An observational, prospective, open label, multicenter study to evaluate the safety and effectiveness of pegfilgrastim as secondary prophylaxis to decrease the incidence of febrile neutropenia in Korean female patients with breast cancer.

PURPOSE: Pegfilgrastim is a widely used long-acting granulocyte colony-stimulating factor (G-CSF) that prevents febrile neutropenia (FN) in patients with breast cancer receiving chemotherapy. This study aimed to evaluate the incidence of chemotherapy-related FN events and other adverse events (AEs) during chemotherapy in Korean patients with breast cancer treated with pegfilgrastim as secondary prophylactic support. MATERIALS AND METHODS: This was a multicenter, open-label, prospective, observational study. A total of 1255 patients were enrolled from 43 institutions. The incidence of FN was evaluated as the primary endpoint. The secondary endpoints included (1) incidence of bone pain, (2) proportion of patients with a relative dose intensity (RDI) of ≥85%, and (3) proportion of patients with AE. RESULTS: Pegfilgrastim administration reduced FN by 11.8-1.6%. The highest incidence of bone pain was observed at the time point of the 1st day after the administration and mild bone pain was the most common of all bone pain severity. The mean RDI was 98.5 ± 7.3%, and the proportion of the patients with and RDI≥85% was 96.9% (1169/1233). AEs were reported in 52.6% of the patients, and serious drug reactions occurred in only 0.7%. CONCLUSION: The use of pegfilgrastim as secondary prophylaxis was effective and safe for preventing FN in patients with breast cancer who were treated with chemotherapy.

A Rare Case of Invasive Cribriform Carcinoma in Male Breast.

BACKGROUND Male breast cancer is a very rare disease that represents 0.6% of all breast carcinomas. Among breast carcinomas, invasive cribriform carcinoma (ICC) is a rare type of breast carcinoma and is more common in older women, with only a few cases in men reported. We present a case of male breast cancer with ICC. CASE REPORT A 58-year-old man presented with a painful and palpable mass in the left breast, which was diagnosed as breast cancer of the ICC type. The patient underwent total mastectomy plus sentinel lymph node biopsy. On the microscope, the tumor was composed of more than 90% cribriform glands with comedo necrosis and dystrophic calcification. On immunohistochemical (IHC) staining, it appeared to be a luminal breast cancer. The IHC staining for c-erb B2 was equivocal (2 positive); hence fluorescence in situ hybridization was performed, and showed no amplification of the HER2/neu oncogene. The Ki-67 labeling index was 30%. The patient received radiotherapy and adjuvant systemic chemotherapy (4 cycles of docetaxel and cyclophosphamide), and has been on antiestrogen therapy (daily tamoxifen, 20 mg) for 30 months with no evidence of disease. CONCLUSIONS ICC is a rare type of invasive carcinoma of the breast, and ICC from the male breast is extremely rare. We report, in this case, the final pathologic results of a male patient diagnosed with ICC breast cancer and treated with surgery, chemotherapy, and radiotherapy.

Determining the etiology of small bowel obstruction in patients without intraabdominal operative history: a retrospective study.

PURPOSE: Most of the causes of small bowel obstruction (SBO) in patients without a history of abdominal surgery are unclear at initial assessment. This study was conducted to identify the etiology and clinical characteristics of SBO in virgin abdomens and discuss the proper management. METHODS: A retrospective review involving operative cases of SBO from a single institute, which had no history of abdominal surgery, was conducted between January 2010 and December 2020. Clinical information, including radiological, operative, and pathologic findings, was investigated to determine the etiology of SBO. RESULTS: A total of 55 patients were included in this study, with a median age of 57 years and male sex (63.6%) constituting the majority. The most frequently reported symptoms were abdominal pain and nausea or vomiting. Neoplasm as an underlying cause accounted for 34.5% of the cases, of which 25.5% were malignant cases. In patients aged ≥60 years (n=23), small bowel neoplasms were the underlying cause in 12 (52.2%), of whom 9 (39.1%) were malignant cases. Adhesions and Crohn disease were more frequent in patients aged <60 years. Coherence between preoperative computed tomography scans and intraoperative findings was found in 63.6% of the cases. CONCLUSION: There were various causes of surgical cases of SBO in virgin abdomens. In older patients, hidden malignancy should be considered as a possible cause of SBO in a virgin abdomen. Patients with symptoms of recurrent bowel obstruction who have no history of prior abdominal surgery require thorough medical history and close follow-up.

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).

The Management of Retained Rectal Foreign Body.

PURPOSE: Because insertion of a foreign body (FB) into the anus is considered a taboo practice, patients with a retained rectal FB may hesitate to obtain medical care, and attending surgeons may lack experience with removing these FBs. We performed this study to evaluate the clinical characteristics of Korean patients with a retained rectal FB and propose management guideline for such cases based on our experience. METHODS: We retrospectively investigated 14 patients between January 2006 and December 2018. We assessed demographic features, mechanism of FB insertion, clinical course between diagnosis and management, and outcomes. RESULTS: All patients were male (mean age, 43 years) and presented with low abdominal pain (n = 2), anal bleeding (n = 2), or concern about a retained rectal FB without symptoms (n = 10). FB insertion was most commonly associated with sexual gratification or anal eroticism (n = 11, 78.6%). All patients underwent general anesthesia for anal sphincter relaxation with the exception of 2 who underwent FB removal in the emergency department. FBs were retrieved transanally using a clamp (n = 2), myoma screw (n = 1), clamp application following abdominal wall compression (n = 2), or laparotomy followed by rectosigmoid colon milking (n = 2). Colotomy and primary repair were performed in four patients, and Hartmann operation was performed in one patient with fecal peritonitis. No morbidity or mortality was reported. All patients refused postextraction anorectal functional and anatomical evaluation and psychological counseling. CONCLUSION: Retained rectal FB is rare; however, colorectal surgeons should be aware of the various methods that can be used for FB retrieval and the therapeutic algorithm applicable in such cases.

Differentiation of gallbladder adenomyomatosis from early-stage gallbladder cancer before surgery.

BACKGROUNDS/AIMS: This study aimed to compare the perioperative and clinical outcomes in patients undergoing laparoscopic cholecystectomy for gallbladder adenomyomatosis (GBA) or early-stage gallbladder cancer (GBC). METHODS: The perioperative and clinical outcomes of 194 patients diagnosed with GBA and 30 patients diagnosed with GBC who underwent laparoscopic cholecystectomy in our institution from January 2011 to December 2017 were retrospectively compared. RESULTS: There were no significant differences between the GBA and GBC groups in sex (male:female ratio 1.0:0.8 vs. 1.0:0.7, p=0.734), BMI (23.9±3.4 vs. 24.0±3.8 kg/m2, p=0.916), or preoperative liver function tests. Patients in the GBC group were significantly older (50.5±14.1 vs. 65.9±10.6 years, p<0.001) and had a higher ASA grade (40.3 vs. 63.4% grade II or III, p=0.043) than patients in the GBA group. Although there was no significant difference in preoperative diagnostic methods (p=0.442), the GBC group showed a significantly higher rate of misdiagnosis on preoperative imaging compared with postoperative histopathologic findings (30.9% vs. 53.3%, p=0.011). There were significantly more patients with gallstones in the GBA group than in the GBC group (68.6% vs. 40.0%, p=0.004). CONCLUSIONS: In older patients hospitalized for biliary colic without gallstones but with a thickened gallbladder wall with inflammation on preoperative diagnostic exam, the possibility of early-stage GBC should be considered.

Retrospectively validating the results of the ACOSOG Z0011 trial in a large Asian Z0011-eligible cohort.

PURPOSE: The Z0011 trial demonstrated that axillary dissection (ALND) could be omitted during breast-conserving therapy for cT1-2N0 breast cancers with 1-2 metastatic SLNs. However, that result has not been validated in a larger cohort and the significance of the small number of SLNs remains unclear. This study aimed to validate the Z0011 results within an Asian Z0011-eligible cohort and determine whether the number of sentinel lymph nodes (SLNs) influenced the Z0011-based outcomes. METHODS: Data from Asian patients who fulfilled the Z0011 criteria were collected from five hospitals. Disease recurrence (DR) was compared between patients who underwent ALND or SLN dissection (SLND) alone. Propensity-score matching was performed to reduce the effects of potential selection biases. RESULTS: During 2010-2016, 1750 Asian patients had 1-2 SLN metastases and fulfilled the Z0011 criteria. These patients included 707 cases treated using SLND alone (40%) and 967 patients with ≤ 2 SLNs (55%). Ninety-five patients (5.4%) experienced DR at a median interval of 50 months, although the rates of DR were similar in the ALND and SLND groups. The adjusted hazard ratios for DR after ALND omission were 0.95 (95% CI 0.55-1.64) among the entire cohort and 0.83 (95% CI 0.34-2.03) among patients with ≤ 2 SLNs. CONCLUSIONS: In this Asian Z0011-eligible cohort, ALND omission did not increase risk of DR, even among patients with ≤ 2 SLNs. Therefore, the Z0011 strategy might be safely applied in Asia, and a small number of SLNs did not significantly influence this strategy.

Age-related risk factors associated with primary contralateral breast cancer among younger women versus older women.

PURPOSE: Contralateral prophylactic mastectomy is increasing, despite unclear evidence of improving survival. To investigate the age-related risk factors for contralateral breast cancer (CBC). METHODS: This study included 8716 patients diagnosed with non-metastatic unilateral invasive breast cancer between 1989 and 2008. Data on primary tumor size, node metastasis, grade and subtype using individual matching were used to adjust for differences in the primary tumor and treatment between younger and older age groups. CBC risk factors, CBC-free survival, and annual CBC risk were analyzed by age. RESULTS: The younger group included 652 patients aged under 35 years, and the older group included 2608 women aged 35 years or older. The median time to CBC development was 6.1 years. CBC was detected in 6.6% of the women in the younger group and 2.5% of those in the older group. Multivariable analysis revealed a relative CBC risk of 2.48 in younger women compared to older women. The risk was significantly higher among women with human epidermal growth factor receptor 2 (HER2)-overexpressing tumors (hazard ratio [HR] 4.98), a family history of breast cancer (HR 7.79), and anti-hormone therapy (HR 3.46). In younger women with HER2-positive cancer, CBC occurrence peaked at 4.6 years after surgery, in those with hormone receptor-positive cancer, it peaked at 7.1 years after surgery, and in triple-negative disease cases, and it increased steadily over time. CONCLUSIONS: After adjusting for primary breast tumor characteristics, patients < 35 years old had 2.5 times the risk of CBC development compared to the older women. CBC occurrence peaked within 5 years after primary breast cancer in younger women with the HER2-positive subtype and after 5 years in cases with the hormone receptor-positive subtype.

Comparing Accuracy of Mammography and Magnetic Resonance Imaging for Residual Calcified Lesions in Breast Cancer Patients Undergoing Neoadjuvant Systemic Therapy.

BACKGROUND: Neoadjuvant systemic therapy (NST) is performed to increase the rate of breast-conserving surgery in advanced breast cancer patients. Although magnetic resonance imaging (MRI) is accurate in predicting residual cancer, if calcification remains, the issue of whether to perform the surgery on the basis of the residual tumor prediction range in mammography (MMG) or MRI has not yet been elucidated. This study aimed to estimate the accuracy of predicting residual tumor after NST for residual microcalcification on mammographic and enhancing lesion on MRI. PATIENTS AND METHODS: This was a single-center, retrospective study. We included breast cancer patients who underwent NST, had microcalcifications in the post-NST MMG, and underwent surgery from January 2, 2013 to December 30, 2014 at Asan Medical Center. Patients with post-NST MMG as well as MRI were included. Final pathologic tumor size with histopathology and biomarker status were obtained postoperatively. RESULTS: In total, 151 patients were included in this study. Overall, MRI correlated better than MMG in predicting the tumor size (intraclass correlation coefficient [ICC], 0.769 vs. 0.651). For hormone receptor (HR)-positive (HR+)/HER2- subtype, MMG had higher correlation than MRI (ICC = 0.747 vs. 0.575). In HR- subtype, MRI had a strong correlation with pathology (HR-/HER2+ or triple negative (TN), ICC = 0.939 vs. 0.750), whereas MMG tended to overestimate the tumor size (HR-/HER2+ or TN, ICC = 0.543 vs. 0.479). CONCLUSION: Post-NST residual microcalcifications on MMG have a lower correlation with residual tumor size than MRI. Other than HR+/HER2- subtype, the extent of calcifications on preoperative evaluation might not be accurate in evaluating the residual extent of the tumor after NST.

Clinical Manifestations of Superior Mesenteric Venous Thrombosis in the Era of Computed Tomography.

PURPOSE: Thrombosis of the portal vein, known as pylephlebitis, is a rare and fatal complication caused by intraperitoneal infections. The disease progression of superior mesenteric venous thrombosis (SMVT) is not severe. This study aimed to determine the clinical features, etiology, and prognosis of SMVT. MATERIALS AND METHODS: We retrospectively reviewed the medical records of 41 patients with SMVT from March 2000 to February 2017. We obtained a list of 305 patients through the International Classification of Disease-9 code system and selected 41 patients with SMVT with computed tomography. Data from the medical records included patient demographics, comorbidities, review of system, laboratory results, clinical courses, and treatment modalities. RESULTS: The causes of SMVT were found to be intraperitoneal inflammation in 27 patients (65.9%), malignancy in 7 patients (17.1%), and unknown in 7 patients (17.1%). Among the patients with intraperitoneal inflammation, 14 presented with appendicitis (51.9%), 7 with diverticulitis (25.9%), and 2 with ileus (7.4%). When comparing patients with and without small bowel resection, the differences in symptom duration, bowel enhancement and blood culture were significant (P=0.010, P=0.039, and P=0.028, respectively). CONCLUSION: SMVT, caused by intraperitoneal inflammation, unlike portal vein thrombosis including pylephlebitis, shows mild prognosis. In addition, rapid symptom progression and positive blood culture can be the prognostic factors related to extensive bowel resection. Use of appropriate antibiotics and understanding of disease progression can help improve the outcomes of patients with SMVT.