Annual Report 2023

Department of Experimental Therapeutics

Noboru Yamamoto, Takafumi Koyama, Kan Yonemori, Shunsuke Kondo, Satoru Iwasa, Hirokazu Shoji, Kazuki Sudo, Jun Sato, Yuki Katsuya, Mao Okada, Ryoko Yamazaki

Introduction

 In April 2015, the affiliation of the Department of Experimental Therapeutics was updated from the NCC-EPOC (cf. the Exploratory Oncology Research & Clinical Trial Center) to the NCC-Hospital. The goal of this department is to perform initial clinical evaluations of promising new anti-cancer compounds emerging from the laboratory in phase I trials. The staff consists of specialists from various oncology fields (i.e., thoracic oncology, breast and medical oncology, gastro-intestinal oncology, hepato-biliary and pancreatic oncology, and immuno-oncology).

The Team and What We Do

 This department plays a key role in new anti-cancer drug development in Japan and other countries in Asia. Our top priority is to conduct FIH trials, but we also perform phase I trials for solid tumors (i.e., all comers). We recently joined the global phase I trials to accelerate the new drug development in Japan. We hold web conferences or teleconferences with EU and US sites, and discuss patient enrollment and further developmental strategies. Routine web conferences are also held between the NCC-Hospital (Tokyo) and the NCC-East hospital (Chiba) every Friday morning, and we share information on adverse events and patient enrollment and refer the candidates to each other to accelerate enrollment. Currently, most of the phase I trials in Japan (i.e., first in Japan phase I trials, first in human trials) are conducted at the NCC-Hospital and the NCC-East hospital with close collaboration.

Research Activities

 Elucidating the proof of concept (POC) is essential in new anti-cancer drug development especially in early phases. We therefore conduct several translational research (TR) projects in collaboration with research institutes. We are also conducting TR with the pharmaceutical industry to discover new targets for anti-immune therapy using human tissue (tumor and normal tissue) samples.  To facilitate the POC analyses in phase I trials, a phase I biobank study has been launched in 2018.

Clinical Trials

 In fiscal year 2023, 99 phase I trials including 58 FIH trials were conducted.

Education

 In 2023, the 5th NCCH & RI Tsukiji TR Board activity conference was held on December 6th at the NCC-Tsukiji campus.

 In 2023, the 5th phase I & TR research workshop was held on September 24th at the NCC-Tsukiji campus.

List of papers published in 2023

Journal

1. Ando Y, Shimoi T, Sunami K, Okita N, Nakamura K, Shibata T, Fujiwara Y, Yamamoto N. Progress report of a cross-organ and biomarker-based basket-type clinical trial: BELIEVE Trial. Cancer science, 115:555-563, 2024

2. Shimoi T, Sunami K, Tahara M, Nishiwaki S, Tanaka S, Baba E, Kanai M, Kinoshita I, Shirota H, Hayashi H, Nishida N, Kubo T, Mamesaya N, Ando Y, Okita N, Shibata T, Nakamura K, Yamamoto N. Dabrafenib and trametinib administration in patients with BRAF V600E/R or non-V600 BRAF mutated advanced solid tumours (BELIEVE, NCCH1901): a multicentre, open-label, and single-arm phase II trial. EClinicalMedicine, 69:102447, 2024

3. Watanabe T, Honma Y, Yonemori K, Sunami K, Yoshimoto S, Mori T. High-grade intraductal carcinoma of the parotid gland harboring CTNNA1::ALK rearrangement: Changes in genetic status using genetic testing during treatment with an ALK inhibitor. Head & neck, 46:E26-E31, 2024

4. Yamamoto N, Koyama T, Sato J, Yoshida T, Sudo K, Iwasa S, Kondo S, Yonemori K, Kawasaki A, Satake K, Shibata S, Shimizu T. Phase I study of the anti-TIGIT antibody tiragolumab in combination with atezolizumab in Japanese patients with advanced or metastatic solid tumors. Cancer chemotherapy and pharmacology, 2024

5. Takeyasu Y, Yoshida T, Masuda K, Matsumoto Y, Shinno Y, Okuma Y, Goto Y, Horinouchi H, Yamamoto N, Ohe Y. Distinct Progression and Efficacy of First-Line Osimertinib Treatment According to Mutation Subtypes in Metastatic NSCLC Harboring EGFR Mutations. JTO clinical and research reports, 5:100636, 2024

6. Katsuya Y, Yoshida T, Takashima A, Yonemori K, Ohba A, Yazaki S, Yagishita S, Nakahama H, Kobayashi O, Yanagida M, Irino Y, Hamada A, Yamamoto N. Immunogenicity after vaccination of COVID-19 vaccines in patients with cancer: a prospective, single center, observational study. International journal of clinical oncology, 29:386-397, 2024

7. Takamizawa S, Koyama T, Sunami K, Sudo K, Hirata M, Kubo T, Tao K, Cho H, Narita Y, Kato K, Yamazaki N, Ohe Y, Okusaka T, Matsui Y, Ogawa C, Yonemori K, Yamamoto N. Identification of barriers to implementation of precision oncology in patients with rare cancers. Cancer science, 115:2023-2035, 2024

8. Kitadai R, Nishikawa T, Yoshida H, Mizoguchi C, Yamamoto K, Kato T, Yonemori K. Mesothelin expression in gynecologic carcinosarcoma: clinicopathological significance and correlation with HER2 expression. Journal of gynecologic oncology, 35:e11, 2024

9. Aiba H, Kojima Y, Shimoi T, Sudo K, Yazaki S, Imai T, Yoshida A, Iwata S, Kobayashi E, Kawai A, Arakawa A, Ogawa C, Kimura H, Yonemori K. Incidence of skeletal-related events in patients with Ewing sarcoma: An observational retrospective study in Japan. Cancer medicine, 13:e7060, 2024

10. Ishimaru S, Shimoi T, Sunami K, Nakajima M, Ando Y, Okita N, Nakamura K, Shibata T, Fujiwara Y, Yamamoto N. Platform trial for off-label oncology drugs using comprehensive genomic profiling under the universal public healthcare system: the BELIEVE trial. International journal of clinical oncology, 29:89-95, 2024

11. Fukushima T, Goto K, Hayashi T, Ikeda K, Hatayama T, Yamanaka R, Iwane K, Tasaka R, Kohada Y, Takemoto K, Kobatake K, Goriki A, Toshida A, Nakahara H, Motonaga M, Tokumo K, Fujii Y, Hayes CN, Okamoto W, Kubo T, Matsumoto T, Shiota M, Yamamoto N, Urabe Y, Hiyama E, Arihiro K, Hinoi T, Hinata N. Comprehensive genomic profiling testing in Japanese castration-resistant prostate cancer patients: results of a single-center retrospective cohort study. Japanese journal of clinical oncology, 54:175-181, 2024

12. Janku F, Kim TM, Iyer G, Spreafico A, Elez E, de Jonge M, Yamamoto N, van der Wekken AJ, Ascierto PA, Maur M, Marmé F, Kiladjian JJ, Basu S, Baffert F, Buigues A, Chen C, Cooke V, Giorgetti E, Kim J, McCarthy F, Moschetta M, Dummer R. First-in-human study of naporafenib (LXH254) with or without spartalizumab in adult patients with advanced solid tumors harboring MAPK signaling pathway alterations. European journal of cancer (Oxford, England : 1990), 196:113458, 2024

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

14. Matsubara N, Kusuhara S, Yamamoto N, Sudo K, Yanagita M, Murayama K, Kawasumi H, Russell DL, Yin D, Shimizu T. Safety and pharmacokinetics of imaradenant (AZD4635) in Japanese patients with advanced solid malignancies: a phase I, open-label study. Cancer chemotherapy and pharmacology, 93:341-352, 2024

15. Nishio M, Murakami S, Kawakami H, Okishio K, Tamiya M, Kobayashi H, Fujimoto D, Sugawara S, Kozuki T, Oya Y, Izumi H, Shiroyama T, Satouchi M, Yamamoto N, Kaname S, Matsuoka D, Otake Y, Takase T, Semba T, Azuma K. Phase II Study of the Liposomal Formulation of Eribulin (E7389-LF) in Combination with Nivolumab: Results from the Small Cell Lung Cancer Cohort. Cancer research communications, 4:226-235, 2024

16. 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

17. Yonemori K, Fujiwara K, Hasegawa K, Yunokawa M, Ushijima K, Suzuki S, Shikama A, Minobe S, Usami T, Kim JW, Kim BG, Wang PH, Chang TC, Yamamoto K, Han S, McKenzie J, Orlowski RJ, Miura T, Makker V, Man Kim Y. Analysis of East Asia subgroup in Study 309/KEYNOTE-775: lenvatinib plus pembrolizumab versus treatment of physician's choice chemotherapy in patients with previously treated advanced or recurrent endometrial cancer. Journal of gynecologic oncology, 35:e40, 2024

18. Katsuya Y. Current and future trends in whole genome sequencing in cancer. Cancer biology & medicine, 21:16-20, 2024

19. 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

20. Heist RS, Sands J, Bardia A, Shimizu T, Lisberg A, Krop I, Yamamoto N, Kogawa T, Al-Hashimi S, Fung SSM, Galor A, Pisetzky F, Basak P, Lau C, Meric-Bernstam F. Clinical management, monitoring, and prophylaxis of adverse events of special interest associated with datopotamab deruxtecan. Cancer treatment reviews, 125:102720, 2024

21. 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

22. Yamamoto N, Tolcher A, Hafez N, Lugowska I, Ramlau R, Macarulla T, Geng J, Li J, Teufel M, Märten A, LoRusso P. Efficacy and Safety of the MDM2-p53 Antagonist Brigimadlin (BI 907828) in Patients with Advanced Biliary Tract Cancer: A Case Series. OncoTargets and therapy, 17:267-280, 2024

23. Mizusawa J, Sato H, Rubinstein LV, Fujiwara T, Yonemori K, Hirakawa A. Racial differences in longitudinal toxicities of anticancer agents in early phase cancer clinical trials. Cancer medicine, 12:18098-18109, 2023

24. Okuma HS, Watanabe K, Tsuchihashi K, Machida R, Sadachi R, Hirakawa A, Ariyama H, Kanai M, Kamikura M, Anjo K, Hiramitsu A, Sekine S, Okita N, Mano H, Nishikawa H, Nakamura K, Yonemori K. Phase II Trial of Nivolumab in Metastatic Rare Cancer with dMMR or MSI-H and Relation with Immune Phenotypic Analysis (the ROCK Trial). Clinical cancer research, 29:5079-5086, 2023

25. Eguchi K, Omura G, Shimoi T, Kageyama D, Igaki H, Abe Y, Watanabe T, Aihara Y, Sakai A, Matsumoto Y, Sakai T, Yonemori K, Mori T, Yoshida A, Yoshimoto S. BCOR-CCNB3 sarcoma arising in the pharynx. Auris, nasus, larynx, 50:618-622, 2023

26. Sanomachi T, Okuma HS, Kitadai R, Kawachi A, Yazaki S, Tokura M, Arakaki M, Saito A, Kita S, Yamamoto K, Maejima A, Kojima Y, Nishikawa T, Sudo K, Shimoi T, Noguchi E, Fujiwara Y, Sugino H, Shiino S, Suto A, Yoshida M, Yonemori K. Low HER2 expression is a predictor of poor prognosis in stage I triple-negative breast cancer. Frontiers in oncology, 13:1157789, 2023

27. Miyakoshi J, Yazaki S, Shimoi T, Onishi M, Saito A, Kita S, Yamamoto K, Kojima Y, Sumiyoshi-Okuma H, Nishikawa T, Sudo K, Noguchi E, Murata T, Shiino S, Takayama S, Suto A, Fujiwara Y, Yoshida M, Yonemori K. Discordance in PD-L1 expression using 22C3 and SP142 assays between primary and metastatic triple-negative breast cancer. Virchows Archiv, 483:855-863, 2023

28. Shirasawa M, Yoshida T, Shiraishi K, Takigami A, Takayanagi D, Imabayashi T, Matsumoto Y, Masuda K, Shinno Y, Okuma Y, Goto Y, Horinouchi H, Yotsukura M, Yoshida Y, Nakagawa K, Tsuchida T, Hamamoto R, Yamamoto N, Motoi N, Kohno T, Watanabe SI, Ohe Y. Identification of inflamed-phenotype of small cell lung cancer leading to the efficacy of anti-PD-L1 antibody and chemotherapy. Lung cancer (Amsterdam, Netherlands), 179:107183, 2023

29. Shirasawa M, Yoshida T, Shiraishi K, Goto N, Yagishita S, Imabayashi T, Matsumoto Y, Masuda K, Shinno Y, Okuma Y, Goto Y, Horinouchi H, Yotsukura M, Yoshida Y, Nakagawa K, Naoki K, Tsuchida T, Hamamoto R, Yamamoto N, Motoi N, Kohno T, Watanabe SI, Ohe Y. Tumor microenvironment-mediated immune profiles and efficacy of anti-PD-L1 antibody plus chemotherapy stratified by DLL3 expression in small-cell lung cancer. British journal of cancer, 129:2003-2013, 2023

30. Shimoda Y, Yoshida T, Miyakoshi J, Torasawa M, Tateishi A, Matsumoto Y, Masuda K, Shinno Y, Okuma Y, Goto Y, Horinouchi H, Yamamoto N, Ohe Y. Incidence of serious adverse events caused by tyrosine kinase inhibitor treatment following immune checkpoint inhibitor therapy in advanced NSCLC patients with oncogenic driver alterations. Cancer immunology, immunotherapy, 72:2613-2621, 2023

31. Torasawa M, Yoshida T, Takeyasu Y, Shimoda Y, Tateishi A, Matsumoto Y, Masuda K, Shinno Y, Okuma Y, Goto Y, Horinouchi H, Yamamoto N, Takahashi K, Ohe Y. Disease progression status during initial immune checkpoint inhibitor (ICI) affects the clinical outcome of ICI retreatment in advanced non-small cell lung cancer patients. Cancer medicine, 12:12388-12401, 2023

32. Nishimatsu K, Matsumoto Y, Kashima J, Imabayashi T, Uchimura K, Furuse H, Masuda K, Shinno Y, Okuma Y, Yoshida T, Goto Y, Horinouchi H, Yamamoto N, Tsuchida T, Ohe Y, Yatabe Y. Concordance between cryobiopsy and forceps biopsy specimens in assessment of immunohistochemistry staining for non-small cell lung carcinoma. Translational lung cancer research, 12:1245-1255, 2023

33. Nakamura T, Yoshida T, Takeyasu Y, Masuda K, Sinno Y, Matsumoto Y, Okuma Y, Goto Y, Horinouchi H, Yamamoto N, Ohe Y. Distinct metastatic spread and progression patterns in patients treated with crizotinib for ROS1- and ALK-rearranged non-small cell lung cancer: a single-center retrospective study. Translational lung cancer research, 12:1436-1444, 2023

34. Torasawa M, Horinouchi H, Yagishita S, Utsumi H, Okuda K, Takekoshi D, Ito S, Wakui H, Murata S, Kaku S, Okuma K, Matsumoto Y, Shinno Y, Okuma Y, Yoshida T, Goto Y, Yamamoto N, Araya J, Ohe Y, Fujita Y. Exploratory analysis to predict pneumonitis during durvalumab consolidation therapy for patients with locally advanced non-small cell lung cancer from proteomic profiling of circulating extracellular vesicles. Thoracic cancer, 14:2909-2923, 2023

35. Tanaka T, Goto Y, Horie M, Masuda K, Shinno Y, Matsumoto Y, Okuma Y, Yoshida T, Horinouchi H, Motoi N, Yatabe Y, Watanabe S, Yamamoto N, Ohe Y. Whole Exome Sequencing of Thymoma Patients Exhibiting Exceptional Responses to Pemetrexed Monotherapy. Cancers, 15:4018, 2023

36. Uehara Y, Koyama T, Katsuya Y, Sato J, Sudo K, Kondo S, Yoshida T, Shoji H, Shimoi T, Yonemori K, Yamamoto N. Travel Time and Distance and Participation in Precision Oncology Trials at the National Cancer Center Hospital. JAMA network open, 6:e2333188, 2023

37. Ikeda H, Nagasaki J, Shimizu D, Katsuya Y, Horinouchi H, Hosomi Y, Tanji E, Iwata T, Itami M, Kawazu M, Ohe Y, Suzuki T, Togashi Y. Immunologic Significance of CD80/CD86 or Major Histocompatibility Complex-II Expression in Thymic Epithelial Tumors. JTO clinical and research reports, 4:100573, 2023

38. Satake T, Kondo S, Tanabe N, Mizuno T, Katsuya Y, Sato J, Koyama T, Yoshida T, Hirata M, Yamamoto N. Pathogenic Germline Variants in BRCA1/2 and p53 Identified by Real-world Comprehensive Cancer Genome Profiling Tests in Asian Patients. Cancer research communications, 3:2302-2311, 2023

39. Nishikawa T, Hasegawa K, Matsumoto K, Mori M, Hirashima Y, Takehara K, Ariyoshi K, Kato T, Yagishita S, Hamada A, Kawasaki M, Kawashima S, Tomatsuri S, Nagasaka Y, Yoshida H, Machida R, Hirakawa A, Nakamura K, Yonemori K. Trastuzumab Deruxtecan for Human Epidermal Growth Factor Receptor 2-Expressing Advanced or Recurrent Uterine Carcinosarcoma (NCCH1615): The STATICE Trial. Journal of clinical oncology, 41:2789-2799, 2023

40. Yoshida H, Mizoguchi C, Saito A, Kitadai R, Yamamoto K, Nishikawa T, Kato T, Yonemori K. Discordances in expression of human epidermal growth factor receptor 2 between primary and metastatic uterine carcinosarcoma: A proposal for HER2-targeted therapy specimen selection. Annals of diagnostic pathology, 65:152150, 2023

41. Saito R, Kuroda T, Yoshida H, Sudo K, Saito M, Tanabe H, Takano H, Yamada K, Kiyokawa T, Yonemori K, Kato T, Okamoto A, Kohno T. Genetic characteristics of platinum-sensitive ovarian clear cell carcinoma. Japanese journal of clinical oncology, 53:781-790, 2023

42. Saito A, Nishikawa T, Yoshida H, Mizoguchi C, Kitadai R, Yamamoto K, Yazaki S, Kojima Y, Ishikawa M, Kato T, Yonemori K. Folate receptor alpha is widely expressed and a potential therapeutic target in uterine and ovarian carcinosarcoma. Gynecologic oncology, 176:115-121, 2023

43. Kojima Y, Yoshida H, Okuya T, Okuma HS, Nishikawa T, Tanioka M, Sudo K, Noguchi E, Shimoi T, Tamura K, Tanase Y, Uno M, Ishikawa M, Arakaki M, Ichikawa H, Yagishita S, Hamada A, Fujiwara Y, Yonemori K, Kato T. Therapeutic target biomarkers of patient-derived xenograft models of gastric-type cervical adenocarcinoma. Gynecologic oncology reports, 50:101302, 2023

44. Saito Y, Shimoi T, Iwata S, Maejima A, Abe K, Udagawa R, Yonemori K, Furukawa T, Wakao F. Impact of relative dose intensity of trabectedin with pegfilgrastim support: a single-centre retrospective study. Journal of chemotherapy (Florence, Italy), 35:737-744, 2023

45. Kojima N, Mori T, Motoi T, Kobayashi E, Yoshida M, Yatabe Y, Ichikawa H, Kawai A, Yonemori K, Antonescu CR, Yoshida A. Frequent CD30 Expression in an Emerging Group of Mesenchymal Tumors With NTRK, BRAF, RAF1, or RET Fusions. Modern pathology, 36:100083, 2023

46. Ishihara S, Ogura K, Maejima A, Shimoi T, Sudo K, Kojima Y, Fukushima S, Osaki S, Kobayashi E, Iwata S, Matsui Y, Yonemori K, Kawai A. Predictive value of peripheral blood markers in soft tissue sarcoma patients treated with eribulin. Japanese journal of clinical oncology, 53:494-500, 2023

47. Aiba H, Kojima Y, Shimoi T, Sudo K, Yazaki S, Imai T, Yoshida A, Iwata S, Kobayashi E, Kawai A, Arakawa A, Ogawa C, Kimura H, Yonemori K. Clinical characteristics of primary cutaneous and subcutaneous Ewing sarcoma. Japanese journal of clinical oncology, 53:604-610, 2023

48. Watanabe S, Shimoi T, Nishikawa T, Kawachi A, Okuma HS, Tokura M, Yazaki S, Mizoguchi C, Arakaki M, Saito A, Kita S, Yamamoto K, Kojima Y, Sudo K, Noguchi E, Yoshida A, Kawai A, Fujiwara Y, Yonemori K. Lymphocyte-to-monocyte ratio as a prognostic and potential tumor microenvironment indicator in advanced soft tissue sarcoma treated with first-line doxorubicin therapy. Scientific reports, 13:10734, 2023

49. Tao K, Yamazaki F, Kubo T, Sunami K, Kumamoto T, Arakawa A, Sugiyama M, Watanabe Y, Nakajima M, Shirakawa N, Tanimura K, Koyama T, Hirata M, Sudo K, Tanabe N, Watanabe T, Yoshida T, Kitami M, Yoshida A, Yatabe Y, Nakano Y, Ohira M, Kamijo T, Nakazawa A, Kato M, Ichimura K, Kohno T, Yamamoto N, Hishiki T, Ichikawa H, Ogawa C. Pediatric Precision Medicine at the National Cancer Center Japan: Prospective Genomic Study of Pediatric Patients with Cancer as Part of the TOP-GEAR Project. JCO precision oncology, 7:e2200266, 2023

50. Sadahiro R, Hatta K, Yamaguchi T, Masanori E, Matsuda Y, Ogawa A, Iwata Y, Tokoro A, Nakahara R, Hirayama T, Yanai Y, Ogawa Y, Kayano A, Ariyoshi K, Oyamada S, Uchitomi Y, Akechi T, Yamamoto N, Okita N, Yorikane E, Shimada K, Furukawa T, Hashimoto H, Maeda M, Sato T, Sekimoto A, Sasaki C, Saito E, Uezono Y, Matsuoka H. A multi-centre, double-blind, randomized, placebo-controlled trial to evaluate the effectiveness and safety of ramelteon for the prevention of postoperative delirium in elderly cancer patients: a study protocol for JORTC-PON2/J-SUPPORT2103/NCCH2103. Japanese journal of clinical oncology, 53:851-857, 2023

51. Iwasa S, Koyama T, Nishino M, Kondo S, Sudo K, Yonemori K, Yoshida T, Tamura K, Shimizu T, Fujiwara Y, Kitano S, Shimomura A, Sato J, Yokoyama F, Iida H, Kondo M, Yamamoto N. First-in-human study of ONO-4578, an antagonist of prostaglandin E(2) receptor 4, alone and with nivolumab in solid tumors. Cancer science, 114:211-220, 2023

52. Shimizu T, Nakagawa K, Hayashi H, Iwasa T, Kawakami H, Watanabe S, Yamamoto N, Yonemori K, Koyama T, Sato J, Tamura K, Kikuchi K, Akaike K, Takeda S, Takeda M. Oral formulation of bendamustine hydrochloride for patients with advanced solid tumors; a phase 1 study. Investigational new drugs, 41:1-12, 2023

53. Tanaka T, Yoshida T, Masuda K, Takeyasu Y, Shinno Y, Matsumoto Y, Okuma Y, Goto Y, Horinouchi H, Yamamoto N, Ohe Y. Prognostic role of modified Glasgow Prognostic score in elderly non-small cell lung cancer patients treated with anti-PD-1 antibodies. Respiratory investigation, 61:74-81, 2023

54. Takamizawa S, Katsuya Y, Chen YN, Mizuno T, Koyama T, Sudo K, Yoshida T, Kondo S, Iwasa S, Yonemori K, Shimizu T, Yamamoto N, Suzuki S. Ocular toxicity of investigational anti-cancer drugs in early phase clinical trials. Investigational new drugs, 41:173-181, 2023

55. Heymach J, Opdam F, Barve M, Gibson N, Sadrolhefazi B, Serra J, Yamamoto N. A Phase I, Open-Label, Dose Confirmation, Escalation, and Expansion Trial of BI 1810631 as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations. Clinical lung cancer, 24:e65-e68, 2023

56. Fukuda A, Yoshida T, Yagishita S, Shiotsuka M, Kobayashi O, Iwata S, Umeguchi H, Yanagida M, Irino Y, Masuda K, Shinno Y, Okuma Y, Goto Y, Horinouchi H, Hamada A, Yamamoto N, Ohe Y. Real-world Data on the Incidence of Coronavirus Disease (COVID-19) in Patients With Advanced Thoracic Cancer During the Early Phase of the Pandemic in Japan. Anticancer research, 43:919-926, 2023

57. Fujiwara Y, Makihara R, Hase T, Hashimoto N, Naito T, Tsubata Y, Okuno T, Takahashi T, Kobayashi H, Shinno Y, Zenke Y, Ikeda T, Hosomi Y, Watanabe K, Kitazono S, Sakiyama N, Makino Y, Yamamoto N. Pharmacokinetic and dose-finding study of osimertinib in patients with impaired renal function and low body weight. Cancer science, 114:2087-2097, 2023

58. 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

59. Shimada K, Nakamura K, Yamamoto N. Mission of the National Cancer Center Hospital in Japan to promote clinical trials for precision medicine. Cancer biology & medicine, 21:1-3, 2023

60. Akagi K, Yagishita S, Ohuchi M, Hayashi Y, Takeyasu Y, Masuda K, Shinno Y, Okuma Y, Yoshida T, Goto Y, Horinouchi H, Yamamoto N, Mukae H, Ohe Y, Hamada A. Impact of ramucirumab pharmacokinetics in combination with docetaxel on the efficacy and survival in patients with advanced non-small cell lung cancer. Lung cancer (Amsterdam, Netherlands), 178:247-253, 2023

61. Okuma HS, Yoshida H, Kobayashi Y, Arakaki M, Mizoguchi C, Inagaki L, Voon PJ, Malik Bin Ismail A, Fen Soo Hoo H, Yusak S, Severino B Imasa M, Nguyen Huy T, Thai Anh T, Kohsaka S, Mano H, Yonemori K, Nakamura K, Yatabe Y. Molecular pathology quality control in Southeast Asia: Results of a multiregional quality assurance study from MASTER KEY Asia. Cancer science, 114:2664-2673, 2023

62. Yagishita S, Nishikawa T, Yoshida H, Shintani D, Sato S, Miwa M, Suzuki M, Yasuda M, Ogitani Y, Jikoh T, Yonemori K, Hasegawa K, Hamada A. Co-Clinical Study of [fam-] Trastuzumab Deruxtecan (DS8201a) in Patient-Derived Xenograft Models of Uterine Carcinosarcoma and Its Association with Clinical Efficacy. Clinical cancer research, 29:2239-2249, 2023

63. Tamura K, Mukohara T, Yonemori K, Kawabata Y, Nicolas X, Tanaka T, Iwata H. Phase 1 study of oral selective estrogen receptor degrader (SERD) amcenestrant (SAR439859), in Japanese women with ER-positive and HER2-negative advanced breast cancer (AMEERA-2). Breast cancer (Tokyo, Japan), 30:506-517, 2023

64. Jo H, Yoshida T, Yagishita S, Ohuchi M, Matsumoto Y, Shinno Y, Okuma Y, Goto Y, Horinouchi H, Yamamoto N, Takahashi K, Motoi N, Hamada A, Ohe Y. Clinical Characteristics and Pharmacokinetics Change of Long-Term Responders to Antiprogrammed Cell Death Protein 1 Inhibitor Among Patients With Advanced NSCLC. JTO clinical and research reports, 4:100474, 2023

65. Makker V, Colombo N, Casado Herráez A, Monk BJ, Mackay H, Santin AD, Miller DS, Moore RG, Baron-Hay S, Ray-Coquard I, Ushijima K, Yonemori K, Kim YM, Guerra Alia EM, Sanli UA, Bird S, Orlowski R, McKenzie J, Okpara C, Barresi G, Lorusso D. Lenvatinib Plus Pembrolizumab in Previously Treated Advanced Endometrial Cancer: Updated Efficacy and Safety From the Randomized Phase III Study 309/KEYNOTE-775. Journal of clinical oncology, 41:2904-2910, 2023

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