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.

Mastectomy with Reconstruction Including Robotic Endoscopic Surgery (MARRES): a prospective cohort study of the Korea Robot-Endoscopy Minimal Access Breast Surgery Study Group (KoREa-BSG) and Korean Breast Cancer Study Group (KBCSG).

BACKGROUND: Robotic nipple-sparing mastectomy (RNSM) has emerged as a new treatment option for breast cancer and risk-reducing mastectomy (RRM) for women who have a high risk of pathogenic variants. Even though several studies have reported that RNSM is a feasible procedure, some argue that it should only be performed by specialized surgeons, and data on oncologic outcomes and patient-reported outcomes (PROs) are limited. Recently, the United States Food and Drug Administration and several surgeons warned that robotic breast surgery should be performed only by specialized surgeons and recommended that the benefits, risks, and alternatives of all available treatment options be discussed with patients so they can make informed treatment decisions. The Korea Robot-Endoscopy Minimal Access Breast Surgery Study Group (KoREa-BSG) has been established to evaluate, standardize, and teach this state-of-the-art procedure. We have designed a multicenter prospective cohort study entitled Mastectomy with Reconstruction Including Robot Endoscopic Surgery (MARRES) to report surgical, PRO, and oncologic outcomes. METHODS: MARRES is a multi-institution cohort study prospectively collecting data from patients undergoing mastectomy and reconstruction. The patient inclusion criteria are adult women older than 19 with breast cancer or a high risk of breast cancer (patients with BRCA1/2, TP53, PALB2 mutations, etc.), who have scheduled therapeutic or RRM and want immediate reconstruction. Surgical outcomes, including pre- and postoperative photos, oncologic outcomes, cost-effectiveness, and PRO, are collected. The primary endpoints are postoperative complication rates within 30 postoperative days and the Clavien-Dindo grade of postoperative complications within 180 postoperative days. The secondary endpoints are 5-year postoperative recurrence-free survival and cancer incidence rate (for those who underwent RRM), patient satisfaction with reconstruction expectations preoperative (baseline) and results within 6 to 12 postoperative months, surgeon satisfaction with postoperative results in 6 postoperative months, and cost-effectiveness of the definitive surgery. Patient recruitment will be completed in April 2025, and the target number of enrolled patients is 2000. DISCUSSION: This study will provide evidence about the surgical outcomes, oncologic outcomes, and patient satisfaction with RNSM and endoscopic nipple-sparing mastectomy (NSM), compared with conventional NSM. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT04585074. Registered April 8, 2020.

Diagnostic accuracy of a three-protein signature in women with suspicious breast lesions: a multicenter prospective trial.

BACKGROUND: Mammography screening has been proven to detect breast cancer at an early stage and reduce mortality; however, it has low accuracy in young women or women with dense breasts. Blood-based diagnostic tools may overcome the limitations of mammography. This study assessed the diagnostic performance of a three-protein signature in patients with suspicious breast lesions. FINDINGS: This trial (MAST; KCT0004847) was a prospective multicenter observational trial. Three-protein signature values were obtained using serum and plasma from women with suspicious lesions for breast malignancy before tumor biopsy. Additionally, blood samples from women who underwent clear or benign mammography were collected for the assays. Among 642 participants, the sensitivity, specificity, and overall accuracy values of the three-protein signature were 74.4%, 66.9%, and 70.6%, respectively, and the concordance index was 0.698 (95% CI 0.656, 0.739). The diagnostic performance was not affected by the demographic features, clinicopathologic characteristics, and co-morbidities of the participants. CONCLUSIONS: The present trial showed an accuracy of 70.6% for the three-protein signature. Considering the value of blood-based biomarkers for the early detection of breast malignancies, further evaluation of this proteomic assay is warranted in larger, population-level trials. This Multi-protein Assessment using Serum to deTermine breast lesion malignancy (MAST) was registered at the Clinical Research Information Service of Korea with the identification number of KCT0004847 ( https://cris.nih.go.kr ).

Epidemiology of Second Non-breast Primary Cancers among Survivors of Breast Cancer: A Korean Population-Based Study by the SMARTSHIP Group.

PURPOSE: This study aimed to evaluate the incidence and prognosis of second non-breast primary cancer (SNBPC) among Korean survivors of breast cancer. Materials and Methods: Data from the Korean National Health Insurance Service were searched to identify women who received curative surgery for initial breast cancer (IBC) between 2003 and 2008 (n=64,340). Among them, patients with the following characteristics were excluded: other cancer diagnosis before IBC (n=10,866), radiotherapy before IBC (n=349), absence of data on sex or age (n=371), or male (n=248). Accordingly, data of 52,506 women until December 2017 were analyzed. SNBPC was defined as a newly diagnosed SNBPC that occurred 5 years or more after IBC diagnosis. RESULTS: The median follow-up time of all patients was 12.13 years. SNBPC was developed in 3,084 (5.87%) women after a median of 7.61 years following IBC diagnosis. The 10-year incidence of SNBPC was 5.78% (95% confidence interval [CI], 5.56 to 6.00). Higher SNBPC incidence was found in survivors with the following factors: old age at IBC diagnosis, low household income, and receiving combined chemotherapy with endocrine therapy, whereas receiving radiotherapy was related to a lower incidence of SNBPC (hazard ratio, 0.89; p < 0.01). Among the patients with SNBPC, the 5-year survival rate was 62.28% (95% CI, 65.53 to 69.02). CONCLUSION: Approximately 5% of breast cancer survivors developed SNBPC within 10 years after IBC diagnosis. The risk of SNBPC was associated with patient's age at IBC diagnosis, income level, and a receipt of systemic treatments.

Current Trends in and Indications for Endoscopy-Assisted Breast Surgery for Breast Cancer.

Endoscopic oncoplastic breast surgery represents a minimal invasive approach with the aim of both safe excision of cancer and preserving the breast shape. It has less noticeable scar, excellent cosmetic outcomes, high patient satisfaction rate. Recently, relative long-term follow-up results have been reported to be very safe (Soybir and Fukuma, J Breast Health 11:52-58, 2015; Fan et al., Chin Med J 122:2945-2950, 2009; Jiang, Zhonghua Wai Ke Za Zhi 45:439-441, 2007).Operative techniques for both endoscopic breast-conserving surgery and endoscopic nipple/areola/skin-sparing mastectomy have been described in detail. Two different working planes in which one of them is subcutaneous and the other one is sub-mammary planes are being used during the surgery. Surgical technique needs some instruments such as endoscopic retractor, light guided specific mammary retractor, wound protector, and energy device such as bipolar scissor, Harmonic Scalpel, LigaSure, Thunderbeat. Endoscopic breast retractors provide magnified visualization and extensive posterior dissection facility. Tunneling method and the hydro-dissection simplify the technique in the subcutaneous field (Soybir and Fukuma, J Breast Health 11:52-58, 2015; Fan et al., Chin Med J 122:2945-2950, 2009). Oncoplastic reconstruction techniques are also applied after the tumor resection by endoscopic method. The complication rate of endoscopic breast surgery is similar with the rate of open breast surgery. Quite successful local recurrence, distant metastasis, and overall survival rates have been declared. However, it looks reasonable to wait for the results with longer follow-up before having a judgement about oncologic efficiency and safety of the endoscopic breast cancer surgery (Tamaki et al., Nihon Geka Gakkai Zasshi 103(11):835-838, 2002; Leff et al., Breast Cancer Res Treat 125(3):607-625, 2011; Fukuma, Nihon Geka Gakkai Zasshi 116(5):316-319, 2015).Recently some surgeons reported about robotic nipple sparing mastectomy and immediate breast reconstruction with Gel implant procedure. Nevertheless, experience with application of a robotic surgery platform in the management of breast cancer is limited. From the preliminary experiences, R-NSM and IBR with Gel implant is a safe procedure, with good cosmetic results, and could be a promising new technique for breast cancer patients indicated for mastectomy (Lai et al., Ann Surg Oncol 26(1):42-52, 2019).

Natural History of Invasive Papillary Breast Carcinoma Followed for 10 Years: A Case Report and Literature Review.

Diachronic research on untreated breast cancer completely depends on past medical records when no more recent, advanced methods are available. Herein, we report a case of invasive papillary breast carcinoma followed for 10 years in a 59-year-old woman who refused any treatment. The diagnosis was based on core needle biopsies. At the patient's first visit in July 2006, the tumor measured 10.4 × 7.2 × 3.5 cm. It was staged as IIIB (T4bN1). In May 2016, the tumor was staged as IIIC (T4bN3a). In the past 10 years, the tumor has increased to 12.1 × 9.0 × 4.2 cm. However, a whole-body bone scan and 18F-FDG PET/CT showed no evidence of distant metastasis. Immunohistochemistry results, corresponding to biopsies taken at subsequent examinations, have remained unaltered since 2006. The tumor was estrogen/progesterone receptor-positive and C-erbB2 expression was not detected. The Ki-67 labeling index was around 10%.

Nationwide survey of use of vacuum-assisted breast biopsy in South Korea.

BACKGROUND: Image-guided vacuum-assisted breast biopsy (VABB) is used for detecting breast lesions in South Korea. However, no clear guidelines for VABB exist. MATERIALS AND METHODS: A 53-item survey was administered to members of the Korean Breast Cancer Society between July 27 and August 27, 2010. RESULTS: Among 62 respondents, 87.1% had performed VABB, with 63.0% performing both diagnosis and treatment. Around 62.5% used VABB for diagnosing Ultrasound Breast Imaging-Reporting and Data System (USG BIRAD) Category 3 lesions, 55% for Category 4A, 57.5% for microcalcifications detected by ultrasonography, and 30% for small Category 5. Furthermore, 81.3% used VABB to treat Category 3 lesions; while 67.8% diagnosed benign lesions on core needle biopsy, requiring surgical excision. About 83% used VABB for small tumors (<3 cm). Among therapeutically excised tumors, 86.4% reported fibroadenoma. CONCLUSION: VABB is performed for diagnosis and treatment in South Korea, and complies with the available guidelines. However, national and global standards and guidelines for VABB need to be established.

Survey of the application of the korean clinical practice recommendations on breast cancer treatment: the utility of the korean breast cancer society guidelines.

This survey was performed to analyze the usability of the third edition of the Korean breast cancer clinical practice guidelines (KBCCPG) in clinical practice. We made a questionnaire composed of 18 general and 82 specific questions regarding benign breast disease (B; 1 question); non-invasive disease (N; 12 questions); early-stage disease (E; 26 questions); advanced disease (A; 24 questions); and metastatic (M) breast cancer-related problems (19 questions). A total of 100 questionnaires, with a link to an online survey, were delivered via e-mail to over 700 members of the Korean Breast Cancer Society (KBCS), and associated academy members, over 20 days between 26th February and 16th May 2010. Out of 270 respondents who read the e-mail, 96 answered the questionnaire. Participants included 87 surgical oncologists, 5 radiation oncologists, 2 oncoplastic surgeons, 1 pathologist, and 1 medical oncologist. The third KBCCPG were perceived as differing from the second guidelines in terms of the level of clinical evidence required before choosing a recommendation. For the progress of the KBCCPG, the guideline committee should try to reinforce all courses of guideline development with several elements including data from clinical trials of Korean breast cancer patients, securing a multidisciplinary approach, developing consistent and reasonable processes for each step of the revision of the guidelines, induction of liberal scientific and ethical discussion about all issues with all KBCS members. The cost-effectiveness of healthcare and the logical development of the KBCCPG would also be ensured. Timely updates of the clinical guidelines for breast cancer treatment are essential to facilitate optimal decision-making in daily practice, and to ensure adequate patient feedback.