Details of a Researcher - Hirata, Kenro

Appetite, coping strategies, and morale in older adults with advanced gastrointestinal cancer: a longitudinal observational study

Yagasaki K., Arahata T., Ishida N., Hirata K., Funato M., Hamamoto Y.

BMC Geriatrics 26 ( 1 ) 2026.12

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Background: Older adults with advanced gastrointestinal cancer face diverse physical challenges associated with the disease, treatments, and aging. Maintaining morale is crucial for these patients, as it enables them to sustain psychological well-being and a sense of fulfillment. We aimed to assess the relationships between appetite, coping strategies, and changes in morale after three months of follow-up in older adults with advanced gastrointestinal cancer. Methods: A three-month longitudinal observational study was conducted among 79 older adults (aged 70 and over) with advanced gastrointestinal cancer receiving chemotherapy as outpatients at a hospital in Japan between 2022 and 2024. We assessed morale using the Philadelphia Geriatric Center Morale Scale, appetite using the Simplified Nutritional Appetite Questionnaire, coping strategies using the Brief Coping Orientation to Problems Experienced Inventory, frailty using the Geriatric 8 scale, and symptoms using the MD Anderson Symptom Inventory. A linear mixed-effects model was used to estimate the difference in change in morale from baseline to three months later between high- and low-appetite groups. Results: Data from 66 participants who completed the follow-up were analyzed. The participants (mean age = 76.8 years) had a mean nutritional appetite score of 14.3, morale score of 12.0, and frailty score of 11.7. Acceptance was the most frequently used coping strategy. At three months from baseline, morale was lower in the low-appetite group than in the high-appetite group. While the change in morale over three months did not differ significantly between the two appetite groups, the use of substances as a coping strategy was significantly associated with lower morale after three months (p = 0.01). Conclusions: While low baseline appetite was associated with lower morale, it was not significantly associated with changes in morale over three months. Instead, reliance on substance use as a coping strategy appeared more important. Therefore, monitoring substance use may be useful for identifying patients who need greater psychological support. Additionally, considering support methods that enable older adults to enjoy eating aligned with their values might be beneficial. These results serve as a foundation for future research aimed at understanding and supporting the morale of older adults with gastrointestinal cancer.
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Randomized phase II study of FOLFIRI plus ramucirumab versus FOLFOXIRI plus ramucirumab as first-line treatment for metastatic colorectal cancer: WJOG9216G (RECAST)

Kito Y., Yamazaki K., Shoji H., Yamada T., Tsushima T., Mitani S., Shiraishi K., Yasui H., Hara H., Hirata K., Esaki T., Shinohara Y., Tsuzuki T., Kajiura S., Masuishi T., Izawa N., Baba E., Murata K., Akazawa N., Suzuki Y., Satake H., Boku N., Hyodo I., Yoshimura K., Kawakami H., Hironaka S., Muro K.

European Journal of Cancer 238 116688 2026.05

ISSN 09598049

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Background FOLFOXIRI plus bevacizumab improved efficacies and increased some adverse events in untreated metastatic colorectal cancer (mCRC), compared with the doublet plus bevacizumab. The clinical outcomes of ramucirumab (RAM) in combination with FOLFIRI or FOLFOXIRI as a first-line treatment are unknown. In this randomized phase II study (WJOG9216G), we compared the efficacy and safety of these regimens to determine which is more promising. Methods Patients with untreated mCRC were randomly assigned to the FOLFIRI-RAM or FOLFOXIRI-RAM arms. The primary endpoint was a confirmed objective response rate (ORR), and secondary endpoints included early tumor shrinkage (ETS), progression-free survival (PFS), overall survival (OS), and safety. Results In total, 122 patients were randomized. The confirmed ORR was 59.3% and 60.3% in the FOLFIRI-RAM and FOLFOXIRI-RAM arms, respectively (odds ratio 1.04; P = 0.91). With a median follow-up period of 42.1 and 40.4 months, PFS was comparable between the FOLFIRI-RAM and FOLFOXIRI-RAM arms (median, 11.5 and 10.5 months). ETS rate (71.2% and 52.4%) and OS (median, 32.6 and 28.2 months) were significantly better in the FOLFIRI-RAM arm than in the FOLFOXIRI-RAM arm. The major grade ≥ 3 adverse events in the FOLFIRI-RAM and FOLFOXIRI-RAM arms were neutropenia (44.1% and 72.6%), anorexia (3.4% and 14.5%), and febrile neutropenia (3.4% and 11.3%). Conclusions FOLFOXIRI plus RAM was not superior to FOLFIRI plus RAM in terms of efficacy, including ORR, in patients with untreated mCRC. Instead, first-line FOLFIRI plus RAM showed clinical efficacy and safety profiles comparable to those of doublet chemotherapy plus bevacizumab.
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A pragmatic phase II trial evaluating treatment strategies using immune checkpoint inhibitors for metastatic esophageal cancer patients with severe dysphagia.

Nagata Y, Arai H, Izawa N, Inagaki C, Sugaya A, Hirata K, Tsushima T, Moriwaki T, Masuishi T, Nagatani Y, Harada K, Taguri M, Sunakawa Y

ESMO gastrointestinal oncology 11 100310 2026.03
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Real-world clinical utility of comprehensive genomic profiling in advanced solid tumors

Saito Y., Horie S., Kogure Y., Mizuno K., Ito Y., Mizukami Y., Kim H., Tamura Z., Koya J., Funakoshi T., Hirata K., Kataoka K.

Nature Medicine 32 ( 2 ) 690 - 701 2026.02

ISSN 10788956

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Comprehensive genomic profiling (CGP) is crucial in precision oncology, yet its real-world utility remains unclear. Here we analyzed data from the Japanese nationwide Center for Cancer Genomics and Advanced Therapeutics database, including clinical and genetic data from 54,185 patients with advanced solid tumors (consisting of 81 common and rare tumor types) who received CGP with a targeted sequencing panel covering 324 genes as part of their clinical care. We assessed the prognostic value of CGP-guided clinical evidence-level classification, showing that alterations predicting response to Pharmaceuticals and Medical Devices Agency-approved or Food and Drug Administration-approved therapies and to therapies supported by well-powered studies with expert consensus are detected in 16.6% and 8.1% of patients, respectively, and are associated with better prognosis than those with lower clinical evidence levels. Only 8% of patients receive CGP-guided approved–experimental genomic biomarker-linked therapies, although the proportion has improved over time. Substantial differences were observed across tumor types, with the proportions exceeding 20% in thyroid and lung cancers but remaining below 2% in pancreatic and liver cancers. Tumor-agnostic biomarker analyses reveal that tumor mutational burden (TMB) ≥20 mutations per megabase predicts better outcome across tumor types, regardless of microsatellite instability status, in TMB-high patients receiving pembrolizumab. Conversely, extramammary Pagetʼs disease is exceptionally resistant to pembrolizumab. The large-scale nationwide database allows evaluating inter-tumor type differences and investigating evidence-scarce situations, delineating where CGP offers greater benefit. These real-world findings complement those from clinical trials and prospective sequencing projects regarding CGP, providing valuable information for individualized treatment.
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Solvent-based or nab-paclitaxel plus ramucirumab for pretreated gastric cancer with peritoneal dissemination and prespecified biomarker analysis (P-SELECT/WJOG10617G): a randomised phase 2 trial in Japan

Hirata K., Hamamoto Y., Shoji H., Hara H., Kondoh C., Yasui H., Kajiwara T., Baba E., Ando T., Sugimoto N., Kawakami H., Katsuya H., Nagase M., Yamamoto Y., Yoshimura K., Ando M., Imamura C.K., Yamazaki K., Hironaka S., Muro K.

Eclinicalmedicine 92 103768 2026.02

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SummaryBackgroundGastric cancer (GC) with peritoneal dissemination remains a challenge with poor prognosis and limited treatment options. We aimed to compare solvent-based paclitaxel (sb-PTX) + ramucirumab (RAM) vs. nanoparticle-albumin-bound paclitaxel (nab-PTX) + RAM as second-line therapy for unresectable or recurrent GC with peritoneal dissemination.MethodsThis prospective, randomised, open-label, multicentre phase 2 trial was conducted at 58 centres within the West Japan Oncology Group (WJOG) in Japan. Eligible participants were patients with histologically-confirmed GC with peritoneal dissemination refractory or intolerant to first-line therapy. Patients were randomised 1:1 to receive sb-PTX + RAM or nab-PTX + RAM. Primary endpoint was overall survival (OS); key secondary endpoints included progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), safety, and protocol-specified biomarker analyses including the assessment of stromal caveolin-1 (Cav-1) expression by immunohistochemistry on archival tumour specimens. The data cutoff for the analysis presented herein was January 27, 2021. This trial was registered in the Japan Registry of Clinical Trials (jRCTs031180022).FindingsBetween Oct 1, 2018, and Jan 27, 2020, 105 patients were assigned to sb-PTX + RAM (n = 53) or nab-PTX + RAM (n = 52). Median follow-up was 18.1 months. Median OS was 8.1 months with sb-PTX + RAM and 7.2 months with nab-PTX + RAM (HR [nab-PTX + RAM vs. sb-PTX + RAM], 0.960; 95% CI, 0.621–1.484; P = 0.631). Median PFS was 5.1 vs. 3.9 months (HR [nab-PTX + RAM vs. sb-PTX + RAM], 0.965; 95% CI, 0.642–1.450; P = 0.893). ORR was 20.7% vs. 20.0% (P = 0.993), and DCR was 77.4% vs. 63.5% (P = 0.150), with sb-PTX + RAM and nab-PTX + RAM. Grade≥3 neuropathy occurred in 7.5% with sb-PTX + RAM and 17.6% with nab-PTX + RAM, and febrile neutropenia in 11.3% vs. 5.9%. In biomarker analysis, OS and PFS improved stepwise with increasing Cav-1 expression in patients receiving nab-PTX + RAM (P = 0.007, P = 0.012); no such association was observed with sb-PTX + RAM. Among patients with high stromal Cav-1 expression (IHC score 3+), nab-PTX + RAM showed some evidence of improved OS compared with sb-PTX + RAM (HR [nab-PTX + RAM vs. sb-PTX + RAM], 0.371; 95% CI, 0.130–1.060; P = 0.055). The interaction between Cav-1 expression and treatment arm showed a non-significant trend (HR for interaction, 0.364; 95% CI, 0.115–1.152; P = 0.086), consistent with this finding.InterpretationTreatment with nab-PTX + RAM did not meet the prespecified threshold (HR < 0.90) for promising efficacy in patients with GC and peritoneal dissemination. High stromal Cav-1 expression was associated with improved efficacy of nab-PTX + RAM. Future studies should prospectively validate the predictive value of stromal Cav-1 in patients receiving nab-PTX + RAM.FundingTaiho Pharmaceutical Co. Ltd.
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Papers, etc., Registered in KOARA 【 Display / hide 】

Establishment of a standard of care for vulnerable older patients with esophageal squamous cell carcinoma

Hirata, Kenro

科学研究費補助金研究成果報告書 2022
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

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Reviews, Commentaries, etc. 【 Display / hide 】

Gastrointestinal: Ten-millimeter advanced duodenal cancer with a gastric phenotype

Matsuura N., Kato M., Irino T., Hirata K., Yahagi N.

Journal of Gastroenterology and Hepatology (Australia) (Journal of Gastroenterology and Hepatology (Australia)) 38 ( 3 ) 347 2023.03

ISSN 08159319
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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

[Domestic presentation]

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

[International presentation] 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

[International presentation] 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