Papers - HOSOKAWA Ayumu
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Postoperative Outcomes and Strategic Refinement in Intraductal Papillary Mucinous Neoplasm Management: A Single Academic Cancer Center Experience. Reviewed
Nanashima A, Imamura N, Hiyoshi M, Tsuchimochi Y, Wada T, Hamada T, Suzuki Y, Araki Y, Hosokawa A, Kawakami H
Cancer diagnosis & prognosis 6 ( 2 ) 291 - 302 2026.3
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Feasibility of endoscopic response evaluation after induction chemotherapy for determining treatment strategies in esophageal cancer: a post hoc analysis of the CROC trial. Reviewed
Katada C, Yokoyama T, Watanabe A, Hamamoto Y, Hosokawa A, Kojima T, Hara H, Yoshii T, Fujii H, Yamaguchi H, Nakajima TE, Izawa N, Ando T, Nomura M, Yamashita K, Kawakami S, Ishiyama H, Inoue Y, Sakamoto Y, Ishikawa H, Muto M, Tahara M, Koizumi W
Esophagus : official journal of the Japan Esophageal Society 23 ( 1 ) 120 - 130 2026.1
Language：English Publishing type：Research paper (scientific journal)
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Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Older Versus Younger Patients With Unresectable Pancreatic Cancer: The Multicenter NAPOLEON-2 Study. Reviewed
Kakihara A, Takeshita S, Shimokawa M, Otsuka T, Arima S, Ido A, Shibuki T, Nakazawa J, Miwa K, Koga F, Ueda Y, Kubotsu Y, Shimokawa H, Komori A, Nishikawa K, Otsu S, Hosokawa A, Sakai T, Oda H, Kawahira M, Arita S, Honda T, Tsuneyoshi K, Taguchi H, Kawaguchi Y, Fujita T, Sakae T, Shirakawa T, Mizuta T, Mitsugi K
Asia-Pacific journal of clinical oncology 2025.11
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Remarkable and Durable Tumor Response to Pembrolizumab in Locally Advanced dMMR/MSI-H Rectal Cancer. Reviewed
Hosokawa A, Yamada R, Otsuki Y, Tamura H, Ichihara A, Fukushima T, Komohara Y
Anticancer research 45 ( 11 ) 5069 - 5076 2025.11
Language：English Publishing type：Research paper (scientific journal)
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Impact of biliary drainage for unresectable pancreatic cancer treated with nanoliposomal irinotecan with fluorouracil and folinic acid: retrospective results from the NAPOLEON-2 study. Reviewed
Nishikawa K, Otsuka T, Shimokawa M, Inagaki T, Komori A, Todaka A, Otsu S, Shibuki T, Nakazawa J, Arima S, Miwa K, Koga F, Ueda Y, Kubotsu Y, Shimokawa H, Takeshita S, Hosokawa A, Sakai T, Oda H, Kawahira M, Arita S, Honda T, Taguchi H, Tsuneyoshi K, Fujita T, Sakae T, Kawaguchi Y, Shirakawa T, Mizuta T, Mitsugi K
BMC cancer 25 ( 1 ) 1614 2025.10
Language：English Publishing type：Research paper (scientific journal)
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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). Reviewed
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 2025.9
Language：English Publishing type：Research paper (scientific journal)
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A multicenter, prospective, observational study of nivolumab readministration for advanced gastric cancer (NIVO RETURNS). Reviewed
Kodama H, Narita Y, Nakamura M, Takahashi M, Mizukami T, Ando T, Mitani S, Komori A, Hosokawa A, Moriwaki T, Sugiyama K, Taguri M, Orihara S, Kagamu H, Yamaguchi T, Nishikawa H, Muro K
Future oncology (London, England) 21 ( 14 ) 1753 - 1759 2025.6
Language：English Publishing type：Research paper (scientific journal)
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Efficacy of liposomal irinotecan + 5-FU/LV vs. S-1 in gemcitabine-refractory metastatic pancreatic cancer: a real-world study using inverse probability of treatment weighting. Reviewed
Imaoka H, Ikeda M, Kobayashi S, Ohba A, Ueno M, Suzuki Y, Tsumura H, Kimura N, Kawaguchi S, Kawamoto Y, Nakachi K, Tsuji K, Kobayashi N, Ashida R, Okano N, Umemoto K, Murohisa G, Hosokawa A, Asagi A, Nebiki H, Suzuki R, Terashima T, Shibata R, Kawata K, Doi T, Ohyama H, Kitano Y, Shioji K, Okuyama H, Naganuma A, Negoro Y, Sakamoto Y, Shimizu S, Morizane C, Ueno M, Furuse J, Nagano H, Japan Oncology Network in Hepatobiliary and Pancreas
Journal of gastroenterology 60 ( 3 ) 356 - 367 2025.3
Language：English Publishing type：Research paper (scientific journal)
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Comparison of inflammatory markers before and after nanoliposomal irinotecan and fluorouracil with folic acid in patients with pancreatic cancer: results from the NAPOLEON-2 study (NN-2302). Reviewed
Araki T, Hayashi K, Shimokawa M, Otsuka T, Sonoda Y, Honda T, Shibuki T, Nakazawa J, Arima S, Miwa K, Koga F, Ueda Y, Kubotsu Y, Shimokawa H, Takeshita S, Nishikawa K, Komori A, Otsu S, Hosokawa A, Sakai T, Oda H, Kawahira M, Arita S, Taguchi H, Tsuneyoshi K, Fujita T, Sakae T, Kawaguchi Y, Shirakawa T, Mizuta T, Mitsugi K
Therapeutic advances in medical oncology 17 17588359251320768 2025.2
Language：English Publishing type：Research paper (scientific journal)
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Relationship between neutropenia caused by nanoliposomal irinotecan/fluorouracil/leucovorin and treatment outcomes in the NAPOLEON-2 study (NN-2301). Reviewed
Araki T, Sonoda Y, Shimokawa M, Otsuka T, Hayashi K, Honda T, Nakao K, Shibuki T, Nakazawa J, Arima S, Miwa K, Okabe Y, Koga F, Ueda Y, Kubotsu Y, Shimokawa H, Takeshita S, Komori A, Nishikawa K, Otsu S, Hosokawa A, Oda H, Sakai T, Arita S, Kawahira M, Taguchi H, Tsuneyoshi K, Kawaguchi Y, Fujita T, Sakae T, Shirakawa T, Mizuta T, Mitsugi K
Scientific reports 15 ( 1 ) 3427 2025.1
Language：English Publishing type：Research paper (scientific journal)
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Impact of prior chemotherapy on nanoliposomal irinotecan with fluorouracil and folinic acid for unresectable pancreatic cancer: a retrospective analysis of data from the multicenter NAPOLEON-2 study. Reviewed
Koike T, Kawaguchi Y, Shimokawa M, Otsuka T, Furukawa K, Shinohara Y, Shimokawa H, Yoshihiro T, Shibuki T, Nakazawa J, Arima S, Miwa K, Koga F, Ueda Y, Kubotsu Y, Takeshita S, Nishikawa K, Komori A, Otsu S, Hosokawa A, Sakai T, Oda H, Kawahira M, Arita S, Honda T, Taguchi H, Tsuneyoshi K, Fujita T, Sakae T, Shirakawa T, Mizuta T, Mitsugi K
Therapeutic advances in medical oncology 17 17588359251393156 2025
Language：English Publishing type：Research paper (scientific journal)
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Efficacy of third-line chemotherapy following nanoliposomal irinotecan combined with fluorouracil and folinic acid as second-line treatment for unresectable pancreatic cancer. Reviewed
Miwa K, Kawasaki R, Shimokawa M, Otsuka T, Tanaka T, Fukahori M, Shibuki T, Nakazawa J, Arima S, Koga F, Ueda Y, Kubotsu Y, Shimokawa H, Takeshita S, Nishikawa K, Komori A, Otsu S, Hosokawa A, Sakai T, Oda H, Kawahira M, Arita S, Honda T, Taguchi H, Tsuneyoshi K, Fujita T, Sakae T, Kawaguchi Y, Shirakawa T, Mizuta T, Mitsugi K
Frontiers in oncology 15 1626689 2025
Language：English Publishing type：Research paper (scientific journal)
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Optimizing Organ-Preservation Strategies Through Chemotherapy-Based Selection in Esophageal Squamous Cell Carcinoma: Results From the CROC Multi-Institutional Phase 2 Clinical Trial. Reviewed
Katada C, Yokoyama T, Watanabe A, Hara H, Yoshii T, Fujii H, Yamaguchi H, Nakajima TE, Izawa N, Ando T, Nomura M, Kojima T, Yamashita K, Kawakami S, Ishiyama H, Inoue Y, Sakamoto Y, Sasaki H, Ishikawa H, Hosokawa A, Hamamoto Y, Muto M, Tahara M, Koizumi W
International journal of radiation oncology, biology, physics 120 ( 5 ) 1353 - 1362 2024.12
Language：English Publishing type：Research paper (scientific journal)
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Naoki K., Igawa S., Uojima H., Tsumura H., Sengoku N., Karayama M., Shimomura A., Ohtake T., Shio Y., Hosokawa A., Komatsu Y., Kumagai Y.
Cancer 2024.11
Language：English Publishing type：Research paper (scientific journal) Publisher：Cancer
Background: Pimitespib (TAS-116), a first-in-class, oral, selective heat-shock protein 90 inhibitor, is approved as fourth-line treatment for gastrointestinal stromal tumors in Japan. This phase 1 study evaluated the cardiac safety of pimitespib. Methods: In this open-label, nonrandomized, multicenter study, Japanese patients (aged ≥20 years) with refractory, advanced solid tumors received placebo on day −1, then pimitespib 160 mg daily on days 1–5 of the cardiac safety evaluation period. Electrocardiograms were conducted at baseline, and on days −2, −1, 1, and 5; and blood samples were collected on days 1 and 5. Patients then received once-daily pimitespib for 5 days every 3 weeks. The primary end point was the time-matched difference in QT interval corrected for heart rate using the Fridericia correction (QTcF) between pimitespib and placebo. Pharmacokinetics, safety, and preliminary efficacy were also assessed. Results: Of the 22 patients in the cardiac safety-evaluable population, no clinically relevant QTc prolongation was observed; the upper bound of the one-sided 95% confidence interval for the time-matched difference in change from baseline in QTcF was <20 msec at all time points on days 1 and 5. Pimitespib pharmacokinetic parameters were consistent with previous data, and the time-matched difference in change from baseline in QTcF showed no marked increase as plasma concentrations increased. The safety profile was acceptable; 40% of patients experienced grade 3 or greater adverse drug reactions, mostly diarrhea (20%). The median progression-free survival was 3.1 months. Conclusions: In Japanese patients with refractory, advanced solid tumors, pimitespib was not associated with clinically relevant QTc prolongation, and there were no cardiovascular safety concerns. Plain Language Summary: Pimitespib is a new anticancer drug that is being used to treat cancer in the stomach or intestines (gastrointestinal stromal tumors). This study demonstrated that pimitespib had no marked effect on heart rhythm or negative effects on the heart or blood vessels and had promising anticancer effects in Japanese patients with advanced solid tumors who were unable to tolerate or benefit from standard treatment.
DOI： 10.1002/cncr.35447
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Real-World Analysis of the Correlation between Overall Survival and Progression-Free Survival in Advanced Pancreatic Cancer: Results of NAPOLEON-1 and 2 Studies. Reviewed
Araki T, Kawahira M, Shimokawa M, Otsuka T, Hayashi K, Sonoda Y, Honda T, Nakao K, Shibuki T, Nakazawa J, Arima S, Fukahori M, Miwa K, Koga F, Ueda Y, Kubotsu Y, Makiyama A, Shimokawa H, Takeshita S, Nishikawa K, Komori A, Otsu S, Hosokawa A, Sakai T, Oda H, Arita S, Taguchi H, Tsuneyoshi K, Kawaguchi Y, Fujita T, Sakae T, Nio K, Ide Y, Ureshino N, Shirakawa T, Mizuta T, Mitsugi K
Oncology 1 - 11 2024.10
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Pathological Complete Response to Liver Metastasis With Pembrolizumab in a Previously Treated Patient With Microsatellite Instability-high Colorectal Cancer. Reviewed
Hosokawa A, Tamura H, Ichihara A, Imamura N, Kai K, Fukushima T, Nanashima A, Komohara Y
Anticancer research 44 ( 9 ) 4119 - 4125 2024.9
Authorship：Lead author Language：English Publishing type：Research paper (scientific journal)
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Efficacy and Safety of Immune Checkpoint Inhibitor Combination Therapy for Dysphagia in Patients with Advanced Esophageal Cancer. Reviewed
Nakayama Y, Ando T, Takagi H, Motoo I, Ueda Y, Sakumura M, Kajiura S, Takahashi S, Shimada S, Takashima Y, Fujinami H, Ogawa K, Tamura H, Hosokawa A, Yasuda I
Journal of clinical medicine 13 ( 16 ) 2024.8
Language：English Publishing type：Research paper (scientific journal)
DOI： 10.3390/jcm13164806
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Nanoliposomal irinotecan with fluorouracil and folinic acid, FOLFIRINOX, and S-1 as second-line treatment for unresectable pancreatic cancer after gemcitabine/nab-paclitaxel. Reviewed
Shibuki T, Otsuka T, Shimokawa M, Nakazawa J, Arima S, Fukahori M, Miwa K, Okabe Y, Koga F, Ueda Y, Kubotsu Y, Makiyama A, Shimokawa H, Takeshita S, Nishikawa K, Komori A, Otsu S, Hosokawa A, Sakai T, Oda H, Kawahira M, Arita S, Honda T, Taguchi H, Tsuneyoshi K, Kawaguchi Y, Fujita T, Sakae T, Nio K, Ide Y, Ureshino N, Shirakawa T, Mizuta T, Mitsugi K
Scientific reports 14 ( 1 ) 16906 2024.7
Language：English Publishing type：Research paper (scientific journal)
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Kodama T., Imajima T., Shimokawa M., Otsuka T., Kawahira M., Nakazawa J., Hori T., Shibuki T., Arima S., Ido A., Miwa K., Okabe Y., Koga F., Ueda Y., Kubotsu Y., Shimokawa H., Takeshita S., Nishikawa K., Komori A., Otsu S., Hosokawa A., Sakai T., Sakai K., Oda H., Kawahira M., Arita S., Honda T., Taguchi H., Tsuneyoshi K., Kawaguchi Y., Fujita T., Sakae T., Shirakawa T., Mizuta T., Mitsugi K.
Scientific Reports 14 ( 1 ) 12422 2024.5
Language：English Publishing type：Research paper (scientific journal) Publisher：Scientific Reports
Nanoliposomal irinotecan with fluorouracil and folinic acid (NFF) is a standard regimen after gemcitabine-based therapy for patients with unresectable or recurrent pancreatic cancer. However, there are limited clinical data on its efficacy and safety in the real-world. We therefore initiated a retrospective and prospective observational study (NAPOLEON-2). The results of the retrospective part were reported herein. In this retrospective study, we evaluated 161 consecutive patients who received NFF as second-or-later-line regimen. The main endpoint was overall survival (OS), and the other endpoints were response rate, disease control rate, progression-free survival (PFS), dose intensity, and adverse events (AEs). The median age was 67 years (range, 38–85 years). The median OS and PFS were 8.1 and 3.4 months, respectively. The objective response and disease control rates were 5% and 52%, respectively. The median relative dose intensity was 81.6% for nanoliposomal irinotecan and 82.9% for fluorouracil. Grade 3 or 4 hematological and nonhematological AEs occurred in 47 and 42 patients, respectively. Common grade 3 or 4 AEs included neutropenia (24%), anorexia (12%), and leukocytopenia (12%). Subanalysis of patients treated with second-line and third-or-later-line demonstrated no statistical significant difference in OS (7.6 months vs. 9.1 months, respectively; hazard ratio, 0.92; 95% confidence interval, 0.64–1.35; p = 0.68). In conclusion, NFF has acceptable efficacy and safety profile even in real-world clinical settings. The prospective study is in progress to validate these findings.
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Ueda A., Yuki S., Ando T., Hosokawa A., Nakada N., Kito Y., Motoo I., Ito K., Sakumura M., Nakayama Y., Ueda Y., Kajiura S., Nakashima K., Harada K., Kawamoto Y., Komatsu Y., Yasuda I.
Cancers 16 ( 5 ) 871 2024.2
Language：English Publishing type：Research paper (scientific journal) Publisher：Cancers
Currently, no established marker exists for predicting peritoneal metastasis progression during chemotherapy, although they are major interruptive factors in sequential chemotherapy in patients with advanced gastric cancer (AGC). This multicenter retrospective study was conducted from June 2015 to July 2019, analyzing 73 patients with AGC who underwent taxane-plus-ramucirumab (TAX/RAM) therapy and had their serum carbohydrate antigen 125 (CA125) concentrations measured. Of 31 patients with elevated CA125 levels above a cutoff of 35 U/mL, 25 (80.6%) had peritoneal metastasis. The CA125 concentrations before TAX/RAM treatment were associated with ascites burden. The overall survival was significantly shorter in the CA125-elevated group. CA125 kinetics, measured at a median of 28 days after chemotherapy, were associated with the ascites response (complete or partial response: −1.86%/day; stable disease: 0.28%/day; progressive disease: 2.33%/day). Progression-free survival in the CA125-increased group, defined by an increase of 0.0067%/day using receiver operating characteristic curve analysis, was significantly poorer among patients with peritoneal metastases. In conclusion, this study highlights that CA125 kinetics can serve as an early predictor for the progression of peritoneal metastasis during TAX/RAM treatment.