Annual Report 2023

Department of Gastroenterology and Gastrointestinal Oncology

Kouhei Shitara, Takashi Kojima, Hideaki Bando, Yasutoshi Kuboki, Akihito Kawazoe, Daisuke Kotani, Nozomu Fuse, Takayuki Yoshino, Izuma Nakamura, Yoshiaki Nakamura, Saori Mishima, Tadayoshi Hashimoto, Yuuki Matsubara

Introduction

 In 2023, approximately 800 patients with gastrointestinal (GI) cancer were treated by staff oncologists and skilled residents in the Department of GI Oncology, which focuses on the optimal chemotherapy with or without radiation for the treatment of GI cancers.

The Team and What We Do

 Inter-divisional tumor board conferences with the Surgical/Radiation Oncology Divisions are held regularly to review the current treatment for each patient and to discuss further treatment strategies. Our activities for each type of GI cancer in 2023 are shown in Table 1. There are ongoing clinical trials, which consist of 78 phase I trials, including global first-in-class (FIC), first-in-human (FIH), and investigational new drugs (INDs), 69 phase II/III clinical trials to approve the INDs, and 11 investigator-initiated clinical trials (IITs). In addition, young skilled residents in their early 30s have become principal investigators for several IITs.

Table 1. Number of new patients

Research Activities

Esophageal Cancer (EC)

 The results of a phase Ib/II study that investigates the safety, efficacy, and proof-of-concept (POC) of Anti PD-L1 antibody monotherapy following radical chemoradiotherapy were reported at ESMO 2022. An observational study to clarify the clinical utility of detecting MRD and monitoring using ctDNA analysis in patients with gastrointestinal cancer who plan to undergo curative treatment is ongoing and the interim analysis was reported at ASCO 2023. Furthermore, we contribute to ongoing international global studies including a phase III trial of lenvatinib and pembrolizumab in combination with chemotherapy for advanced esophageal squamous cell carcinoma.

Gastric Cancer (GC)

 We continue to conduct various researches to clarify the immune profiles or multiple biomarker expression in gastric cancer as collaborations with the division of cancer immunology, pathological department and pharmaceutical company. Based on our investigator-initiated trials of lenvatinib plus pembrolizumab or regorafenib plus nivolumab for gastric cancer, two global phase III studies are ongoing, and the results are awaited (LEAP-015 and INTEGRATE2b). Furthermore, we conducted a phase II study of first-line chemotherapy and regorafenib plus nivolumab and the primary results were reported at ASCO 2024. An investigator-initiated trial investigating trastuzumab deruxtecan in combination with chemotherapy and immunotherapy for gastric cancer with low HER2 expression is also ongoing. The results from the phase I trial of photoimmunotherapy plus nivolumab for patients with EGFR expressing gastric cancer were reported at DDW 2023 and manuscript is prepared. We are also actively developing perioperative therapies. An investigator-initiated phase II trial investigating lenvatinib plus pembrolizumab as perioperative therapy in combination with FLOT was conducted and reported at ESMO 2024. A new trial is planned to investigate FLOT plus lenvatinib and pembrolizumab followed by short course of radiation to achieve non operative management with organ preservation in patients with clinical response. A phase II study of neoadjuvant trastuzumab deruxtecan, another preoperative treatment, is being conducted as an investigator-initiated trial, with results of the single-agent cohort reported at the ASCO-GI 2024, and enrollment has begun in a cohort that will combine trastuzumab deruxtecan plus chemotherapy and immunotherapy. As a new concept, an investigator-initiated trial is ongoing to combine sulfasalazine and oxyfedrine to induce ferroptosis and cancer cell death. Our department has contributed to several international global studies, including pivotal phase III trials of zolbetuximab plus chemotherapy, which led to Japanese approval for gastric cancer in 2024. We published the findings from these trials in major journals such as the Lancet and The New England Journal of Medicine as the first/lead author.

Colorectal Cancer (CRC)

 We have been conducting our initiative SCRUM-Japan platform, which is a nationwide cancer genome screening system using tissue/plasma-based next-generation sequencing (MONSTAR-SCREEN-2, GOZILA [Nat. Med 2024]) and whole exome/whole transcriptome sequencing for metastatic solid tumors. Utilizing these screening systems, the umbrella type of IITs for patients with metastatic CRC or solid tumors with BRAF non-V600E mutation, MET amplification, and MSI-high resectable rectal cancer are ongoing. We have also launched IITs in resectable colorectal cancer (CIRCULATE-Japan project [Nat. Med 2024]) to stratify them according to recurrence risk based on the Signatera assay for detecting minimal residual disease. Most recently, our department contributed to several international global studies including a phase III trial of lenvatinib and pembrolizumab (LEAP-017) for colorectal cancer and published the results in Journal of Clinical Oncology 2024 as the first/lead author.

Education

 Our residents learn the latest evidence-based medicine and pragmatically apply this knowledge to enhance care for patients with GI cancers, and eventually qualify as comprehensive GI oncologists through daily practice and direct training from our staff. Accordingly, our staff actively provide numerous valuable opportunities to polish their chemotherapy skills, especially in collaboration with the Department of Experimental Therapeutics, as well as diagnostic and therapeutic endoscopy skills in collaboration with the Department of Digestive Endoscopy. We regularly hold tumor board meetings and frequently conduct numerous face-to-face meetings with experts in different fields. We instruct them on how to conduct valuable clinical trials, help them attend international academic conferences, and explain the best way to present at academic meetings as well as work on many high-impact articles in scholarly journals. To date, our department has helped many residents to become ‘true’ skilled GI oncologists who play major roles at leading cancer centers nationwide.

Future Prospects

 We continue to provide the best treatment for cancer patients and the best education for residents, and aim to perform the following activities:

1)  Provide more of the latest, cutting-edge medicine to cancer patients and to foster the next generation of skilled GI oncologists.

2)  Achieve medical innovation in Japan and play a leading role in the clinical development of INDs by contributing to various clinical trials including FIC, FIH early trials, IITs with proof-of-concept, and international clinical trials.

3)  Establish global research networks with cutting-edge researchers to enhance our research activities.

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. Bando H, Tsukada Y, Kumagai S, Miyashita Y, Taketomi A, Yuki S, Komatsu Y, Akiyoshi T, Shinozaki E, Kanemitsu Y, Takashima A, Shiozawa M, Shiomi A, Yamazaki K, Matsuhashi N, Hasegawa H, Kato T, Oki E, Fukui M, Wakabayashi M, Fuse N, Nishikawa H, Ito M, Yoshino T . VOLTAGE-2: multicenter phase II study of nivolumab monotherapy in patients with mismatch repair-deficient resectable locally advanced rectal cancer. Gastrointestinal Oncology, 3:2024

3. 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

4. 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

5. Kawazoe A, Yamamoto N, Sugimoto N, Kawakami H, Oshima T, Yamaguchi K, Hino K, Hirao M, Kurokawa Y, Kawakami T, Tsuda M, Hara H, Kaname S, Matsuoka D, Otake Y, Yasuda K, Takase T, Takashima S, Semba T, Muro K. Phase II Study of the Liposomal Formulation of Eribulin (E7389-LF) in Combination with Nivolumab: Results from the Gastric Cancer Cohort. Clinical cancer research, 30:1264-1272, 2024

6. 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

7. 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

8. Okunaka M, Kotani D, Fujiwara H, Sato K, Fujiwara N, Mishima S, Sakashita S, Yoshino T, Fujita T, Kojima T. Prognosis of patients with residual pathological disease after neoadjuvant docetaxel, cisplatin, and 5-fluorouracil therapy and surgery for esophageal squamous cell carcinoma: a retrospective cohort study. Therapeutic advances in medical oncology, 16:17588359241229432, 2024

9. Randon G, Nakamura Y, Yaeger R, Lonardi S, Cremolini C, Elez E, Nichetti F, Ghelardi F, Nasca V, Bergamo F, Conca V, Ros J, Bando H, Maddalena G, Oldani S, Prisciandaro M, Raimondi A, Schrock AB, Agnelli L, Walch H, Yoshino T, Pietrantonio F. Negative Hyperselection of Patients with HER2+ and RAS Wild-Type Metastatic Colorectal Cancer Receiving Dual HER2 Blockade: the PRESSING-HER2 Study. Clinical cancer research, 30:436-443, 2024

10. 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

11. Bokemeyer C, Ciardiello F, Dubreuil O, Guigay J, Kasper S, Pfeiffer P, Pinto C, Yamaguchi K, Yoshino T, Zielinski C, Esser R, Tabernero J. Cetuximab every 2 weeks versus standard weekly dosing administration schedule. Future oncology (London, England), 20:393-407, 2024

12. 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

13. Olsen S, Nakamura Y. Serial comprehensive genomic profiling by next-generation sequencing for patients with metastatic colorectal cancer. Cancer science, 115:321-323, 2024

14. 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

15. Tabernero J, Yoshino T, Stintzing S, de Gramont A, Gibbs P, Jonker DJ, Nygren P, Papadimitriou C, Prager GW, Tell R, Lenz HJ. A Randomized Phase III Study of Arfolitixorin versus Leucovorin with 5-Fluorouracil, Oxaliplatin, and Bevacizumab for First-Line Treatment of Metastatic Colorectal Cancer: The AGENT Trial. Cancer research communications, 4:28-37, 2024

16. Augustyniak M, Lou E, Jacobs G, Fleming M, Marshall J, Coutinho A, Yoshino T. Learning Outcomes of "GetSMART," Education for Diagnostics and Targeted Treatment for HER2+ Metastatic Gastric and Colorectal Cancers. Journal of cancer education, 39:118-125, 2024

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

18. 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

19. 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

20. Takahashi S, Bando H, Kinoshita I, Modi S, Tsurutani J, Bang YJ, Sato Y, Nakatani S, Lee C, Sugihara M, Okuda Y, Iwata H. Trastuzumab deruxtecan in patients with human epidermal growth factor receptor 2-expressing salivary gland carcinoma: a pooled analysis of two phase I studies. Japanese journal of clinical oncology, 54:434-443, 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. Hara H, Satoh T, Kojima T, Tsushima T, Sunakawa Y, Okada M, Ding N, Wu H, Li L, Yu T, Barnes G, Kato K. Second-line tislelizumab versus chemotherapy in Japanese patients with advanced or metastatic esophageal squamous cell carcinoma: subgroup analysis from RATIONALE-302. Esophagus, 21:102-110, 2024

23. Cohen R, Raeisi M, Chibaudel B, Yoshino T, Shi Q, Zalcberg JR, Adams R, Cremolini C, Grothey A, Mayer RJ, Van Cutsem E, Tabernero J, Bando H, Misumi T, Overman MJ, André T, de Gramont A. Efficacy of immune checkpoint inhibitors for metastatic colorectal cancer with microsatellite instability in second or latter line using synthetic control arms: A non-randomised evaluation. European journal of cancer (Oxford, England : 1990), 199:113537, 2024

24. Bando H, Yamaguchi K, Mitani S, Sawada K, Mishima S, Komine K, Okugawa Y, Hosoda W, Ebi H. Japanese Society of Medical Oncology clinical guidelines: Molecular testing for colorectal cancer treatment, 5th edition. Cancer science, 115:1014-1021, 2024

25. 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

26. Yuki S, Yamazaki K, Sunakawa Y, Taniguchi H, Bando H, Shiozawa M, Nishina T, Yasui H, Kanazawa A, Ando K, Horita Y, Goto M, Okano N, Moriwaki T, Satoh T, Tsuji A, Yamashita K, Asano C, Abe Y, Nomura S, Yoshino T. Plasma Angiogenic Factors as Predictors of the Efficacy of Second-line Chemotherapy Combined with Angiogenesis Inhibitors in Metastatic Colorectal Cancer: Results From the GI-SCREEN CRC-Ukit Study. Clinical colorectal cancer, 23:147-159.e7, 2024

27. Ogata T, Narita Y, Oze I, Kumanishi R, Nakazawa T, Matsubara Y, Kodama H, Nakata A, Honda K, Masuishi T, Bando H, Taniguchi H, Kadowaki S, Ando M, Ito S, Tajika M, Muro K. Chronological improvement of survival in patients with advanced gastric cancer over 15 years. Therapeutic advances in medical oncology, 16:17588359241229428, 2024

28. 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

29. 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

30. 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

31. 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

32. Kagawa Y, Smith JJ, Fokas E, Watanabe J, Cercek A, Greten FR, Bando H, Shi Q, Garcia-Aguilar J, Romesser PB, Horvat N, Sanoff H, Hall W, Kato T, Rödel C, Dasari A, Yoshino T. Future direction of total neoadjuvant therapy for locally advanced rectal cancer. Nature reviews. Gastroenterology & hepatology, 21:444-455, 2024

33. 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

34. Gallois C, Shi Q, Pederson LD, André T, Iveson TJ, Sobrero AF, Alberts S, de Gramont A, Meyerhardt JA, George T, Schmoll HE, Souglakos I, Harkin A, Labianca R, Sinicrope FA, Oki E, Shields AF, Boukovinas I, Kerr R, Lonardi S, Yothers G, Yoshino T, Goldberg RM, Taieb J, Papamichael D. Oxaliplatin-Based Adjuvant Chemotherapy in Older Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 12 Trials. Journal of clinical oncology, JCO2301326, 2024

35. 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

36. Kotani D, Takashima A, Kato T, Satoh T, Masuishi T, Komatsu Y, Shiozawa M, Esaki T, Izawa N, Takeuchi S, Bando H, Iwasa S, Hasegawa H, Yamaguchi T, Taniguchi H, Ushida Y, Oizaki T, Inoue C, Yoshino T. Safety and Efficacy of Encorafenib, Binimetinib, and Cetuximab for BRAF(V600E)-Mutant Metastatic Colorectal Cancer: Results of the Japanese Expanded Access Program. Clinical colorectal cancer, 23:174-182.e6., 2024

37. 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

38. Aoki Y, Nakamura Y, Denda T, Ohta T, Esaki T, Shiozawa M, Yamaguchi K, Yamazaki K, Sunakawa Y, Kato T, Okano N, Taniguchi H, Sato T, Oki E, Nishina T, Komatsu Y, Matsuhashi N, Goto M, Yasui H, Ohtsubo K, Moriwaki T, Takahashi N, Horita Y, Boku S, Wakabayashi M, Ikeno T, Mitani R, Yuasa M, Yoshino T. Clinical Validation of Plasma-Based Genotyping for RAS and BRAF V600E Mutation in Metastatic Colorectal Cancer: SCRUM-Japan GOZILA Substudy. JCO precision oncology, 7:e2200688, 2023

39. Yoshino T, Shi Q, Misumi T, Bando H, Wakabayashi M, Raeisi M, Andre T, de Gramont A. A synthetic control arm for refractory metastatic colorectal cancer: the no placebo initiative. Nature medicine, 29:2389-2390, 2023

40. Kobayashi S, Bando H, Taketomi A, Takamoto T, Shinozaki E, Shiozawa M, Hara H, Yamazaki K, Komori K, Matsuhashi N, Kato T, Kagawa Y, Yokota M, Oki E, Komine K, Takahashi S, Wakabayashi M, Yoshino T. NEXUS trial: a multicenter phase II clinical study evaluating the efficacy and safety of the perioperative use of encorafenib, binimetinib, and cetuximab in patients with previously untreated surgically resectable BRAF V600E mutant colorectal oligometastases. BMC cancer, 23:779, 2023

41. 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

42. Kato K, Doki Y, Ogata T, Motoyama S, Kawakami H, Ueno M, Kojima T, Shirakawa Y, Okada M, Ishihara R, Kubota Y, Amaya-Chanaga C, Chen T, Matsumura Y, Kitagawa Y. First-line nivolumab plus ipilimumab or chemotherapy versus chemotherapy alone in advanced esophageal squamous cell carcinoma: a Japanese subgroup analysis of open-label, phase 3 trial (CheckMate 648/ONO-4538-50). Esophagus, 20:291-301, 2023

43. 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

44. 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

45. Xu J, Kato K, Raymond E, Hubner RA, Shu Y, Pan Y, Park SR, Ping L, Jiang Y, Zhang J, Wu X, Yao Y, Shen L, Kojima T, Gotovkin E, Ishihara R, Wyrwicz L, Van Cutsem E, Jimenez-Fonseca P, Lin CY, Wang L, Shi J, Li L, Yoon HH. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced or metastatic oesophageal squamous cell carcinoma (RATIONALE-306): a global, randomised, placebo-controlled, phase 3 study. The Lancet. Oncology, 24:483-495, 2023

46. Ando K, Nakamura Y, Kitao H, Shimokawa M, Kotani D, Bando H, Nishina T, Yamada T, Yuki S, Narita Y, Hara H, Ohta T, Esaki T, Hamamoto Y, Kato K, Yamamoto Y, Minashi K, Ohtsubo K, Izawa N, Kawakami H, Kato T, Satoh T, Okano N, Tsuji A, Yamazaki K, Yoshino T, Maehara Y, Oki E. Mutational spectrum of TP53 gene correlates with nivolumab treatment efficacy in advanced gastric cancer (TP53MUT study). British journal of cancer, 129:1032-1039, 2023

47. Yuki S, Yamazaki K, Sunakawa Y, Taniguchi H, Bando H, Shiozawa M, Nishina T, Yasui H, Kagawa Y, Takahashi N, Denda T, Esaki T, Kawakami H, Satake H, Takashima A, Matsuhashi N, Kato T, Asano C, Abe Y, Nomura S, Yoshino T. Role of plasma angiogenesis factors in the efficacy of first-line chemotherapy combined with biologics in RAS wild-type metastatic colorectal cancer: Results from the GI-SCREEN CRC-Ukit study. Cancer medicine, 12:18702-18716, 2023

48. Mishima S, Nakamura Y, Tukachinsky H, Taniguchi H, Kadowaki S, Kato K, Oki E, Satoh T, Aoki D, Yamazaki K, Esaki T, Ueno M, Nishina T, Sunakawa Y, Denda T, Bando H, Kuramoto N, Horasawa S, Abutani H, Lee JK, Madison RW, Oxnard GR, Yoshino T. Validity and utility of blood tumor mutational burden (bTMB) is dependent on circulating tumor DNA (ctDNA) shed: SCRUM-Japan MONSTAR-SCREEN. The Journal of Liquid Biopsy, 1:100003, 2023

49. Umemoto K, Sunakawa Y, Ueno M, Furukawa M, Mizuno N, Sudo K, Kawamoto Y, Kajiwara T, Ohtsubo K, Okano N, Matsuhashi N, Itoh S, Matsumoto T, Shimizu S, Otsuru T, Hasegawa H, Okuyama H, Ohama H, Moriwaki T, Ohta T, Odegaard JI, Nakamura Y, Bando H, Yoshino T, Ikeda M, Morizane C. Clinical significance of circulating-tumour DNA analysis by metastatic sites in pancreatic cancer. British journal of cancer, 128:1603-1608, 2023

50. Okumura T, Fujii T, Terabayashi K, Kojima T, Takeda S, Kashiwada T, Toriyama K, Hijioka S, Miyazaki T, Yamamoto M, Tanabe S, Shirakawa Y, Furukawa M, Honma Y, Hoshino I, Nabeya Y, Yamaguchi H, Uemoto S, Shimada Y, Matsubara H, Ozawa S, Makuuchi H, Imamura M. MicroRNAs associated with postoperative outcomes in patients with limited stage neuroendocrine carcinoma of the esophagus. Oncology letters, 26:276, 2023

51. 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

52. 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

53. 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

54. 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

55. 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

56. Ura T, Hironaka S, Tsubosa Y, Mizusawa J, Kato K, Tsushima T, Fushiki K, Chin K, Tomori A, Okuno T, Matsushita H, Kojima T, Doki Y, Kusaba H, Fujitani K, Seki S, Kitagawa Y. Early tumor shrinkage and depth of response in patients with metastatic esophageal cancer treated with 2-weekly docetaxel combined with cisplatin plus fluorouracil: an exploratory analysis of the JCOG0807. Esophagus, 20:272-280, 2023

57. Kitagawa Y, Ishihara R, Ishikawa H, Ito Y, Oyama T, Oyama T, Kato K, Kato H, Kawakubo H, Kawachi H, Kuribayashi S, Kono K, Kojima T, Takeuchi H, Tsushima T, Toh Y, Nemoto K, Booka E, Makino T, Matsuda S, Matsubara H, Mano M, Minashi K, Miyazaki T, Muto M, Yamaji T, Yamatsuji T, Yoshida M. Esophageal cancer practice guidelines 2022 edited by the Japan Esophageal Society: part 2. Esophagus, 20:373-389, 2023

58. Ohtsu A, Goto K, Yoshino T. Improvement of patient care using cancer genomic profiling: SCRUM-/CIRCULATE-Japan experience. Proceedings of the Japan Academy. Series B, Physical and biological sciences, 99:241-253, 2023

59. Habu T, Kumanishi R, Ogata T, Fujisawa T, Mishima S, Kotani D, Kadowaki S, Nakamura M, Hojo H, Fujiwara H, Kumagai S, Koyama S, Fujita T, Kinoshita T, Nishikawa H, Yano T, Tajika M, Muro K, Mitsunaga S, Kojima T, Bando H. Complete response to definitive chemoradiotherapy in unresectable locally advanced esophageal squamous cell carcinoma. Esophagus, 20:533-540, 2023

60. Harada T, Tsuji T, Yanagisawa T, Ueno J, Hijikata N, Ishikawa A, Hiroshige K, Kotani D, Kojima T, Fujita T. Skeletal muscle mass recovery after oesophagectomy and neoadjuvant chemotherapy in oesophageal cancer: retrospective cohort study. BMJ supportive & palliative care, spcare-2023-004245, 2023

61. Harada T, Tsuji T, Ueno J, Hijikata N, Ishikawa A, Kotani D, Kojima T, Fujita T. Association of sarcopenia with relative dose intensity of neoadjuvant chemotherapy in older patients with locally advanced esophageal cancer: A retrospective cohort study. Journal of geriatric oncology, 14:101580, 2023

62. Kitaguchi D, Tsukada Y, Ito M, Horasawa S, Bando H, Yoshino T, Yamada K, Ajioka Y, Sugihara K. Survival outcomes following salvage abdominoperineal resection for recurrent and persistent anal squamous cell carcinoma. European journal of surgical oncology, 49:106929, 2023

63. Adachi M, Aoyama N, Kojima M, Sakamoto N, Miyazaki S, Taki T, Watanabe R, Matsuura K, Kotani D, Kojima T, Fujita T, Tabuchi K, Ishii G, Sakashita S. The area of residual tumor predicts esophageal squamous cell carcinoma prognosis following neoadjuvant chemotherapy. Journal of cancer research and clinical oncology, 149:4663-4673, 2023

64. Shitara K, Kawazoe A, Hirakawa A, Nakanishi Y, Furuki S, Fukuda M, Ueno Y, Raizer J, Arozullah A. Phase 1 trial of zolbetuximab in Japanese patients with CLDN18.2+ gastric or gastroesophageal junction adenocarcinoma. Cancer science, 114:1606-1615, 2023

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66. Wainberg ZA, Xie J, Valderrama A, Yin L, Zhang S, Shih CS, Bhagia P, Gu Q, Shitara K, Janjigian YY, Tabernero J. Event-Free Survival as a Surrogate for Overall Survival in Gastric and Gastroesophageal Junction Adenocarcinoma: A Meta-analysis in the Neoadjuvant ± Adjuvant Setting. Clinical cancer research, 29:1360-1367, 2023

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69. Nakai C, Mimaki S, Matsushima K, Shinozaki E, Yamazaki K, Muro K, Yamaguchi K, Nishina T, Yuki S, Shitara K, Bando H, Suzuki Y, Akagi K, Nomura S, Fujii S, Sugiyama M, Nishida N, Mizokami M, Koh Y, Koshizaka T, Okada H, Abe Y, Ohtsu A, Yoshino T, Tsuchihara K. Regulation of MEK inhibitor selumetinib sensitivity by AKT phosphorylation in the novel BRAF L525R mutant. International journal of clinical oncology, 28:654-663, 2023

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71. Akimoto E, Kuwata T, Shitara K, Kawazoe A, Sakamoto N, Ishii G, Ochiai A, Kinoshita T. Impact of Programmed Death-Ligand 1 Expression on Mismatch Repair Deficiency and Epstein-Barr Virus Status on Survival Outcomes in Patients with Stage II/III Gastric Cancer After Surgery. Annals of surgical oncology, 30:5227-5236, 2023

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86. Klempner SJ, Lee KW, Shitara K, Metges JP, Lonardi S, Ilson DH, Fazio N, Kim TY, Bai LY, Moran D, Yang J, Arozullah A, Park JW, Raizer JJ, Bang YJ, Shah MA. ILUSTRO: Phase II Multicohort Trial of Zolbetuximab in Patients with Advanced or Metastatic Claudin 18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma. Clinical cancer research, 29:3882-3891, 2023

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88. Du J, Kageyama SI, Yamashita R, Tanaka K, Okumura M, Motegi A, Hojo H, Nakamura M, Hirata H, Sunakawa H, Kotani D, Yano T, Kojima T, Hamaya Y, Kojima M, Nakamura Y, Suzuki A, Suzuki Y, Tsuchihara K, Akimoto T. Transposable elements potentiate radiotherapy-induced cellular immune reactions via RIG-I-mediated virus-sensing pathways. Communications biology, 6:818, 2023

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90. Taieb J, Sinicrope FA, Pederson L, Lonardi S, Alberts SR, George TJ, Yothers G, Van Cutsem E, Saltz L, Ogino S, Kerr R, Yoshino T, Goldberg RM, André T, Laurent-Puig P, Shi Q. Different prognostic values of KRAS exon 2 submutations and BRAF V600E mutation in microsatellite stable (MSS) and unstable (MSI) stage III colon cancer: an ACCENT/IDEA pooled analysis of seven trials. Annals of oncology, 34:1025-1034, 2023

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93. Moehler M, Xiao H, Blum SI, Elimova E, Cella D, Shitara K, Ajani JA, Janjigian YY, Garrido M, Shen L, Yamaguchi K, Liu T, Schenker M, Kowalyszyn R, Bragagnoli AC, Bruges R, Montesarchio V, Pazo-Cid R, Hunter S, Davenport E, Wang J, Kondo K, Li M, Wyrwicz L. Health-Related Quality of Life With Nivolumab Plus Chemotherapy Versus Chemotherapy in Patients With Advanced Gastric/Gastroesophageal Junction Cancer or Esophageal Adenocarcinoma From CheckMate 649. Journal of clinical oncology, 41:5388-5399, 2023

94. Fujikawa K, Saito T, Kurose K, Kojima T, Funakoshi T, Sato E, Kakimi K, Iida S, Doki Y, Oka M, Ueda R, Wada H. Integrated analysis of phase 1a and 1b randomized controlled trials; Treg-targeted cancer immunotherapy with the humanized anti-CCR4 antibody, KW-0761, for advanced solid tumors. PloS one, 18:e0291772, 2023

95. Fukuoka S, Koga Y, Yamauchi M, Koganemaru S, Yasunaga M, Shitara K, Doi T, Yoshino T, Kuronita T, Elenbaas B, Wahra P, Zhang H, Crowley L, Jenkins MH, Clark A, Kojima T. p70S6K/Akt dual inhibitor DIACC3010 is efficacious in preclinical models of gastric cancer alone and in combination with trastuzumab. Scientific reports, 13:16017, 2023

96. Nakamura Y, Mizuno N, Sunakawa Y, Canon JL, Galsky MD, Hamilton E, Hayashi H, Jerusalem G, Kim ST, Lee KW, Kankeu Fonkoua LA, Monk BJ, Nguyen D, Oh DY, Okines A, O'Malley DM, Pohlmann P, Reck M, Shin SJ, Sudo K, Takahashi S, Van Marcke C, Yu EY, Groisberg R, Ramos J, Tan S, Stinchcombe TE, Bekaii-Saab T. Tucatinib and Trastuzumab for Previously Treated Human Epidermal Growth Factor Receptor 2-Positive Metastatic Biliary Tract Cancer (SGNTUC-019): A Phase II Basket Study. Journal of clinical oncology, 41:5569-5578, 2023

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