), breast cancer-specific survival (BCSS), and overall survival post-ILRR were calculated. RESULTS: The median follow-up from the ILRR was 65 months (range 1-249 months), and the 5-year post-ILRR DMFS rate was 58.9%. We found three factors-lymph node metastasis, a disease-free interval < 30 months, and RR as the ILRR type-that were independent prognostic factors for both DMFS [hazard ratio (HR) = 2.08, 1.60, and 1.59; P < 0.001, 0.002, and 0.003, respectively] and BCSS (HR = 2.28, 1.99, and 1.48; P < 0.001, < 0.001, and 0.016, respectively) post-ILRR. Patients were classified into four groups according to the presence these three prognostic indicators: the low-, intermediate-, high-, and extremely high-risk groups. The 5-year post-ILRR DMFS rates were 79.4%, 68.1%, 47.6%, and 36.0%, respectively. CONCLUSIONS: This risk stratification system for subsequent distant metastases after ILRR can be used to make more informed decisions regarding prognosis-based local or systemic management strategies.

Clinical Implication of HER2 Status in Hormone Receptor-Positive Mucinous Breast Cancer.

PURPOSE: Mucinous carcinoma (MC) is a rare breast cancer with favorable outcome. Unlike typical breast cancer, the current guidelines do not recommend chemotherapy or anti-human epidermal growth factor receptor 2 (HER2) therapy for hormone receptor (HR)-positive MC, regardless of HER2 status. We evaluated the prognostic implication of HER2 status in HR-positive MC. METHODS: We retrospectively reviewed the data of 471 patients with pure MC (stages I-III) who underwent curative surgery. We analyzed 5-year disease-free survival (DFS) and distant metastasis-free survival (DMFS), according to clinicopathological characteristics. RESULTS: The median follow-up duration was 79.0 months. Overall, the 5-year DFS rate was 95.7% and the 5-year DMFS rate was 96.2%. Nodal status was the only significant factor for DFS (relative risk [RR], 3.40; 95% confidence interval [CI] 3.40-9.67, p = 0.021). Among HR-positive/node-negative patients with tumor size ≥ 3 cm, HER2-positive patients showed significantly worse DFS (RR, 8.76; 95% CI 1.45-52.76, p = 0.018) and DMFS (RR, 11.37; 95% CI 1.37-74.70, p = 0.011). This finding was consistently significant, when combining both "HR-positive/node-negative/tumor size ≥ 3 cm" and "HR-positive/node-positive" MC (n = 125) for DFS (RR, 4.30; 95% CI 1.43-12.97, p = 0.009) and DMFS (RR, 4.93; 95% CI 1.63-14.90, p = 0.005). Intriguingly, within this subgroup, among HER2-positive tumors, whereas 5-year DFS was 60.2% in patients who did not receive trastuzumab, 100% of those who received trastuzumab were disease free (p = 0.053). CONCLUSIONS: In HR-positive, node-negative MC with tumor size ≥ 3 cm, patients with HER2-positive MC showed worse survival, suggesting a potential role of an anti-HER2 strategy in this subgroup.

The effects of poloxamer and sodium alginate mixture (Guardix-SG®) on range of motion after axillary lymph node dissection: A single-center, prospective, randomized, double-blind pilot study.

PURPOSE: Restricted shoulder mobility is a major upper extremity dysfunction associated with lower quality of life and disability after breast cancer surgery. We hypothesized that a poloxamer and sodium alginate mixture (Guardix-SG®) applied after axillary lymph node dissection (ALND) would significantly improve shoulder range of motion (ROM) in patients with breast cancer. METHODS: We conducted a double-blind, randomized, prospective study to evaluate the clinical efficacy and safety of Guardix-SG® for the prevention of upper extremity dysfunction after ALND. The primary outcome measure was shoulder ROM at baseline (T0) and 3 (T1), 6 (T2), and 12 months (T3) after surgery. Secondary outcome measures were the Disabilities of the Arm, Shoulder, and Hand score(DASH), pain associated with movement, which was assessed using a numeric rating scale, and lymphedema assessed using body composition analyzer. RESULTS: A total of 83 women with breast cancer were randomly assigned to either the Guardix-SG® group or the control group. In the Guardix-SG® group (n = 37), Guardix-SG® was applied to the axillary region after ALND. In the control group (n = 46), ALND was performed without using Guardix-SG®. Comparing ROM for shoulder flexion before surgery (178.2°) and 12 months after surgery (172.3°), that was restored 12 months after surgery in the Guardix-SG® group, and there was no statistically significant difference between that at before surgery and 12 months after surgery (p = 0.182). No adverse effect was observed in either group. CONCLUSIONS: The results of this study have shown that Guardix-SG® help improve shoulder ROM without causing adverse effects in patients who underwent breast cancer surgery. However, there was no statistically significant difference from the control group. A further large-scale study is needed to obtain a more conclusive conclusion. TRIAL REGISTRATION: CRISKCT0003386; https://cris.nih.go.kr (20181207).

Prediction of Late Breast Cancer-Specific Mortality in Recurrence-Free Breast Cancer Survivors Treated for Five Years with Tamoxifen.

PURPOSE: The extension of endocrine therapy beyond 5 years for recurrence-free survivors of breast cancer improves survival; however, the issue on how to clinically identify appropriate candidates remains controversial. This study aimed to identify prognostic factors for breast-cancer-specific mortality in patients who have had 5 years of tamoxifen treatment and categorize subgroups based on the risk of death using combinations of these prognostic factors to assist in the clinical decision to perform further endocrine therapy. METHODS: In total, 3,158 patients with breast cancer were enrolled. Breast cancer-specific survival rates after 5 years of tamoxifen treatment were calculated, and associated prognostic factors were analyzed using a Cox proportional-hazards model. RESULTS: An age extreme at diagnosis (i.e., < 40 or ≥ 60 years), tumor size > 2 cm, and positive lymphovascular invasion were robust independent prognostic factors for late breast cancer-specific death in tamoxifen-treated patients (hazard ratio [HR] = 2.162, 1.739, and 1.993; p = 0.001, 0.047, and 0.011, respectively). Lymph node metastasis and progesterone receptor negativity had borderline significance in this regard (HR = 1.741 and 1.638, p = 0.099 and 0.061). The study patients were classified into four groups according to the number of prognostic indicators, i.e., low, intermediate, high, and extremely high risk. The additional 5- and 10-year cumulative risks of breast cancer-specific death were 0.8% and 1.5% in the low-risk group, 0.9% and 3.9% in the intermediate-risk group, 1.3% and 7.3% in the high-risk group, and 4.8% and 13.8% in the extremely high-risk group, respectively. CONCLUSION: This new risk stratification system for late mortality in breast cancer can be used to identify the right candidates for extended endocrine therapy after 5 years of tamoxifen treatment.

Extent of resection for T2N0 gallbladder carcinoma regarding concurrent extrahepatic bile duct resection.

BACKGROUNDS/AIMS: Gallbladder carcinoma (GBCa) T2 lesions are considered to be advanced tumors showing diverse features in tumor extent. When this T2 lesion does not involve the cystic duct and there is no evidence of lymph node metastasis, we have to consider what is the most reasonable extent of resection - that is, whether to perform concurrent extra-hepatic bile duct resection (EHBD) resection or not. This study intends to evaluate the adequacy of EHBD resection in patients undergoing resection for T2N0 GBCa. METHODS: From our institutional database of GBCa, 48 cases of T2N0 GBCa who underwent R0 resection during November 1995 and August 2008 were selected. Patients who underwent prior laparoscopic cholecystectomy were excluded. Their medical records were reviewed retrospectively. RESULTS: Their mean age was 63.2±83.3 years and females were 25. The mean serum CA19-9 level was 37.3±89.3 ng/ml. The extents of liver resection were wedge resection (n=36) and segment 4a+5 resection (n=12). Concurrent EHBD resection was performed in 16 (33.3%) patients. No fatal surgical complication occurred. The majority of tumor pathology was adenocarcinoma (n=42), with additional unusual types as papillary (n=3), saromatoid (n=1), signet ring cell (n=1) and adenosquamous (n=1) cancers. The overall survival rate was 87.1% at 1 year, 69.5% at 3 years and 61.7% at 5 years. After exclusion of mortalities not related to cancer, the overall patient survival rate was 89.6% at 1 year, 72.9% at 3 years and 64.7% at 5 years, with 3-year survival rates of 72% in the EHBD resection group and 69.2% in the non-resection group (p=0.661). CONCLUSIONS: The results of this study indicate that concurrent EHBD resection did not improve patient survival when R0 resection was achieved in patients with T2N0 GBCa. Therefore, routine EHBD resection may not be indicated for T2N0 GBCa unless the tumor is close to the cystic duct.