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Affiliation |
Faculty of Medicine College Hospital Clinical oncology |
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Professor |
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External Link |
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HOSOKAWA Ayumu
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Papers 【 display / non-display 】
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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 2024.7
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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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.
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The Efficacy and Safety of Nivolumab Plus mFOLFOX6 in Gastric Cancer with Severe Peritoneal Metastasis. Reviewed
Nakayama Y, Ando T, Takahashi N, Tsukada K, Takagi H, Goto Y, Nakaya A, Nakada N, Yoshita H, Motoo I, Ueda A, Ueda Y, Sakumura M, Kajiura S, Ogawa K, Hosokawa A, Yasuda I
Journal of clinical medicine 13 ( 3 ) 2024.1
Language：English Publishing type：Research paper (scientific journal)
DOI： 10.3390/jcm13030834
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Takagi H., Kajiura S., Hosokawa A., Horikawa N., Terada I., Hata T., Kobayashi Y., Tsukioka Y., Yabushita K., Matsuo T., Yoshita H., Ueda A., Ogawa K., Ando T., Hayashi R., Yasuda I.
Traditional and Kampo Medicine 10 ( 3 ) 278 - 284 2023.9
Language：English Publishing type：Research paper (scientific journal) Publisher：Traditional and Kampo Medicine
Aim: 5-Fluorouracil/folinic acid and oxaliplatin plus bevacizumab (FOLFOX + BV) is a standard chemotherapy regimen for metastatic colorectal cancer (mCRC). This study was aimed at evaluating the preventive effects of shakuyakukanzoto against oxaliplatin-induced neurotoxicity associated with FOLFOX + BV administration. Methods: In this single-arm, open-label, phase II clinical trial, we enrolled patients with previously untreated, histologically confirmed mCRC from six hospitals in Japan who were aged 20 years and older and had an Eastern Cooperative Oncology Group performance status of 0–1. The patients received shakuyakukanzoto 2.5 g thrice daily, orally, until disease progression and/or unacceptable toxicity was noted. The primary endpoint was the incidence of neurotoxicity following oxaliplatin administration at a dose of 500 mg/m2. Neurotoxicity was evaluated according to the Neurotoxicity Criteria of Debiopharm (DEB-NTC). The trial was registered in the UMIN Clinical Trials Registry of Japan (UMIN000001853). Results: Forty-one non-pretreated mCRC patients were included between April 2009 and September 2013. At an oxaliplatin dose of 500 mg/m2, neurotoxicity of DEB-NTC grade 1–2 developed in 25.0% of patients; no patient had DEB-NTC grade 3 neurotoxicity. The most common grade 3/4 adverse events were neutropenia (34.1%), hypertension (24.4%), and fatigue (9.8%). The response rate of the 38 patients with measurable lesions was 55.2%. The median progression-free and overall survival was 14.9 and 35.2 months respectively. Conclusion: Shakuyakukanzoto substantially reduced oxaliplatin-induced neurotoxicity without negatively affecting tumor response or survival in FOLFOX + BV-treated patients with CRC.
DOI： 10.1002/tkm2.1389
Books 【 display / non-display 】
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特集I 大腸癌化学療法 大腸癌化学療法における血管新生阻害薬の位置づけ
中島孝治, 柴田伸弘、田原良博, 細川歩（ Role： Joint author）
消化器・肝臓内科, 5: 24-32, 2019 2019
Language：Japanese Book type：General book, introductory book for general audience
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【逸脱症例から学ぶ がん薬物療法 標準治療の実践!】(第1章)がん薬物治療 再発大腸がん
米澤玲美, 細川 歩（ Role： Joint author , 第1章 がん薬物治療, 10. 再発大腸がん）
勝俣範之編, 48-50, 月刊薬事 61巻 第10号, 株式会社じほう 2019
Language：Japanese Book type：General book, introductory book for general audience
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消化器がん化学療法 副作用マネジメント プロのコツ改訂第2版
柴田伸弘, 細川 歩（ Role： Joint author , 第III章 【副作用症状別】プロのコツ 3. 腎・泌尿器）
小松 嘉人(編). メジカルビュー社, 283-296 , 2019 2019
Language：Japanese Book type：General book, introductory book for general audience
Presentations 【 display / non-display 】
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消化器悪性腫瘍に対する薬物療法の進歩 当科における膵癌化学療法の現状 FOLFIRINOX療法とGEM/nab-PTX療法について
田原 良博, 細川 歩, 中島 孝治, 米澤 瑛美, 坂元 一樹, 山嶋 友実, 宮後 冴, 米澤 玲美, 黒木 大介, 野田 貴穂, 鈴木 翔, 久保田 良政, 松本 英丈, 芦塚 伸也, 安倍 弘生, 三池 忠, 坂 哲臣, 山本 章二朗, 稲津 東彦, 河上 洋
第114回日本消化器病学会九州支部例会
Event date： 2019.11.8 - 2019.11.9
Language：Japanese Presentation type：Symposium, workshop panel (public)
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Pembrolizumabを投与したMSI-High大腸癌の1例
田村 穂高, 中島 孝治, 田原 良博, 細川 歩, 河上 洋
第114回日本消化器病学会九州支部例会
Event date： 2019.11.8 - 2019.11.9
Language：Japanese Presentation type：Oral presentation (general)
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Methotrexate+5-fluorouracil療法が著効したDIC合併胃癌骨髄癌腫症の1例
井手 雄太郎, 米澤 瑛美, 田原 良博, 貴島 翔子, 坂元 一樹, 野田 貴穂, 鈴木 翔, 安倍 弘生, 三池 忠, 山本 章二朗, 中島 孝治, 日高 智徳, 細川 歩, 下田 和哉, 河上 洋
第114回日本消化器病学会九州支部例会
Event date： 2019.11.8 - 2019.11.9
Language：Japanese Presentation type：Oral presentation (general)
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当院における切除不能進行・再発胃癌に対するニボルマブ療法の現状
米澤 玲美, 細川 歩, 中島 孝治, 田原 良博, 山嶋 友実, 宮後 冴, 松本 英丈, 芦塚 伸也, 稲津 東彦, 河上 洋
第114回日本消化器病学会九州支部例会
Event date： 2019.11.8 - 2019.11.9
Language：Japanese Presentation type：Oral presentation (general)
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The results of Japanese subgroup analyses from TAGS: a phase 3 study of FTD/TPI (TAS-102) in heavily pretreated mGC
細川歩, 設樂 紘平, 西川和宏, 藤谷和正, 保坂尚志, 肥田圭介, 間狩洋一, 天貝賢二, 行澤 斉悟, 安藤 孝将, David H Ilson, Josep Tabernero, 土井 俊彦
第17回日本臨床腫瘍学会学術集会
Event date： 2019.7.18 - 2019.7.20
Language：English Presentation type：Oral presentation (general)
Past consigned research fund received 【 display / non-display 】
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EFFECT OF TAS-116 ON CARDIOVASCULAR SAFETY PARAMETERS IN PATIENTS WITH ADVANCED SOLID TUMORS
2020.02 - 2020.12
Investigational New Drug Test
Consigned research type：Investigational New Drug Test