Annual Report 2023

Department of Experimental Therapeutics

Toshihiko Doi, Yasutoshi Kuboki, Kiyotaka Yoh, Yoichi Naito, Kohei Shitara, Kenichi Harano, Junichiro Yuda, Shigehiro Koganemaru, Chikako Funasaka, Hiromichi Nakajima

Introduction

 The NCC-EPOC Phase I Group was organized to promote early drug development, especially first in human (FIH) trials, and in 2012 the phase I group consisted of two subunits (NCCE-Kashiwa & NCC-Tsukiji) organized by each hospital. The goal of each of the units is to perform initial clinical evaluation of promising new anti-cancer compounds emerging from the laboratory. Our Phase I unit is the largest program in Japan, indeed in Asia, and we contribute to the development of new cancer drugs through early phase trials.

 In April 2013, the Department of Experimental Therapeutics was launched to strongly promote the EPOC missions as previously described. The members of the Department of Experimental Therapeutics consisted of specialists in their oncology fields. We have also conducted/contributed to IIT using unapproved drugs and new academic seeds.

The Team and What We Do

 Our team has conducted and managed early drug development, especially first in human (FIH) trials.

Research Activities

 This department plays an important role in new anti-cancer drug development in our center as well as in Japan, and while conducting FIH trials is the top priority, we also perform phase I trials. Recently, we joined the global phase I trial to accelerate new drug development in Japan. Web or teleconferences are held with the EU and US sites, and we are discussing patient enrollment as well as further developmental strategies. Routine web conferences are also held between the Kashiwa and Tsukiji campuses every Friday morning; we share information about adverse events and patient enrollment as well as referring the candidates to each other to accelerate enrollment. Several IIT-FIH trials using new class seeds and also unapproved company agents are conducted by each unit.

Clinical Trials

 In 2023, 203 patients were enrolled in the phase I and phase I/II trials.

List of papers published in 2023

Journal

1. Takei S, Tanaka Y, Lin YT, Koyama S, Fukuoka S, Hara H, Nakamura Y, Kuboki Y, Kotani D, Kojima T, Bando H, Mishima S, Ueno T, Kojima S, Wakabayashi M, Sakamoto N, Kojima M, Kuwata T, Yoshino T, Nishikawa H, Mano H, Endo I, Shitara K, Kawazoe A. Multiomic molecular characterization of the response to combination immunotherapy in MSS/pMMR metastatic colorectal cancer. Journal for immunotherapy of cancer, 12:e008210, 2024

2. Sunami K, Naito Y, Saigusa Y, Amano T, Ennishi D, Imai M, Kage H, Kanai M, Kenmotsu H, Komine K, Koyama T, Maeda T, Morita S, Sakai D, Hirata M, Ito M, Kozuki T, Sakashita H, Horinouchi H, Okuma Y, Takashima A, Kubo T, Hironaka S, Segawa Y, Yakushijin Y, Bando H, Makiyama A, Suzuki T, Kinoshita I, Kohsaka S, Ohe Y, Ishioka C, Yamamoto K, Tsuchihara K, Yoshino T. A Learning Program for Treatment Recommendations by Molecular Tumor Boards and Artificial Intelligence. JAMA oncology, 10:95-102, 2024

3. Shitara K, Rha SY, Wyrwicz LS, Oshima T, Karaseva N, Osipov M, Yasui H, Yabusaki H, Afanasyev S, Park YK, Al-Batran SE, Yoshikawa T, Yanez P, Dib Bartolomeo M, Lonardi S, Tabernero J, Van Cutsem E, Janjigian YY, Oh DY, Xu J, Fang X, Shih CS, Bhagia P, Bang YJ. Neoadjuvant and adjuvant pembrolizumab plus chemotherapy in locally advanced gastric or gastro-oesophageal cancer (KEYNOTE-585): an interim analysis of the multicentre, double-blind, randomised phase 3 study. The Lancet. Oncology, 25:212-224, 2024

4. Doi T, Yamamoto N, Ohkubo S. Pimitespib for the treatment of advanced gastrointestinal stromal tumors and other tumors. Future oncology (London, England), 20:507-519, 2024

5. Doi T, Takahashi S, Aoki D, Yonemori K, Hara H, Hasegawa K, Takehara K, Harano K, Yunokawa M, Nomura H, Shimoi T, Horie K, Ogasawara A, Okame S. A first-in-human phase I study of TAS-117, an allosteric AKT inhibitor, in patients with advanced solid tumors. Cancer chemotherapy and pharmacology, 93:605-616, 2024

6. Yamamoto N, Satouchi M, Doi T, Fujiwara Y, Yanagitani N, Kawa Y, Yoh K, Leopold L, Munteanu M, Sawada T, Han S, Noguchi K, Nishio M. KEYNOTE-434 part B: A phase 1 study evaluating the combination of epacadostat, pembrolizumab, and chemotherapy in Japanese patients with previously untreated advanced non-small-cell lung cancer. Investigational new drugs, 42:261-271, 2024

7. Kitagawa Y, Matsuda S, Gotoda T, Kato K, Wijnhoven B, Lordick F, Bhandari P, Kawakubo H, Kodera Y, Terashima M, Muro K, Takeuchi H, Mansfield PF, Kurokawa Y, So J, Mönig SP, Shitara K, Rha SY, Janjigian Y, Takahari D, Chau I, Sharma P, Ji J, de Manzoni G, Nilsson M, Kassab P, Hofstetter WL, Smyth EC, Lorenzen S, Doki Y, Law S, Oh DY, Ho KY, Koike T, Shen L, van Hillegersberg R, Kawakami H, Xu RH, Wainberg Z, Yahagi N, Lee YY, Singh R, Ryu MH, Ishihara R, Xiao Z, Kusano C, Grabsch HI, Hara H, Mukaisho KI, Makino T, Kanda M, Booka E, Suzuki S, Hatta W, Kato M, Maekawa A, Kawazoe A, Yamamoto S, Nakayama I, Narita Y, Yang HK, Yoshida M, Sano T. Clinical practice guidelines for esophagogastric junction cancer: Upper GI Oncology Summit 2023. Gastric cancer, 27:401-425, 2024

8. Hashimoto T, Nakamura Y, Mishima S, Nakayama I, Kotani D, Kawazoe A, Kuboki Y, Bando H, Kojima T, Iida N, Shibuki T, Imai M, Fujisawa T, Nagamine M, Sakamoto N, Kuwata T, Yoshino T, Shitara K. Whole-transcriptome sequencing in advanced gastric or gastroesophageal cancer: A deep dive into its clinical potential. Cancer science, 115:1622-1633, 2024

9. Arend RC, Monk BJ, Shapira-Frommer R, Haggerty AF, Alvarez EA, Amit A, Alvarez Secord A, Muller C, Casado Herraez A, Herzog TJ, Tewari KS, Cohen JG, Huang M, Yachnin A, Holeman LL, Ledermann JA, Rachmilewitz Minei T, Buyse M, Fain Shmueli S, Lavi M, Harats D, Penson RT. Ofranergene Obadenovec (Ofra-Vec, VB-111) With Weekly Paclitaxel for Platinum-Resistant Ovarian Cancer: Randomized Controlled Phase III Trial (OVAL Study/GOG 3018). Journal of clinical oncology, 42:170-179, 2024

10. Kikuchi Y, Shimada H, Hatanaka Y, Kinoshita I, Ikarashi D, Nakatsura T, Kitano S, Naito Y, Tanaka T, Yamashita K, Oshima Y, Nanami T. Clinical practice guidelines for molecular tumor markers, 2nd edition review part 1. International journal of clinical oncology, 29:1-19, 2024

11. Nishida T, Naito Y, Takahashi T, Saito T, Hisamori S, Manaka D, Ogawa K, Hirota S, Ichikawa H. Molecular and clinicopathological features of KIT/PDGFRA wild-type gastrointestinal stromal tumors. Cancer science, 115:894-904, 2024

12. Udagawa H, Nilsson MB, Robichaux JP, He J, Poteete A, Jiang H, Heeke S, Elamin YY, Shibata Y, Matsumoto S, Yoh K, Okazaki S, Masuko T, Odintsov I, Somwar R, Ladanyi M, Goto K, Heymach JV. HER4 and EGFR Activate Cell Signaling in NRG1 Fusion-Driven Cancers: Implications for HER2-HER3-specific Versus Pan-HER Targeting Strategies. Journal of thoracic oncology, 19:106-118, 2024

13. Kitagawa S, Zenke Y, Taki T, Aokage K, Sakai T, Shibata Y, Izumi H, Nosaki K, Umemura S, Matsumoto S, Yoh K, Sakamoto N, Sakashita S, Kojima M, Tsuboi M, Goto K, Ishii G. Prognostic value of predominant subtype in pathological stage II-III lung adenocarcinoma with epidermal growth factor receptor mutation. Lung cancer (Amsterdam, Netherlands), 188:107453, 2024

14. Tsukita Y, Taguri M, Goto Y, Hosomi Y, Mizutani T, Watanabe K, Yoh K, Takahashi S, Kubota K, Kunitoh H. Multi-institutional study of osimertinib dose-optimization in non-small cell lung cancer patients with EGFR activating mutation aged 70 years or older ('MONEY' trial). Japanese journal of clinical oncology, 54:730-734, 2024

15. Koganemaru S, Fuchigami H, Yamashita H, Morizono C, Sunakawa H, Kawazoe A, Nakamura Y, Kuboki Y, Shitara K, Yano T, Doi T, Yasunaga M. Quantitative Analysis of the Concentration of Trifluridine in Tumor Hypoxic Regions Using a Novel Platform Combining Functional Endoscopy and Mass Spectrometry. Clinical pharmacology and therapeutics, 115:62-70, 2024

16. Shitara K. Trastuzumab deruxtecan in previously treated HER2-positive gastric cancer: a plain language summary of the DESTINY-Gastric01 study. Future oncology (London, England), 20:59-70, 2024

17. Shitara K, Yamaguchi K, Muro K, Yasui H, Sakai D, Oshima T, Fujimura M, Sato Y, Yamazaki S, Wakabayashi T, Sugihara M, Kamio T, Shoji H. Trastuzumab deruxtecan in patients with locally advanced or metastatic HER2-positive gastric cancer: a multicenter, open-label, expanded-access study. International journal of clinical oncology, 29:27-35, 2024

18. Kubota Y, Shitara K. Zolbetuximab for Claudin18.2-positive gastric or gastroesophageal junction cancer. Therapeutic advances in medical oncology, 16:17588359231217967, 2024

19. Sunakawa Y, Kuboki Y, Watanabe J, Terazawa T, Kawakami H, Yokota M, Nakamura M, Kotaka M, Sugimoto N, Ojima H, Oki E, Kajiwara T, Yamamoto Y, Tsuji Y, Denda T, Tamura T, Ishihara S, Taniguchi H, Nakajima TE, Morita S, Shirao K, Takenaka N, Ozawa D, Yoshino T. Exploratory Biomarker Analysis Using Plasma Angiogenesis-Related Factors and Cell-Free DNA in the TRUSTY Study: A Randomized, Phase II/III Study of Trifluridine/Tipiracil Plus Bevacizumab as Second-Line Treatment for Metastatic Colorectal Cancer. Targeted oncology, 19:59-69, 2024

20. Kubota Y, Kawazoe A, Mishima S, Nakamura Y, Kotani D, Kuboki Y, Bando H, Kojima T, Doi T, Yoshino T, Kuwata T, Shitara K. Corrigendum to "Comprehensive clinical and molecular characterization of claudin 18.2 expression in advanced gastric or gastroesophageal junction cancer": [ESMO Open 8 (2023) 100762]. ESMO open, 9:102232, 2024

21. Okunaka M, Kotani D, Mishima S, Nakamura M, Kawazoe A, Bando H, Yoshino T, Shitara K. Potential Efficacy of Shiunko for Anti-Epidermal Growth Factor Receptor (EGFR) Monoclonal Antibody-Induced Skin Fissure: A Single Institutional Case Series. Integrative cancer therapies, 23:15347354231225962, 2024

22. Brahmer JR, Long GV, Hamid O, Garon EB, Herbst RS, Andre T, Armand P, Bajorin D, Bellmunt J, Burtness B, Choueiri TK, Cohen EEW, Diaz LA Jr, Shitara K, Kulkarni G, McDermott D, Shah M, Tabernero J, Vogel A, Zinzani PL, Jafari N, Bird S, Snyder E, Gause C, Bracco OL, Pietanza MC, Gruber T, Ribas A. Safety profile of pembrolizumab monotherapy based on an aggregate safety evaluation of 8937 patients. European journal of cancer (Oxford, England : 1990), 199:113530, 2024

23. Shitara K, Muro K, Watanabe J, Yamazaki K, Ohori H, Shiozawa M, Takashima A, Yokota M, Makiyama A, Akazawa N, Ojima H, Yuasa Y, Miwa K, Yasui H, Oki E, Sato T, Naitoh T, Komatsu Y, Kato T, Mori I, Yamanaka K, Hihara M, Soeda J, Misumi T, Yamamoto K, Yamashita R, Akagi K, Ochiai A, Uetake H, Tsuchihara K, Yoshino T. Baseline ctDNA gene alterations as a biomarker of survival after panitumumab and chemotherapy in metastatic colorectal cancer. Nature medicine, 30:730-739, 2024

24. Shitara K, Falcone A, Fakih MG, George B, Sundar R, Ranjan S, Van Cutsem E. Efficacy and Safety of Trifluridine/Tipiracil-Containing Combinations in Colorectal Cancer and Other Advanced Solid Tumors: A Systematic Review. The oncologist, 29:e601-e615, 2024

25. Janjigian YY, Ajani JA, Moehler M, Shen L, Garrido M, Gallardo C, Wyrwicz L, Yamaguchi K, Cleary JM, Elimova E, Karamouzis M, Bruges R, Skoczylas T, Bragagnoli A, Liu T, Tehfe M, Zander T, Kowalyszyn R, Pazo-Cid R, Schenker M, Feeny K, Wang R, Lei M, Chen C, Nathani R, Shitara K. First-Line Nivolumab Plus Chemotherapy for Advanced Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma: 3-Year Follow-Up of the Phase III CheckMate 649 Trial. Journal of clinical oncology, 42:2012-2020, 2024

26. Yoshino T, Hooda N, Younan D, Muro K, Shitara K, Heinemann V, O'neil BH, Herrero FR, Peeters M, Soeda J, Suh M, Reichert H, Mezzi K, Fryzek J, Chia V, Rehn M, Stintzing S. A meta-analysis of efficacy and safety data from head-to-head first-line trials of epidermal growth factor receptor inhibitors versus bevacizumab in adult patients with RAS wild-type metastatic colorectal cancer by sidedness. European journal of cancer (Oxford, England : 1990), 202:113975, 2024

27. Nakayama I, Qi C, Chen Y, Nakamura Y, Shen L, Shitara K. Claudin 18.2 as a novel therapeutic target. Nature reviews. Clinical oncology, 21:354-369, 2024

28. Hashimoto T, Nakamura Y, Oki E, Kobayashi S, Yuda J, Shibuki T, Bando H, Yoshino T. Bridging horizons beyond CIRCULATE-Japan: a new paradigm in molecular residual disease detection via whole genome sequencing-based circulating tumor DNA assay. International journal of clinical oncology, 29:495-511, 2024

29. Kuboki Y, Fakih M, Strickler J, Yaeger R, Masuishi T, Kim EJ, Bestvina CM, Kopetz S, Falchook GS, Langer C, Krauss J, Puri S, Cardona P, Chan E, Varrieur T, Mukundan L, Anderson A, Tran Q, Hong DS. Sotorasib with panitumumab in chemotherapy-refractory KRAS(G12C)-mutated colorectal cancer: a phase 1b trial. Nature medicine, 30:265-270, 2024

30. Funasaka C, Hanai A, Zenda S, Mori K, Fukui M, Hirano N, Shinohara R, Fuse N, Wakabayashi M, Itagaki M, Tomioka Y, Nishina M, Arai Y, Kogawa T, Ozaki Y, Nishimura M, Kobayashi T, Hara F, Takano T, Mukohara T. Mitigation of paclitaxel-induced peripheral neuropathy in breast cancer patients using limb-cooling apparatus: a study protocol for a randomized controlled trial. Frontiers in oncology, 13:1216813, 2023

31. Sasada S, Kondo N, Hashimoto H, Takahashi Y, Terata K, Kida K, Sagara Y, Ueno T, Anan K, Suto A, Kanbayashi C, Takahashi M, Nakamura R, Ishiba T, Tsuneizumi M, Nishimura S, Naito Y, Hara F, Shien T, Iwata H. Prognostic impact of adjuvant endocrine therapy for estrogen receptor-positive and HER2-negative T1a/bN0M0 breast cancer. Breast cancer research and treatment, 202:473-483, 2023

32. Muro K, Shitara K, Yamaguchi K, Yoshikawa T, Satake H, Hara H, Sugimoto N, Machida N, Goto M, Kawakami H, Amagai K, Omuro Y, Esaki T, Hironaka S, Nishina T, Komatsu Y, Matsubara H, Shiratori S, Han S, Satoh T, Ohtsu A. Efficacy of Pembrolizumab Monotherapy in Japanese Patients with Advanced Gastric or Gastroesophageal Junction Cancer. Journal of gastrointestinal cancer, 54:951-961, 2023

33. 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

34. Watanabe J, Muro K, Shitara K, Yamazaki K, Shiozawa M, Ohori H, Takashima A, Yokota M, Makiyama A, Akazawa N, Ojima H, Yuasa Y, Miwa K, Yasui H, Oki E, Sato T, Naitoh T, Komatsu Y, Kato T, Hihara M, Soeda J, Misumi T, Yamamoto K, Akagi K, Ochiai A, Uetake H, Tsuchihara K, Yoshino T. Panitumumab vs Bevacizumab Added to Standard First-line Chemotherapy and Overall Survival Among Patients With RAS Wild-type, Left-Sided Metastatic Colorectal Cancer: A Randomized Clinical Trial. JAMA, 329:1271-1282, 2023

35. Lee DH, Kim HR, Keam B, Kato K, Kuboki Y, Gao H, Yovine A, Robbins SH, Ahn MJ. Safety and tolerability of first-line durvalumab with tremelimumab and chemotherapy in esophageal squamous cell carcinoma. Cancer medicine, 12:16066-16075, 2023

36. Izutsu K, Kumode T, Yuda J, Nagai H, Mishima Y, Suehiro Y, Yamamoto K, Fujisaki T, Ishitsuka K, Ishizawa K, Ikezoe T, Nishikori M, Akahane D, Fujita J, Dinh M, Soong D, Noguchi H, Buchbjerg JK, Favaro E, Fukuhara N. Subcutaneous epcoritamab monotherapy in Japanese adults with relapsed/refractory diffuse large B-cell lymphoma. Cancer science, 114:4643-4653, 2023

37. Naito Y, Mishima S, Akagi K, Hayashi N, Hirasawa A, Hishiki T, Igarashi A, Ikeda M, Kadowaki S, Kajiyama H, Kato M, Kenmotsu H, Kodera Y, Komine K, Koyama T, Maeda O, Miyachi M, Nishihara H, Nishiyama H, Ohga S, Okamoto W, Oki E, Ono S, Sanada M, Sekine I, Takano T, Tao K, Terashima K, Tsuchihara K, Yatabe Y, Yoshino T, Baba E. Japanese Society of Medical Oncology/Japan Society of Clinical Oncology/Japanese Society of Pediatric Hematology/Oncology-led clinical recommendations on the diagnosis and use of tropomyosin receptor kinase inhibitors in adult and pediatric patients with neurotrophic receptor tyrosine kinase fusion-positive advanced solid tumors. International journal of clinical oncology, 28:827-840, 2023

38. Mishima S, Naito Y, Akagi K, Hayashi N, Hirasawa A, Hishiki T, Igarashi A, Ikeda M, Kadowaki S, Kajiyama H, Kato M, Kenmotsu H, Kodera Y, Komine K, Koyama T, Maeda O, Miyachi M, Nishihara H, Nishiyama H, Ohga S, Okamoto W, Oki E, Ono S, Sanada M, Sekine I, Takano T, Tao K, Terashima K, Tsuchihara K, Yatabe Y, Yoshino T, Baba E. Japanese Society of Medical Oncology/Japan Society of Clinical Oncology/Japanese Society of Pediatric Hematology/Oncology-led clinical recommendations on the diagnosis and use of immunotherapy in patients with high tumor mutational burden tumors. International journal of clinical oncology, 28:941-955, 2023

39. Mishima S, Naito Y, Akagi K, Hayashi N, Hirasawa A, Hishiki T, Igarashi A, Ikeda M, Kadowaki S, Kajiyama H, Kato M, Kenmotsu H, Kodera Y, Komine K, Koyama T, Maeda O, Miyachi M, Nishihara H, Nishiyama H, Ohga S, Okamoto W, Oki E, Ono S, Sanada M, Sekine I, Takano T, Tao K, Terashima K, Tsuchihara K, Yatabe Y, Yoshino T, Baba E. Japanese Society of Medical Oncology/Japan Society of Clinical Oncology/Japanese Society of Pediatric Hematology/Oncology-led clinical recommendations on the diagnosis and use of immunotherapy in patients with DNA mismatch repair deficient (dMMR) tumors, third edition. International journal of clinical oncology, 28:1237-1258, 2023

40. Shitara K, Hirao M, Iwasa S, Oshima T, Komatsu Y, Kawazoe A, Sato Y, Hamakawa T, Yonemori K, Machida N, Yuki S, Suzuki T, Okumura S, Takase T, Semba T, Zimmermann B, Teng A, Yamaguchi K. Phase I Study of the Liposomal Formulation of Eribulin (E7389-LF): Results from the Advanced Gastric Cancer Expansion Cohort. Clinical cancer research, 29:1460-1467, 2023

41. Shimizu T, Sands J, Yoh K, Spira A, Garon EB, Kitazono S, Johnson ML, Meric-Bernstam F, Tolcher AW, Yamamoto N, Greenberg J, Kawasaki Y, Zebger-Gong H, Kobayashi F, Phillips P, Lisberg AE, Heist RS. First-in-Human, Phase I Dose-Escalation and Dose-Expansion Study of Trophoblast Cell-Surface Antigen 2-Directed Antibody-Drug Conjugate Datopotamab Deruxtecan in Non-Small-Cell Lung Cancer: TROPION-PanTumor01. Journal of clinical oncology, 41:4678-4687, 2023

42. Ida H, Shimizu T, Nishino M, Nakamura Y, Yazaki S, Katsuya Y, Sato J, Koyama T, Iwasa S, Sudo K, Kondo S, Yonemori K, Shitara K, Shiono S, Matsuoka D, Yasuda K, Otake Y, Suzuki T, Takase T, Takashima S, Yamaguchi K, Semba T, Yamamoto N. Phase Ib/II Study of a Liposomal Formulation of Eribulin (E7389-LF) plus Nivolumab in Patients with Advanced Solid Tumors: Results from Phase Ib. Cancer research communications, 3:1189-1199, 2023

43. 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

44. Baba K, Kawamoto M, Mamishin K, Uematsu M, Kiyohara H, Hirota A, Takahashi N, Fukuda M, Kusuhara S, Nakajima H, Funasaka C, Nakao T, Kondoh C, Harano K, Matsubara N, Naito Y, Hosono A, Kawasaki T, Mukohara T. The impact of the COVID-19 pandemic on perioperative chemotherapy for breast cancer. Cancer medicine, 12:12095-12105, 2023

45. Doi T, Matsubara N, Naito Y, Kuboki Y, Harano K, Ono M, Urasaki T, Ohmoto A, Kawanai T, Hisai T, Ikezawa H, Shiba S, Ito K, Semba T, Asano O, Takahashi S. First-in-human study of E7130 (a tumor microenvironment-ameliorating microtubule inhibitor) in patients with advanced solid tumors: Primary results of the dose-escalation part. Cancer, 129:2348-2359, 2023

46. George S, Heinrich MC, Somaiah N, Oppelt P, McLeod R, Nishioka S, Kundu MG, Qian X, Kumar P, Laadem A, Lau Y, Tran BP, Fallon M, Dosunmu O, Shi J, Naito Y. A Phase I, Multicenter, Open-Label, First-in-Human Study of DS-6157a in Patients with Advanced Gastrointestinal Stromal Tumor. Clinical cancer research, 29:3659-3667, 2023

47. Uematsu M, Nakajima H, Hosono A, Kiyohara H, Hirota A, Takahashi N, Fukuda M, Kusuhara S, Nakao T, Funasaka C, Kondoh C, Harano K, Matsubara N, Naito Y, Akimoto T, Mukohara T. Safety of immune checkpoint inhibitors after proton beam therapy in head and neck mucosal melanoma: a case series. Melanoma research, 33:547-552, 2023

48. Terada M, Ito A, Kikawa Y, Koizumi K, Naito Y, Shimoi T, Ishihara M, Yamanaka T, Ozaki Y, Hara F, Nakamura R, Hattori M, Miyashita M, Kondo N, Yoshinami T, Takada M, Matsumoto K, Narui K, Sasada S, Iwamoto T, Hosoda M, Takano Y, Oba T, Sakai H, Murakami A, Higuchi T, Tsuchida J, Tanabe Y, Shigechi T, Tokuda E, Harao M, Kashiwagi S, Mase J, Watanabe J, Nagai SE, Yamauchi C, Yamamoto Y, Iwata H, Saji S, Toyama T. The Japanese Breast Cancer Society Clinical Practice Guidelines for systemic treatment of breast cancer, 2022 edition. Breast cancer (Tokyo, Japan), 30:872-884, 2023

49. Misawa S, Denda T, Kodama S, Suzuki T, Naito Y, Kogawa T, Takada M, Suichi T, Shiosakai K, Kuwabara S. Efficacy and safety of mirogabalin for chemotherapy-induced peripheral neuropathy: a prospective single-arm trial (MiroCIP study). BMC cancer, 23:1098, 2023

50. 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

51. 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

52. Kagawa Y, Nakai T, Taki T, Hashimoto H, Tanaka Y, Sakai T, Shibata Y, Izumi H, Nosaki K, Udagawa H, Zenke Y, Matsumoto S, Yoh K, Miyazaki S, Watanabe R, Kojima M, Sakashita S, Sakamoto N, Tsuboi M, Goto K, Ishii G. Prognostic impact and gene expression analysis of peri-tumoral alveolar macrophage in resected lung adenocarcinoma. Cancer science, 114:3423-3432, 2023

53. Sakai T, Matsumoto S, Ueda Y, Shibata Y, Ikeda T, Nakamura A, Kodani M, Ohashi K, Furuya N, Izumi H, Nosaki K, Umemura S, Zenke Y, Udagawa H, Sugiyama E, Yoh K, Goto K. Clinicogenomic Features and Targetable Mutations in NSCLCs Harboring BRAF Non-V600E Mutations: A Multi-Institutional Genomic Screening Study (LC-SCRUM-Asia). Journal of thoracic oncology, 18:1538-1549, 2023

54. Kenmotsu H, Yamamoto N, Misumi T, Yoh K, Saito H, Sugawara S, Yamazaki K, Nakagawa K, Sugio K, Seto T, Toyooka S, Date H, Mitsudomi T, Okamoto I, Yokoi K, Saka H, Okamoto H, Takiguchi Y, Takahashi T, Tsuboi M. Five-Year Overall Survival Analysis of the JIPANG Study: Pemetrexed or Vinorelbine Plus Cisplatin for Resected Stage II-IIIA Nonsquamous Non-Small-Cell Lung Cancer. Journal of clinical oncology, 41:5242-5246, 2023

55. Yu HA, Goto Y, Hayashi H, Felip E, Chih-Hsin Yang J, Reck M, Yoh K, Lee SH, Paz-Ares L, Besse B, Bironzo P, Kim DW, Johnson ML, Wu YL, John T, Kao S, Kozuki T, Massarelli E, Patel J, Smit E, Reckamp KL, Dong Q, Shrestha P, Fan PD, Patel P, Sporchia A, Sternberg DW, Sellami D, Jänne PA. HERTHENA-Lung01, a Phase II Trial of Patritumab Deruxtecan (HER3-DXd) in Epidermal Growth Factor Receptor-Mutated Non-Small-Cell Lung Cancer After Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and Platinum-Based Chemotherapy. Journal of clinical oncology, 41:5363-5375, 2023

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