Details of a Researcher - Hirata, Kenro

Papers - Hirata, Kenro

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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

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

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

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

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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Comment on "Proton Pump Inhibitors Attenuate the Effectiveness of Nivolumab Monotherapy in Patients with Advanced Gastric Cancer: a Retrospective Study".

Kawazoe H, Hirata K, Ohtani H

Journal of gastrointestinal cancer 57 ( 1 ) 18 2026.01

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The efficacy and safety of FOLFOX therapy for advanced esophageal squamous cell carcinoma

Shiraishi K., Okada M., Yamamoto S., Matsubara Y., Masuishi T., Shimozaki K., Yamamoto Y., Hirose S., Sugiyama K., Furuta M., Machida N., Takahashi N., Yoshii T., Kito Y., Tsuzuki T., Boku S., Tsuchihashi K., Sugaya A., Takayama T., Komori A., Mitani S., Matsumoto T., Nishimura T., Hirata K.

Scientific Reports 15 ( 1 ) 8031 2025.12

Cisplatin-based chemotherapy is the standard advanced esophageal squamous cell carcinoma (ESCC) treatment. However, the 5-fluorouracil plus L-leucovorin and oxaliplatin (FOLFOX) regimen is available in Japan as an alternative to cisplatin-based chemotherapy, but its efficacy and safety remain unclear. Hence, we aimed to evaluate patients with advanced ESCC who received FOLFOX therapy retrospectively. Patients with advanced ESCC who received FOLFOX therapy at 18 institutions between April 2019 and October 2020 were included. Fifty-two patients received first-line FOLFOX treatment, while 39 received later-line FOLFOX treatment. The median progression-free survival, median overall survival, and objective response rate were 3.8 months (95% confidence interval [CI]: 3.0–5.0), 13.9 months (95% CI: 10.3–17.9 months), and 35% in the first-line group and 2.4 months (95% CI: 2.1–3.8 months), 7.2 months (95% CI: 5.3–9.8 months), and 4% in the later-line group, respectively. The most frequent grade 3 or 4 adverse events were neutropenia (23%) and anemia (12%) in the first-line group and neutropenia (18%), anorexia (13%), anemia (10%), and nausea (10%) in the later-line group. First-line FOLFOX treatment is suitable for patients with advanced ESCC. However, FOLFOX has shown limited efficacy as a later-line treatment.

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Site-specific prevalence of the NFE2L2 mutation in esophageal squamous cell carcinoma

Chida A., Hayashi H., Ishida N., So E., Kishimoto S., Horie S., Tsugaru K., Matsuda S., Kawakubo H., Nishihara H., Hamamoto Y., Kanai T., Kitagawa Y., Hirata K.

International Journal of Clinical Oncology 30 ( 12 ) 2576 - 2586 2025.12

ISSN 13419625

Background: Precision medicine for esophageal squamous cell carcinoma (ESCC) has not been implemented owing to a lack of site-specific therapeutic markers and biomarkers. We hypothesized that the genomic background of each subsite of the esophagus might be different, allowing us to develop site-specific treatment strategies (cervical, upper thoracic, middle thoracic and lower thoracic). Methods: This was a single-center retrospective cohort study. Patients diagnosed with ESCC who underwent comprehensive genomic profiling (CGP) at Keio University Hospital between April 2017 and March 2024 were recruited. Genomic profiles were analyzed and compared across esophageal subsites. Results: Among the 107 patients with ESCC who underwent CGP, 6 were cervical, 16 were upper thoracic, 54 were middle thoracic, and 31 were lower thoracic. The most frequently altered genes were TP53, followed by CDKN2A and NFE2L2. The frequency of NFE2L2 mutations was significantly higher in the middle thoracic region (P = 0.041). The mutation rate increased from Stage I to IV (P = 0.0046). NFE2L2 mutations were rarely observed in early-stage cancers, suggesting that they may subsequently be acquired during growth and metastasis. Furthermore, a significant association was observed between a history of heavy alcohol consumption and NFE2L2 mutations. The overall survival of patients with unresectable or metastatic ESCC harboring NFE2L2 mutations was 12.0 months, compared to 29.7 months in patients without the mutations (HR: 2.37, P = 0.047). Conclusion: NFE2L2 mutations were more common in the middle thoracic esophagus, appeared to be associated with tumor progression, and were linked to poor prognosis.

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Proton Pump Inhibitors Attenuate the Effectiveness of Nivolumab Monotherapy in Patients with Advanced Gastric Cancer: A Retrospective Study.

Yamaguchi M, Kawazoe H, Kasai Y, Hirata K, Ohtani H

Journal of gastrointestinal cancer 56 ( 1 ) 226 2025.11

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Efficacy of Vonoprazan-Based Triple Therapy with Sitafloxacin and Amoxicillin for Third-Line Helicobacter pylori Eradication:. Multicenter Prospective Analysis on Drug Resistance and gyrA Mutations

Wasaki S., Mori H., Matsuzaki J., Suzuki H., Hirata K., Imaeda H., Yoshioka M., Nakazawa A., Okazawa A., Kanai T., Masaoka T.

Digestive Diseases 43 ( 5 ) 498 - 505 2025.10

ISSN 02572753

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WJOG18524G: a single-arm phase II study evaluating bemarituzumab combined with ramucirumab and paclitaxel in fibroblast growth factor receptor 2b (FGFR2b)-positive advanced gastric or gastroesophageal junction cancer (RAINBIRD).

Shimozaki K, Hirata K, Hayashi H, Sato Y, Komatsu Y, Taniguchi S, Takahashi N, Yamaguchi K, Furuta M, Kawakami T, Narita Y, Ando T, Makiyama A, Mitani S, Ogata T, Takegawa N, Okamoto W, Nishina T, Komoda M, Hosokawa A, Boku N, Kawakami H, Yamazaki K, Muro K

ESMO gastrointestinal oncology 9 100189 2025.09

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Phase II Study (NO LIMIT, WJOG13320G) of First-Line Nivolumab Plus Low-Dose Ipilimumab for Microsatellite Instability-High Advanced Gastric or Esophagogastric Junction Cancer

Kawakami H., Kadowaki S., Makiyama A., Tsuda M., Hirata K., Sugimoto N., MacHida N., Hara H., Hirano H., Esaki T., Komatsu Y., Hironaka S., Kobayashi Y., Kakimi K., Chiba Y., Boku N., Hyodo I., Muro K.

Journal of Clinical Oncology 43 ( 19 ) 2184 - 2195 2025.07

ISSN 0732183X

PURPOSEMicrosatellite instability-high (MSI-H) advanced gastric or esophagogastric junction cancer (AGC), accounting for 5%-6% of all AGC cases, has shown an enhanced responsiveness to immunotherapy. We performed a single-arm phase II study to evaluate the combination of nivolumab (NIVO) and low-dose (LD) ipilimumab (IPI) for first-line treatment of MSI-H AGC.PATIENTS AND METHODSPatients with MSI-H AGC received NIVO (240 mg once every 2 weeks) and IPI (1 mg/kg once every 6 weeks). The primary end point was overall response rate (ORR) assessed by blinded independent central review. Secondary end points included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), safety, and biomarker analysis. MSI-H status was confirmed with an MSI-IVD Kit (Falco).RESULTSTwenty-nine patients were enrolled. The ORR was 62.1% (95% CI, 42.3 to 79.3), with a complete response rate of 10.3%. The DCR was 79.3% (95% CI, 60.3 to 92.0). Treatment-related adverse events (TRAEs) of any grade occurred in 93.1% of patients, with those of grade ≥3 manifesting in 37.9% of patients. At the data cutoff (median follow-up of 9.0 months), treatment had been discontinued in 21 patients, with such discontinuation being due to TRAEs in 12 (41.4%) patients. However, after exclusion of one patient with progressive disease, the remaining 11 patients showed long-term antitumor efficacy after treatment discontinuation (range of response duration, 0.9+ to 15.6+ months). The median PFS was 13.8 months (95% CI, 13.7 months to not reached [NR]) and the median OS was NR (95% CI, 13.7 months to NR), with a 12-month OS rate of 79.5%.CONCLUSIONNIVO plus LD-IPI showed robust and durable antitumor efficacy as a first-line treatment for MSI-H AGC. Although TRAEs often led to treatment discontinuation, treatment efficacy was subsequently sustained in most patients.

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A rare case of ALK-positive histiocytosis with neurological involvement in a 70-year-old woman successfully managed with partial resection and alectinib.

So E, Ishida N, Chida A, Horie S, Kishimoto S, Tsugaru K, Hayashi H, Koda Y, Ozaki M, Okita H, Kanai T, Hirata K

International cancer conference journal 14 ( 3 ) 327 - 334 2025.07

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Investigating the Synergistic Effects of Pembrolizumab and Chemotherapy in Gastric and Gastroesophageal Junction Cancer

Okui J., Nagashima K., Matsuda S., Sato Y., Kawakubo H., Takeuchi M., Hirata K., Tsugaru K., Yamamoto S., Nomura M., Tsushima T., Takeuchi H., Kato K., Kitagawa Y.

Journal of Gastric Cancer 25 ( 3 ) 455 - 465 2025.07

ISSN 2093582X

Purpose: Although immune checkpoint inhibitors (ICIs) and chemotherapy combinations have been approved for the treatment of gastric and gastroesophageal junction cancer (GC/ GEJC), whether immunochemotherapy (ICT) offers advantages over the simple addition of individual monotherapies remains unclear. This study aimed to investigate whether ICT has a synergistic effect in patients with advanced GC/GEJC. Materials and Methods: Reconstructed individual patient data were electronically extracted from the Kaplan-Meier curves of 3 randomized controlled trials comparing pembrolizumab (KEYNOTE-061, KEYNOTE-062, and KEYNOTE-859). The observed progression-free survival (PFS) curve for each monotherapy was used to estimate the simulated PFS curve expected under an independent drug action model. If the observed curve demonstrated significantly better PFS than the simulated curve, combined ICI and chemotherapy was determined to have a synergistic effect, implying a superior outcome compared to adding-component monotherapy. Results: In patients with programmed cell death ligand 1 combined positive scores of ≥1 (n=2,194), the 1-year and median PFS of the observed and simulated curves were 28.0% vs. 27.9% and 6.89 months vs. 6.88 months, respectively. The one-sample log-rank test revealed no significant differences between the observed and simulated curves (P=0.107). Conclusions: The observed PFS with ICT was comparable to the predicted PFS based on the data for each monotherapy. Our findings do not provide direct evidence of synergistic effects, but they suggest that combining ICI and chemotherapy does not compromise efficacy. These results may support the continued clinical use of ICT in patients with advanced GC/GEJC.

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Prognostic factors for overall survival in advanced digestive neuroendocrine carcinoma treated with first-line cisplatin-based chemotherapy: a post hoc analysis of JCOG1213

Hirano H., Hirata K., Honma Y., Morizane C., Machida N., Kato K., Okusaka T., Boku N., Sekine S., Hiraoka N., Mizusawa J., Sano Y., Shibuya Y., Takahashi M., Fujimori N., Nomura M., Doki Y., Ueno M., Yoshikawa T., Takeuchi H.

ESMO Gastrointestinal Oncology 8 100178 2025.06

Background: There is no consensus on prognostic factors for advanced digestive neuroendocrine carcinoma (ADNEC). JCOG1213 was a phase III randomized trial that demonstrated equivalent overall survival (OS) between cisplatin plus etoposide and cisplatin plus irinotecan as first-line chemotherapy for ADNEC. We aimed to retrospectively explore prognostic factors for OS in patients with ADNEC using data from JCOG1213. Patients and methods: The patients included in this post hoc analysis had ADNEC (2019 World Health Organization classification system) that was histologically confirmed by a central pathological review whose records included all clinical data required for multivariable analysis using a Cox proportional hazards model. Results: Among 170 patients enrolled in JCOG1213, a total of 129 patients with ADNEC were included in this analysis. Multivariable analysis identified elevated serum lactate dehydrogenase (LDH; >222 IU/l) as a significantly unfavorable prognostic factor for OS [hazard ratio (HR) 1.721, 95% confidence interval (CI) 1.144-2.589, P = 0.0092]. OS of patients with elevated serum LDH was shorter than that of patients without elevated serum LDH [median 9.5 months (95% CI 8.1-10.7 months) versus 15.6 months (95% CI 11.4-19.7 months); HR 1.799, 95% CI 1.242-2.604, P = 0.0019]. There were no distinct differences either in objective response rates or progression-free survival between patients with and without elevated serum LDH. Conclusion: Serum LDH may serve as a simple, non-invasive, and clinically informative biomarker for prognostic evaluation in patients with ADNEC undergoing first-line platinum-based chemotherapy.

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Investigating the synergistic effects of immunochemotherapy in esophageal squamous cell carcinoma.

Okui J, Nagashima K, Matsuda S, Sato Y, Kawakubo H, Takeuchi M, Hirata K, Yamamoto S, Nomura M, Tsushima T, Takeuchi H, Kato K, Kitagawa Y

Esophagus : official journal of the Japan Esophageal Society 22 ( 2 ) 188 - 197 2025.04

ISSN 1612-9059

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Clinical utility of comprehensive genomic profiling for advanced pancreatic cancer: insights from real-world data analysis

So E., Hayashi H., Shimozaki K., Horie S., Kishimoto S., Chida A., Saito Y., Tsugaru K., Hirata K., Tanishima S., Nishihara H., Kanai T., Hamamoto Y.

International Journal of Clinical Oncology 30 ( 4 ) 728 - 737 2025.04

ISSN 13419625

Background: Precision medicine is a promising therapeutic strategy for pancreatic cancer. However, only a few patients are eligible for genotype-matched treatments because of the low detection rate of actionable genomic alterations, and the clinical application of comprehensive genomic profiling (CGP) in pancreatic cancer has not been completely investigated. CGP provides considerable information, including the prognosis and eligibility of patients for genotype-matched treatments, which can guide physicians’ treatment strategies. This study aimed to investigate the contribution of CGP to patient outcomes. Methods: This single-center retrospective cohort study enrolled patients with recurrent or metastatic pancreatic cancer with adenocarcinoma or adenosquamous carcinoma who underwent systemic chemotherapy between April 2018 and April 2022. We reviewed the medical records for patient characteristics, survival, and genomic information. We compared overall survival (OS) between patients who received CGP (CGP group) and those who did not (non-CGP group). Results: Of 111 eligible patients, 59 underwent CGP. Median OS was significantly longer in the CGP than the non-CGP group (25.2 vs. 11.8 months; hazard ratio, 0.49; P = 0.0013). Six patients (10.2%) underwent genotype-matched treatments, with a median OS of 35.5 months, compared to 17.0 months for those who did not. The CGP group demonstrated a higher transition rate to subsequent chemotherapy than did the non-CGP group (76.3% vs. 48.1%, P = 0.0030). Conclusions: OS was prolonged in patients with pancreatic cancer who underwent CGP, probably due to its influence on physicians’ treatment strategies. These findings highlight the importance of the proactive and timely implementation of CGP in patients with pancreatic cancer.

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Clinical characteristics of gastrointestinal stromal tumors with hypoglycemia

Chida A., Kawasaki K., Kuramoto J., Hayashi H., Kawahara T., Makiuchi S., So E., Shimizu S., Kishimoto S., Horie S., Saito Y., Shimozaki K., Tsugaru K., Togasaki K., Hirata K., Nishihara H., Kanai Y., Kanai T., Hamamoto Y.

Oncology Letters 28 ( 6 ) 568 2024.12

ISSN 17921074

The development of tyrosine‑kinase inhibitors has improved survival rates for patients with gastrointestinal stromal tumors (GISTs). Despite the progress, not all the patients can universally receive the benefit from treatment due to the individual underlying conditions in a real‑world setting. The present study focused on the well‑known but under‑studied condition of GIST with hypoglycemia. Hypoglycemia in GIST is characterized by hypoglycemic symptoms such as dizziness, sweating and confusion. It is caused by several factors such as multiple liver metastases, drug adverse effects, postoperative complications and paraneoplastic syndrome [non‑islet cell tumor hypoglycemia (NICTH)]. Comprehensive analysis of this condition has been hindered due to its rarity, and has been mostly limited to case reports. In the present study, a single‑institution retrospective analysis of GIST with hypoglycemia was conducted to investigate its prevalence and prognosis, and the cause of this condition. The present study identified that the prevalence of hypoglycemic episodes of GIST was 4.1% in all patients with GIST, and recurrent hypoglycemic cases had a poor prognosis. The present study identified 1 case with recurrent hypoglycemia due to NICTH. Since NICTH is a rare hypoglycemic cause and requires further evaluation, an autopsy and genetic sequencing were performed using the available clinical materials. Through this histological and genetic investigation, the histological diversity of NICTH‑GIST was revealed and insulin‑like growth factor II (IGF‑II) amplification was identified. Furthermore, a chronological analysis was performed using multiple resected archived samples from the same case, and revealed that diffuse IGF‑II expression may have occurred in the early phase of tumor development. The present study catalogued the characteristics of GIST with hypoglycemia with a focus on NICTH‑GIST.

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Definitive chemoradiotherapy with paclitaxel for locally advanced esophageal squamous cell carcinoma in older patients (PARADISE-1): a phase I trial

Hirata K., Yoshida K., Katada C., Watanabe A., Tsushima T., Yamaguchi T., Yamamoto S., Ishikawa H., Sato Y., Imamura C.K., Tanigawara Y., Ito Y., Kato K., Kitagawa Y., Hamamoto Y.

BMC Cancer 24 ( 1 ) 873 2024.12

Background: In older patients, esophageal squamous cell carcinoma (ESCC) is difficult to treat using standard therapies, including surgery and cisplatin-based chemoradiotherapy. Paclitaxel (PTX) has radiosensitizing activity. We conducted a phase I trial of PTX combined with radiotherapy to establish a standard therapy for locally advanced ESCC in older patients. Methods: Enrollment was conducted at six centers in Japan from April 2016 to September 2019. The participants were aged ≥ 70 years, had locally advanced ESCC, and were intolerant to surgery or unwilling. A fixed 60-Gy radiation dose was administered in 30 fractions. PTX dosing levels started at 30 mg/m2 weekly for 6 weeks. Depending on the number of DLTs, the dose was set to be increased by 10 mg/m2 or switched to biweekly. A geriatric assessment was performed before treatment using the Geriatric-8 screening tool. The primary endpoint was dose-limiting toxicity (DLT). Results: We enrolled 24 patients (6 per group); DLT was observed in one (grade 4 hypokalemia), one (grade 3 aspiration), two (grade 3 radiodermatitis, grade 3 esophageal hemorrhage), and two (grade 3 anorexia, grade 5 pneumonitis) patients in the weekly PTX 30, 40, 50, and 60 mg/m2 groups, respectively. All adverse events, except death in the 60 mg/m2 group, showed reversible improvement, and the safety profile was considered acceptable. The 2-year survival and complete response rates were 40.0% and 54.2%, respectively. There was a significant difference in survival between favorable and unfavorable Geriatric-8 scores. Conclusions: The recommended PTX dose with concomitant radiation was determined to be 50 mg/m2 weekly. Phase II trials at this dose are underway.

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The Effectiveness and Feasibility of Palliative Care via Video Telemedicine for Patients with Advanced Cancer: A Nonrandomized Prospective Clinical Trial Comparing Combination of Telemedicine and in-Person Care with in-Person Care Alone

Chida A., Hamamoto Y., Hirata K., Sato Y., So E., Kishimoto S., Noguchi S., Horie S., Saito Y., Shimozaki K., Tsugaru K., Togasaki K., Kawasaki K., Hayashi H., Kanai T.

Palliative Medicine Reports 5 ( 1 ) 503 - 511 2024.11

Background: Palliative care has been shown to be effective for patients with advanced cancer; however, the best approach to deliver palliative care needs to be considered. We hypothesized that a combination of palliative care via video telemedicine (TMD) and usual outpatient treatment would improve patients’ quality of life (QOL) and ameliorate depression and prognosis. Methods: Patients with advanced cancer who terminated treatment with chemotherapy were enrolled. Patients who could perform videoconferencing were assigned to the TMD group and those who could not perform were assigned to the (no TMD; control) group. The primary endpoint was QOL, which was evaluated using the difference in the Functional Assessment of Cancer Therapy-General (FACT-G) scores between baseline and one-month follow-up. Secondary endpoints included depression, measured using the Center for Epidemiological Studies Depression (CES-D) scale, overall survival, and patient satisfaction. Results: Fifty patients were included in this study (25 in each group). A comparison of measures of QOL at one month showed that the TMD group maintained a better QOL. FACT-G decreased by 0.21 and 5.96 points in the TMD and no TMD groups, respectively (p = 0.047). The TMD group maintained better QOL. There were trends suggesting improvements in depression and survival which did not reach significance. CES-D increased by 0.92 and 3.50 points in the TMD and no TMD groups, respectively (p = 0.26). Median survival time was 7.82 (3.30–14.59) and 6.37 (2.33–11.04) months in the TMD and no TMD groups, respectively. The results of the Patient Satisfaction Questionnaire suggest that video TMD could be a feasible tool in palliative care. Conclusion: Video TMD is effective in maintaining the QOL of patients with advanced cancer and is feasible based on patient satisfaction. It is desirable to further evaluate the usefulness of palliative care using video TMD and evaluate its clinical applications.

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