Details of a Researcher - Hirata, Kenro

Prospective feasibility study of indigo naturalis ointment for chemotherapy-induced oral mucositis

Hirata, K., Yamada, Y., Hamamoto, Y., Tsunoda, K., Muramatsu, H., Horie, S., Sukawa, Y., Naganuma, M., Nakagawa, T. and Kanai, T.

BMJ Support Palliat Care 2021.10

ISSN 2045-435x

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OBJECTIVES: Indigo naturalis, a herbal medicine effective against ulcerative colitis, exhibits anti-inflammatory effects and induces interleukin-22-mediated antimicrobial peptide production. Anti-inflammatory activity and the prevention of secondary infection are essential for the management of chemotherapy-induced oral mucositis (CIOM); therefore, we developed an indigo naturalis ointment to be administered topically for CIOM and evaluated its feasibility. METHODS: We performed a single-centre, open-label, prospective feasibility study from March 2017 to December 2018. The key eligibility criteria for the subjects were as follows: (1) receiving chemotherapy for a malignant tumour; (2) grade 1 or 2 CIOM and (3) receiving continuous oral care. The treatment protocol comprised topical indigo naturalis ointment application three times a day for 7 days. The primary endpoint assessed was feasibility. The secondary endpoints assessed were the changes in oral findings, oral cavity pain and safety. RESULTS: Nineteen patients with CIOM were enrolled. The average feasibility (the proportion of prescribed applications that were carried out) observed in this study was 94.7%±8.9% (95% CI 90.5% to 99.0%), which was higher than the expected feasibility. The revised oral assessment guide scores of the mucous membrane domain and total scores were significantly improved. All patients reported a reduction in oral cavity pain, with a median pain resolution duration of 6 days. No serious adverse events were observed. CONCLUSIONS: The indigo naturalis ointment was feasible, and showed the potential for efficacy and safety. Larger randomised controlled trials are needed to further assess the efficacy and safety of indigo naturalis compared with a placebo. TRIAL REGISTRATION NUMBER: UMIN000024271.
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Analysis of risk factors for immune-related adverse events in various solid tumors using real-world data

Shimozaki K., Sukawa Y., Sato Y., Horie S., Chida A., Tsugaru K., Togasaki K., Kawasaki K., Hirata K., Hayashi H., Hamamoto Y., Kanai T.

Future Oncology （Future Oncology) 17 （ 20 ） 2593 - 2603 2021.07

ISSN 14796694

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The aim of this study was to determine the risk factors for immune-related adverse events (irAEs) induced by immune checkpoint inhibitors. The authors conducted a retrospective study in which patients with malignant melanoma, non-small-cell lung cancer, gastric cancer or renal cell carcinoma who received anti-PD-1/PD-L1 antibodies were included. Of 247 patients, 118 developed a total of 182 irAEs. In the multivariate Fine-Gray regression analysis, serum albumin level ≥3.6 g/dl (hazard ratio: 1.62; 95% CI: 1.10-2.39; p = 0.015) and history of Type I hypersensitivity reactions (hazard ratio: 1.48; 95% CI: 1.02-2.14; p = 0.037) were significantly associated with the development of irAEs. High serum albumin levels and history of Type I hypersensitivity reactions are risk factors for irAEs.
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Clinical, Endoscopic, and Pathological Characteristics of Immune Checkpoint Inhibitor-Induced Gastroenterocolitis

Hayashi Y., Hosoe N., Takabayashi K., Limpias Kamiya K.J.L., Tsugaru K., Shimozaki K., Hirata K., Fukuhara K., Fukuhara S., Mutaguchi M., Sujino T., Sukawa Y., Hamamoto Y., Naganuma M., Takaishi H., Shimoda M., Ogata H., Kanai T.

Digestive Diseases and Sciences （Digestive Diseases and Sciences) 66 （ 6 ） 2129 - 2134 2021.06

ISSN 01632116
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The entire intestinal tract surveillance using capsule endoscopy after immune checkpoint inhibitor administration: A prospective observational study

Shimozaki K., Hirata K., Horie S., Chida A., Tsugaru K., Hayashi Y., Kawasaki K., Miyanaga R., Hayashi H., Mizuno R., Funakoshi T., Hosoe N., Hamamoto Y., Kanai T.

Diagnostics （Diagnostics) 11 （ 3 ） 2021.03

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Background: Despite the proven efficacy of immune checkpoint inhibitors (ICIs) against various types of malignancies, they have been found to induce immune-related adverse events, such as enterocolitis; however, the clinical features of ICI-induced enterocolitis remain to be sufficiently elucidated, which is significant, considering the importance of early detection in the appropriate management and treatment of ICI-induced enterocolitis. Therefore, the current study aimed to determine the utility of capsule endoscopy as a screening tool for ICI-induced enterocolitis. Methods: This single-center, prospective, observational study was conducted on patients with malignancy who received any ICI between April 2016 and July 2020 at Keio University Hospital. Next, second-generation capsule endoscopy (CCE-2) was performed on day 60 after ICI initiation to explore the entire gastrointestinal tract. Results: Among the 30 patients enrolled herein, 23 underwent CCE-2. Accordingly, a total of 23 findings were observed in 14 (60.8%) patients at any portion of the gastrointestinal tract (7 patients in the colon, 4 patients in the small intestine, 2 patients in both the colon and the small intestine, and 1 patient in the stomach). After capsule endoscopy, 2 patients (8.7%) developed ICI-induced enterocolitis: both had significantly higher Capsule Scoring of Ulcerative Colitis than those who had not developed ICI-induced enterocolitis (p = 0.0455). No adverse events related to CCE-2 were observed. Conclusions: CCE-2 might be a safe and useful entire intestinal tract screening method for the early detection of ICI-induced enterocolitis in patients with malignancies.
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An investigator-initiated phase 2 study of nivolumab plus low-dose ipilimumab as first-line therapy for microsatellite instability—high advanced gastric or esophagogastric junction cancer (No limit, wjog13320g/ca209-7w7)

Kawakami H., Hironaka S., Esaki T., Chayama K., Tsuda M., Sugimoto N., Kadowaki S., Makiyama A., Machida N., Hirano H., Hirata K., Hara H., Yabusaki H., Komatsu Y., Muro K.

Cancers （Cancers) 13 （ 4 ） 1 - 12 2021.02

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Nivolumab (NIVO) plus low-dose ipilimumab (IPI) has shown a promising survival benefit in first-line treatment of microsatellite instability-high (MSI-H) colorectal cancer. We hypothesized that this regimen might also be beneficial for MSI-H gastric cancer (GC), which accounts for ~5% of all GC cases. NO LIMIT (WJOG13320G/CA209-7W7) is an investigator-initiated, single-arm, open-label, 14-center phase 2 trial of NIVO plus low-dose IPI for MSI-H GC in the first-line setting. Eligibility criteria include unresectable advanced, recurrent, or metastatic gastric or esophagogastric junction cancer with a histologically confirmed diagnosis of adenocarcinoma; confirmed MSI-H status with the MSI-IVD Kit (FALCO); no prior systemic anticancer therapy; an Eastern Cooperative Oncology Group performance status of 0 or 1; and a measurable lesion per RECIST 1.1. The primary objective of the study is to determine the overall response rate (ORR) for the NIVO+IPI regimen as assessed by blinded independent central review. Secondary end points include progression-free survival, overall survival, duration of response, safety, tolerability, and biomarkers. The number of patients was set at 28 on the basis of the threshold and expected ORR values of 35 and 65%, respectively, with a one-sided alpha error of 0.025 and power of 0.80. Subjects will receive treatment with nivolumab (240 mg) biweekly in combination with ipilimumab (1 mg/kg) every 6 weeks. The results of this study should clarify the therapeutic potential of NIVO+IPI for MSI-H GC in the first-line setting.
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Papers, etc., Registered in KOARA 【 Display / hide 】

Establishment of a foundation for tailor-made medicine for elderly esophageal cancer patients who are intolerant to standard therapies

Hirata, Kenrō

科学研究費補助金研究成果報告書 2019
早期胃癌におけるCD44 variant 9発現は有用な癌再発バイオマーカーとなる

Hirata, Kenro

（慶應義塾大学大学院医学研究科) 2013
早期胃癌におけるCD44 variant 9発現は有用な癌再発バイオマーカーとなる

Hirata, Kenro

（慶應義塾大学大学院医学研究科) 2013
早期胃癌におけるCD44 variant 9発現は有用な癌再発バイオマーカーとなる

Hirata, Kenro

（慶應義塾大学大学院医学研究科) 2013
The influence of H. pylori infection on iron absorption in the duodenum

Hirata, Kenro

科学研究費補助金研究成果報告書 2012

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Presentations 【 Display / hide 】

Vulnerable臨床病期IB-III食道扁平上皮癌患者に対するパクリタキセル併用放射線療法の第I相試験

2021.09
,
Oral presentation (general)
Randomized phase II trial of weekly paclitaxel + ramucirumab versus weekly nab-paclitaxel + ramucirumab for unresectable advanced or recurrent gastric cancer with peritoneal dissemination refractory to first-line therapy: WJOG10617G/P-SELECT.

Kenro Hirata, Yasuo Hamamoto, Kenji Tsuchihashi, Chihiro Kondoh, Kentaro Yamazaki, Shuichi Hironaka, Masahiko Ando, Chiyo K Imamura, Kenichi Yoshimura, Kei Muro

The European Society for Medical Oncology Cancer Congress 2019,

2019.09
,
Poster presentation
咽頭メラノーシスの視認は上気道消化管新生物予測に有用である

Kenro Hirata

第15回日本臨床腫瘍学会学術集会,

2017.07
Soft palatal melanosis as a predictor for neoplasia in the upper aerodigestive tract.

Kenro Hirata

American Society of Clinical Oncology 2017,

2017.06
上気道消化管新生物予測における咽頭メラノーシスの有用性の検討

Kenro Hirata

アルコール医学生物学研究会,

2017.01
,
Oral presentation (general)

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Research Projects of Competitive Funds, etc. 【 Display / hide 】

がん化学療法後に増悪した根治切除不能な進行・再発食道扁平上皮癌に対するNivolumab療法におけるバイオマーカー探索を含む前向き観察研究

2021

-

Present

Joint research, Principal investigator
化学療法誘発性口腔粘膜炎における青黛軟膏の臨床開発

2021

-

Present

Joint research, Principal investigator
Vulnerable高齢食道扁平上皮癌患者に対する標準治療の確立

2020.04

-

2023.03

Research grant, Principal investigator
BRAF変異型Stage IV大腸癌に対するFOLFOXIRI+BEV療法の有効性に関する後方視的検討

2020.04

-

2021.03

Other, Principal investigator
オンライン診療を用いた緩和ケアの有用性に関する検討

2020.04

-

2021.03

Joint research, Principal investigator

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Awards 【 Display / hide 】

有吉・福岡賞

2021.06, 西日本がん研究機構（West Japan Oncology Group: WJOG）

Type of Award： Award from publisher, newspaper, foundation, etc.
J-HOPE award

2019.03, The University of Texas MD Anderson Cancer Center

Type of Award： Award from publisher, newspaper, foundation, etc.
内科学教室同窓会　松木康夫賞

2018.06
第８回 ICAT publication award

2013.12
第７回 ICAT award 最優秀賞

2012.12