Faculty Profiles - SHIEN Tadahiko

Papers - SHIEN Tadahiko

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Design Paper: A Prospective, Multicenter, Single-arm, Phase II Trial of Tailored Axillary Surgery in Patients with Clinically Node-positive Breast Cancer in the Upfront Surgery Setting.

Yasuaki Sagara, Kaori Terata, Takehiko Sakai, Shin Takayama, Dai Kitagawa, Tsuguo Iwatani, Takahiro Tsukioki, Mami Ogita, Naoko Sanuki, Masayuki Yoshida, Hitoshi Tsuda, Seiichiro Yamamoto, Hiroji Iwata, Tadahiko Shien

JMA journal 8 ( 1 ) 264 - 269 2025.1

Language：English Publishing type：Research paper (scientific journal)

INTRODUCTION: This prospective, multicenter, single-arm Phase II trial investigates the feasibility and the safety of tailored axillary surgery (TAS) in patients with clinically node-positive breast cancer who are undergoing upfront surgery. The trial aims to establish the criteria for safely omitting axillary lymph node dissection (ALND) in these cases, potentially shifting breast cancer management by minimizing surgical complications and preserving the patients' quality of life (QOL). METHODS: The study includes patients who were diagnosed with invasive breast cancer, particularly those with limited metastatic lymph nodes. The primary objective of this work is to determine the specific combination of clinical and pathological factors that would result in a non-TAS lymph node metastasis proportion of less than 10%. The secondary objectives include assessing the identification rate of the metastatic lymph nodes, the incidence of upper limb lymphedema, and the QOL measures. RESULTS: The results will identify the patient eligibility criteria for the Phase III TAS trial, potentially allowing the omission of ALND in selected patients. This may lead to reduced surgical complications and better preservation of the QOL of patients with breast cancer. CONCLUSIONS: The trial's outcome will contribute to the development of the criteria for safely omitting ALND in certain patients with clinically node-positive breast cancer. This approach aims to enhance breast cancer management by reducing surgical burden and improving the patient outcomes.jRCTs: 061220113.

DOI： 10.31662/jmaj.2024-0187

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[Ⅱ. Recurrence Score in Patients with BRCA1/2 Mutation from the OlympiA and TAILORx Trial Results].

Yuko Takahashi, Takahiro Tsukioki, Tsuguo Iwatani, Tadahiko Shien

Gan to kagaku ryoho. Cancer & chemotherapy 51 ( 12 ) 1209 - 1211 2024.12

乳腺内分泌腫瘍臨床病理学的検査と遺伝学的検査からルミナール乳癌の周術期薬物療法の適応を考える OlympiA試験とTAILORx試験

高橋侑子, 突沖貴宏, 岩谷胤生, 枝園忠彦

癌と化学療法 51 ( 12 ) 1209 - 1211 2024.12

Real-World Comparative Analysis of Trastuzumab Originator and Biosimilars: Safety, Efficacy, and Cost Effectiveness. Reviewed International journal

Tomoka Mamori, Maki Tanioka, Kenji Takada, Hirofumi Hamano, Takahiro Tsukioki, Yuko Takahashi, Tsuguo Iwatani, Tadahiko Shien, Shinichi Toyooka

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy 2024.10

Language：English Publishing type：Research paper (scientific journal)

BACKGROUND: Despite the global use of trastuzumab biosimilars, concerns remain regarding their efficacy and safety. In particular, when used concurrently with pertuzumab, trastuzumab biosimilars lack extensive real-world data and safety information. Additionally, as cancer drug expenditures continue to rise worldwide, cost savings from biosimilars have become increasingly important. OBJECTIVE: This study aims to assess the safety, efficacy, and cost effectiveness of trastuzumab originators and their biosimilars in real-world clinical settings, focusing on a large patient population. METHODS: The analysis included 31,661 patients with HER2-positive breast cancer from the Medical Data Vision Co., Ltd. database in Japan. Additionally, adverse event reports for the trastuzumab originator and its biosimilars were obtained for 58,799 patients from the World Health Organization's VigiBase, the global adverse event reporting database. RESULTS: No significant differences were observed in heart failure hospitalizations, liver dysfunction, or infusion reaction rates in both the Medical Data Vision Co., Ltd. database and the World Health Organization's VigiBase. In the Medical Data Vision Co., Ltd. database, the addition of pertuzumab did not significantly influence the incidence of adverse events, and the use of biosimilars significantly reduced medical costs, with no significant difference in breast cancer recurrence rates. CONCLUSIONS: By analyzing two large and diverse datasets from multiple perspectives, we obtained reliable results that the trastuzumab originator and its biosimilars have similar safety profiles. The concurrent use of pertuzumab was also found to be safe. The use of biosimilars can lead to cost savings. These findings provide crucial insights for the evaluation and adoption of biosimilars in clinical practice.

DOI： 10.1007/s40259-024-00686-x

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Radiation hepatitis after postmastectomy radiation therapy for early breast cancer: difficult to differentiate from drug-induced liver injury caused by abemaciclib. International journal

Shogo Nakamoto, Takahiro Waki, Asuka Mimata, Takahiro Tsukioki, Yuko Takahashi, Yoko Iwatani, Tsuguo Iwatani, Tadahiko Shien

International cancer conference journal 13 ( 4 ) 471 - 475 2024.10

Language：English Publishing type：Research paper (scientific journal)

Abemaciclib (ABM) is recommended for adjuvant endocrine therapy in hormone receptor-positive, human epidermal growth factor receptor type 2-negative early breast cancer (EBC) patients at high risk of recurrence. Here, we present a case of radiation hepatitis challenging to differentiate from drug-induced liver injury during ABM treatment. The patient, a woman in her 40 s, underwent right mastectomy, axillary dissection, and postmastectomy radiation therapy (PMRT) after neoadjuvant chemotherapy for EBC. Subsequently, she received ABM as adjuvant endocrine therapy. Despite suspending ABM due to Grade 3 leukopenia, she developed Grade 3 hepatic dysfunction upon cessation. Based on the dynamic contrast-enhanced computed tomography, we diagnosed the cause of liver dysfunction as radiation hepatitis. Spontaneous improvement allowed us to resume ABM treatment. Clinicians may need to consider radiation hepatitis as a potential cause of hepatic dysfunction in patients who underwent PMRT, along with drug-induced liver injury.

DOI： 10.1007/s13691-024-00714-1

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明日からの乳癌診療に使える!最新の薬剤の使いどころ転移・再発乳癌に対するSG(サシツズマブゴビテカン)の使いどころ

突沖貴宏, 三又明日香, 中本翔伍, 岩谷陽子, 谷岡真樹, 岩谷胤生, 枝園忠彦

日本癌治療学会学術集会抄録集 62回 OSY11 - 5 2024.10

異時性遠隔再発を認めた非浸潤性乳管癌の2例

藤原由樹, 枝園忠彦, 三又明日香, 中本翔伍, 突沖貴宏, 高橋侑子, 谷岡真樹, 岩谷胤生

日本癌治療学会学術集会抄録集 62回 P73 - 2 2024.10

Primary angiosarcoma of the breast: a literature review. Reviewed International journal

Yidan Zhu, Shogo Nakamoto, Takahiro Tsukioki, Yuko Takahashi, Yoko Iwatani, Tsuguo Iwatani, Xinfeng Zhang, Maki Tanioka, Tadahiko Shien

Chinese clinical oncology 2024.9

Authorship：Last author Language：English Publishing type：Research paper (scientific journal)

BACKGROUND AND OBJECTIVE: Primary angiosarcoma of the breast (PBA) is an extremely rare and heterogeneous disease. PBA is difficult to diagnose and has a poor prognosis. In order to better understand the disease and provide evidence-based treatment for PBA patients, a review of the published literature in the English language was conducted. METHODS: A literature review in agreement with the PRISMA protocol was conducted. Medline and Cochrane databases were searched for English articles on PBA patients in September 2023 with a predetermined strategy. The articles were categorized and assessed based on hierarchical levels of scientific evidence. KEY CONTENT AND FINDINGS: A total of 255 articles were identified, among these 137 publications which included 1,888 patients met the criteria for inclusion in the final analysis. No prospective, randomized trials exclusive to PBA have been recognized. This article provides an overview of the most current and comprehensive evidence concerning the epidemiology, etiology, genomic features, clinical presentations, diagnosis, treatment, and prognosis of PBA. CONCLUSIONS: Despite the fact that current evidence is largely derived from retrospective studies, database analyses, and case reports, we utilized this information to tackle important clinical questions concerning optimal patient management practices for PBA. Complete surgical excision continues to be the mainstay treatment for PBA. However, the effectiveness of adjuvant therapies is still unclear. This narrative review highlights the urgent need for more rigorously designed research to enhance the management and treatment strategies for PBA.

DOI： 10.21037/cco-24-16

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Reply to the Letter to the editor "Does axillary lymph node recurrence breast cancer subtype information matter for prognosis estimation?". Reviewed

Hirohito Seki, Shinsuke Sasada, Tadahiko Shien

Breast cancer (Tokyo, Japan) 2024.9

Prognosis of isolated locoregional recurrence after early breast cancer with immediate breast reconstruction surgery: a retrospective multi‑institutional study. Reviewed

Hirohito Seki, Akiko Ogiya, Naomi Nagura, Ayaka Shimo, Kazutaka Narui, Shinsuke Sasada, Makoto Ishitobi, Hiroko Nogi, Naoto Kondo, Teruhisa Sakurai, Chikako Yamauchi, Hiroki Mori, Miho Saiga, Naoki Niikura, Tadahiko Shien

Breast cancer (Tokyo, Japan) 31 ( 5 ) 935 - 944 2024.9

Authorship：Last author Language：English Publishing type：Research paper (scientific journal)

BACKGROUND: The prognosis in patients with breast cancer with isolated locoregional recurrence (ILRR) without simultaneous distant metastases after immediate breast reconstruction (IBR) remains unknown. We aimed to investigate the prognosis in this patient population. METHODS: This multi-institutional retrospective observational study evaluated 3295 patients with primary breast cancer who underwent IBR at 12 Japanese medical facilities between January 1, 2008 and December 31, 2016. The outcome measures were the prognostic factors for ILRR after IBR, 5-year distant metastasis-free interval (DMFI), and 5-year overall survival (OS). RESULTS: Mastectomy or skin-sparing mastectomy was performed in 3295 patients. ILRR occurred in 70 patients, and the median observation period from ILRR diagnosis was 39.3 months. Of the 70 patients, 9 (12.9%) had axillary lymph node recurrence (ALNR) at the time of ILRR diagnosis. The 5-year DMFI and OS rates after ILRR were 92.4% and 91.2%, respectively. Pathological lymph node metastasis at primary surgery (P = 0.041) and ALNR (P = 0.022) at ILRR were significantly associated with DMFI in the univariate analysis. ALNR was the only independent prognostic factor in the multivariate analysis (P = 0.041). Post-mastectomy radiation therapy (PMRT; P = 0.022) and ALNR (P = 0.043) were significantly associated with OS in the univariate analysis, and both PMRT (P = 0.010) and ALNR (P = 0.028) were independent prognostic factors in the multivariate analysis for OS. CONCLUSIONS: Although patients with breast cancer who had ILRR after IBR have favorable prognosis, ALNR may lead to poor prognosis. To the best of our knowledge, this study is the first to report the prognosis of these patients.

DOI： 10.1007/s12282-024-01607-0

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The effect of exercise and educational programs for breast cancer patients on the development of breast cancer-related lymphoedema: secondary endpoint from a randomized controlled trial in the Setouchi Breast Project-10. Reviewed

Shogo Nakamoto, Takayuki Iwamoto, Naruto Taira, Yukiko Kajiwara, Kengo Kawada, Daisuke Takabatake, Yuichiro Miyoshi, Shinichiro Kubo, Yoko Suzuki, Mari Yamamoto, Yutaka Ogasawara, Minami Hatono, Seiji Yoshitomi, Kyoko Hara, Asako Sasahara, Shozo Ohsumi, Masahiko Ikeda, Hiroyoshi Doihara, Yuri Mizota, Seiichiro Yamamoto, Tadahiko Shien, Shinichi Toyooka

Breast cancer (Tokyo, Japan) 31 ( 5 ) 969 - 978 2024.9

Language：English Publishing type：Research paper (scientific journal)

BACKGROUND: Although the association between higher physical activity and preventive effect on breast-cancer-related lymphoedema (BCRL) has been reported, it is unclear what intervention is optimal. We aimed to investigate the effect of exercise and educational programs on BCRL development. METHODS: This study was a secondary endpoint analysis from a prospective randomized controlled trial. We enrolled patients with stage 0-III breast cancer from March 2016 to March 2020 and randomly assigned them to the control (n = 111), education (n = 115), or exercise (n = 104) group. As secondary endpoint, we assessed the incidence of and preventive effect on BCRL at 12 months post-intervention. RESULTS: There were no significant differences in the incidence of BCRL at 12 months post-intervention between the exercise and control groups (9.8% and 10.8%, P = 0.83) and the education and control groups (11.6% and 10.8%, P = 1.00). There were no significant differences in time to BCRL onset from the day of surgery between the exercise and control groups (event rate at 12 months: 20.7% and 17.2%, log-rank, P = 0.54) and the education and control groups (18.8% and 17.2%, log-rank, P = 0.57). The multivariable analyses indicated that axillary dissection and obesity significantly increased the risk of BCRL [hazard ratio (HR): 2.36, 95% confidence interval (CI) 1.52-3.67 and HR: 1.68, 95% CI 1.07-2.63, respectively]. CONCLUSIONS: The intervention did not decrease the risk of BCRL, and axillary dissection and obesity were the risk factors of BCRL. TRIAL REGISTRATION NUMBER: UMIN000020595 at UMIN Clinical Trial Registry.

DOI： 10.1007/s12282-024-01610-5

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枝園忠彦, 突沖貴宏, 高橋侑子, 岩谷胤生

日本臨床 82 ( 増刊7 乳癌学2024(下) ) 249 - 254 2024.9

Status of incremental costs of first-line treatment recommended in Japanese clinical guidelines for metastatic breast cancer patients Reviewed

Tsuguo Iwatani, Keita Sasaki, Ryunosuke Machida, Tadahiko Shien, Fumikata Hara, Tomomi Fujisawa, Yuko Takano, Yoshie Kobayashi, Michiyo Saimura, Kei Koizumi, Mitsuo Terada, Shinsuke Sasada, Kanako Saito, Miwa Sumiyoshi, Hiroji Iwata

Japanese Journal of Clinical Oncology 2024.8

Publishing type：Research paper (scientific journal) Publisher：Oxford University Press (OUP)

Abstract

Background

The increasing incidence and prevalence of breast cancer alongside diagnostic and treatment technology advances have produced a debate about the financial burden cancer places on the healthcare system and concerns about access.

Methods

This study was conducted at 51 hospitals belonging to the Breast Cancer Study Group of the Japan Clinical Oncology Group using a web-based survey. The survey period conducted from July 2021 to June 2022. The study population included patients with metastatic breast cancer who received the related treatment as their first-line therapy. The proportion of patients who selected that regimen as their first-line treatment was tabulated. The total cost increase for each current standard therapy in comparison to conventional treatments was calculated.

Results

A total of 702 patients (pts) were surveyed. Of those enrolled, 342 (48.7%) received high-cost treatment [estimated monthly drug costs exceeding ~500 000 Japanese Yen (JPY)]. Of these, 16 pts (4.7%) were receiving very high-cost treatment, amounting to more than 1 000 000 JPY per month. Fifty three (15.5%) of the patients who received high-cost treatment were 75 years of age or older. Of these, 1 pt (0.3%) were receiving very high-cost treatment. Analyses of incremental costs by current drugs showed that abemaciclib was costly with total additional cost of 6 365 670 JPY per patient. The total additional cost of the regimen per patient that included palbociclib was the second highest at 4011248 JPY, followed by atezolizumab at 3209033 JPY.

Conclusions

The findings indicate that evaluating the financial implications of high-cost treatments requires considering not only drug prices but also analysis of total cost increase.

DOI： 10.1093/jjco/hyae109

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術前薬物療法後病理学的完全奏効到達症例における早期遠隔再発症例の検討

高橋侑子, 三又明日香, 中本翔伍, 岩谷陽子, 突沖貴宏, 谷岡真樹, 岩谷胤生, 枝園忠彦

日本乳癌学会総会プログラム抄録集 32回 297 - 297 2024.7

転移再発乳癌におけるがんゲノムプロファイリングの現状と問題点がん遺伝子パネル検査の前向き観察研究(REIWA study)の中間解析結果と乳癌ゲノム医療の問題点

多田寛, 増田紘子, 安立弥生, 岩谷胤生, 上本康明, 大谷陽子, 梶原友紀子, 北川大, 古川孝広, 相良安昭, 枝園忠彦, 田辺裕子, 谷岡真樹, 原文堅, 八十島宏行, 服部正也, 吉村健一, 岩田広治, 増田慎三

日本乳癌学会総会プログラム抄録集 32回 25 - 25 2024.7

多様な背景を持つ乳癌患者の意思決定支援 LGBTに対する乳癌診療の事例報告

枝園忠彦, 染田朋子, 露無祐子, 三又明日香, 間森智花, 中本翔吾, 岩谷陽子, 突沖貴宏, 高橋侑子, 岩谷胤生, 谷岡真樹

日本乳癌学会総会プログラム抄録集 32回 29 - 29 2024.7

当院における乳腺葉状腫瘍の正診率と再発率の検討

中本翔伍, 突沖貴宏, 三又明日香, 高橋侑子, 岩谷陽子, 岩谷胤生, 谷岡真樹, 枝園忠彦

日本乳癌学会総会プログラム抄録集 32回 407 - 407 2024.7

重篤な薬剤性心不全にて長期入院加療を要した2症例の検討

間森智加, 突沖貴宏, 三又明日香, 中本翔伍, 岩谷陽子, 高橋侑子, 谷岡真樹, 岩谷胤生, 枝園忠彦

日本乳癌学会総会プログラム抄録集 32回 480 - 480 2024.7

BRCA病的バリアントを有する乳癌患者における術前化学療法に対する治療奏効率の検討

三又明日香, 高橋侑子, 中本翔伍, 突沖貴宏, 岩谷陽子, 谷岡真樹, 岩谷胤生, 枝園忠彦

日本乳癌学会総会プログラム抄録集 32回 289 - 289 2024.7

Nipple-areolar complex malposition in breast reconstruction after nipple-sparing mastectomy: a multi-institutional retrospective observational study in Japan. Reviewed

Sayuri Kato, Hiroki Mori, Miho Saiga, Satoko Watanabe, Shinsuke Sasada, Ayano Sasaki, Akiko Ogiya, Mao Yamamoto, Kazutaka Narui, Junji Takano, Hirohito Seki, Naomi Nagura, Makoto Ishitobi, Tadahiko Shien

Breast cancer (Tokyo, Japan) 31 ( 4 ) 649 - 658 2024.7

Authorship：Last author Language：English Publishing type：Research paper (scientific journal)

BACKGROUND: Position of the nipple-areolar complex (NAC) is an important factor in the esthetic impression of the breast, and NAC malposition is often an issue in breast reconstruction after nipple-sparing mastectomy (NSM). The purpose of this study was to evaluate the degree of NAC malposition depending on several factors using data quantified with the Mamma Balance application (Medic Engineering K.K., Kyoto, Japan). METHODS: Patients who underwent unilateral breast reconstruction after NSM at eight hospitals in Japan between 2007 and 2020 were retrospectively investigated. Using Mamma Balance, NAC malposition was quantified separately in horizontal and vertical directions using patient photographs from pre-operatively and 6-24 months post-operatively. The degree of malpositioning was then statistically compared using various factors. RESULTS: The NAC deviated more cranially and medially with implants than that with flaps. Cases with latissimus dorsi flap showed lateral malposition more often than cases with deep inferior epigastric artery perforator flap. With flaps, lateral incisions showed more lateral malposition, and peri-areolar incisions tended to show more medial NAC malposition. In cases with severe post-operative infection of the implant, the NAC tended to deviate cranially. In radiation cases, the NAC deviated cranially. No significant difference was observed according to the degree of breast ptosis or use of the pull-down operation. Only a very weak correlation was observed between a larger amount of mastectomy and more cranial NAC malposition with both flaps and implants. CONCLUSIONS: This study provides insights into the tendencies and characteristics of NAC malposition.

DOI： 10.1007/s12282-024-01578-2

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