Annual Report 2022

Department of General Internal Medicine

Yoichi Naito, Yasutoshi Kuboki, Tomofumi Miura, Kensuke Shinmura, Kazuo Watanabe, Tetsuya Sakai, Saori Mishima, Hiromichi Nakajima

Introduction

 We provide general management across cancer types, support for medical treatment in each department (management for complications, adverse events, etc.), and management aimed at training oncology specialists. As an educational hospital of the Japanese Society of Internal Medicine, we contribute to the training for internal medicine with the aim of nurturing general medical specialists. Based on our experience with immune-related adverse events (irAEs) associated with an increasing number of indications and use of immune checkpoint inhibitors in a wide range of diseases and our experience with managing cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) associated with chimeric antigen receptor (CAR) T-cell therapy, we work with all the departments, including the Department of Pharmacy and the Department of Nursing, to recognize the occurrence of irAEs, CRS, and ICANS and implement countermeasures. We also assist in irAE-related research.

The Team and What We Do

• Increased number of reported irAEs, CRS, and ICANS (Figure 1)
• Implementation of irAE collaboration seminar
• Revision of a manual for immune checkpoint inhibitors
• Development of manual for drug-induced liver injury and plasma exchange
• Development of manual for acute kidney injury and plasmapheresis

Research Activities

• Contribution to the training of internal medicine trainees
• Case presentation support for trainees at the congress of the Japanese Society of Internal Medicine or related congress
• Paper writing support
• Intensive lectures on medical oncology for new residents (updated)
• Support/guidance for new research (e.g., observational study to confirm the pharmacokinetics of mycophenolate mofetil for liver damage caused by immune checkpoint inhibitors)
• irAE cooperation seminar with regional institutions

Clinical Trials

 One observational study is currently planned by the Department of Pharmacy, a study that we fully support.

Education

 We will further collaborate with regional institutions to gather outstanding trainees, and develop close connections with several academic institutions. We will revise a manual for immune checkpoint inhibitors, and develop safe and cost-effective practice. We plan to have approximately 100 case consultations on immune related AEs.

Future Prospects

 We will continue to provide high-quality training. The medical treatment for cancer at our hospital is at the top level in Japan, and we will continue to improve the medical treatment system so that the valuable experience gained at this hospital can be returned to general medical treatment, and to establish a consulting system. We will continue the irAE cooperation program and promote research planning for issue identification and improvement. We will deepen our cooperation with the Department of Pharmacy and Department of Nursing, and continue our efforts to share and improve issues within the hospital.

 We will further focus on management for adverse events caused by various drugs, in-hospital and out-of-hospital collaboration. We will prepare a manual on renal failure and hemodialysis, train personnel who will be a consultant for renal failure, and establish a cooperative system with collaborating facilities.

 Regarding education, we will cooperate with the Human Resource Development Center to enhance internal education and will continuously cooperate with external parties. We will continuously confirm that medical issues can be shared with the risk management department.

 Contribute to the development of supportive care in collaboration with the XXX.

List of papers published in 2022

Journal

1. Doi T, Shitara K, Kojima T, Kuboki Y, Matsubara N, Bando H, Yoh K, Naito Y, Hirai H, Kurokawa Y, Kato T, Morizane C. Phase I study of the irreversible fibroblast growth factor receptor 1-4 inhibitor futibatinib in Japanese patients with advanced solid tumors. Cancer science, 114:574-585, 2023

2. Hiroyuki Otani, Amano K, Morita T, Miura T, Mori N, Tatara R, Kessoku T, Matsuda Y, Tagami K, Mori M, Taniyama T, Nakajima N, Nakanishi E, Kako J, Shirado AN, Yokomichi N, Miyashita M. Impact of taste/smell disturbances on dietary intakes and cachexia-related quality of life in patients with advanced cancer. Supportive care in cancer, 31:141, 2023

3. Murano T, Ikematsu H, Shinmura K, Okumura K, Kuwata T, Ushiama M, Yoshida T, Takashima K, Nakajo K, Kadota T, Yoda Y, Oono Y, Yano T. Endoscopic management of familial adenomatous polyposis targeting colorectal lesions greater than 5 mm in size: a single-center retrospective study. Familial cancer, 22:83-89, 2023

4. Funasaka C, Naito Y, Kusuhara S, Nakao T, Nakajima H, Kawamoto M, Baba K, Mamishin K, Kondoh C, Harano K, Matsubara N, Hosono A, Sasaki T, Kawasaki T, Mukohara T. Clinical features of CDK4/6 inhibitor-related interstitial lung disease in patients with breast cancer: a case series study. Japanese journal of clinical oncology, 53:105-114, 2023

5. Koganemaru S, Kawai T, Fuchigami H, Maeda N, Koyama K, Kuboki Y, Mukohara T, Doi T, Yasunaga M. Quantitative analysis of drug distribution in heterogeneous tissues using dual-stacking capillary electrophoresis-mass spectrometry. British journal of pharmacology, 180:762-774, 2023

6. Naito Y, Nishida T, Doi T. Current status of and future prospects for the treatment of unresectable or metastatic gastrointestinal stromal tumours. Gastric cancer, 26:339-351, 2023

7. Sugimoto A, Matsumoto S, Udagawa H, Itotani R, Usui Y, Umemura S, Nishino K, Nakachi I, Kuyama S, Daga H, Hara S, Miyamoto S, Kato T, Sakakibara-Konishi J, Tabata E, Nakagawa T, Kawaguchi T, Sakai T, Shibata Y, Izumi H, Nosaki K, Zenke Y, Yoh K, Goto K. A Large-Scale Prospective Concordance Study of Plasma- and Tissue-Based Next-Generation Targeted Sequencing for Advanced Non-Small Cell Lung Cancer (LC-SCRUM-Liquid). Clinical cancer research, 29:1506-1514, 2023

8. Tamiya Y, Matsumoto S, Zenke Y, Yoh K, Ikeda T, Shibata Y, Kato T, Nishino K, Nakamura A, Furuya N, Miyamoto S, Kuyama S, Nomura S, Ikeno T, Udagawa H, Sugiyama E, Nosaki K, Izumi H, Sakai T, Hashimoto N, Goto K. Large-scale clinico-genomic profile of non-small cell lung cancer with KRAS G12C: Results from LC-SCRUM-Asia study. Lung cancer (Amsterdam, Netherlands), 176:103-111, 2023

9. Tanaka Y, Nakai T, Suzuki A, Kagawa Y, Noritake O, Taki T, Hashimoto H, Sakai T, Shibata Y, Izumi H, Nosaki K, Udagawa H, Zenke Y, Matsumoto S, Yoh K, Miyazaki S, Sakamoto N, Sakashita S, Kojima M, Watanbe R, Tsuboi M, Goto K, Ishii G. Clinicopathological significance of peritumoral alveolar macrophages in patients with resected early-stage lung squamous cell carcinoma. Cancer immunology, immunotherapy, 72:2205-2215, 2023

10. Yoshino T, Taieb J, Kuboki Y, Pfeiffer P, Kumar A, Hochster HS. Trifluridine/tipiracil with or without bevacizumab in metastatic colorectal cancer: results of a systematic review and meta-analysis. Therapeutic advances in medical oncology, 15:17588359221146137, 2023

11. Sunakawa H, Yoda Y, Takahashi M, Arai K, Kano Y, Yamashita H, Aoyama N, Mitsui T, Inaba A, Takashima K, Nakajo K, Murano T, Kadota T, Shinmura K, Ikematsu H, Yano T. Prospective study on the risk of transmission due to droplets and aerosols during an endoscopic procedure and the usefulness of extraoral suction devices. Digestive endoscopy, 35:332-341, 2023

12. Mitsui T, Nakajo K, Takashima K, Murano T, Kadota T, Shinmura K, Yoda Y, Ikematsu H, Maeda S, Yano T. Usefulness of endoscopic ultrasound in predicting treatment efficacy of salvage endoscopic therapy for local failure after chemoradiotherapy for esophageal squamous cell carcinoma. Esophagus, 20:116-123, 2023

13. Sakamoto T, Ikematsu H, Tamai N, Mizuguchi Y, Takamaru H, Murano T, Shinmura K, Sasabe M, Furuhashi H, Sumiyama K, Saito Y. Detection of colorectal adenomas with texture and color enhancement imaging: Multicenter observational study. Digestive endoscopy, 35:529-537, 2023

14. Kano Y, Kadota T, Inaba A, Sunakawa H, Takashima K, Nakajo K, Murano T, Shinmura K, Yoda Y, Ikematsu H, Akimoto T, Yano T. Efficacy and safety of repeated endoscopic radial incision and cutting procedure for benign esophageal stricture. Endoscopy international open, 11:E230-E236, 2023

15. Takahara N, Nakai Y, Isayama H, Sasaki T, Morine Y, Watanabe K, Ueno M, Ioka T, Kanai M, Kondo S, Okano N, Koike K. A prospective multicenter phase II study of FOLFIRINOX as a first-line treatment for patients with advanced and recurrent biliary tract cancer. Investigational new drugs, 41:76-85, 2023

16. Kubota Y, Kawazoe A, Mishima S, Nakamura Y, Kotani D, Kuboki Y, Bando H, Kojima T, Doi T, Yoshino T, Kuwata T, Shitara K. Comprehensive clinical and molecular characterization of claudin 18.2 expression in advanced gastric or gastroesophageal junction cancer. ESMO open, 8:100762, 2023

17. Kuboki Y, Terazawa T, Masuishi T, Nakamura M, Watanabe J, Ojima H, Makiyama A, Kotaka M, Hara H, Kagawa Y, Sugimoto N, Kawakami H, Takashima A, Kajiwara T, Oki E, Sunakawa Y, Ishihara S, Taniguchi H, Nakajima TE, Morita S, Shirao K, Takenaka N, Ozawa D, Yoshino T. Trifluridine/tipiracil+bevacizumab (BEV) vs. fluoropyrimidine-irinotecan+BEV as second-line therapy for metastatic colorectal cancer: a randomised noninferiority trial. British journal of cancer, 128:1897-1905, 2023

18. Fujiwara Y, Kuboki Y, Furukawa M, Mizuno N, Hara H, Ioka T, Ueno M, Takahashi Y, Takahashi S, Takeuchi S, Lihou C, Ji T, Tian C, Shimizu T. FIGHT-102: A phase 1 study of pemigatinib in Japanese patients with advanced malignancies. Cancer medicine, 12:10597-10611, 2023

19. Yoshida Y, Kobayashi S, Ueno M, Morizane C, Tsuji K, Maruki Y, Mori K, Watanabe K, Ohba A, Furuta M, Todaka A, Tsujimoto A, Ozaka M, Okano N, Yane K, Umemoto K, Kawamoto Y, Terashima T, Tsumura H, Doi K, Shioji K, Asagi A, Kojima Y, Suzuki E, Toshiyama R, Furukawa M, Naganuma A, Suzuki R, Miwa H, Ikeda M, Furuse J. Efficacy of chemotherapy for patients with metastatic or recurrent pancreatic adenosquamous carcinoma: A multicenter retrospective analysis. Pancreatology, 22:1159-1166, 2022

20. Abe A, Amano K, Morita T, Miura T, Mori N, Tatara R, Kessoku T, Matsuda Y, Tagami K, Otani H, Mori M, Taniyama T, Nakajima N, Nakanishi E, Kako J, Kiuchi D, Ishiki H, Matsuoka H, Satomi E, Miyashita M. Beliefs and Perceptions About Parenteral Nutrition and Hydration by Advanced Cancer Patients. Palliative medicine reports, 3:132-139, 2022

21. Yonemori K, Kuboki Y, Hasegawa K, Iwata T, Kato H, Takehara K, Hirashima Y, Kato H, Passey C, Buchbjerg JK, Harris JR, Andreassen CM, Nicacio L, Soumaoro I, Fujiwara K. Tisotumab vedotin in Japanese patients with recurrent/metastatic cervical cancer: Results from the innovaTV 206 study. Cancer science, 113:2788-2797, 2022

22. Imai M, Nakamura Y, Sunami K, Kage H, Komine K, Koyama T, Amano T, Ennishi D, Kanai M, Kenmotsu H, Maeda T, Morita S, Sakai D, Bando H, Makiyama A, Suzuki T, Hirata M, Kohsaka S, Tsuchihara K, Naito Y, Yoshino T. Expert panel consensus recommendations on the use of circulating tumor DNA assays for patients with advanced solid tumors. Cancer science, 113:3646-3656, 2022

23. Sunami K, Naito Y, Komine K, Amano T, Ennishi D, Imai M, Kage H, Kanai M, Kenmotsu H, Koyama T, Maeda T, Morita S, Sakai D, Kohsaka S, Tsuchihara K, Saigusa Y, Yoshino T. Chronological improvement in precision oncology implementation in Japan. Cancer science, 113:3995-4000, 2022

24. Naito Y, Sunami K, Kage H, Komine K, Amano T, Imai M, Koyama T, Ennishi D, Kanai M, Kenmotsu H, Maeda T, Morita S, Sakai D, Watanabe K, Shirota H, Kinoshita I, Yoshioka M, Mamesaya N, Ito M, Kohsaka S, Saigusa Y, Yamamoto K, Hirata M, Tsuchihara K, Yoshino T. Concordance Between Recommendations From Multidisciplinary Molecular Tumor Boards and Central Consensus for Cancer Treatment in Japan. JAMA network open, 5:e2245081, 2022

25. Asai M, Matsumoto Y, Miura T, Hasuo H, Maeda I, Ogawa A, Morita T, Uchitomi Y, Kinoshita H. Psychological Distress among Caregivers for Patients Who Die of Cancer: A Preliminary Study in Japan. Journal of Nippon Medical School = Nippon Ika Daigaku zasshi, 89:428-435, 2022

26. Miura T, Mitsunaga S, Matsuzaki J, Takizawa S, Kato K, Ochiai A, Ochiya T. Serum microRNAs as new criteria for referral to early palliative care services in treatment-naïve advanced cancer patients. Oncotarget, 13:1341-1349, 2022

27. Kotani H, Masuda N, Yamashita T, Naito Y, Taira T, Inoue K, Takahashi M, Yonemori K, Toyoizumi S, Mori Y, Nagasawa T, Hori N, Iwata H. Efficacy and safety of talazoparib in Japanese patients with germline BRCA-mutated locally advanced or metastatic breast cancer: results of the phase 1 dose-expansion study. Breast cancer (Tokyo, Japan), 29:1088-1098, 2022

28. Mizuno M, Chiba I, Mukohara T, Kondo M, Maruo K, Ohigashi T, Naruo M, Asano Y, Onishi T, Tanabe H, Muta R, Mishima S, Okano S, Yuda M, Hosono A, Ueda Y, Bando H, Itagaki H, Ferrans CE, Akimoto T. Effectiveness of an online support program to help female cancer patients manage their health and illness: Protocol for a randomized controlled trial. Contemporary clinical trials communications, 30:101035, 2022

29. Modi S, Jacot W, Yamashita T, Sohn J, Vidal M, Tokunaga E, Tsurutani J, Ueno NT, Prat A, Chae YS, Lee KS, Niikura N, Park YH, Xu B, Wang X, Gil-Gil M, Li W, Pierga JY, Im SA, Moore HCF, Rugo HS, Yerushalmi R, Zagouri F, Gombos A, Kim SB, Liu Q, Luo T, Saura C, Schmid P, Sun T, Gambhire D, Yung L, Wang Y, Singh J, Vitazka P, Meinhardt G, Harbeck N, Cameron DA. Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer. The New England journal of medicine, 387:9-20, 2022

30. Niguma K, Mamishin K, Naito Y, Nomura S, Wakabayashi M, Kusuhara S, Funasaka C, Nakao T, Fukasawa Y, Kondoh C, Harano K, Kogawa T, Matsubara N, Hosono A, Onishi T, Kawasaki T, Mukohara T. Impact of Older Age and Medico-social Factors on the Decision to Offer Adjuvant Chemotherapy to Patients With Breast Cancer. Anticancer research, 42:3743-3751, 2022

31. Abe Y, Taira N, Kashiwabara K, Tsurutani J, Kitada M, Takahashi M, Kato H, Kikawa Y, Sakata E, Naito Y, Hasegawa Y, Saito T, Iwasa T, Takashima T, Aihara T, Mukai H, Hara F, Shien T, Doihara H, Toyooka S. Association of Genetic Polymorphism with Taxane-induced Peripheral Neuropathy: Sub-analysis of a Randomized Phase II Study to Determine the Optimal Dose of 3-week Cycle Nab-Paclitaxel in Metastatic Breast Cancer Patients. Acta medica Okayama, 76:661-671, 2022

32. Kuboki Y, Shimizu T, Yonemori K, Kojima T, Kondo S, Koganemaru S, Iwasa S, Harano K, Koyama T, Lu V, Zhou X, Niu H, Yanai T, Garcia-Ribas I, Doi T, Yamamoto N. Safety, Tolerability, and Pharmacokinetics of TAK-931, a Cell Division Cycle 7 Inhibitor, in Patients with Advanced Solid Tumors: A Phase I First-in-Human Study. Cancer research communications, 2:1426-1435, 2022

33. Tamiya Y, Nakai T, Suzuki A, Mimaki S, Tsuchihara K, Sato K, Yoh K, Matsumoto S, Zenke Y, Nosaki K, Izumi H, Shibata Y, Sakai T, Taki T, Miyazaki S, Watanabe R, Sakamoto N, Sakashita S, Kojima M, Hashimoto N, Tsuboi M, Goto K, Ishii G. The impact of tertiary lymphoid structures on clinicopathological, genetic and gene expression characteristics in lung adenocarcinoma. Lung cancer (Amsterdam, Netherlands), 174:125-132, 2022

34. Sawada K, Kotani D, Yukami H, Mishima S, Fujiwara H, Kadota T, Nakajo K, Yoda Y, Nakamura M, Hojo H, Yano T, Fujita T, Kojima T. Definitive chemoradiotherapy has comparable survival outcomes to esophagectomy in patients with clinical T1N0M0 esophageal squamous cell carcinoma: real-world data. International journal of clinical oncology, 27:1279-1288, 2022

35. Yukami H, Kawazoe A, Lin YT, Koyama S, Fukuoka S, Hara H, Takahashi N, Kojima T, Asayama M, Yoshii T, Bando H, Kotani D, Nakamura Y, Kuboki Y, Mishima S, Wakabayashi M, Kuwata T, Goto M, Higuchi K, Yoshino T, Doi T, Nishikawa H, Shitara K. Updated Efficacy Outcomes of Anti-PD-1 Antibodies plus Multikinase Inhibitors for Patients with Advanced Gastric Cancer with or without Liver Metastases in Clinical Trials. Clinical cancer research, 28:3480-3488, 2022

36. Aoki Y, Kawazoe A, Kubota Y, Chida K, Mishima S, Kotani D, Nakamura Y, Kuboki Y, Bando H, Kojima T, Doi T, Yoshino T, Kuwata T, Shitara K. Characteristics and clinical outcomes of patients with advanced gastric or gastroesophageal cancer treated in and out of randomized clinical trials of first-line immune checkpoint inhibitors. International journal of clinical oncology, 27:1413-1420, 2022

37. Hori K, Ikematsu H, Yamamoto Y, Matsuzaki H, Takeshita N, Shinmura K, Yoda Y, Kiuchi T, Takemoto S, Yokota H, Yano T. Detecting colon polyps in endoscopic images using artificial intelligence constructed with automated collection of annotated images from an endoscopy reporting system. Digestive endoscopy, 34:1021-1029, 2022

38. Yamashita H, Nakajo K, Takashima K, Murano T, Kadota T, Sinmura K, Yoda Y, Ikematsu H, Fujii S, Yano T. Recurrent metastasis risk factors in esophageal cancer after salvage endoscopic resection for local failure following chemoradiotherapy. Digestive endoscopy, 34:1356-1369, 2022

39. Shimoda R, Akutagawa T, Tomonaga M, Murano T, Shinmura K, Yoshioka M, Teramura Y, Kiyomi F, Ikematsu H. Estimating colorectal polyp size with a virtual scale endoscope and visual estimation during colonoscopy: Prospective, preliminary comparison of accuracy. Digestive endoscopy, 34:1471-1477, 2022

40. Yamashita H, Ikematsu H, Murano T, Aoyama N, Kano Y, Mitsui T, Sunakawa H, Shinmura K, Takashima K, Nakajo K, Kadota T, Yoda Y, Yano T. The usefulness of a double-balloon endolumenal interventional platform for colorectal endoscopic submucosal dissection by non-expert endoscopists in a porcine model (with video). Surgical endoscopy, 36:7818-7826, 2022

41. Nakajo K, Yoda Y, Yamashita H, Takashima K, Murano T, Kadota T, Shinmura K, Ikematsu H, Akimoto T, Yano T. Salvage endoscopic resection for cT1N0M0 local recurrence after chemoradiotherapy for esophageal squamous cell carcinoma: endoscopic submucosal dissection versus endoscopic mucosal resection. Japanese journal of clinical oncology, 52:982-991, 2022

42. Mitsui T, Yoda Y, Sunakawa H, Takayama S, Nishihara K, Inaba A, Sato D, Minamide T, Takashima K, Nakajo K, Murano T, Kadota T, Shinmura K, Ikematsu H, Yano T. Development of new gastric endoscopic submucosal dissection training model: A reproducibility evaluation study. Endoscopy international open, 10:E1261-E1267, 2022

43. Irisawa A, Takeno M, Watanabe K, Takahashi H, Mitsunaga S, Ikeda M. Incidence of and risk factors for severe neutropenia during treatment with the modified FOLFIRINOX therapy in patients with advanced pancreatic cancer. Scientific reports, 12:15574, 2022

44. Terada Tatsuto, Miura Tomofumi, Kosugi Kazuhiro, Natsume Maika, Yajima Midori Y., Shimotsuura Yasutaka, Eto Tetsuya, Matsumoto Yoshihisa. Efficacy of Aconiti tuber for chemotherapy-induced peripheral neuropathy with peripheral coldness and/or symptoms relief by warming: A case series. Traditional & Kampo Medicine, 9:57-60, 2022

45. Tsuno T, Fujimiya T, Kawaguchi T, Yanaizumi R, Kojima K, Miyasato A, Azuma K, Saeki T, Mawatari H, Igarashi T, Miura T, Ogura H, Kondo J, Tanoue T, Hamada H, Oyama Y, Kotani A, Yamaguchi T, Hakamata H. Psychological barriers to the use of opioid analgesics for treating pain in patients with advanced recurrent cancer (BAROC): protocol for a multicentre cohort study. BMJ open, 12:e054914, 2022

46. Usui Y, Kosugi K, Nishiguchi Y, Miura T, Fujisawa D, Uehara Y, Kawaguchi T, Izumi K, Takehana J, Matsumoto Y. Parenting experiences of cancer patients with minor children and their conversations about the possibility of death: a cross-sectional web-based survey for an online cancer community. Supportive care in cancer, 30:7715-7720, 2022

47. Chitose H, Kuwana M, Miura T, Inoue M, Nagasu Y, Shimizu R, Hattori Y, Uehara Y, Kosugi K, Matsumoto Y. A Japanese Nationwide Survey of Nutritional Counseling for Cancer Patients and Risk Factors of Burnout among Registered Dietitians. Palliative medicine reports, 3:211-219, 2022

48. Amano K, Baracos VE, Morita T, Miura T, Mori N, Tatara R, Kessoku T, Tokoro A, Tagami K, Otani H, Mori M, Taniyama T, Nakajima N, Nakanishi E, Kako J, Kiuchi D, Ishiki H, Matsuoka H, Satomi E, Miyashita M. The impact of cachexia on dietary intakes, symptoms, and quality of life in advanced cancer. JCSM Rapid Communications, 5:162- 170, 2022

49. Yokota S, Amano K, Oyamada S, Ishiki H, Maeda I, Miura T, Hatano Y, Uneno Y, Hori T, Matsuda Y, Kohara H, Suzuki K, Morita T, Mori M, the East-Asian collaborative cross-cultural Study to Elucidate the Dying process (EASED) investigators. Effects of artificial nutrition and hydration on survival in patients with head and neck cancer and esophageal cancer admitted to palliative care units. Clinical Nutrition Open Science, 41:33-43, 2022

50. Shimizu T, Kuboki Y, Lin CC, Yonemori K, Yanai T, Faller DV, Dobler L, Gupta N, Sedarati F, Kim KP. A Phase 1 Study of Sapanisertib (TAK-228) in East Asian Patients with Advanced Nonhematological Malignancies. Targeted oncology, 17:15-24, 2022

51. Shimizu T, Kuboki Y, Lin CC, Yonemori K, Yanai T, Faller DV, Dobler L, Gupta N, Sedarati F, Kim KP. Correction to: A Phase 1 Study of Sapanisertib (TAK-228) in East Asian Patients with Advanced Nonhematological Malignancies. Targeted oncology, 17:377, 2022

52. Wermke M, Felip E, Gambardella V, Kuboki Y, Morgensztern D, Hamed ZO, Liu M, Studeny M, Owonikoko TK. Phase I trial of the DLL3/CD3 bispecific T-cell engager BI 764532 in DLL3-positive small-cell lung cancer and neuroendocrine carcinomas. Future oncology (London, England), 18:2639-2649, 2022

53. Nishina T, Fujita T, Yoshizuka N, Sugibayashi K, Murayama K, Kuboki Y. Safety, tolerability, pharmacokinetics and preliminary antitumour activity of an antisense oligonucleotide targeting STAT3 (danvatirsen) as monotherapy and in combination with durvalumab in Japanese patients with advanced solid malignancies: a phase 1 study. BMJ open, 12:e055718, 2022

54. Miura T, Elgersma R, Okizaki A, Inoue MK, Amano K, Mori M, Chitose H, Matsumoto Y, Jager-Wittenaar H, Ottery FD. A Japanese translation, cultural adaptation, and linguistic and content validity confirmation of the Scored Patient-Generated Subjective Global Assessment. Supportive care in cancer, 29:7329-7338, 2021

55. Amano K, Ishiki H, Miura T, Maeda I, Hatano Y, Oyamada S, Yokomichi N, Tagami K, Odagiri T, Ito T, Baba M, Morita T, Mori M. C-Reactive Protein and Its Relationship with Pain in Patients with Advanced Cancer Cachexia: Secondary Cross-Sectional Analysis of a Multicenter Prospective Cohort Study. Palliative medicine reports, 2:122-131, 2021

56. Suzuki H, Mitsunaga S, Ikeda M, Aoyama T, Yoshizawa K, Yoshimatsu H, Kawai N, Masuda M, Miura T, Ochiai A. Clinical and Tumor Characteristics of Patients with High Serum Levels of Growth Differentiation Factor 15 in Advanced Pancreatic Cancer. Cancers, 13:4842, 2021

57. Miura T, Okizaki A, Hasuo H, Satomi E, Tagami K, Imai K, Kojima T, Satake H, Ishiki H, Inoue A, Yamaguchi T. Dexamethasone 8 mg for Cancer-Related Fatigue in Inpatients with Advanced Cancer Undergoing Palliative Care: A Multicenter Phase II Trial. Palliative medicine reports, 2:316-323, 2021

58. Amano K, Satomi E, Oyamada S, Ishiki H, Sakashita A, Miura T, Maeda I, Hatano Y, Yamauchi T, Oya K, Nakagawa J, Hiratsuka Y, Hirohashi T, Morita T, Mori M, the East-Asian collaborative cross-cultural Study to Elucidate the Dying process (EASED) investigators. The prevalence of artificially administered nutrition and hydration in different age groups among patients with advanced cancer admitted to palliative care units. Clinical Nutrition Open Science, 40:69-78, 2021