Annual Report 2024
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 sub-units (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 conferences and 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 2024, 226 patients were enrolled in the phase I and phase I/II trials.
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. Konno Y, Mayama M, Takehara K, Yokoyama Y, Suzuki J, Susumu N, Harano K, Nakagawa S, Nakanishi T, Yamagami W, Yoshihara K, Nomura H, Okamoto A, Aoki D, Watari H. Prognostic impact of the number of resected pelvic nodes in endometrial cancer: Japanese Gynecologic Oncology Group Study JGOG2043 post hoc analysis. Journal of gynecologic oncology, 36:e3, 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. Umemura S, Udagawa H, Ikeda T, Murakami H, Daga H, Toyozawa R, Kozuki T, Sakakibara-Konishi J, Ohe Y, Morise M, Kato T, Shingyoji M, Hara S, Furuya N, Teranishi S, Takata S, Miyamoto S, Nakachi I, Wakabayashi M, Nomura S, Sato A, Ishii G, Tsuchihara K, Sugiyama E, Kirita K, Sakai T, Shibata Y, Izumi H, Nosaki K, Zenke Y, Matsumoto S, Yoh K, Niho S, Goto K. Clinical Significance of a Prospective Large Genomic Screening for SCLC: The Genetic Classification and a Biomarker-Driven Phase 2 Trial of Gedatolisib. Journal of thoracic oncology, 20:177-193, 2025
5. Yuda J, Wang C, Terasawa T, Tajimi M, Osaga S, Miura M, Takaoka S, Tanizawa Y. Treatment selection and influencing factors for chronic lymphocytic leukemia: a physician survey in Japan. International journal of clinical oncology, 30:157-167, 2025
6. 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
7. 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
8. 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
9. Oi H, Taki T, Kuroe T, Sakamoto N, Sakashita S, Kojima M, Sugiyama E, Umemura S, Sakai T, Izumi H, Zenke Y, Matsumoto S, Yoh K, Ishii M, Tsuboi M, Goto K, Ishii G. NETosis in pulmonary pleomorphic carcinoma. Cancer science, 116:524-532, 2025
10. Iwata H, Naito Y, Hattori M, Yoshimura A, Yonemori K, Aizawa M, Mori Y, Yoshimitsu J, Umeyama Y, Mukohara T. Safety and pharmacokinetics of vepdegestrant in Japanese patients with ER+ advanced breast cancer: a phase 1 study. International journal of clinical oncology, 30:72-82, 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. Nakagawa K, Garon EB, Seto T, Nishio M, Aix SP, Paz-Ares L, Chiu CH, Park K, Novello S, Nadal E, Nishino K, Yoh K, Shih JY, Chik JYK, Moro-Sibilot D, Puri T, Chacko Varughese S, Frimodt-Moller B, Visseren-Grul C, Reck M. RELAY: Final Overall Survival for Erlotinib Plus Ramucirumab or Placebo in Untreated, EGFR-Mutated Metastatic NSCLC. Journal of thoracic oncology, 20:487-499, 2025
13. 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
14. Sonehara K, Tateishi K, Yoh K, Usui K, Hosomi Y, Kishi K, Naka G, Watanabe K, Tamano S, Uemura K, Kunitoh H. Real-World Study of EGFR-TKI Rechallenge With Another TKI After First-Line Osimertinib Discontinuation in Patients With EGFR-Mutated Non-Small Cell Lung Cancer: A Subset Analysis of the Reiwa Study. Thoracic cancer, 16:e15507, 2025
15. Awano N, Yoh K, Usui K, Hosomi Y, Kishi K, Naka G, Watanabe K, Tamano S, Uemura K, Kunitoh H. Outcome of osimertinib-treated patients with epidermal growth factor receptor mutation-positive nonsmall cell lung cancer requiring dose reduction: a secondary analysis of the Reiwa study. Japanese journal of clinical oncology, 55:261-268, 2025
16. 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
17. Kobayashi T, Watanabe K, Hosomi Y, Yoh K, Usui K, Kishi K, Naka G, Tamano S, Uemura K, Kunitoh H. Clinical outcomes of patients with EGFR-mutated NSCLC developing interstitial lung disease during first-line osimertinib therapy: a sub-analysis of the Reiwa study. Japanese journal of clinical oncology, 55:275-282, 2025
18. Hirata T, Watanabe K, Hosomi Y, Yoh K, Usui K, Kishi K, Naka G, Tamano S, Uemura K, Kunitoh H. Observational study of the efficacy and safety of first-line osimertinib and later treatments for uncommon epidermal growth factor receptor-activating mutation-positive advanced non-small cell lung cancer. Japanese journal of clinical oncology, 55:269-274, 2025
19. 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
20. Ito Y, Zenke Y, Sakai T, Shibata Y, Izumi H, Nosaki K, Umemura S, Matsumoto S, Yoh K, Nakamura M, Hojo H, Izumo T, Goto K. A simplified scoring system for predicting treatment response in limited-stage small-cell lung cancer (EAST score). Future oncology (London, England), 21:473-481, 2025
21. 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
22. Sands J, Ahn MJ, Lisberg A, Cho BC, Blumenschein G Jr, Shum E, Pons Tostivint E, Goto Y, Yoh K, Heist R, Shimizu J, Lee JS, Baas P, Planchard D, Pérol M, Felip E, Su WC, Zebger-Gong H, Lan L, Liu C, Howarth P, Chiaverelli R, Paz-Ares L. Datopotamab Deruxtecan in Advanced or Metastatic Non-Small Cell Lung Cancer With Actionable Genomic Alterations: Results From the Phase II TROPION-Lung05 Study. Journal of clinical oncology, 43:1254-1265, 2025
23. 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
24. Misawa S, Denda T, Kodama S, Suzuki T, Naito Y, Kogawa T, Takada M, Hino A, Shiosakai K, Kuwabara S. One-year incidence of chemotherapy-induced peripheral neuropathy in oxaliplatin- or taxane-based chemotherapy: a multicenter, prospective registry study (MiroCIP study). Expert opinion on pharmacotherapy, 26:335-344, 2025
25. 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
26. 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
27. 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
28. Konno Y, Mayama M, Takehara K, Yokoyama Y, Suzuki J, Susumu N, Harano K, Nakagawa S, Nakanishi T, Yamagami W, Yoshihara K, Nomura H, Okamoto A, Aoki D, Watari H. Prognostic significance of para-aortic node metastasis in endometrial cancer: Japanese Gynecologic Oncology Group Study JGOG2043 post hoc analysis. Journal of gynecologic oncology, 2025
29. 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
30. Marabelle A, O'Malley DM, Hendifar AE, Ascierto PA, Motola-Kuba D, Penel N, Cassier PA, Bariani G, De Jesus-Acosta A, Doi T, Longo F, Miller WH Jr, Oh DY, Gottfried M, Yao L, Jin F, Gozman A, Maio M. Pembrolizumab in microsatellite-instability-high and mismatch-repair-deficient advanced solid tumors: updated results of the KEYNOTE-158 trial. Nature cancer, 6:253-258, 2025
31. 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
32. Uehara Y, Izumi H, Taki T, Sakai T, Udagawa H, Sugiyama E, Umemura S, Zenke Y, Matsumoto S, Yoh K, Kubota S, Aokage K, Sakamoto N, Sakashita S, Kojima M, Nagamine M, Hosomi Y, Tsuboi M, Goto K, Ishii G. Solid Predominant Histology and High Podoplanin Expression in Cancer-Associated Fibroblast Predict Primary Resistance to Osimertinib in EGFR-Mutated Lung Adenocarcinoma. JTO clinical and research reports, 6:100779, 2025
33. Luo HY, Lu YX, Shitara K, Lenz HJ, Xu RH. Global alliances in translational cancer research. Cancer cell, 43:581-586, 2025
34. Heymach JV, Opdam F, Barve M, Tu HY, Wu YL, Berz D, Schröter L, Botilde Y, Sadrolhefazi B, Serra J, Yoh K, Yamamoto N. HER2-Selective Tyrosine Kinase Inhibitor, Zongertinib (BI 1810631), in Patients With Advanced/Metastatic Solid Tumors With HER2 Alterations: A Phase Ia Dose-Escalation Study. Journal of clinical oncology, 43:1337-1347, 2025
35. 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
36. Uehara Y, Izumi H, Kobayashi IS, Matsumoto S, Hosomi Y, Okuno T, Sugisaka J, Takase N, Taima K, Sasaki S, Teranishi S, Miyamoto S, Mori M, Nakashima C, Asano S, Oi H, Sakai T, Shibata Y, Udagawa H, Sugiyama E, Nosaki K, Umemura S, Zenke Y, Yoh K, Ikeda S, Costa DB, Kobayashi SS, Goto K. Efficacy of EGFR tyrosine kinase inhibitors in patients with non-small cell lung cancer with EGFR exon 19 insertions: clinical-genomic, preclinical analysis through LC-SCRUM-Asia (multi-institutional genomic screening registry). Lung cancer (Amsterdam, Netherlands), 202:108479, 2025
37. 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
38. 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
39. Biesdorf C, Guan X, Siddani SR, Hoffman D, Boehm N, Medeiros BC, Doi T, de Jonge M, Rasco D, Menon RM, Polepally AR. Pharmacokinetics and immunogenicity of eftozanermin alfa in subjects with previously-treated solid tumors or hematologic malignancies: results from a phase 1 first-in-human study. Cancer chemotherapy and pharmacology, 93:329-339, 2024
40. 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
41. 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
42. 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
43. 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
44. Mori S, Izumi H, Araki M, Liu J, Tanaka Y, Kagawa Y, Sagae Y, Ma B, Isaka Y, Sasakura Y, Kumagai S, Sakae Y, Tanaka K, Shibata Y, Udagawa H, Matsumoto S, Yoh K, Okuno Y, Goto K, Kobayashi SS. LTK mutations responsible for resistance to lorlatinib in non-small cell lung cancer harboring CLIP1-LTK fusion. Communications biology, 7:412, 2024
45. 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
46. Hirota S, Tateishi U, Nakamoto Y, Yamamoto H, Sakurai S, Kikuchi H, Kanda T, Kurokawa Y, Cho H, Nishida T, Sawaki A, Ozaka M, Komatsu Y, Naito Y, Honma Y, Takahashi F, Hashimoto H, Udo M, Araki M, Nishidate S. English version of Japanese Clinical Practice Guidelines 2022 for gastrointestinal stromal tumor (GIST) issued by the Japan Society of Clinical Oncology. International journal of clinical oncology, 29:647-680, 2024
47. 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
48. Kuboki Y, Koyama T, Matsubara N, Naito Y, Kondo S, Harano K, Yonemori K, Yoh K, Gu Y, Mita T, Chen X, Ueda E, Yamamoto N, Doi T, Shimizu T. PD-1 inhibition with retifanlimab and/or arginase inhibition with INCB001158 in Japanese patients with solid tumors: A phase I study. Cancer medicine, 13:e6980, 2024
49. Okahisa M, Udagawa H, Matsumoto S, Kato T, Yokouchi H, Furuya N, Kanemaru R, Toyozawa R, Nishiyama A, Ohashi K, Miyamoto S, Nishino K, Nakamura A, Iwama E, Niho S, Oi H, Sakai T, Shibata Y, Izumi H, Sugiyama E, Nosaki K, Umemura S, Zenke Y, Yoh K, Kah Mun Low G, Zhuo J, Goto K. Clinical outcomes in patients with non-small cell lung cancer harboring EGFR Exon20 in-frame insertions in the near-loop and far-loop: Results from LC-SCRUM-Asia. Lung cancer (Amsterdam, Netherlands), 191:107798, 2024
50. Sun JM, Adenis A, C Enzinger P, Shah MA, Kato K, Bennouna J, Doi T, Hawk NN, Yu L, Shah S, Bhagia P, Shen L. LEAP-014: first-line lenvatinib + pembrolizumab + chemotherapy in advanced/metastatic esophageal squamous cell carcinoma. Future oncology (London, England), 20:2709-2721, 2024
51. Kakuwa T, Watanabe T, Niino M, Kawata A, Satoh T, Matsumura N, Yokoyama Y, Kawana K, Hirashima Y, Kyo S, Yasuda M, Harano K, Machida H, Tokunaga H, Kaneuchi M, Tabata T, Kobayashi Y, Nagase S, Katabuchi H, Mikami M, Yamamoto Y, Rikitake R, Ichinose Y, Higashi T. Quality of care measurement for patients with ovarian cancer in Japan. The journal of obstetrics and gynaecology research, 50:1182-1191, 2024
52. Li BT, Meric-Bernstam F, Bardia A, Naito Y, Siena S, Aftimos P, Anderson I, Curigliano G, de Miguel M, Kalra M, Oh DY, Park JO, Postel-Vinay S, Rha SY, Satoh T, Spanggaard I, Michelini F, Smith A, Machado KK, Saura C. Trastuzumab deruxtecan in patients with solid tumours harbouring specific activating HER2 mutations (DESTINY-PanTumor01): an international, phase 2 study. The Lancet. Oncology, 25:707-719, 2024
53. Tan RYC, Ong WS, Lee KH, Park S, Iqbal J, Park YH, Lee JE, Yu JH, Lin CH, Lu YS, Ono M, Ueno T, Naito Y, Onishi T, Lim GH, Tan SM, Lee HB, Koh J, Han W, Im SA, Tan VKM, Phyu N, Wong FY, Tan PH, Yap YS. Outcomes in Nonmetastatic Hormone Receptor-Positive HER2-Negative Pure Mucinous Breast Cancer: A Multicenter Cohort Study. Journal of the National Comprehensive Cancer Network : JNCCN, 22:e237121, 2024
54. 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
55. Nosaki K, Yoh K, Toyozawa R, Horinouchi H, Morise M, Ohashi K, Murakami H, Satouchi M, Sakakibara-Konishi J, Yano S, Okumura F, Matsumoto S, Shimokawa M, Seto T, Goto K. Phase 2 trial of crizotinib in Japanese patients with advanced NSCLC harboring a MET gene alteration: a Co-MET study. International journal of clinical oncology, 29:1142-1151, 2024
56. Kohsaka S, Yagishita S, Shirai Y, Matsuno Y, Ueno T, Kojima S, Ikeuchi H, Ikegami M, Kitada R, Yoshioka KI, Toshimitsu K, Tabata K, Yokoi A, Doi T, Yamamoto N, Owa T, Hamada A, Mano H. A molecular glue RBM39-degrader induces synthetic lethality in cancer cells with homologous recombination repair deficiency. NPJ precision oncology, 8:117, 2024
57. Mansoor W, Joo S, Norquist JM, Kato K, Sun JM, Shah MA, Enzinger P, Adenis A, Doi T, Kojima T, Metges JP, Li Z, Kim SB, Cho BC, Sunpaweravong P, Alsina M, Goekkurt E, Suryawanshi S, Shah S, Shen L. Health-related quality-of-life analysis from KEYNOTE-590: pembrolizumab plus chemotherapy versus chemotherapy for advanced esophageal cancer. The oncologist, 29:e1324-e1335, 2024
58. Yamamoto N, Kuboki Y, Harano K, Koyama T, Kondo S, Hagiwara A, Suzuki N, Fujikawa E, Toyoizumi K, Mukai M, Doi T. A phase 1/1b, open-label, dose-escalation study of PD-1 inhibitor, cetrelimab alone and in combination with FGFR inhibitor, erdafitinib in Japanese patients with advanced solid tumors. Investigational new drugs, 42:376-385, 2024
59. Shitara K, Shah MA, Lordick F, Bang YJ, Ilson D, Van Cutsem E, Enzinger P, Kim SS, Klempner SJ, Moran D, Park JW, Bhattacharya P, Ajani JA, Xu RH. Zolbetuximab plus chemotherapy for locally advanced unresectable or metastatic stomach or gastroesophageal junction cancers: a plain language summary. Future oncology (London, England), 20:1861-1877, 2024
60. Katoh M, Nakayama I, Wainberg ZA, Shitara K, Katoh M. Monoclonal antibodies that target fibroblast growth factor receptor 2 isoform b and Claudin-18 isoform 2 splicing variants in gastric cancer and other solid tumours. Clinical and translational medicine, 14:e1736, 2024
61. Tsushima T, Sato N, Guo YM, Nakamura H, Kunisada K, Chi SG, Akie K, Takahashi Y, Nakamura S, Shimada K, Ishii G, Minami Y, Yuda J. Richter transformation acquiring PLCG2 mutation during Bruton tyrosine kinase inhibitors treatment. EJHaem, 5:642-645, 2024
62. Peterlin P, Saada-Bouzid E, Moskovitz M, Pigneux A, Yuda J, Sinnollareddy M, Henner WR, Chen D, Freise KJ, Leibman RS, Avigdor A, Shimizu T. First-in-human clinical trial results with ABBV-184, a first-in-class T-cell receptor/anti-CD3 bispecific protein, in adults with previously treated AML or NSCLC. Expert review of anticancer therapy, 24:893-904, 2024
63. Niho S, Goto Y, Toyozawa R, Daga H, Ohashi K, Takahashi T, Tanaka H, Sakakibara-Konishi J, Hattori Y, Morise M, Kodani M, Ikeda T, Izumi H, Matsumoto S, Yoh K, Nomura S, Goto K. Phase II study of brigatinib in patients with ROS1 fusion-positive non-small-cell lung cancer: the Barossa study. ESMO open, 9:103642, 2024
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Book
1. Nakajima H, Mukohara T. Understanding mechanisms of resistance to HER2-targeted therapies in HER2-positive breast cancer. In: Bonavida B (ed), Overcoming Cancers Resistant to HER-2 Antibodies: Breaking Tolerance to Antibody-Mediated Immunotherapy, United Kingdom, Academic Press, pp 45-56, 2024