Annual Report 2024

Department of Gastroenterology and Gastrointestinal Oncology

Kouhei Shitara, Takashi Kojima, Hideaki Bando, Yasutoshi Kuboki, Akihito Kawazoe, Daisuke Kotani, Nozomu Fuse, Takayuki Yoshino, Izuma 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 2024 are shown in Table 1. There are ongoing clinical trials, which consist of 103 phase I trials, including global first-in-class (FIC), first-in-human (FIH), and investigational new drugs (INDs), 65 phase II/III clinical trials to approve the INDs, and 13 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

Activities

Esophageal Cancer (EC)

 We currently conduct an observational study on circulating tumor DNA in the blood in gastrointestinal cancers, with a focus on esophageal and gastric cancers, and reported the interim analysis results in the journal Annals of Surgery. Additionally, we actively enrolled patients in numerous industry-sponsored trials and clinical trials, such as the phase III trial of lenvatinib plus pembrolizumab in combination with chemotherapy targeting first-line treatment for unresectable advanced esophageal cancer, thereby playing a central role in treatment development.

Gastric Cancer (GC)

 We continue to conduct various research 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 were conducted (LEAP-015 and INTEGRATE2b). Results of the LEAP-015 trial, which evaluated the addition of lenvatinib plus pembrolizumab to chemotherapy, were presented in an oral session at ASCO 2025 and published in the Journal of Clinical Oncology (first author: Shitara). The INTEGRATE2b trial, which assessed the efficacy and safety of regorafenib plus nivolumab in later-line settings, will be reported in the near future. The primary results of a phase I trial of photoimmunotherapy combined with nivolumab for EGFR-positive gastric cancer were published in Gastric Cancer.

 Two investigator-initiated trials are also conducted: one evaluating chemotherapy combined with regorafenib plus nivolumab for unresectable GC, and another exploring perioperative therapy with lenvatinib, pembrolizumab, and FLOT. Manuscripts are currently submitted or in preparation. An investigator-initiated multicenter single-arm phase II trial of trastuzumab deruxtecan (T-DXd) in combination with CAPOX plus nivolumab in unresectable HER2-low GC completed enrollment in November 2024 and is under analysis. Likewise, an investigator-initiated multicenter phase II trial of preoperative T-DXd for resectable HER2-positive gastric cancer has completed enrollment of the combination cohort (with durvalumab plus capecitabine) and is under analysis. For CLDN18.2-positive unresectable gastric cancer, we are conducting a multicenter randomized phase II trial led to evaluate the efficacy and safety of omitting the initial high dose to reduce early gastrointestinal toxicity. In resectable gastroesophageal junction adenocarcinoma, an investigator-initiated trial of total neoadjuvant therapy combining FLOT plus pembrolizumab with short-course radiotherapy, aiming for curative treatment without surgery in responders, was initiated in June 2025. Another investigator-initiated trial combining sulfasalazine and oxyfedrine to induce ferroptosis in cancer cells is ongoing and continues to enroll patients.

 We are also centrally involved in industry-sponsored trials. In addition to LEAP-015 study, we reported as first author in The New England Journal of Medicine the results of an international randomized phase III (DESTINY-Gastric 04) trial comparing T-DXd with standard therapy in previously treated HER2-positive GC.

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. We are also currently planning a IIT in patients with MSS colorectal cancer to evaluate anti-CCR8 antibody in combination with fruquintinib, or anti-CCR8 antibody in combination with fruquintinib and pembrolizumab.

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 and 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 2024

Journal

1. Ghelardi F, Fucà G, Cavalli C, Shitara K, Cohen R, Ambrosini M, Maron SB, Cerantola R, Nasca V, Liberti GD, Zambelli L, Palazzo M, Salati M, Aoki Y, Kawazoe A, Cowzer D, Lonardi S, André T, Randon G, Pietrantonio F. The Prognostic Nutritional Index in patients with microsatellite instability-high metastatic gastric or gastroesophageal cancers receiving immune checkpoint inhibitors. Digestive and liver disease, 57:23-29, 2025

2. Nakamura Y, Ozaki H, Ueno M, Komatsu Y, Yuki S, Esaki T, Taniguchi H, Sunakawa Y, Yamaguchi K, Kato K, Denda T, Nishina T, Takahashi N, Satoh T, Yasui H, Satake H, Oki E, Kato T, Ohta T, Matsuhashi N, Goto M, Okano N, Ohtsubo K, Yamazaki K, Yamashita R, Iida N, Yuasa M, Bando H, Yoshino T. Targeted therapy guided by circulating tumor DNA analysis in advanced gastrointestinal tumors. Nature medicine, 31:165-175, 2025

3. Pavlakis N, Shitara K, Sjoquist K, Martin A, Jaworski A, Tebbutt N, Bang YJ, Alcindor T, O'Callaghan C, Strickland A, Rha SY, Lee KW, Kim JS, Bai LY, Hara H, Oh DY, Yip S, Zalcberg J, Price T, Simes J, Goldstein D. INTEGRATE IIa Phase III Study: Regorafenib for Refractory Advanced Gastric Cancer. Journal of clinical oncology, 43:453-463, 2025

4. Oda S, Kuno H, Fujita T, Hiyama T, Kotani D, Kadota T, Sakashita S, Kobayashi T. Clinical usefulness of four-dimensional dynamic ventilation CT for borderline resectable locally advanced esophageal cancer. Japanese journal of radiology, 43:434-444, 2025

5. Koganemaru S, Fuchigami H, Morizono C, Shinohara H, Kuboki Y, Furuuchi K, Uenaka T, Doi T, Yasunaga M. Potential Mechanisms of Interstitial Lung Disease Induced by Antibody-Drug Conjugates Based on Quantitative Analysis of Drug Distribution. Molecular cancer therapeutics, 24:242-250, 2025

6. Okazawa-Sakai M, Sakai SA, Hyodo I, Horasawa S, Sawada K, Fujisawa T, Yamamoto Y, Boku S, Hayasaki Y, Isobe M, Shintani D, Hasegawa K, Egawa-Takata T, Ito K, Ihira K, Watari H, Takehara K, Yagi H, Kato K, Chiyoda T, Harano K, Nakamura Y, Yamashita R, Yoshino T, Aoki D. Gut microbiome associated with PARP inhibitor efficacy in patients with ovarian cancer. Journal of gynecologic oncology, 36:e38, 2025

7. Jubashi A, Nakayama I, Koganemaru S, Sakamoto N, Oda S, Matsubara Y, Miyashita Y, Sato S, Ushiyama S, Kobayashi A, Okazaki U, Okemoto D, Yamamoto K, Mishima S, Kotani D, Kawazoe A, Hashimoto T, Nakamura Y, Kuboki Y, Bando H, Kojima T, Yoshino T, Miyaaki H, Nakao K, Shitara K. Prognostic and predictive factors for the efficacy and safety of trastuzumab deruxtecan in HER2-positive gastric or gastroesophageal junction cancer. Gastric cancer, 28:63-73, 2025

8. Harada T, Tsuji T, Ueno J, Konishi N, Yanagisawa T, HIjikata N, Ishikawa A, Hashimoto K, Kagaya H, Tatematsu N, Zenda S, Kotani D, Kojima T, Fujita T. Clinical mechanism of muscle mass loss during neoadjuvant chemotherapy in older patients with esophageal cancer: a prospective cohort study. Diseases of the esophagus, 38:doae096, 2025

9. Nakamura Y, Kaneva K, Lo C, Neems D, Freaney JE, Boulos H, Hyun SW, Islam F, Yamada-Hanff J, Driessen TM, Sonnenschein A, DeSantis DF, Kotani D, Watanabe J, Kotaka M, Mishima S, Bando H, Yamazaki K, Taniguchi H, Takemasa I, Kato T, Sangli C, Tell R, Blidner R, Yoshino T, Sasser K, Oki E, Nimeiri H. A Tumor-Naïve ctDNA Assay Detects Minimal Residual Disease in Resected Stage II or III Colorectal Cancer and Predicts Recurrence: Subset Analysis from the GALAXY Study in CIRCULATE-Japan. Clinical cancer research, 31:328-338, 2025

10. Evans MG, Krause HB, Xiu J, Elliott A, Lou E, Ghani H, Yantiss RK, Garcia-Buitrago M, Matsubara Y, Nakamura Y, Shia J, Yaeger R, Radovich M, Bryant DA, Oberley MJ, Hechtman JF. Evidence for Unified Assessment Criteria of HER2 Immunohistochemistry in Colorectal Carcinoma. Modern pathology, 38:100654, 2025

11. Tsuge A, Watanabe S, Kawazoe A, Togashi Y, Itahashi K, Masuda M, Sai A, Takei S, Muraoka H, Ohkubo S, Sugiyama D, Yan Y, Fukuoka S, Doi T, Shitara K, Koyama S, Nishikawa H. The HSP90 Inhibitor Pimitespib Targets Regulatory T Cells in the Tumor Microenvironment. Cancer immunology research, 13:273-285, 2025

12. Nakayama I, Nakamura Y, Shitara K. The immunotherapy challenge in locally advanced gastroesophageal cancer: VESTIGE trial's insights and future pathways. Annals of oncology, 36:130-133, 2025

13. André T, Shiu KK, Kim TW, Jensen BV, Jensen LH, Punt CJA, Smith D, Garcia-Carbonero R, Alcaide-Garcia J, Gibbs P, de la Fouchardiere C, Rivera F, Elez E, Le DT, Yoshino T, Zuo Y, Fogelman D, Adelberg D, Diaz LA. Pembrolizumab versus chemotherapy in microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer: 5-year follow-up from the randomized phase III KEYNOTE-177 study. Annals of oncology, 36:277-284, 2025

14. Sakai SA, Saeki K, Chi S, Hamaya Y, Du J, Nakamura M, Hojo H, Kojima T, Nakamura Y, Bando H, Kojima M, Suzuki A, Suzuki Y, Akimoto T, Tsuchihara K, Haeno H, Yamashita R, Kageyama SI. Mathematical Modeling Predicts Optimal Immune Checkpoint Inhibitor and Radiotherapy Combinations and Timing of Administration. Cancer immunology research, 13:353-364, 2025

15. Koganemaru S, Koyama S, Suto F, Koga M, Inaki K, Kuwahara Y, Arita T, Hirata T, Goto H, Wada N, Kobayashi M, Shibutani T, Okabayashi T, Nakamaru K, Kawazoe A, Togashi Y, Nishikawa H, Shitara K. The Tumor Immune Microenvironment and Therapeutic Efficacy of Trastuzumab Deruxtecan in Gastric Cancer. Cancer research communications, 5:84-93, 2025

16. Bando H, Naito Y, Yamada T, Fujisawa T, Imai M, Sakamoto Y, Saigusa Y, Yamamoto K, Tomioka Y, Takeshita N, Sunami K, Futamura M, Notake C, Aoki S, Okano K, Yoshino T. A prospective study comparing highly qualified Molecular Tumor Boards with AI-powered software as a medical device. International journal of clinical oncology, 30:172-179, 2025

17. Strickler JH, Bekaii-Saab T, Cercek A, Heinemann V, Nakamura Y, Raghav K, Siena S, Tabernero J, Van Cutsem E, Yoshino T, Ramos J, Guan X, Andre T. MOUNTAINEER-03 phase III study design: first-line mFOLFOX6 + tucatinib + trastuzumab for HER2+ metastatic colorectal cancer. Future oncology (London, England), 21:303-311, 2025

18. Aoki Y, Nakayama I, Shitara K. Human Epidermal Growth Factor Receptor 2 Positive Advanced Gastric or Esophagogastric Adenocarcinoma: Reflecting on the Past to Gain a New Insights. Current oncology reports, 27:15-29, 2025

19. Imai M, Nakamura Y, Yoshino T. Transforming cancer screening: the potential of multi-cancer early detection (MCED) technologies. International journal of clinical oncology, 30:180-193, 2025

20. Nagata H, Kinoshita T, Sakashita S, Kojima M, Taki T, Kuwata T, Yura M, Shitara K, Ishii G, Sakamoto N. Area of Residual Tumor Measurement After Preoperative Chemotherapy as an Objective and Quantitative Method for Predicting the Prognosis of Gastric Cancer: A Single-Center Retrospective Study. World journal of surgery, 49:717-726, 2025

21. Imai M, Nakamura Y, Shin S, Okamoto W, Kato T, Esaki T, Kato K, Komatsu Y, Yuki S, Masuishi T, Nishina T, Sawada K, Sato A, Kuwata T, Yamashita R, Fujisawa T, Bando H, Ock CY, Fujii S, Yoshino T. Artificial Intelligence-Powered Human Epidermal Growth Factor Receptor 2 and Tumor Microenvironment Analysis in Human Epidermal Growth Factor Receptor 2-Amplified Metastatic Colorectal Cancer: Exploratory Analysis of Phase II TRIUMPH Trial. JCO precision oncology, 9:e2400385, 2025

22. Okines AFC, Curigliano G, Mizuno N, Oh DY, Rorive A, Soliman H, Takahashi S, Bekaii-Saab T, Burkard ME, Chung KY, Debruyne PR, Fox JR, Gambardella V, Gil-Martin M, Hamilton EP, Monk BJ, Nakamura Y, Nguyen D, O'Malley DM, Olawaiye AB, Pothuri B, Reck M, Sudo K, Sunakawa Y, Van Marcke C, Yu EY, Ramos J, Tan S, Bieda M, Stinchcombe TE, Pohlmann PR. Tucatinib and trastuzumab in HER2-mutated metastatic breast cancer: a phase 2 basket trial. Nature medicine, 31:909-916, 2025

23. Katsuya Y, Ikeda M, Koyama T, Sato J, Okada M, Matsubara N, Kondoh C, Mukohara T, Watanabe K, Kotani D, Ogawa Y, Taoka S, Yamamoto N. A Phase I, First-In-Human Study of CBA-1205, an Anti-DLK1 Monoclonal Antibody, in Patients With Advanced Solid Tumors. Cancer science, 116:1012-1022, 2025

24. Nakayama I, Shitara K. Cell-Based Therapies in GI Cancers: Current Landscape and Future Directions. American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting, 45:e471716, 2025

25. Rha SY, Zhang Y, Elme A, Pazo Cid R, Alacacioglu A, Ziogas DC, Shitara K, Ranceva A, Nemecek R, Santoro A, Calderon CA, Korphaisarn K, Davis T, Zahlten-Kuemeli A, Conn C, Tan M, Honeycutt H, Wainberg ZA. Prevalence of FGFR2b Protein Overexpression in Advanced Gastric Cancers During Prescreening for the Phase III FORTITUDE-101 Trial. JCO precision oncology, 9:e2400710, 2025

26. Kopetz S, Yoshino T, Van Cutsem E, Eng C, Kim TW, Wasan HS, Desai J, Ciardiello F, Yaeger R, Maughan TS, Beyzarov E, Zhang X, Ferrier G, Zhang X, Tabernero J. Encorafenib, cetuximab and chemotherapy in BRAF-mutant colorectal cancer: a randomized phase 3 trial. Nature medicine, 31:901-908, 2025

27. André T, Elez E, Lenz HJ, Jensen LH, Touchefeu Y, Van Cutsem E, Garcia-Carbonero R, Tougeron D, Mendez GA, Schenker M, de la Fouchardiere C, Limon ML, Yoshino T, Li J, Manzano Mozo JL, Dahan L, Tortora G, Chalabi M, Goekkurt E, Braghiroli MI, Joshi R, Cil T, Aubin F, Cela E, Chen T, Lei M, Jin L, Blum SI, Lonardi S. Nivolumab plus ipilimumab versus nivolumab in microsatellite instability-high metastatic colorectal cancer (CheckMate 8HW): a randomised, open-label, phase 3 trial. Lancet (London, England), 405:383-395, 2025

28. Satoh T, Barthélémy P, Nogova L, Honda K, Hirano H, Lee KW, Rha SY, Ryu MH, Park JO, Doi T, Ajani J, Hangai N, Kremer J, Mina M, Liu M, Shitara K. Phase 2 study of futibatinib in patients with gastric or gastroesophageal junction cancer harboring FGFR2 amplifications. European journal of cancer (Oxford, England : 1990), 218:115262, 2025

29. Kobayashi S, Nakamura Y, Hashimoto T, Bando H, Oki E, Karasaki T, Horinouchi H, Ozaki Y, Iwata H, Kato T, Miyake H, Ohba A, Ikeda M, Chiyoda T, Hasegawa K, Fujisawa T, Matsuura K, Namikawa K, Yajima S, Yoshino T, Hasegawa K. Japan society of clinical oncology position paper on appropriate clinical use of molecular residual disease (MRD) testing. International journal of clinical oncology, 30:605-654, 2025

30. Sobrero A, Dasari A, Aquino J, Lonardi S, Garcia-Carbonero R, Elez E, Yoshino T, Yao J, Garcia-Alfonso P, Kocsis J, Gracian AC, Sartore-Bianchi A, Satoh T, Randrian V, Tomasek J, Chong G, Price T, Yu Z, Geiger A, Chen L, Yang Z, Schelman WR, Kania M, Tabernero J, Eng C. Health-related quality of life associated with fruquintinib in patients with metastatic colorectal cancer: Results from the FRESCO-2 study. European journal of cancer (Oxford, England : 1990), 218:115268, 2025

31. Sakai SA, Nomura R, Nagasawa S, Chi S, Suzuki A, Suzuki Y, Imai M, Nakamura Y, Yoshino T, Ishikawa S, Tsuchihara K, Kageyama SI, Yamashita R. SpatialKNifeY (SKNY): Extending from spatial domain to surrounding area to identify microenvironment features with single-cell spatial omics data. PLoS computational biology, 21:e1012854, 2025

32. Bando H, Kumagai S, Kotani D, Mishima S, Irie T, Itahashi K, Tanaka Y, Habu T, Fukaya S, Kondo M, Tsushima T, Hara H, Kadowaki S, Kato K, Chin K, Yamaguchi K, Kageyama SI, Hojo H, Nakamura M, Tachibana H, Wakabayashi M, Fukui M, Fuse N, Koyama S, Mano H, Nishikawa H, Shitara K, Yoshino T, Kojima T. Atezolizumab following definitive chemoradiotherapy in patients with unresectable locally advanced esophageal squamous cell carcinoma - a multicenter phase 2 trial (EPOC1802). Nature cancer, 6:445-459, 2025

33. Harada K, Sakamoto N, Kitaoka T, Nakamura Y, Kondo R, Morisue R, Hashimoto H, Yamamoto Y, Ukai S, Maruyama R, Sakashita S, Kojima M, Tanabe K, Ohdan H, Shitara K, Kinoshita T, Ishii G, Yasui W, Ochiai A, Ishikawa S. PI3 expression predicts recurrence after chemotherapy with DNA-damaging drugs in gastric cancer. The Journal of pathology, 265:472-485, 2025

34. Stintzing S, Tabernero J, Satoh T, Dasari A, Lonardi S, Eng C, Garcia-Carbonero R, Elez E, Yoshino T, Sobrero AF, Yao JC, Kasper S, Arnold D, Basic E, Granold M, Petschulies M, Wu L, Chung YC, Chen L, Yang Z, Van Cutsem E. Quality-adjusted survival in patients with metastatic colorectal cancer treated with fruquintinib plus best supportive care: results from FRESCO-2. ESMO open, 10:104297, 2025

35. Shimozaki K, Ooki A, Yoshino K, Tamba M, Udagawa S, Osumi H, Fukuoka S, Nakayama I, Wakatsuki T, Ogura M, Takahari D, Shinozaki E, Chin K, Yamaguchi K. Investigating the role of immunotherapy for real-world patients with HER2-negative advanced gastric cancer between 2011 and 2023. Therapeutic advances in medical oncology, 17:17588359251322670, 2025

36. Luo HY, Lu YX, Shitara K, Lenz HJ, Xu RH. Global alliances in translational cancer research. Cancer cell, 43:581-586, 2025

37. Shiota M, Matsubara N, Kato T, Eto M, Osawa T, Abe T, Shinohara N, Nishimoto K, Yasumizu Y, Tanaka N, Oya M, Fujisawa T, Horasawa S, Nakamura Y, Yoshino T, Nonomura N. Genomic characterization of metastatic patterns in prostate cancer using circulating tumor DNA data from the SCRUM-Japan MONSTAR SCREEN project. The journal of liquid biopsy, 7:100282, 2025

38. Cohen R, Raeisi M, Chibaudel B, Yothers G, Goldberg RM, Bachet JB, Wolmark N, Yoshino T, Schmoll HJ, Haller DG, Kerr R, Lonardi S, George TJ, Shacham-Shmueli E, Shi Q, André T, de Gramont A. Impact of tumor and node stages on the efficacy of adjuvant oxaliplatin-based chemotherapy in stage III colon cancer patients: an ACCENT pooled analysis. ESMO open, 10:104481, 2025

39. Shitara K, Janjigian YY, Ajani J, Moehler M, Yao J, Wang X, Chhibber A, Pandya D, Shen L, Garrido M, Gallardo C, Wyrwicz L, Yamaguchi K, Skoczylas T, Bragagnoli A, Liu T, Schenker M, Yañez P, Kowalyszyn R, Karamouzis M, Zander T, Feeney K, Elimova E, Doshi P, Li M, Lei M. Nivolumab plus chemotherapy or ipilimumab in gastroesophageal cancer: exploratory biomarker analyses of a randomized phase 3 trial. Nature medicine, 31:1519-1530, 2025

40. Xu J, Kato K, Hubner R, Park SR, Kojima T, Ishihara R, Wyrwicz L, Van Cutsem E, Jimenez-Fonseca P, Wu H, Wang L, Yan S, Shi J, Kadva A, Yoon HH. First-Line Tislelizumab Plus Chemotherapy for Esophageal Squamous Cell Carcinoma with Programmed Death-Ligand 1 Expression ≧ 1%: A Retrospective Analysis of RATIONALE-306. Advances in therapy, 42:2269-2284, 2025

41. Harada T, Tsuji T, Fukushima T, Konishi N, Nakajima H, Suzuki K, Ikeda T, Toyama S, Matsumori K, Yanagisawa T, Hashimoto K, Kagaya H, Zenda S, Kojima T, Fujita T, Ueno J, Hijikata N, Ishikawa A, Hayashi R. Current status of prehabilitation before esophagectomy for patients with esophageal cancer among board-certified hospitals by the Japan Esophageal Society. Esophagus, 22:340-348, 2025

42. Sledge GW Jr, Yoshino T, Xiu J, Helmstetter A, Ribeiro JR, Klimov S, Gilg B, Gao JJ, Elton J, Oberley MJ, Radovich M, Abraham J, Spetzler D. Real-world evidence provides clinical insights into tissue-agnostic therapeutic approvals. Nature communications, 16:2646, 2025

43. Cercek A, Bachet JB, Capdevila J, Starling N, Chen E, Salvatore L, Bando H, O'Donnell S, Harfst L, Szijgyarto Z, Heinemann V. A Phase Two, Single-Arm, Open-Label Study With Dostarlimab Monotherapy in Participants With Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer (AZUR-1). Clinical colorectal cancer, 24:325-330, 2025

44. Takei S, Kotani D, Laliotis G, Sato K, Fujiwara N, Kawazoe A, Hashimoto T, Mishima S, Nakayama I, Nakamura Y, Bando H, Kuboki Y, Sakashita S, Spickard E, George GV, Dutta P, Sharma S, Malhotra M, Sethi H, Jurdi A, Liu MC, Yoshino T, Shitara K, Kojima T, Fujita T. Circulating Tumor DNA Assessment to Predict Risk of Recurrence after Surgery in Patients with Locally Advanced Esophageal Squamous Cell Carcinoma: A Prospective Observational Study. Annals of surgery, 2025

45. Janjigian YY, Cecchini M, Shitara K, Enzinger PC, Wainberg ZA, Chau I, Satoh T, Lee J, Nebozhyn M, Loboda A, Kobie J, Vajdi A, Shih CS, Cristescu R, Cao ZA. Genomic Landscape of Late-Stage Gastric Cancer: Analysis From KEYNOTE-059, KEYNOTE-061, and KEYNOTE-062 Studies. JCO precision oncology, 9:e2400456, 2025

46. Hoyek C, Pirozzi A, Zheng B, Lida N, Ramaker R, Abidoye S, Eslinger C, Shibuki T, Wu CSY, Sonbol MB, Ahn DH, Borad M, Ikeda M, Nakamura Y, Rimassa L, Yoshino T, Strickler J, Bekaii-Saab T. CLO25-095: Baseline Genomic Alterations as Predictors of Response to Anti-HER2 Therapy in HER2-Amplified Advanced Colorectal Cancer (aCRC). Journal of the National Comprehensive Cancer Network : JNCCN, 23:CLO25-095, 2025

47. Elez E, Kopetz S, Tabernero J, Bekaii-Saab T, Taieb J, Yoshino T, Manji G, Fernandez K, Abbattista A, Zhang X, Morris VK. SEAMARK: phase II study of first-line encorafenib and cetuximab plus pembrolizumab for MSI-H/dMMR BRAFV600E-mutant mCRC. Future oncology (London, England), 20:653-663, 2024

48. Kato K, Kojima T, Hara H, Tsuji A, Yasui H, Muro K, Satoh T, Ogata T, Ishihara R, Goto M, Baba H, Nishina T, Han S, Iwakami K, Yatsuzuka N, Doi T. First-line pembrolizumab plus chemotherapy for advanced/metastatic esophageal cancer: 1-year extended follow-up in the Japanese subgroup of the phase 3 KEYNOTE-590 study. Esophagus, 21:306-318, 2024

49. Kawamoto Y, Morizane C, Komatsu Y, Kondo S, Ueno M, Kobayashi S, Furukawa M, Lee L, Satoh T, Sakai D, Ikeda M, Imaoka H, Miura A, Hatanaka Y, Yokota I, Nakamura Y, Yoshino T. Phase II trial of niraparib for BRCA-mutated biliary tract, pancreatic and other gastrointestinal cancers: NIR-B. Future oncology (London, England), 20:1901-1907, 2024

50. Hattori M, Serelli-Lee V, Naito Y, Yamanaka T, Yasojima H, Nakamura R, Fujisawa T, Imai M, Nakamura Y, Bando H, Kawaguchi T, Yoshino T, Iwata H. Genomic Landscape of Circulating Tumor DNA in Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor-2-Negative Metastatic Breast Cancer Treated With Abemaciclib: Data From the SCRUM-Japan Cancer Genome Screening Project. JCO precision oncology, 8:e2300647, 2024

51. Bando H, Misumi T, Sakamoto Y, Takeda Y, Nakamura Y, Mizuguchi K, Aoyagi Y, Miki I, Kuroda T, Kasai R, Suzuki T, Yoshino T, Ohtsu A. Appropriate Relevancy and Reliability of Real-World Data for the Utilization of Regulatory Submission. Clinical colorectal cancer, 23:111-117, 2024

52. Shitara K, Bang YJ, Iwasa S, Sugimoto N, Ryu MH, Sakai D, Chung HC, Kawakami H, Yabusaki H, Sakamoto Y, Nishina T, Inaki K, Kuwahara Y, Wada N, Suto F, Arita T, Sugihara M, Tsuchihashi Z, Saito K, Kojima A, Yamaguchi K. Trastuzumab deruxtecan in HER2-positive advanced gastric cancer: exploratory biomarker analysis of the randomized, phase 2 DESTINY-Gastric01 trial. Nature medicine, 30:1933-1942, 2024

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