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Annual Report 2023

Department for The Promotion of Drug and Diagnostic Development

Division of Drug and Diagnostic Development Promotion

Translational Research Support Office

Hideaki Bando, Yoshiaki Nakamura, Takao Fujisawa, Mitsuho Imai, Tadayoshi Hashimoto, Taro Shibuki, Riu Yamashita, Naoko Iida, Yasutoshii Sakamoto, Masayuki Hata, Hiroko Ichiki, Hiroshi Uchigata, Ryuta Mitani, Mayumi Fujita, Tomoe Murakami, Yui Ogata, Atsuko Shimizu, Izumi Miki, Satoshi Horasawa, Hiroki Sokuoka, Naomi Kuramoto, Megumi Futamura, Mihoko Yuasa, Yu Komura, Machiko Kumagami, Akio Dodo, Yuri Murata, Chiemi Notake, Mizuho Kikuchi, Yuko Oka, Yoshiko Onuma, Shiho Kanno

Translational Research Sample Management Office

Yoshikatsu Koga, Mari Takahashi, Yasuko Tada, Hitomi Nakai, Yumie Takeshima, Naoko Ozaki, Mana Shimamura, Fubuki Omoya, Tomomi Kitaoka, Eriko Tajima

Supportive and Palliative Care Research Support Office

Sadamoto Zenda, Yasuhito Kamizono, Tomoka Okano, Sanae Shimada, Marie Yokoyama

Perioperative Treatment Development Promotion Office

Shin Kobayashi

Hematological Treatment Development Promotion Office

Junichiro Yuda

International Research Promotion Office

Yoshiaki Nakamura, Mitsuho Imai, Machiko Kumagami

Department of Data Science

Data Science Office

Toshihiro Misumi, Yuriko Takeda, Motoko Suzuki, Tomomi Nishikawa, Hiromichi Kimura, Kouji Oba, Saori Mishima

Biostatistics Office

Masashi Wakabayashi, Yuriko Takeda, Motoko Suzuki, Tomomi Nishikawa, Hiromichi Kimura

The Team and What We Do

Division of Drug and Diagnostic Development Promotion

Translational Research Support Office

 It mainly supports secretariat and data center operations of multicenter clinical research.

Translational Research Sample Management Office

 Research specimens, primarily obtained from patients, are appropriately controlled through collection, processing, storage, and disposal.

Supportive and Palliative Care Research Support Office

 It mainly supports research on supportive and palliative care.

Hematological Treatment Development Promotion Office

 This office supports therapeutic development of drugs mainly related to hematology and oncology.

Perioperative Treatment Development Promotion Office

 Primarily supports the development of treatments related to perioperative care.

International Research Promotion Office

 Mainly supports the promotion of international research aimed at the development of pharmaceutical products and diagnostic agents.

Data Science Office

 This office is responsible for data center operations for ARCAD-Asia.

Biostatistics Office

 It mainly supports biostatistics for the Clinical Research Support Office

Research Activities

 Support was provided for approximately 50 clinical studies. Large-scale multi-center collaborative studies included patient registrations of solid and hematological malignancies as follows: 2,768 cases in MONSTAR-SCREEN-2, 547 cases in SCRUM disease registry, 5,515 cases in GOZILA, 7,102 cases in CIRCULATE-Japan, 161 cases in COSMOS, and 212 cases in HM-SCREEN-2. There were 23 paper publications, including in Cancer Discovery, and 45 conference presentations. Utilizing the SCRUM-Japan platform, regulatory approvals were obtained for 4 new drugs and 2 diagnostic agents. For international expansion, LC-SCRUM-Asia Pacific (LC-SCRUM-AP) was established, and patient registration began in October 2022 from Taiwan, Thailand, and Malaysia. As of the end of March 2024, 285 cases have been registered from 4 facilities across these 3 countries. In ARCAD-Asia, individual subject data from 13 trials involving 4,173 cases were integrated. This was then combined with the ARCAD database operated by the French ARCAD Foundation and the U.S. Mayo Clinic, resulting in a comprehensive database of 63 trials with 45,224 cases.

Education

 By fiscal year 2023, 11 staff members obtained the Genomic Medical Research Coordinator qualification, 1 obtained the Certified CRC qualification, 5 obtained the GCP Passport qualification, 1 obtained the IT Passport qualification, and 2 obtained the Level 2 Statistics Certification. Additionally, we implemented candidate selection using professional networks, resulting in the hiring of one staff member who already possessed the GCP Passport qualification. For retention management, we encouraged joining academic societies and obtaining qualifications and implemented the conversion of part-time staff to full-time positions to promote long-term employment.

Future Prospects

(1) Regarding LC-SCRUM-AP, in the fiscal year 2023, we visited Vietnam as a new participating country and initiated discussions about research participation. In the fiscal year 2024, we plan to continue discussions with Vietnam while expanding facilities in existing participating countries such as Taiwan, Thailand, and Malaysia. We are also considering Indonesia as a new participating country and are in discussion with relevant organizations.

(2) We launched MONSTAR-SCREEN-3 in fiscal year 2024 based on multi-omics data, including DNA/RNA analysis of tissues and blood, and spatial transcriptome analysis.

(3) The second phase of ARCAD-Asia has been launched in fiscal year 2024, and ARCAD-Gastric, which expands from colorectal cancer to gastric cancer, is scheduled to be fully operational.

(4) Since fiscal year 2023, we have been conducting joint research with the Tohoku Medical Megabank Organization titled "Development of molecular residual disease detection and early cancer detection methods using liquid biopsy multi-omics with artificial intelligence," aimed at developing MRD and MCED assays.

List of papers published in 2023

Journal

1. Ouchi A, Sadachi R, Hamaguchi T, Tsukamoto S, Shimada Y, Inomata M, Takii Y, Komori K, Shiomi A, Shiozawa M, Ohue M, Watanabe J, Ito M, Kawashima Y, Kobatake T, Souda H, Saida Y, Hashimoto T, Sano Y, Kanemitsu Y. Prognostic Relevance of Primary Tumor Sidedness in Early-stage Colorectal Cancer: An Integrated Analysis of 4 Randomized Controlled Trials (JCOG2003A). Annals of surgery, 279:283-289, 2024

2. 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

3. Ikenaga N, Hashimoto T, Mizusawa J, Kitabayashi R, Sano Y, Fukuda H, Nakata K, Shibuya K, Kitahata Y, Takada M, Kamei K, Kurahara H, Ban D, Kobayashi S, Nagano H, Imamura H, Unno M, Takahashi A, Yagi S, Wada H, Shirakawa H, Yamamoto N, Hirono S, Gotohda N, Hatano E, Nakamura M, Ueno M. A multi-institutional randomized phase III study comparing minimally invasive distal pancreatectomy versus open distal pancreatectomy for pancreatic cancer; Japan Clinical Oncology Group study JCOG2202 (LAPAN study). BMC cancer, 24:231, 2024

4. 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

5. 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

6. Uozumi S, Enokida T, Suzuki S, Nishizawa A, Kamata H, Okano T, Kawasaki T, Fujisawa T, Ueda Y, Okano S, Tahara M, Yamaguchi M. Efficacy and safety of adapalene gel as a reactive treatment for cetuximab-induced skin toxicity in recurrent or metastatic squamous cell carcinoma of the head and neck: A historical cohort comparison study. Journal of oncology pharmacy practice, 30:295-303, 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. Une N, Kobayashi S, Kitaguchi D, Sunakawa T, Sasaki K, Ogane T, Hayashi K, Kosugi N, Kudo M, Sugimoto M, Hasegawa H, Takeshita N, Gotohda N, Ito M. Intraoperative artificial intelligence system identifying liver vessels in laparoscopic liver resection: a retrospective experimental study. Surgical endoscopy, 38:1088-1095, 2024

10. 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

11. 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

12. 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

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. 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

15. 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

16. 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

17. 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

18. 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

19. 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

20. 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

21. 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

22. 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

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. 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

25. 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

26. 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

27. 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

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. 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

30. Kagoura M, Kobayashi S, Kojima M, Kudo M, Sugimoto M, Konishi M, Gotohda N. Survival outcome of patient with pT1N0 biliary tract cancer treated with surgery alone. European journal of surgical oncology, 50:107980, 2024

31. 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

32. Shirakawa T, Makiyama A, Shimokawa M, Otsuka T, Shinohara Y, Koga F, Ueda Y, Nakazawa J, Otsu S, Komori A, Arima S, Fukahori M, Taguchi H, Honda T, Shibuki T, Nio K, Ide Y, Ureshino N, Mizuta T, Mitsugi K, Akashi K, Baba E. Author Correction: C-reactive protein/albumin ratio is the most significant inflammatory marker in unresectable pancreatic cancer treated with FOLFIRINOX or gemcitabine plus nab-paclitaxel. Scientific reports, 14:5311, 2024

33. Lenz HJ, Parikh A, Spigel DR, Cohn AL, Yoshino T, Kochenderfer M, Elez E, Shao SH, Deming D, Holdridge R, Larson T, Chen E, Mahipal A, Ucar A, Cullen D, Baskin-Bey E, Kang T, Hammell AB, Yao J, Tabernero J. Modified FOLFOX6 plus bevacizumab with and without nivolumab for first-line treatment of metastatic colorectal cancer: phase 2 results from the CheckMate 9X8 randomized clinical trial. Journal for immunotherapy of cancer, 12:e008409, 2024

34. 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

35. Ito S, Sano T, Mizusawa J, Tokunaga M, Hashimoto T, Imamura H, Teshima S, Nihei K, Yamada M, Choda Y, Imamura K, Hato S, Terashima M, Sasako M. Identifying Risk Factors of Complications following Total Gastrectomy for Gastric Cancer: Comparison between Splenectomy and Spleen-Preserving Surgery - A Supplementary Analysis of JCOG0110. Digestive surgery, 40:114-120, 2023

36. 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

37. Hashimoto T, Otsu S, Hironaka S, Takashima A, Mizusawa J, Kataoka T, Fukuda H, Tsukamoto S, Hamaguchi T, Kanemitsu Y. Phase II biomarker identification study of anti-VEGF agents with FOLFIRI for pretreated metastatic colorectal cancer. Future oncology (London, England), 19:1593-1600, 2023

38. Hashimoto T, Tsukada Y, Ito M, Kanato K, Mizusawa J, Fukuda H, Tsukamoto S, Takashima A, Kanemitsu Y. Utility of circulating tumour DNA for prognosis and prediction of therapeutic effect in locally recurrent rectal cancer: study protocol for a multi-institutional, prospective observational study (JCOG1801A1, CAP-LR study). BMJ open, 13:e073217, 2023

39. 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

40. Hashimoto T, Maruyama S, Takii Y, Mizusawa J, Kataoka T, Fukuda H, Tsukamoto S, Takashima A, Hamaguchi T, Kanemitsu Y. A randomized phase II study comparing preoperative mFOLFOX6 versus FOLFOXIRI for locally advanced colon cancer: JCOG2006. Future oncology (London, England), 19:1897-1904, 2023

41. Hashimoto T, Nakayama I, Ohashi M, Mizusawa J, Kawachi H, Kita R, Fukuda H, Kurokawa Y, Boku N, Yoshikawa T, Terashima M. Randomized phase II study comparing neoadjuvant 5-fluorouracil/oxaliplatin/docetaxel versus docetaxel/oxaliplatin/S-1 for patients with type 4 or large type 3 gastric cancer. Future oncology (London, England), 19:2147-2155, 2023

42. Miyoshi T, Ito H, Wakabayashi M, Hashimoto T, Sekino Y, Suzuki K, Tsuboi M, Moriya Y, Yoshino I, Isaka T, Hattori A, Mimae T, Isaka M, Maniwa T, Endo M, Yoshioka H, Nakagawa K, Nakajima R, Tsutani Y, Saji H, Okada M, Aokage K, Fukuda H, Watanabe SI. Risk factors for loss of pulmonary function after wedge resection for peripheral ground-glass opacity dominant lung cancer. European journal of cardio-thoracic surgery, 64:ezad365, 2023

43. Hashimoto T, Tsukamoto S, Murofushi K, Ito Y, Hirano H, Tsukada Y, Sasaki K, Mizusawa J, Fukuda H, Takashima A, Kanemitsu Y. Total neoadjuvant therapy followed by a watch-and-wait strategy for patients with rectal cancer (TOWARd): protocol for single-arm phase II/III confirmatory trial (JCOG2010). BJS open, 7:zrad110, 2023

44. Takeda Y, Misumi T, Bando H, Suzuki M, Wakabayashi M, Oki E, Yamazaki K, Kakeji Y, Shitara K, Terashima M, Raeisi M, Maehara Y, Ohtsu A, Andre T, de Gramont A, Shi Q, Yoshino T . ARCAD-Asia initiative: leveraging yesterday’s data for tomorrow. ESMO Gastrointestinal Oncology, 2:2023

45. 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

46. 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

47. 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

48. 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

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. Hosono N, Chi S, Yamauchi T, Fukushima K, Shibayama H, Katagiri S, Gotoh A, Eguchi M, Morishita T, Ogasawara R, Kondo T, Yanada M, Yamamoto K, Kobayashi T, Kuroda J, Usuki K, Utsu Y, Yoshimitsu M, Ishitsuka K, Ono T, Takahashi N, Iyama S, Kojima K, Nakamura Y, Fukuhara S, Izutsu K, Abutani H, Yamauchi N, Yuda J, Minami Y. Clinical utility of genomic profiling of AML using paraffin-embedded bone marrow clots: HM-SCREEN-Japan 01. Cancer science, 114:2098-2108, 2023

51. 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

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