Faculty Profiles - SHIEN Tadahiko

Papers - SHIEN Tadahiko

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乳癌領域外科治療の個別化 de-novo Stage IV乳がんに対する原発巣切除について残されたCQと次の展開

枝園忠彦, 岡美苗, 中山恵利香, 三又明日香, 桑原ちひろ, 間森智加, 中本翔吾, 突沖貴宏, 高橋侑子, 岩谷胤生

日本外科学会定期学術集会抄録集 124回 WS - 7 2024.4

外科と救急のダブルボード取得を目指した外科救急連携コース

黒田新士, 安井和也, 岡崎幹生, 小谷恭弘, 枝園忠彦, 小林純子, 中尾篤典, 笠原真悟, 豊岡伸一, 藤原俊義

日本外科学会定期学術集会抄録集 124回 SP - 6 2024.4

自壊を来たした乳腺巨大葉状腫瘍の1例

藤原亮太, 突沖貴宏, 三又明日香, 高橋侑子, 岩谷陽子, 岩谷胤生, 枝園忠彦

日本臨床外科学会雑誌 85 ( 3 ) 460 - 460 2024.3

自壊を来たした乳腺巨大葉状腫瘍の1例

藤原亮太, 突沖貴宏, 三又明日香, 高橋侑子, 岩谷陽子, 岩谷胤生, 枝園忠彦

日本臨床外科学会雑誌 85 ( 3 ) 460 - 460 2024.3

Ectopic Breast Cancer Arising within an Axillary Lymph Node. Reviewed

Kei Toshima, Tadahiko Shien, Midori Filiz Nishimura, Yoko Suzuki, Shogo Nakamoto, Maya Uno, Ryo Yoshioka, Takahiro Tsukioki, Yuko Takahashi, Takayuki Iwamoto, Tsuguo Iwatani, Hiroyuki Yanai

Acta medica Okayama 78 ( 1 ) 89 - 93 2024.2

Authorship：Corresponding author Language：English

We report our experience with the diagnosis and treatment of an ectopic breast cancer arising within an axillary lymph node. The patient was a 65-year-old woman diagnosed breast cancer and axillary lymph node metastasis. We performed a partial mastectomy and axillary lymph node dissection. Postoperative pathology revealed no malignant lesions in the breast; however, a nodule in one of axillary lymph nodes had mixed benign and malignant components, leading to a diagnosis of invasive ductal carcinoma derived from ectopic mammary tissue. This case represents a very rare form of breast cancer, and the malignancy was difficult to distinguish from metastasis.

DOI： 10.18926/AMO/66676

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Lung Oligometastasis of Breast Cancer: Prospective Cohort Study of Treatment Strategies (SBP-06). Reviewed

Reina Maeda, Tadahiko Shien, Mina Takahashi, Kengo Kawada, Yukiko Kajiwara, Shinichiro Kubo, Daisuke Takabatake, Shoichiro Ohtani, Kinya Matsuoka, Hajime Hikino, Yutaka Ogasawara, Naruto Taira, Shozo Osumi, Masahiko Ikeda, Hiroyoshi Doihara

Acta medica Okayama 78 ( 1 ) 15 - 20 2024.2

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

While local treatment of metastases is considered to be unrelated to prognosis, previous studies have suggested that local treatment of isolated lung metastases may have positive prognostic impact. We designed this prospective cohort study to investigate the clinical situation and its outcomes. We enrolled patients with fewer than 3 lung nodules suspected of being oligometastases after curative breast cancer surgery. Treatments, including local and systemic therapy, were selected by the physician and patient in consultation. The primary outcome was overall survival (OS); secondary outcomes were the efficacy and the safety of the surgery for lung oligometastases. Between May 2015 and May 2019, 14 patients were enrolled. Resection of lung nodules (metastasectomy) was performed in 11 (78.6%) of 14 patients, and one of these cases was diagnosed as primary lung cancer. Metastasectomies were all performed employing video-assisted thoracic surgery (VATS) without perioperative complications. Systemic therapies were administered to all patients except one. The respective 3-year and 5-year OS rates of patients with lung oligometastases were 91.6% and 81.5%, respectively. Progression occurred in 6 patients: 3 of the 10 with metastasectomy and all 3 without this surgical procedure. Lung metastasectomy was worthwhile as a diagnostic evaluation and may provide long-term benefit in some patients.

DOI： 10.18926/AMO/66666

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Pilot trial of an electronic patient-reported outcome monitoring system in patients with metastatic breast cancer undergoing chemotherapy. Reviewed

Naruto Taira, Yuichiro Kikawa, Takayuki Iwamoto, Yuichiro Miyoshi, Kyoko Hara, Seiji Yoshitomi, Hajime Hikino, Hirotoshi Takahashi, Daisuke Takabatake, Shinichiro Kubo, Masahiko Ikeda, Hiroyoshi Doihara, Tadahiko Shien, Hiromi Okuyama, Yuko Tanabe, Fumikata Hara, Kosho Yamanouchi, Yasuhiro Hagiwara, Masataka Sawaki

Breast cancer (Tokyo, Japan) 31 ( 2 ) 283 - 294 2024.1

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

BACKGROUND: Electronic patient-reported outcomes monitoring (ePROM) is a useful communication tool for patients and healthcare providers in cancer chemotherapy. In this study, we examined the feasibility of our newly developed ePROM system, which we refer to as "Hibilog". METHODS: An ePROM app was developed by extracting 18 items from the Patient-Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE). Symptom monitoring was conducted every two weeks for patients with metastatic breast cancer undergoing chemotherapy. The primary outcome was the response rate to the ePROM system. The secondary outcomes were response time, item missing rate, and distribution of responses for each symptom. RESULTS: A total of 71 cases (mean age 52.6 years) were analyzed. Performance status was 0 in 76% of the cases and 1 or higher in 24%. First-line treatment was being administered in 30% of cases, second-line treatment in 17%, and third-line or higher treatment in 53%. The response rate to the ePROM system from registration to week 40 remained high at around 80%, indicating good compliance. The average response time was 5.5 min and the missing rate for each item was below 0.4%. Among 1,093 responses, the top 3 symptoms causing interference with daily life were Fatigue (63%), Numbness and tingling (48%), and General pain (46%). CONCLUSION: Our developed ePROM system was able to capture symptoms accurately in patients with metastatic breast cancer undergoing chemotherapy while maintaining a high response compliance.

DOI： 10.1007/s12282-023-01537-3

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Current status and challenges of breast cancer prevention~DNA methylation would lead to groundbreaking progress in breast cancer prevention~. Reviewed International journal

Takahiro Tsukioki, Seema A Khan, Tadahiko Shien

Genes and environment : the official journal of the Japanese Environmental Mutagen Society 45 ( 1 ) 35 - 35 2023.12

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

The number of breast cancer patients is increasing worldwide. Furthermore, breast cancer often develops in young people, even those only in their 30s, who play a central role in their families and society. Results from many cohort studies suggest that dietary factors, alcohol consumption, lack of physical activity, obesity, nulliparity, breastfeeding, oral contraceptive use, fertility treatment and hormone replacement therapy are risk factors for breast cancer. However, the effects of lifestyle habits on the human body are complexly intertwined with various factors, and the effects vary from person to person depending on their constitution, etc., so there is no basis for this. Therefore, primary prevention of breast cancer is still not being implemented appropriately and efficiently. Furthermore, advances in genomic technology make it possible to assess the risk of developing breast cancer in some individuals. As a result, the establishment of breast cancer prevention methods has become a health priority for high-risk individuals.Drugs such as tamoxifen and raloxifene are known to prevent the development of breast cancer, based on the results of multiple randomized controlled trials, but there are concerns regarding the side effects of these powerful agents. In addition, several clinical studies have shown that prophylactic mastectomy for women who have BRCA mutations or who are identified as being at high risk reduces the incidence of breast cancer development. However, many issues, such as changes in long-term quality of life after preventive surgery, the optimal timing of surgery and the identification of women who are at high risk but will not develop breast cancer, remain uncertain. In other words, although many researchers have focused on chemoprevention and surgical prevention and clear preventive effects of these strategies have been confirmed, it cannot be said that they are widely accepted. Therefore, the current evidence for chemoprevention and surgical prevention, as well as highlights of several interesting lines of research currently underway, are summarized in this article.

DOI： 10.1186/s41021-023-00287-0

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Systemic immunity markers are associated with clinical outcomes of atezolizumab treatment in patients with triple-negative advanced breast cancer: a retrospective multicenter observational study. Reviewed International journal

Shogo Nakamoto, Tadahiko Shien, Mitsuya Itoh, Yutaka Yamamoto, Shozo Ohsumi, Seiji Yoshitomi, Hajime Hikino, Kazuya Miyoshi, Akifumi Notsu, Naruto Taira, Hiroyoshi Doihara, Masahiko Ikeda

Clinical and experimental medicine 23 ( 8 ) 5129 - 5138 2023.12

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

Immune checkpoint inhibitors (ICI) are reportedly efficacious against triple-negative breast cancer (TNBC) and are now recommended as first-line therapy. Systemic immunity markers, the absolute lymphocyte count (ALC) and the neutrophil-to-lymphocyte ratio (NLR), have been identified as predict ICI efficacy in patients with various cancers. We retrospectively enrolled 36 TNBC patients who received atezolizumab treatment between September 2019 and May 2021 at eight Japanese medical institutions. We evaluated systemic immunity markers, including dynamic changes in these markers, as predictors of survival benefit derived from atezolizumab treatment. Median time-to-treatment failure (TTF) and overall survival (OS) were 116 days and "not reached", respectively. Patients with low NLR at baseline and decreased NLR at the start of the second cycle (SO2nd) had significantly longer OS than those with high NLR at baseline and increased NLR (SO2nd) (log-rank P < 0.001 and log-rank P = 0.049, respectively). Multivariate analyses identified high ALC at baseline and decreased NLR (SO2nd) as independent predictive markers for longer TTF (P = 0.043 and P = 0.002, respectively), and low NLR at baseline and decreased NLR (SO2nd) as independent predictive markers for longer OS (P < 0.001 and P = 0.013, respectively). The safety profile was consistent with those of previous trials. This retrospective multicenter observational study showed the clinical efficacy and safety of atezolizumab treatment. Furthermore, systemic immunity markers, including their dynamic changes, were found to be associated with clinical outcomes of atezolizumab treatment in patients with advanced or metastatic TNBC.

DOI： 10.1007/s10238-023-01230-x

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多遺伝子パネル検査を用いて治療方針を決定した若年の非浸潤性乳管癌患者の一例

鈴木陽子, 岩谷胤生, 仁科卓也, 吉本皓一, 宇野摩耶, 中本翔伍, 高橋侑子, 突沖貴宏, 岩本高行, 伊波茂道, 平沢晃, 枝園忠彦

日本臨床外科学会雑誌 84 ( 11 ) 1830 - 1830 2023.11

多遺伝子パネル検査を用いて治療方針を決定した若年の非浸潤性乳管癌患者の一例

鈴木陽子, 岩谷胤生, 仁科卓也, 吉本皓一, 宇野摩耶, 中本翔伍, 高橋侑子, 突沖貴宏, 岩本高行, 伊波茂道, 平沢晃, 枝園忠彦

日本臨床外科学会雑誌 84 ( 11 ) 1830 - 1830 2023.11

The Japanese Breast Cancer Society Clinical Practice Guidelines for surgical treatment of breast cancer, 2022 edition. Reviewed

Takehiko Sakai, Goro Kutomi, Tadahiko Shien, Sota Asaga, Tomoyuki Aruga, Makoto Ishitobi, Sayaka Kuba, Masataka Sawaki, Kaori Terata, Koichi Tomita, Chikako Yamauchi, Yutaka Yamamoto, Hiroji Iwata, Shigehira Saji

Breast cancer (Tokyo, Japan) 2023.10

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

The 2022 revision of the Japanese Breast Cancer Society (JBCS) Clinical Practice Guidelines for surgical treatment of breast cancer was updated following a systematic review of the literature using the Medical Information Network Distribution Service (MINDS) procedure, which focuses on the balance of benefits and harms for various clinical questions (CQs). Experts in surgery designated by the JBCS addressed five areas: breast surgery, axillary surgery, breast reconstruction, surgical treatment for recurrent and metastatic breast cancer, and other related topics. The revision of the guidelines encompassed 4 CQs, 7 background questions (BQs), and 14 future research questions (FRQs). A significant revision in the 2022 edition pertained to axillary management after neoadjuvant chemotherapy in CQ2. The primary aim of the 2022 JBCS Clinical Practice Guidelines is to provide evidence-based recommendations to empower patients and healthcare professionals in making informed decisions regarding surgical treatment for breast cancer.

DOI： 10.1007/s12282-023-01510-0

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Patients Offer Radiofrequency Ablation Therapy for Early Breast Cancer as Local Therapy (PO-RAFAELO) Study under the Patient-proposed Health Services. Reviewed

Shin Takayama, Takayuki Kinoshita, Sho Shiino, Kenjiro Jimbo, Ken-Ichi Watanabe, Tomomi Fujisawa, Naohito Yamamoto, Tatsuya Onishi, Tadahiko Shien, Mitsuya Ito, Mina Takahashi, Manabu Futamura, Tomoyuki Aruga, Koji Kaneko, Akihiko Suto

JMA journal 6 ( 4 ) 505 - 512 2023.10

Language：English

INTRODUCTION: Due to the increase in the number of early-stage breast cancer patients, there is growing interest in minimally invasive local therapies for breast cancer. Radiofrequency ablation (RFA) therapy is one of the most promising minimally invasive treatments. The Radiofrequency Ablation Therapy for Early Breast Cancer as Local Therapy (RAFAELO) study, a multicenter collaborative study that aims to validate the efficacy and safety of RFA and to standardize its use for early-stage breast cancer, was conducted under the Advanced Medical Care B system in 2013. This study enrolled the expected number of patients in November 2017; moreover, it is currently in the follow-up period. Some patients with early-stage breast cancer who are eligible for RFA could not receive the RFA treatment, as it is still not covered by insurance. Therefore, the Patients Offer Radiofrequency Ablation Therapy for Early Breast Cancer as Local Therapy (PO-RAFAELO) study under the Patient-proposed Health Services (PPHS) was proposed and approved in March 2019. METHODS: The PPHS is a system that allows patients to receive prompt access to advanced medical care at a medical facility close to them, starting with their request. This system is considered a part of the specific and special medical coverage. The PO-RAFAELO study is the only study in the surgical field utilizing the PPHS, aiming to help in achieving regulatory approval and insurance coverage of RFA for breast cancer. RESULTS: As of January 2023, 120 patients have undergone RFA using the PPHS and no grade 3 or higher early adverse events have occurred. CONCLUSIONS: A certain number of patients with early-stage breast cancer prefer nonsurgical treatment, and it is important to provide information regarding the availability of RFA for early-stage breast cancer under the PPHS.Trial registration: registered with Japan Registry of Clinical Trial on March 06, 2019 (Trial ID: jRCTs032180187).

DOI： 10.31662/jmaj.2023-0047

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Long-Term Outcomes of Breast Cancer Patients with Local Recurrence After Mastectomy Undergoing Immediate Breast Reconstruction: A Retrospective Multi-institutional Study of 4153 Cases. Reviewed International journal

Akiko Ogiya, Naomi Nagura, Ayaka Shimo, Hiroko Nogi, Kazutaka Narui, Hirohito Seki, Hiroki Mori, Shinsuke Sasada, Makoto Ishitobi, Naoto Kondo, Chikako Yamauchi, Kohei Akazawa, Tadahiko Shien

Annals of surgical oncology 30 ( 11 ) 6532 - 6540 2023.10

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

BACKGROUND: The number of breast cancer patients in Japan undergoing immediate breast reconstruction (IBR) has increased and the postoperative follow-up period has been extended. This study was conducted to clarify the clinical aspects of, and factors associated with, local recurrence (LR) after IBR. METHODS: This was a multicenter study which included 4153 early breast cancer patients who underwent IBR. Clinicopathological characteristics were examined and factors potentially contributing to LR were analyzed. Risk factors for LR were examined separately for non-invasive and invasive breast cancers. RESULTS: The median follow-up period was 75 months. The 7-year LR rates were 2.1% and 4.3% for non-invasive and invasive cancers, respectively (p < 0.001). The proportions of LR detected by palpation, subjective symptoms, and ultrasonography were 40.0%, 27.3%, and 25.9%, respectively. Overall, 75.7% of LR were solitary, and 92.7% of these cases had no further recurrences during the observational period. Multivariate analysis of LR for invasive cancer showed that skin-sparing mastectomy (SSM) or nipple-sparing mastectomy (NSM), the presence of lymphovascular invasion, cancer at the surgical margin, and not receiving radiation therapy were factors related to LR. The 7-year overall survival rates of the patients with LR and non-LR of invasive cancers were 92.5% and 97.3%, respectively, (p = 0.002). CONCLUSIONS: The rate of LR after IBR was acceptably low and IBR can thus be performed safely for early breast cancer patients. Invasive cancer, SSM/NSM, lymphovascular invasion, and/or cancer at the surgical margin should prompt awareness of the possibility of LR.

DOI： 10.1245/s10434-023-13832-6

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ASO Visual Abstract: Long-Term Outcomes of Breast Cancer Patients with Local Recurrence After Mastectomy Undergoing Immediate Breast Reconstruction-A Retrospective, Multi-institutional Study of 4153 Cases. Reviewed International journal

Akiko Ogiya, Naomi Nagura, Ayaka Shimo, Hiroko Nogi, Kazutaka Narui, Hirohito Seki, Hiroki Mori, Shinsuke Sasada, Makoto Ishitobi, Naoto Kondo, Chikako Yamauchi, Kohei Akazawa, Tadahiko Shien

Annals of surgical oncology 30 ( 11 ) 6543 - 6544 2023.10

ASO Author Reflections: Long Term Outcomes of Breast Cancer Patients with Local Recurrence After Mastectomy Undergoing Immediate Breast Reconstruction. Reviewed International journal

Akiko Ogiya, Naomi Nagura, Ayaka Shimo, Hiroko Nogi, Kazutaka Narui, Hirohito Seki, Hiroki Mori, Shinsuke Sasada, Makoto Ishitobi, Naoto Kondo, Chikako Yamauchi, Kohei Akazawa, Tadahiko Shien

Annals of surgical oncology 30 ( 11 ) 6541 - 6542 2023.10

ライフイベント時に本当に必要な支援とは? 高いチーム力でダイバーシティとインクルージョンを目指す当院のキャリア支援

小林純子, 竹原裕子, 溝尾妙子, 菊地覚次, 三好健太郎, 黒田新士, 田邊俊介, 楳田祐三, 小谷恭弘, 杉本誠一郎, 岡崎幹生, 枝園忠彦, 豊岡伸一, 藤原俊義, 笠原真悟

日本臨床外科学会雑誌 84 ( 増刊 ) S73 - S73 2023.10

Prognostic impact of adjuvant endocrine therapy for estrogen receptor-positive and HER2-negative T1a/bN0M0 breast cancer. Reviewed International journal

Shinsuke Sasada, Naoto Kondo, Hiroya Hashimoto, Yuko Takahashi, Kaori Terata, Kumiko Kida, Yasuaki Sagara, Takayuki Ueno, Keisei Anan, Akihiko Suto, Chizuko Kanbayashi, Mina Takahashi, Rikiya Nakamura, Toshiyuki Ishiba, Michiko Tsuneizumi, Seiichiro Nishimura, Yoichi Naito, Fumikata Hara, Tadahiko Shien, Hiroji Iwata

Breast cancer research and treatment 2023.9

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

PURPOSE: Mammography screening has increased the detection of subcentimeter breast cancers. The prognosis for estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative T1a/bN0M0 breast cancers is excellent; however, the necessity of adjuvant endocrine therapy (ET) is uncertain. METHODS: We evaluated the effectiveness of adjuvant ET in patients with ER-positive and HER2-negative T1a/bN0M0 breast cancer who underwent surgery from 2008 to 2012. Standard ET was administrated after surgery. The primary endpoint was the cumulative incidence of distant metastasis. All statistical tests were 2-sided. RESULTS: Adjuvant ET was administered to 3991 (83%) of the 4758 eligible patients (1202 T1a [25.3%] and 3556 T1b [74.7%], diseases). The median follow-up period was 9.2 years. The 9-year cumulative incidence of distant metastasis was 1.5% with ET and 2.6% without ET (adjusted subdistribution hazard ratio [sHR], 0.54; 95% CI, 0.32-0.93). In multivariate analysis, the independent risk factors for distant metastasis were no history of ET, mastectomy, high-grade, and lymphatic invasion. The 9-year overall survival was 97.0% and 94.4% with and without ET, respectively (adjusted HR, 0.57; 95% CI, 0.39-0.83). In addition, adjuvant ET reduced the incidence of ipsilateral and contralateral breast cancer (9-year rates; 1.1% vs. 6.9%; sHR, 0.17, and 1.9% vs. 5.2%; sHR, 0.33). CONCLUSIONS: The prognosis was favorable in patients with ER-positive and HER2-negative T1a/bN0M0 breast cancer. Furthermore, adjuvant ET reduced the incidence of distant metastasis with minimal absolute risk difference. These findings support considering the omission of adjuvant ET, especially for patients with low-grade and no lymphatic invasion disease.

DOI： 10.1007/s10549-023-07097-6

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乳癌術後乳房再建の現状と課題第26回日本乳癌学会班研究「乳房再建の安全性と予後に関する研究」全国アンケート調査 Reviewed

笹田伸介, 近藤直人, 石飛真人, 野木裕子, 山内智香子, 森弘樹, 荻谷朗子, 成井一隆, 名倉直美, 志茂彩華, 関大仁, 櫻井照久, 寺田かおり, 雜賀美帆, 枝園忠彦

乳癌の臨床 38 ( 4 ) 325 - 335 2023.8

Authorship：Last author Language：Japanese Publisher：(株)篠原出版新社

近年,乳癌診療の一部として乳房再建術が普及している.乳房再建の実態と周術期治療への影響を検討するため,大規模アンケート調査を行った.429施設より回答が得られ,乳房再建を提供している施設は73%であった.そのうち,自家組織を用いた乳房再建は75%,遊離皮弁を用いた乳房再建は48%の施設で実施されており,それぞれ形成外科医が2名以上,3名以上所属している施設が多かった.乳房再建が周術期治療に及ぼす影響は,化学療法は「変更なし」と回答した施設が94%であったのに対し,放射線療法は15%が「変更する」とし,適応症例や照射範囲を縮小する傾向があった.高度な技術を要する乳房再建術は複数の形成外科医を必要とし,周術期治療の変化が予後に与える影響を評価する必要がある.(著者抄録)

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Development and validation of a symptom illustration scale from the patient-reported outcome common terminology criteria for adverse events for patients with breast cancer. Reviewed

Yoko Suzuki, Takayuki Iwamoto, Maya Uno, Minami Hatono, Yukiko Kajiwara, Yuko Takahashi, Mariko Kochi, Tadahiko Shien, Yuichiro Kikawa, Yukari Uemura, Yasuhiro Hagiwara, Seiichiro Yamamoto, Naruto Taira, Hiroyoshi Doihara, Shinichi Toyooka

Breast cancer (Tokyo, Japan) 30 ( 5 ) 856 - 868 2023.7

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

PURPOSE: Emojis are commonly used for daily communication and may be useful in assessing patient-reported outcomes (PROs) in breast cancer. The purpose of this study is to develop and validate a Symptom Illustration Scale (SIS) as a new PRO measurement. METHODS: Eighteen original SIS items were developed from the PRO-CTCAE. In cohort one, the SIS validity and reliability were examined in patients with breast cancer, using a semi-structured five-question survey to investigate content validity. PROs with PRO-CTCAE and SIS were examined twice to determine criteria validity and test-retest reliability. In cohort two, the responsiveness of the scales were examined in patients treated with anthracycline, docetaxel, paclitaxel, and endocrine therapy. PROs with PRO-CTCAE and SIS were investigated two or three times, depending on the therapy. RESULTS: Patients were enrolled from August 2019 to October 2020. In cohort one (n = 70), most patients had no difficulties with the SIS, but 16 patients indicated that it was difficult to understand severities in the SIS. For criterion validity, Spearman rank correlation coefficients (rs) between PRO-CTCAE and SIS items were ≥ 0.41, except for "Decreased appetite." For test-retest reliability, κ coefficients of the SIS were ≥ 0.41 for 16/18 items (88.9%). Response time was significantly shorter for the SIS than for PRO-CTCAE (p < 0.001). In cohort two (n = 106), score changes between PRO-CTCAE and SIS for relevant symptoms all had correlations with rs ≥ 0.41. CONCLUSION: An original SIS from the PRO-CTCAE for patients with breast cancer were verified the validity, reliability, and responsiveness. Further studies to improve and validate the SIS are needed.

DOI： 10.1007/s12282-023-01480-3

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