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国立がん研究センター 中央病院

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Department of Breast Surgery

Takayuki Kinoshita, Shin Takayama, Sota Asaga, Kenjiro Jimbo, Eriko Iwamoto, Sho Shiino


The Breast Surgery Department deals with treatment of breast cancer through surgeries, as well as diagnosis of breast diseases and assessment of lymph nodes in the axillary and clavicular regions that are suspected of harboring metastases. The trend in surgical procedures has been changing year by year. Although breast-conserving therapy (BCT) accounted for 40% of the total surgeries in our division in 2015, BCT is on the decline in recent years. One of the reasons for such decline is increasing needs of immediate reconstruction surgery. In 2010, immediate breast reconstruction became one of the choices for patients in whom breast preservation was impossible, and a total of 130 immediate breast reconstructions were performed in 2015, comprising more than 20% of all the cases. The number of cases of immediate breast reconstruction has gradually increased year by year to match the increase in needs of patients. Sentinel lymph node (SLN) biopsies (SLNB) were performed in 83% of the cases. Following SLNB, axillary lymph node dissection (ALND) could be avoided when the SLNB was negative. One-step nucleic acid amplification (OSNA) assay, that quantitatively measures CK19 mRNA detects sentinel lymph node metastases even in molecular levels, in conjunction with this assay and conventional microscopic method, we began to be able to evaluate the SLN more precisely. Further, by comparing the OSNA results with that of conventional histological diagnosis, we try to search for the possibility of omitting axillary lymph node dissection by using two methods. Thus, we are striving continuously to meet the diverse needs of breast cancer patients.

Routine activities

Our division comprises of four staff surgeons, one chief resident, and three or four rotating residents. From 7:20 every morning, all the staff and the residents perform in-patient rounds together. The journal club and research conference are scheduled on every Tuesday morning after rounds. Weekly conferences are held on Monday and Wednesday from 17:00 to 18:00 for shared discussions with surgeons, medical oncologists, radiologists, and radiology and sonography technicians. The diagnostic images of pre-operative patients are reviewed and compared to pathological reports for every postoperative patient. A breast pathology/imaging conference is held on the second Wednesday of each month from 19:00 to 20:00 to discuss problems with diagnostic imaging, and with pathologically interesting cases. A conference about studies, institutional treatment guidelines and recent topics regarding breast cancer is held on the last Wednesday of each month by a multidisciplinary team. Treatment Guidelines for primary and metastatic breast cancer have been updated regularly through this multidisciplinary discussion since 2003.


We perform surgeries from Monday to Friday; there are generally 13 to 15 cases of breast cancer in a week.

Table 1 shows the total number of patients with primary breast cancer (including breast primary sarcoma) and other breast disease. The types and number of operative procedures are shown in Table 2. The rate of mastectomy was 55% (340/614), including 130 cases of immediate reconstruction. SLNB was performed in 331 patients, and 251 patients were spared from ALND in 2014.

Research activities and Clinical trials

Radiofrequency ablation therapy for early breast cancer as local therapy (RAFAELO study)

The trial of image-guided radiofrequency ablation (non-surgical therapy) has been accomplished for early-stage breast carcinomas of less than 1.0 cm in diameter (Phase I/II study; Kinoshita et al.). After years of trial, the indication has just been expanded up to 1.5 cm in diameter and this technique has been certified as an advanced medical treatment by the Ministry of Health, Labour and Welfare. Our secondary goals are to determine the size, configuration and pathological features of acute RFA treatment of breast cancers, and we have conducted clinical studies to evaluate the oncologic safety of RFA in terms of local recurrence.

Intensive vs. standard post-operative surveillance in high risk breast cancer patients (JCOG1204, INSPIRE Trial)

This is a multi-center randomized phase 3 trial that started in 2012. This clinical trial is to prove the hypothesis that postoperative intensive follow-up of patients with breast cancer is good for a standard follow-up.

Denosumab adjuvant treatment (D-CARE)

This phase 3 multi-center, randomized, double blind, placebo controlled study is continuing, designed to compare the treatment effect of denosumab with that of a placebo on prolonging bone metastasis-free survival in subjects with early-stage breast cancer at high risk of disease recurrence.

Scalp-cooling device during chemotherapy

A feasibility study to test the use of a scalp-cooling device that breast cancer patients will wear while undergoing chemotherapy treatment has started and continued in order to slow or halt hair loss during chemotherapy.

Postoperative Therapy with Endocrine and TS-1 (POTENT study)

This multi-center randomized trial has continued from 2012. This study compares invasive disease-free survival in patients with or without TS-1 administration together with adjuvant endocrine therapy in hormone positive and HER2 negative high recurrence risk patients

Registration database system for breast cancer patients who had lymph node metastasis diagnosis by the OSNA® method (LynoLog Database)

The aim of this study is to accumulate the administrative data on cases with the OSNA method in a common database, the LynoLog Database, and to evaluate the clinical significance of intraoperative SLN metastases detected by OSNA.

Olaparib as adjuvant treatment in patients with germline BRCA mutated high risk HER2 negative primary breast cancer (OlympiA)

A randomized, double-blind, parallel group, placebo-controlled multi-center phase III study started in 2014. The aim of the study is to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy.

Table 1. Number of patients

Table 2. Type of procedure

Table 3. Survival (2006.1-2007.12)

List of papers published in 2015


  1. Jimbo K, Kinoshita T, Asaga S, Hojo T. Oncological safety of breast-conserving surgery after primary systemic chemotherapy in cT3-4 breast cancer patients. Surg Today, 45:1255-1262, 2015
  2. Ono M, Tsuda H, Yunokawa M, Yonemori K, Shimizu C, Tamura K, Kinoshita T, Fujiwara Y. Prognostic impact of Ki-67 labeling indices with 3 different cutoff values, histological grade, and nuclear grade in hormone-receptor-positive, HER2-negative, node-negative invasive breast cancers. Breast Cancer, 22:141-152, 2015
  3. Hojo T, Masuda N, Mizutani T, Shibata T, Kinoshita T, Tamura K, Hara F, Fujisawa T, Inoue K, Saji S, Nakamura K, Fukuda H, Iwata H. Intensive vs. Standard Post-Operative Surveillance in High-Risk Breast Cancer Patients (INSPIRE): Japan Clinical Oncology Group Study JCOG1204. Jpn J Clin Oncol, 45:983-986, 2015
  4. Yoshida M, Ogawa R, Yoshida H, Maeshima A, Kanai Y, Kinoshita T, Hiraoka N, Sekine S. TERT promoter mutations are frequent and show association with MED12 mutations in phyllodes tumors of the breast. Br J Cancer, 113:1244-1248, 2015
  5. Asaga S, Kinoshita T, Hojo T, Jimbo K, Yoshida M. Predictive Factors for Non-Sentinel Lymph Node Metastasis in Patients With Clinically Node-Negative Ipsilateral Multiple Breast Cancer Treated With Total Mastectomy. Clin Breast Cancer, 15:362-369, 2015
  6. Shiino S, Tsuda H, Yoshida M, Jimbo K, Asaga S, Hojo T, Kinoshita T. Intraductal papillomas on core biopsy can be upgraded to malignancy on subsequent excisional biopsy regardless of the presence of atypical features. Pathol Int, 65:293-300, 2015
  7. Kikuyama M, Akashi-Tanaka S, Hojo T, Kinoshita T, Ogawa T, Seto Y, Tsuda H. Utility of intraoperative frozen section examinations of surgical margins: implication of margin-exposed tumor component features on further surgical treatment. Jpn J Clin Oncol, 45:19-25, 2015
  8. Ono M, Tsuda H, Kobayashi T, Takeshita F, Takahashi RU, Tamura K, Akashi-Tanaka S, Moriya T, Yamasaki T, Kinoshita T, Yamamoto J, Fujiwara Y, Ochiya T. The expression and clinical significance of ribophorin II (RPN2) in human breast cancer. Pathol Int, 65:301-308, 2015