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Annual Report 2020

Division of Experimental Therapeutics

Kashiwa: Toshihiko Doi, Kiyotaka Yo, Yoichi Naito, Kohei Shitara, Hideaki Takahash, Yasutoshi Kuboki
Tsukiji: Noboru Yamamoto, Toshio Shimizu, Kan Yonemori, Satoru Iwasa, Shunsuke Kondo, Tatsuya Yoshida, Kazuki Sudo, Takafumi Koyama, Yuki Katsuya, Makoto Nishino

Introduction

The Department of Experimental Therapeutics supports efforts toward the creation of new drugs and other products from breakthroughs originating from academic institutions by achieving results at the level of basic research. We evaluate and discover excellent research and development proposals and provide integrated management of the program so that basic research outcomes are linked through to clinical research and clinical trials for approval. We have conducted several IITs as applications for approval and have promoted research and development in the field of medicine.

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 the FIH trials, but we also perform phase I trials for solid tumors (i.e., all comers). We recently joined global phase I trials to accelerate new drug development in Japan. We hold web conferences and teleconferences with EU and US sites and discuss patient enrollment and further developmental strategy. Routine web conferences are also held between the NCC Hospital (Tokyo) and the NCC-East hospital (Chiba) every Friday morning, sharing information on adverse events and patient enrollment and referring candidates to each other to accelerate enrollment.

Research activities

We promote the following activities for the proper conduct of research and trials.

planning clinical trials as IITs to achieve POC of new academic seeds.
Explanatory meetings for researchers and office employees on compliance with laws, ordinances and guidelines.

We consider development design with the goal of creating innovative drugs and medical devices, as well as ensuring that research projects based on promising results proceed more rapidly and in greater depth.

List of papers published in 2020

Journal

Kashiwa

1. Naito Y, Aburatani H, Amano T, Baba E, Furukawa T, Hayashida T, Hiyama E, Ikeda S, Kanai M, Kato M, Kinoshita I, Kiyota N, Kohno T, Kohsaka S, Komine K, Matsumura I, Miura Y, Nakamura Y, Natsume A, Nishio K, Oda K, Oda N, Okita N, Oseto K, Sunami K, Takahashi H, Takeda M, Tashiro S, Toyooka S, Ueno H, Yachida S, Yoshino T, Tsuchihara K. Clinical practice guidance for next-generation sequencing in cancer diagnosis and treatment (edition 2.1). Int J Clin Oncol, 26:233-283, 2021

2. Kashima Y, Togashi Y, Fukuoka S, Kamada T, Irie T, Suzuki A, Nakamura Y, Shitara K, Minamide T, Yoshida T, Taoka N, Kawase T, Wada T, Inaki K, Chihara M, Ebisuno Y, Tsukamoto S, Fujii R, Ohashi A, Suzuki Y, Tsuchihara K, Nishikawa H, Doi T. Potentiality of multiple modalities for single-cell analyses to evaluate the tumor microenvironment in clinical specimens. Sci Rep, 11:341, 2021

3. Doi T, Fujiwara Y, Shitara K, Shimizu T, Yonemori K, Matsubara N, Ohno I, Kogawa T, Naito Y, Leopold L, Munteanu M, Yatsuzuka N, Han SR, Samkari A, Yamamoto N. The safety and tolerability of epacadostat alone and in combination with pembrolizumab in patients with advanced solid tumors: results from a first-in-Japanese phase I study (KEYNOTE-434). Invest New Drugs, 39:152-162, 2021

4. Koganemaru S, Shitara K. Antibody-drug conjugates to treat gastric cancer. Expert Opin Biol Ther, 21:923-930, 2021

5. Hatake K, Chou T, Doi T, Terui Y, Kato H, Hirose T, Seo S, Pourdehnad M, Ogaki Y, Fujimoto H, Hagner PR, Yamamoto K. Phase I, multicenter, dose-escalation study of avadomide in adult Japanese patients with advanced malignancies. Cancer Sci, 112:331-338, 2021

6. Kawazoe A, Shitara K, Boku N, Yoshikawa T, Terashima M. Current status of immunotherapy for advanced gastric cancer. Jpn J Clin Oncol, 51:20-27, 2021

7. Kotani D, Shitara K. Trastuzumab deruxtecan for the treatment of patients with HER2-positive gastric cancer. Ther Adv Med Oncol, 13:1758835920986518, 2021

8. Kawazoe A, Takahari D, Keisho C, Nakamura Y, Ikeno T, Wakabayashi M, Nomura S, Tamura H, Fukutani M, Hirano N, Saito Y, Kambe M, Sato A, Shitara K. A multicenter phase II study of TAS-114 in combination with S-1 in patients with pretreated advanced gastric cancer (EPOC1604). Gastric Cancer, 24:190-196, 2021

9. Kawazoe A, Ando T, Hosaka H, Fujita J, Koeda K, Nishikawa K, Amagai K, Fujitani K, Ogata K, Watanabe K, Yamamoto Y, Shitara K. Safety and activity of trifluridine/tipiracil and ramucirumab in previously treated advanced gastric cancer: an open-label, single-arm, phase 2 trial. Lancet Gastroenterol Hepatol, 6:209-217, 2021

10. Sunami K, Naito Y, Aimono E, Amano T, Ennishi D, Kage H, Kanai M, Komine K, Koyama T, Maeda T, Morita S, Sakai D, Kohsaka S, Tsuchihara K, Yoshino T. The initial assessment of expert panel performance in core hospitals for cancer genomic medicine in Japan. Int J Clin Oncol, 26:443-449, 2021

11. Powderly J, Spira A, Kondo S, Doi T, Luke JJ, Rasco D, Gao B, Tanner M, Cassier PA, Gazzah A, Italiano A, Tosi D, Afar DE, Parikh A, Engelhardt B, Englert S, Lambert SL, Kasichayanula S, Mensing S, Menon R, Vosganian G, Tolcher A. Model Informed Dosing Regimen and Phase I Results of the Anti-PD-1 Antibody Budigalimab (ABBV-181). Clin Transl Sci, 14:277-287, 2021

12. Minami H, Doi T, Toyoda M, Imamura Y, Kiyota N, Mitsuma A, Shimokata T, Naito Y, Matsubara N, Tajima T, Tokushige K, Ishihara K, Cameron S, Ando Y. Phase I study of the antiprogrammed cell death-1 Ab spartalizumab (PDR001) in Japanese patients with advanced malignancies. Cancer Sci, 112:725-733, 2021

13. Fujitani K, Shitara K, Takashima A, Koeda K, Hara H, Nakayama N, Hironaka S, Nishikawa K, Kimura Y, Amagai K, Hosaka H, Komatsu Y, Shimada K, Kawabata R, Ohdan H, Kodera Y, Nakamura M, Nakajima TE, Miyata Y, Moriwaki T, Kusumoto T, Nishikawa K, Ogata K, Shimura M, Morita S, Koizumi W. Effect of early tumor response on the health-related quality of life among patients on second-line chemotherapy for advanced gastric cancer in the ABSOLUTE trial. Gastric Cancer, 24:467-476, 2021

14. Fujitani K, Shitara K, Takashima A, Koeda K, Hara H, Nakayama N, Hironaka S, Nishikawa K, Kimura Y, Amagai K, Hosaka H, Komatsu Y, Shimada K, Kawabata R, Ohdan H, Kodera Y, Nakamura M, Nakajima TE, Miyata Y, Moriwaki T, Kusumoto T, Nishikawa K, Ogata K, Shimura M, Morita S, Koizumi W. Correction to: Effect of early tumor response on the health-related quality of life among patients on second-line chemotherapy for advanced gastric cancer in the ABSOLUTE trial. Gastric Cancer, 24:477-478, 2021

15. Yoh K, Seto T, Satouchi M, Nishio M, Yamamoto N, Murakami H, Nogami N, Nosaki K, Kohno T, Tsuta K, Nomura S, Ikeno T, Wakabayashi M, Sato A, Matsumoto S, Goto K. Final survival results for the LURET phase II study of vandetanib in previously treated patients with RET-rearranged advanced non-small cell lung cancer. Lung Cancer, 155:40-45, 2021

16. Perets R, Bar J, Rasco DW, Ahn MJ, Yoh K, Kim DW, Nagrial A, Satouchi M, Lee DH, Spigel DR, Kotasek D, Gutierrez M, Niu J, Siddiqi S, Li X, Cyrus J, Chackerian A, Chain A, Altura RA, Cho BC. Safety and efficacy of quavonlimab, a novel anti-CTLA-4 antibody (MK-1308), in combination with pembrolizumab in first-line advanced non-small-cell lung cancer. Ann Oncol, 32:395-403, 2021

17. Tanimoto A, Matsumoto S, Takeuchi S, Arai S, Fukuda K, Nishiyama A, Yoh K, Ikeda T, Furuya N, Nishino K, Ohe Y, Goto K, Yano S. Proteasome Inhibition Overcomes ALK-TKI Resistance in ALK-Rearranged/TP53-Mutant NSCLC via Noxa Expression. Clin Cancer Res, 27:1410-1420, 2021

18. Shibata Y, Matsumoto S, Yoh K, Goto K. Evaluation of variant frequency in SARS-CoV-2 infection-related genes utilizing lung cancer genomic database. Lung Cancer, 152:199-201, 2021

19. Takeuchi S, Yanagitani N, Seto T, Hattori Y, Ohashi K, Morise M, Matsumoto S, Yoh K, Goto K, Nishio M, Takahara S, Kawakami T, Imai Y, Yoshimura K, Tanimoto A, Nishiyama A, Murayama T, Yano S. Phase 1/2 study of alectinib in RET-rearranged previously-treated non-small cell lung cancer (ALL-RET). Transl Lung Cancer Res, 10:314-325, 2021

20. Hasegawa Y, Matsubara N, Kogawa T, Naito Y, Harano K, Hosono A, Onishi T, Hojo T, Shimokawa M, Mukohara T. Neo-Bioscore in Guiding Post-surgical Therapy in Patients With Triple-negative Breast Cancer Who Received Neoadjuvant Chemotherapy. In Vivo, 35:1041-1049, 2021

21. Tsurutani J, Hara F, Kitada M, Takahashi M, Kikawa Y, Kato H, Sakata E, Naito Y, Hasegawa Y, Saito T, Iwasa T, Taira N, Takashima T, Kashiwabara K, Aihara T, Mukai H. Randomized phase II study to determine the optimal dose of 3-week cycle nab-paclitaxel in patients with metastatic breast cancer. Breast, 55:63-68, 2021

22. Yamamoto M, Yoshida M, Furuse J, Sano K, Ohtsuka M, Yamashita S, Beppu T, Iwashita Y, Wada K, Nakajima TE, Sakamoto K, Hayano K, Mori Y, Asai K, Matsuyama R, Hirashita T, Hibi T, Sakai N, Tabata T, Kawakami H, Takeda H, Mizukami T, Ozaka M, Ueno M, Naito Y, Okano N, Ueno T, Hijioka S, Shikata S, Ukai T, Strasberg S, Sarr MG, Jagannath P, Hwang TL, Han HS, Yoon YS, Wang HJ, Luo SC, Adam R, Gimenez M, Scatton O, Oh DY, Takada T. Clinical practice guidelines for the management of liver metastases from extrahepatic primary cancers 2021. J Hepatobiliary Pancreat Sci, 28:1-25, 2021

23. Takahashi H, Ikeda M, Shiba S, Imaoka H, Todaka A, Shioji K, Yane K, Kojima Y, Kobayashi S, Asagi A, Ozaka M, Takada R, Nagashio Y, Horiguchi S, Kasuga A, Suzuki E, Terashima T, Ueno M, Morizane C, Furuse J. Multicenter Retrospective Analysis of Chemotherapy for Advanced Pancreatic Acinar Cell Carcinoma: Potential Efficacy of Platinum- and Irinotecan-Containing Regimens. Pancreas, 50:77-82, 2021

24. Umemoto K, Takahashi H, Morizane C, Yamada I, Shimizu S, Shioji K, Yoshida Y, Motoya M, Mizuno N, Kojima Y, Terashima T, Uesugi K, Ueno M, Furuse J, Akimoto T, Ikeda M. FOLFIRINOX in advanced pancreatic cancer patients with the double-variant type of UGT1A1 *28 and *6 polymorphism: a multicenter, retrospective study. Cancer Chemother Pharmacol, 87:397-404, 2021

25. Kadota T, Ikematsu H, Sasaki T, Saito Y, Ito M, Mizutani T, Ogawa G, Shitara K, Ito Y, Kushima R, Kanemitsu Y, Muto M. Protocol for a single-arm confirmatory trial of adjuvant chemoradiation for patients with high-risk rectal submucosal invasive cancer after local resection: Japan Clinical Oncology Group Study JCOG1612 (RESCUE study). BMJ Open, 10:e034947, 2020

26. Nakajima TE, Yamaguchi K, Boku N, Hyodo I, Mizusawa J, Hara H, Nishina T, Sakamoto T, Shitara K, Shinozaki K, Katayama H, Nakamura S, Muro K, Terashima M. Randomized phase II/III study of 5-fluorouracil/l-leucovorin versus 5-fluorouracil/l-leucovorin plus paclitaxel administered to patients with severe peritoneal metastases of gastric cancer (JCOG1108/WJOG7312G). Gastric Cancer, 23:677-688, 2020

27. Kojima T, Shah MA, Muro K, Francois E, Adenis A, Hsu CH, Doi T, Moriwaki T, Kim SB, Lee SH, Bennouna J, Kato K, Shen L, Enzinger P, Qin SK, Ferreira P, Chen J, Girotto G, de la Fouchardiere C, Senellart H, Al-Rajabi R, Lordick F, Wang R, Suryawanshi S, Bhagia P, Kang SP, Metges JP. Randomized Phase III KEYNOTE-181 Study of Pembrolizumab Versus Chemotherapy in Advanced Esophageal Cancer. J Clin Oncol, 38:4138-4148, 2020

28. Kawazoe A, Kuboki Y, Shinozaki E, Hara H, Nishina T, Komatsu Y, Yuki S, Wakabayashi M, Nomura S, Sato A, Kuwata T, Kawazu M, Mano H, Togashi Y, Nishikawa H, Yoshino T. Multicenter Phase I/II Trial of Napabucasin and Pembrolizumab in Patients with Metastatic Colorectal Cancer (EPOC1503/SCOOP Trial). Clin Cancer Res, 26:5887-5894, 2020

29. Kumagai S, Togashi Y, Sakai C, Kawazoe A, Kawazu M, Ueno T, Sato E, Kuwata T, Kinoshita T, Yamamoto M, Nomura S, Tsukamoto T, Mano H, Shitara K, Nishikawa H. An Oncogenic Alteration Creates a Microenvironment that Promotes Tumor Progression by Conferring a Metabolic Advantage to Regulatory T Cells. Immunity, 53:187-203.e8, 2020

30. Kumagai S, Togashi Y, Kamada T, Sugiyama E, Nishinakamura H, Takeuchi Y, Vitaly K, Itahashi K, Maeda Y, Matsui S, Shibahara T, Yamashita Y, Irie T, Tsuge A, Fukuoka S, Kawazoe A, Udagawa H, Kirita K, Aokage K, Ishii G, Kuwata T, Nakama K, Kawazu M, Ueno T, Yamazaki N, Goto K, Tsuboi M, Mano H, Doi T, Shitara K, Nishikawa H. The PD-1 expression balance between effector and regulatory T cells predicts the clinical efficacy of PD-1 blockade therapies. Nat Immunol, 21:1346-1358, 2020

31. Tsumura R, Koga Y, Hamada A, Kuwata T, Sasaki H, Doi T, Aikawa K, Ohashi A, Katano I, Ikarashi Y, Ito M, Ochiai A. Report of the use of patient-derived xenograft models in the development of anticancer drugs in Japan. Cancer Sci, 111:3386-3394, 2020

32. Fukuoka S, Hara H, Takahashi N, Kojima T, Kawazoe A, Asayama M, Yoshii T, Kotani D, Tamura H, Mikamoto Y, Hirano N, Wakabayashi M, Nomura S, Sato A, Kuwata T, Togashi Y, Nishikawa H, Shitara K. Regorafenib Plus Nivolumab in Patients With Advanced Gastric or Colorectal Cancer: An Open-Label, Dose-Escalation, and Dose-Expansion Phase Ib Trial (REGONIVO, EPOC1603). J Clin Oncol, 38:2053-2061, 2020

33. Kawazoe A, Yamaguchi K, Yasui H, Negoro Y, Azuma M, Amagai K, Hara H, Baba H, Tsuda M, Hosaka H, Kawakami H, Oshima T, Omuro Y, Machida N, Esaki T, Yoshida K, Nishina T, Komatsu Y, Han SR, Shiratori S, Shitara K. Safety and efficacy of pembrolizumab in combination with S-1 plus oxaliplatin as a first-line treatment in patients with advanced gastric/gastroesophageal junction cancer: Cohort 1 data from the KEYNOTE-659 phase IIb study. Eur J Cancer, 129:97-106, 2020

34. Doi T, Fujiwara Y, Koyama T, Ikeda M, Helwig C, Watanabe M, Vugmeyster Y, Kudo M. Phase I Study of the Bifunctional Fusion Protein Bintrafusp Alfa in Asian Patients with Advanced Solid Tumors, Including a Hepatocellular Carcinoma Safety-Assessment Cohort. Oncologist, 25:e1292-e1302, 2020

35. Kawazoe A, Kuboki Y, Bando H, Fukuoka S, Kojima T, Naito Y, Iino S, Yodo Y, Doi T, Shitara K, Yoshino T. Phase 1 study of napabucasin, a cancer stemness inhibitor, in patients with advanced solid tumors. Cancer Chemother Pharmacol, 85:855-862, 2020

36. Kawazoe A, Fukuoka S, Nakamura Y, Kuboki Y, Wakabayashi M, Nomura S, Mikamoto Y, Shima H, Fujishiro N, Higuchi T, Sato A, Kuwata T, Shitara K. Lenvatinib plus pembrolizumab in patients with advanced gastric cancer in the first-line or second-line setting (EPOC1706): an open-label, single-arm, phase 2 trial. Lancet Oncol, 21:1057-1065, 2020

37. Shitara K, Bang YJ, Iwasa S, Sugimoto N, Ryu MH, Sakai D, Chung HC, Kawakami H, Yabusaki H, Lee J, Saito K, Kawaguchi Y, Kamio T, Kojima A, Sugihara M, Yamaguchi K. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer. N Engl J Med, 382:2419-2430, 2020

38. Sasaki A, Harano K, Kogawa T, Matsubara N, Naito Y, Hosono A, Mukai H, Yoshino T, Mukohara T. Intestinal Perforation due to Neutropenic Enterocolitis in a Patient Treated with Bevacizumab for Ovarian Cancer. Case Rep Oncol Med, 2020:7231358, 2020

39. Kubota Y, Kawazoe A, Sasaki A, Mishima S, Sawada K, Nakamura Y, Kotani D, Kuboki Y, Taniguchi H, Kojima T, Doi T, Yoshino T, Ishii G, Kuwata T, Shitara K. The Impact of Molecular Subtype on Efficacy of Chemotherapy and Checkpoint Inhibition in Advanced Gastric Cancer. Clin Cancer Res, 26:3784-3790, 2020

40. Ishii T, Kawazoe A, Sasaki A, Mishima S, Kentaro S, Nakamura Y, Kotani D, Kuboki Y, Taniguchi H, Kojima T, Doi T, Yoshino T, Kuwata T, Ishii G, Shitara K. Clinical and molecular factors for selection of nivolumab or irinotecan as third-line treatment for advanced gastric cancer. Ther Adv Med Oncol, 12:1758835920942377, 2020

41. Sasaki A, Kawazoe A, Eto T, Okunaka M, Mishima S, Sawada K, Nakamura Y, Kotani D, Kuboki Y, Taniguchi H, Kojima T, Doi T, Yoshino T, Akimoto T, Shitara K. Improved efficacy of taxanes and ramucirumab combination chemotherapy after exposure to anti-PD-1 therapy in advanced gastric cancer. ESMO Open, 4:2020

42. Doi T, Matsubara N, Kawai A, Naka N, Takahashi S, Uemura H, Yamamoto N. Phase I study of TAS-115, a novel oral multi-kinase inhibitor, in patients with advanced solid tumors. Invest New Drugs, 38:1175-1185, 2020

43. Shitara K, Yamazaki K, Tsushima T, Naito T, Matsubara N, Watanabe M, Sarholz B, Johne A, Doi T. Phase I trial of the MET inhibitor tepotinib in Japanese patients with solid tumors. Jpn J Clin Oncol, 50:859-866, 2020

44. Sasaki A, Nakamura Y, Togashi Y, Kuno H, Hojo H, Kageyama S, Nakamura N, Takashima K, Kadota T, Yoda Y, Mishima S, Sawada K, Kotani D, Kawazoe A, Kuboki Y, Taniguchi H, Kojima T, Doi T, Yoshino T, Yano T, Kobayashi T, Akimoto T, Nishikawa H, Shitara K. Enhanced tumor response to radiotherapy after PD-1 blockade in metastatic gastric cancer. Gastric Cancer, 23:893-903, 2020

45. Mishima S, Kawazoe A, Shitara K. Safety of pembrolizumab in recurrent or advanced gastric cancer expressing PD-L1 refractory to platinum and fluoropyrimidine. Expert Opin Drug Saf, 19:1063-1068, 2020

46. Doi T, Boku N, Onozawa Y, Takahashi K, Kawaguchi O, Ohtsu A. Phase I dose-escalation study of the safety, tolerability, and pharmacokinetics of aflibercept in combination with S-1 in Japanese patients with advanced solid malignancies. Invest New Drugs, 38:1390-1399, 2020

47. Shitara K, Van Cutsem E, Bang YJ, Fuchs C, Wyrwicz L, Lee KW, Kudaba I, Garrido M, Chung HC, Lee J, Castro HR, Mansoor W, Braghiroli MI, Karaseva N, Caglevic C, Villanueva L, Goekkurt E, Satake H, Enzinger P, Alsina M, Benson A, Chao J, Ko AH, Wainberg ZA, Kher U, Shah S, Kang SP, Tabernero J. Efficacy and Safety of Pembrolizumab or Pembrolizumab Plus Chemotherapy vs Chemotherapy Alone for Patients With First-line, Advanced Gastric Cancer: The KEYNOTE-062 Phase 3 Randomized Clinical Trial. JAMA Oncol, 6:1571-1580, 2020

48. Nakamura Y, Sasaki A, Yukami H, Jogo T, Kawazoe A, Kuboki Y, Taniguchi H, Yamashita R, Kuwata T, Ozawa M, Nakamura M, Yoshino T, Shitara K. Emergence of Concurrent Multiple EGFR Mutations and MET Amplification in a Patient With EGFR-Amplified Advanced Gastric Cancer Treated With Cetuximab. JCO Precis Oncol, 4:2020

49. Okunaka M, Kotani D, Demachi K, Kawazoe A, Yoshino T, Kawasaki T, Shitara K. Retrospective cohort study of nanoparticle albumin-bound paclitaxel plus ramucirumab versus paclitaxel plus ramucirumab as second-line treatment in patients with advanced gastric cancer. BMC Cancer, 20:1111, 2020

50. Kondo S, Tajimi M, Funai T, Inoue K, Asou H, Ranka VK, Wacheck V, Doi T. Phase 1 dose-escalation study of a novel oral PI3K/mTOR dual inhibitor, LY3023414, in patients with cancer. Invest New Drugs, 38:1836-1845, 2020

51. Kang YK, Bang YJ, Kondo S, Chung HC, Muro K, Dussault I, Helwig C, Osada M, Doi T. Safety and Tolerability of Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGFβ and PD-L1, in Asian Patients with Pretreated Recurrent or Refractory Gastric Cancer. Clin Cancer Res, 26:3202-3210, 2020

52. Piha-Paul SA, Oh DY, Ueno M, Malka D, Chung HC, Nagrial A, Kelley RK, Ros W, Italiano A, Nakagawa K, Rugo HS, de Braud F, Varga AI, Hansen A, Wang H, Krishnan S, Norwood KG, Doi T. Efficacy and safety of pembrolizumab for the treatment of advanced biliary cancer: Results from the KEYNOTE-158 and KEYNOTE-028 studies. Int J Cancer, 147:2190-2198, 2020

53. Kondo S, Tajimi M, Funai T, Inoue K, Asou H, Ranka VK, Wacheck V, Doi T. Correction to: Phase 1 dose-escalation study of a novel oral PI3K/mTOR dual inhibitor, LY3023414, in patients with cancer. Invest New Drugs, 38:1846, 2020

54. Gelderblom H, Jones RL, George S, Valverde Morales C, Benson C, Jean-Yves Blay, Renouf DJ, Doi T, Le Cesne A, Leahy M, Hertle S, Aimone P, Brandt U, Sch?ffski P. Imatinib in combination with phosphoinositol kinase inhibitor buparlisib in patients with gastrointestinal stromal tumour who failed prior therapy with imatinib and sunitinib: a Phase 1b, multicentre study. Br J Cancer, 122:1158-1165, 2020

55. Tsurutani J, Iwata H, Krop I, J?nne PA, Doi T, Takahashi S, Park H, Redfern C, Tamura K, Wise-Draper TM, Saito K, Sugihara M, Singh J, Jikoh T, Gallant G, Li BT. Targeting HER2 with Trastuzumab Deruxtecan: A Dose-Expansion, Phase I Study in Multiple Advanced Solid Tumors. Cancer Discov, 10:688-701, 2020

56. Strosberg J, Mizuno N, Doi T, Grande E, Delord JP, Shapira-Frommer R, Bergsland E, Shah M, Fakih M, Takahashi S, Piha-Paul SA, O'Neil B, Thomas S, Lolkema MP, Chen M, Ibrahim N, Norwood K, Hadoux J. Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Neuroendocrine Tumors: Results From the Phase II KEYNOTE-158 Study. Clin Cancer Res, 26:2124-2130, 2020

57. Modi S, Park H, Murthy RK, Iwata H, Tamura K, Tsurutani J, Moreno-Aspitia A, Doi T, Sagara Y, Redfern C, Krop IE, Lee C, Fujisaki Y, Sugihara M, Zhang L, Shahidi J, Takahashi S. Antitumor Activity and Safety of Trastuzumab Deruxtecan in Patients With HER2-Low-Expressing Advanced Breast Cancer: Results From a Phase Ib Study. J Clin Oncol, 38:1887-1896, 2020

58. Modi S, Park H, Murthy RK, Iwata H, Tamura K, Tsurutani J, Moreno-Aspitia A, Doi T, Sagara Y, Redfern C, Krop IE, Lee C, Fujisaki Y, Sugihara M, Zhang L, Shahidi J, Takahashi S. Reply to T.J.A. Dekker. J Clin Oncol, 38:3351-3352, 2020

59. Nishida T, Doi T. A new approach to refractory gastrointestinal stromal tumours with diverse acquired mutations. Lancet Oncol, 21:864-865, 2020

60. Tabernero J, Alsina M, Shitara K, Doi T, Dvorkin M, Mansoor W, Arkenau HT, Prokharau A, Ghidini M, Faustino C, Gorbunova V, Zhavrid E, Nishikawa K, Ando T, Yal??n ?, Van Cutsem E, Sabater J, Skanji D, Leger C, Amellal N, Ilson DH. Health-related quality of life associated with trifluridine/tipiracil in heavily pretreated metastatic gastric cancer: results from TAGS. Gastric Cancer, 23:689-698, 2020

61. Mehnert JM, Bergsland E, O'Neil BH, Santoro A, Schellens JHM, Cohen RB, Doi T, Ott PA, Pishvaian MJ, Puzanov I, Aung KL, Hsu C, Le Tourneau C, Hollebecque A, ?lez E, Tamura K, Gould M, Yang P, Stein K, Piha-Paul SA. Pembrolizumab for the treatment of programmed death-ligand 1-positive advanced carcinoid or pancreatic neuroendocrine tumors: Results from the KEYNOTE-028 study. Cancer, 126:3021-3030, 2020

62. Hong DS, Fakih MG, Strickler JH, Desai J, Durm GA, Shapiro GI, Falchook GS, Price TJ, Sacher A, Denlinger CS, Bang YJ, Dy GK, Krauss JC, Kuboki Y, Kuo JC, Coveler AL, Park K, Kim TW, Barlesi F, Munster PN, Ramalingam SS, Burns TF, Meric-Bernstam F, Henary H, Ngang J, Ngarmchamnanrith G, Kim J, Houk BE, Canon J, Lipford JR, Friberg G, Lito P, Govindan R, Li BT. KRAS(G12C) Inhibition with Sotorasib in Advanced Solid Tumors. N Engl J Med, 383:1207-1217, 2020

63. Izawa N, Shitara K, Yonesaka K, Yamanaka T, Yoshino T, Sunakawa Y, Masuishi T, Denda T, Yamazaki K, Moriwaki T, Okuda H, Kondoh C, Nishina T, Makiyama A, Baba H, Yamaguchi H, Nakamura M, Hyodo I, Muro K, Nakajima TE. Early Tumor Shrinkage and Depth of Response in the Second-Line Treatment for KRAS exon2 Wild-Type Metastatic Colorectal Cancer: An Exploratory Analysis of the Randomized Phase 2 Trial Comparing Panitumumab and Bevacizumab in Combination with FOLFIRI (WJOG6210G). Target Oncol, 15:623-633, 2020

64. Kaito A, Kuwata T, Tokunaga M, Shitara K, Sato R, Akimoto T, Kinoshita T. Erratum: Author's Affiliation Correction. Type II human epidermal growth factor receptor heterogeneity is a poor prognosticator for type II human epidermal growth factor receptor positive gastric cancer (World J Clin Cases 2019; Aug 6; 7 (15): 1964-1977). World J Clin Cases, 8:5494-5495, 2020

65. Yoh K, Atagi S, Reck M, Garon EB, Ponce Aix S, Moro-Sibilot D, Winfree KB, Frimodt-Moller B, Zimmermann A, Visseren-Grul C, Nakagawa K. Patient-reported outcomes in RELAY, a phase 3 trial of ramucirumab plus erlotinib versus placebo plus erlotinib in untreated EGFR-mutated metastatic non-small-cell lung cancer. Curr Med Res Opin, 36:1667-1675, 2020

66. Yoh K, Takamochi K, Shukuya T, Hishida T, Tsuboi M, Sakurai H, Goto Y, Yoshida K, Ohde Y, Okumura S, Ohashi Y, Kunitoh H. Corrigendum to: Pattern of care in adjuvant therapy for resected Stage I non-small cell lung cancer: real-world data from Japan. Jpn J Clin Oncol, 50:481, 2020

67. Nishio M, Seto T, Reck M, Garon EB, Chiu CH, Yoh K, Imamura F, Park K, Shih JY, Visseren-Grul C, Frimodt-Moller B, Zimmermann A, Homma G, Enatsu S, Nakagawa K. Ramucirumab or placebo plus erlotinib in EGFR-mutated, metastatic non-small-cell lung cancer: East Asian subset of RELAY. Cancer Sci, 111:4510-4525, 2020

68. Yamamoto N, Hayashi H, Planchard D, Morán T, Gregorc V, Dowell J, Sakai H, Yoh K, Nishio M, Cortot AB, Benhadji KA, Soni N, Huang J, Makris L, Cedres S. A randomized, phase 2 study of deoxyuridine triphosphatase inhibitor, TAS-114, in combination with S-1 versus S-1 alone in patients with advanced non-small-cell lung cancer. Invest New Drugs, 38:1588-1597, 2020

69. Nakamura M, Kageyama SI, Udagawa H, Zenke Y, Yoh K, Niho S, Hojo H, Motegi A, Kirita K, Matsumoto S, Goto K, Akimoto T. Differences in failure patterns according to the EGFR mutation status after proton beam therapy for early stage non-small cell lung cancer. Radiother Oncol, 149:14-17, 2020

70. Udagawa H, Kirita K, Naito T, Nomura S, Ishibashi M, Matsuzawa R, Hisakane K, Usui Y, Matsumoto S, Yoh K, Niho S, Ishii G, Goto K. Feasibility and utility of transbronchial cryobiopsy in precision medicine for lung cancer: Prospective single-arm study. Cancer Sci, 111:2488-2498, 2020

71. Demetri GD, Antonescu CR, Bjerkehagen B, Bovée JVMG, Boye K, Chacón M, Dei Tos AP, Desai J, Fletcher JA, Gelderblom H, George S, Gronchi A, Haas RL, Hindi N, Hohenberger P, Joensuu H, Jones RL, Judson I, Kang YK, Kawai A, Lazar AJ, Le Cesne A, Maestro R, Maki RG, Martín J, Patel S, Penault-Llorca F, Premanand Raut C, Rutkowski P, Safwat A, Sbaraglia M, Schaefer IM, Shen L, Serrano C, Schöffski P, Stacchiotti S, Sundby Hall K, Tap WD, Thomas DM, Trent J, Valverde C, van der Graaf WTA, von Mehren M, Wagner A, Wardelmann E, Naito Y, Zalcberg J, Blay JY. Diagnosis and management of tropomyosin receptor kinase (TRK) fusion sarcomas: expert recommendations from the World Sarcoma Network. Ann Oncol, 31:1506-1517, 2020

72. Shingaki S, Kogawa T, Shimokawa M, Harano K, Naito Y, Kusuhara S, Fujimoto Y, Matsubara N, Hosono A, Mukai H, Onishi T, Hojo T, Mukohara T. Use of eribulin as an earlier-line chemotherapy for patients with HER2-negative metastatic breast cancer. J Cancer, 11:4099-4105, 2020

73. Matsumoto K, Takahashi M, Sato K, Osaki A, Takano T, Naito Y, Matsuura K, Aogi K, Fujiwara K, Tamura K, Baba M, Tokunaga S, Hirano G, Imoto S, Miyazaki C, Yanagihara K, Imamura CK, Chiba Y, Saeki T. A double-blind, randomized, multicenter phase 3 study of palonosetron vs granisetron combined with dexamethasone and fosaprepitant to prevent chemotherapy-induced nausea and vomiting in patients with breast cancer receiving anthracycline and cyclophosphamide. Cancer Med, 9:3319-3327, 2020

74. Shimoi T, Nagai SE, Yoshinami T, Takahashi M, Arioka H, Ishihara M, Kikawa Y, Koizumi K, Kondo N, Sagara Y, Takada M, Takano T, Tsurutani J, Naito Y, Nakamura R, Hattori M, Hara F, Hayashi N, Mizuno T, Miyashita M, Yamashita N, Yamanaka T, Saji S, Iwata H, Toyama T. The Japanese Breast Cancer Society Clinical Practice Guidelines for systemic treatment of breast cancer, 2018 edition. Breast Cancer, 27:322-331, 2020

75. Tap WD, Wagner AJ, Schöffski P, Martin-Broto J, Krarup-Hansen A, Ganjoo KN, Yen CC, Abdul Razak AR, Spira A, Kawai A, Le Cesne A, Van Tine BA, Naito Y, Park SH, Fedenko A, Pápai Z, Soldatenkova V, Shahir A, Mo G, Wright J, Jones RL. Effect of Doxorubicin Plus Olaratumab vs Doxorubicin Plus Placebo on Survival in Patients With Advanced Soft Tissue Sarcomas: The ANNOUNCE Randomized Clinical Trial. JAMA, 323:1266-1276, 2020

76. Inoue M, Naito Y, Kogawa T, Kusuhara S, Fukasawa Y, Fukasawa Y, Harano K Matsubara N, Hosono A, Mukohara T. Safety and Efficacy of Palbociclib in Male Metastatic Breast Cancer: A Report of Two Cases. Ann Case Report, 14:416, 2020

77. Yoshino T, Pentheroudakis G, Mishima S, Overman MJ, Yeh KH, Baba E, Naito Y, Calvo F, Saxena A, Chen LT, Takeda M, Cervantes A, Taniguchi H, Yoshida K, Kodera Y, Kitagawa Y, Tabernero J, Burris H, Douillard JY. JSCO-ESMO-ASCO-JSMO-TOS: international expert consensus recommendations for tumour-agnostic treatments in patients with solid tumours with microsatellite instability or NTRK fusions. Ann Oncol, 31:861-872, 2020

78. Watanabe K, Mitsunaga S, Kojima M, Suzuki H, Irisawa A, Takahashi H, Sasaki M, Hashimoto Y, Imaoka H, Ohno I, Ikeda M, Akimoto T, Ochiai A. The "histological replacement growth pattern" represents aggressive invasive behavior in liver metastasis from pancreatic cancer. Cancer Med, 9:3130-3141, 2020

79. Kan M, Imaoka H, Watanabe K, Sasaki M, Takahashi H, Hashimoto Y, Ohno I, Mitsunaga S, Umemoto K, Kimura G, Suzuki Y, Eguchi H, Otsuru T, Goda K, Ikeda M. Chemotherapy-induced neutropenia as a prognostic factor in patients with pancreatic cancer treated with gemcitabine plus nab-paclitaxel: a retrospective cohort study. Cancer Chemother Pharmacol, 86:203-210, 2020

80. Okano N, Morizane C, Nomura S, Takahashi H, Tsumura H, Satake H, Mizuno N, Tsuji K, Shioji K, Asagi A, Yasui K, Kitagawa S, Kashiwada T, Ishiguro A, Kanai M, Ueno M, Ogura T, Shimizu S, Tobimatsu K, Motoya M, Nakashima K, Ikeda M, Okusaka T, Furuse J. Phase II clinical trial of gemcitabine plus oxaliplatin in patients with metastatic pancreatic adenocarcinoma with a family history of pancreatic/breast/ovarian/prostate cancer or personal history of breast/ovarian/prostate cancer (FABRIC study). Int J Clin Oncol, 25:1835-1843, 2020

Tsukiji

1. Arakawa A, Ichikawa H, Kubo T, Motoi N, Kumamoto T, Nakajima M, Yonemori K, Noguchi E, Sunami K, Shiraishi K, Kakishima H, Yoshida H, Hishiki T, Kawakubo N, Kuroda T, Kiyokawa T, Yamada K, Yanaihara N, Takahashi K, Okamoto A, Hirabayashi S, Hasegawa D, Manabe A, Ono K, Matsuoka M, Arai Y, Togashi Y, Shibata T, Nishikawa H, Aoki K, Yamamoto N, Kohno T, Ogawa C. Vaginal Transmission of Cancer from Mothers with Cervical Cancer to Infants. N Engl J Med, 384:42-50, 2021

2. Shirasawa M, Yoshida T, Takayanagi D, Shiraishi K, Yagishita S, Sekine K, Kanda S, Matsumoto Y, Masuda K, Shinno Y, Okuma Y, Goto Y, Horinouchi H, Hamada A, Kohno T, Yamamoto N, Watanabe SI, Ohe Y, Motoi N. Activity and Immune Correlates of Programmed Death-1 Blockade Therapy in Patients With Advanced Large Cell Neuroendocrine Carcinoma. Clin Lung Cancer, 2021

4. Sunami K, Naito Y, Aimono E, Amano T, Ennishi D, Kage H, Kanai M, Komine K, Koyama T, Maeda T, Morita S, Sakai D, Kohsaka S, Tsuchihara K, Yoshino T. The initial assessment of expert panel performance in core hospitals for cancer genomic medicine in Japan. Int J Clin Oncol, 26:443-449, 2021

5. Powderly J, Spira A, Kondo S, Doi T, Luke JJ, Rasco D, Gao B, Tanner M, Cassier PA, Gazzah A, Italiano A, Tosi D, Afar DE, Parikh A, Engelhardt B, Englert S, Lambert SL, Kasichayanula S, Mensing S, Menon R, Vosganian G, Tolcher A. Model Informed Dosing Regimen and Phase I Results of the Anti-PD-1 Antibody Budigalimab (ABBV-181). Clin Transl Sci, 14:277-287, 2021

6. Yoh K, Seto T, Satouchi M, Nishio M, Yamamoto N, Murakami H, Nogami N, Nosaki K, Kohno T, Tsuta K, Nomura S, Ikeno T, Wakabayashi M, Sato A, Matsumoto S, Goto K. Final survival results for the LURET phase II study of vandetanib in previously treated patients with RET-rearranged advanced non-small cell lung cancer. Lung Cancer, 155:40-45, 2021

7. Fujiwara Y, Kenmotsu H, Yamamoto N, Shimizu T, Yonemori K, Ocampo C, Parikh A, Okubo S, Fukasawa K, Murakami H. Phase 1 study of telisotuzumab vedotin in Japanese patients with advanced solid tumors. Cancer Med, 10:2350-2358, 2021

8. Fukahori M, Kato K, Taniguchi H, Ohtomo R, Takahashi N, Shoji H, Iwasa S, Honma Y, Takashima A, Hamaguchi T, Yamada Y, Shimada Y, Ito Y, Itami J, Hokamura N, Igaki H, Tachimori Y, Miwa K, Torimura T, Boku N. Relationship between cervical esophageal squamous cell carcinoma and human papilloma virus infection and gene mutations. Mol Clin Oncol, 14:41, 2021

9. Harding JJ, Moreno V, Bang YJ, Hong MH, Patnaik A, Trigo J, Szpurka AM, Yamamoto N, Doi T, Fu S, Calderon B, Velez de Mendizabal N, Calvo E, Yu D, Gandhi L, Liu ZT, Galvao VR, Leow CC, de Miguel MJ. Blocking TIM-3 in Treatment-refractory Advanced Solid Tumors: A Phase Ia/b Study of LY3321367 with or without an Anti-PD-L1 Antibody. Clin Cancer Res, 27:2168-2178, 2021

10. Hellmann MD, Bivi N, Calderon B, Shimizu T, Delafontaine B, Liu ZT, Szpurka AM, Copeland V, Hodi FS, Rottey S, Aftimos P, Piao Y, Gandhi L, Galvao VR, Leow CC, Doi T. Safety and Immunogenicity of LY3415244, a Bispecific Antibody Against TIM-3 and PD-L1, in Patients With Advanced Solid Tumors. Clin Cancer Res, 27:2773-2781, 2021

11. Ikeda M, Okusaka T, Ohno I, Mitsunaga S, Kondo S, Ueno H, Morizane C, Gemmoto K, Suna H, Ushida Y, Furuse J. Phase I studies of peptide vaccine cocktails derived from GPC3, WDRPUH and NEIL3 for advanced hepatocellular carcinoma. Immunotherapy, 13:371-385, 2021

12. Kitadai R, Shimoi T, Sudo K, Noguchi E, Nagata Y, Sawada R, Takashima A, Boku N, Yonemori K. Efficacy of second-line treatment and prognostic factors in patients with advanced malignant peritoneal mesothelioma: a retrospective study. BMC Cancer, 21:294, 2021

13. Kitano S, Shimizu T, Koyama T, Ebata T, Iwasa S, Kondo S, Shimomura A, Fujiwara Y, Yamamoto N, Paccaly A, Li S, Rietschel P, Sims T. Dose exploration results from Phase 1 study of cemiplimab, a human monoclonal programmed death (PD)-1 antibody, in Japanese patients with advanced malignancies. Cancer Chemother Pharmacol, 87:53-64, 2021

14. Kondo S, Shimizu T, Koyama T, Sato J, Iwasa S, Yonemori K, Fujiwara Y, Shimomura A, Kitano S, Tamura K, Yamamoto N. First-in-human study of the cancer peptide vaccine TAS0313 in patients with advanced solid tumors. Cancer Sci, 112:1514-1523, 2021

15. Kudo M, Tsuchiya K, Kato N, Hagihara A, Numata K, Aikata H, Inaba Y, Kondo S, Motomura K, Furuse J, Ikeda M, Morimoto M, Achira M, Kuroda S, Kimura A. Cabozantinib in Japanese patients with advanced hepatocellular carcinoma: a phase 2 multicenter study. J Gastroenterol, 56:181-190, 2021

16. Lala M, Li TR, de Alwis DP, Sinha V, Mayawala K, Li M, Yamamoto N, Siu LL, Chartash E, Aboshady H, Jain L. Corrigendum to "A six-weekly (Q6W) dosing schedule for pembrolizumab in patients with cancer based on evaluation using modelling and simulation" [Eur J Canc 131 (2020) 68-75]. Eur J Cancer, 144:400, 2021

17. Masuda K, Horinouchi H, Tanaka M, Higashiyama R, Shinno Y, Sato J, Matsumoto Y, Okuma Y, Yoshida T, Goto Y, Yamamoto N, Ohe Y. Efficacy of anti-PD-1 antibodies in NSCLC patients with an EGFR mutation and high PD-L1 expression. J Cancer Res Clin Oncol, 147:245-251, 2021

18. Ono A, Murakami H, Seto T, Shimizu T, Watanabe S, Takeshita S, Takeda K, Toyoshima J, Nagase I, Bahceci E, Morishita M, Morita S, Fukuoka M, Nakagawa K. Safety and Antitumor Activity of Repeated ASP3026 Administration in Japanese Patients with Solid Tumors: A Phase I Study. Drugs R D, 21:65-78, 2021

19. Warnink-Kavelaars J, van Oers HA, Haverman L, Buizer AI, Alsem MW, Engelbert RHH, Menke LA. Parenting a child with Marfan syndrome: Distress and everyday problems. Am J Med Genet A, 185:50-59, 2021

20. Shimizu T, Kim DW, Loong HH, Lin CC, Ng MC, Yamamoto N, Ma B, Tan DS. Overcoming the impact of the COVID-19 pandemic on oncology early phase trials and drug development in Asia-Experiences and perspectives of the Asian Oncology Early Phase 1 Consortium. Asia Pac J Clin Oncol, 2021

21. Shirasawa M, Yoshida T, Horinouchi H, Kitano S, Arakawa S, Matsumoto Y, Shinno Y, Okuma Y, Goto Y, Kanda S, Watanabe R, Yamamoto N, Watanabe SI, Ohe Y, Motoi N. Prognostic impact of peripheral blood neutrophil to lymphocyte ratio in advanced-stage pulmonary large cell neuroendocrine carcinoma and its association with the immune-related tumour microenvironment. Br J Cancer, 124:925-932, 2021

22. Takahashi S, Fujiwara Y, Nakano K, Shimizu T, Tomomatsu J, Koyama T, Ogura M, Tachibana M, Kakurai Y, Yamashita T, Sakajiri S, Yamamoto N. Safety and pharmacokinetics of milademetan, a MDM2 inhibitor, in Japanese patients with solid tumors: A phase I study. Cancer Sci, 112:2361-2370, 2021

23. Takeyasu Y, Yoshida T, Shibaki R, Matsumoto Y, Goto Y, Kanda S, Horinouchi H, Yamamoto N, Motoi N, Ohe Y. Differential Efficacy of Pembrolizumab According to Metastatic Sites in Patients With PD-L1 Strongly Positive (TPS≧ 50%) NSCLC. Clin Lung Cancer, 22:127-133.e3, 2021

24. Yamamoto N, Shimizu T, Yonemori K, Kitano S, Kondo S, Iwasa S, Koyama T, Sudo K, Sato J, Tamura K, Tomomatsu J, Ono M, Fukuda N, Takahashi S. A first-in-human, phase 1 study of the NEDD8 activating enzyme E1 inhibitor TAS4464 in patients with advanced solid tumors. Invest New Drugs, 2021

25. Yonemori K, Shimizu T, Kondo S, Iwasa S, Koyama T, Kitano S, Sato J, Shimomura A, Shibaki R, Suri A, Kase Y, Sumino S, Tamura K, Yamamoto N. The safety, tolerability and pharmacokinetics of niraparib in Japanese patients with solid tumours: results of a phase I dose-escalation study. Jpn J Clin Oncol, 51:693-699, 2021

26. Fujiwara Y, Kuchiba A, Koyama T, Machida R, Shimomura A, Kitano S, Shimizu T, Yamamoto N. Infection risk with PI3K-AKT-mTOR pathway inhibitors and immune checkpoint inhibitors in patients with advanced solid tumours in phase I clinical trials. ESMO Open, 5:2020

27. Sato J, Satouchi M, Itoh S, Okuma Y, Niho S, Mizugaki H, Murakami H, Fujisaka Y, Kozuki T, Nakamura K, Nagasaka Y, Kawasaki M, Yamada T, Machida R, Kuchiba A, Ohe Y, Yamamoto N. Lenvatinib in patients with advanced or metastatic thymic carcinoma (REMORA): a multicentre, phase 2 trial. Lancet Oncol, 21:843-850, 2020

28. Nagata Y, Kato K, Miyamoto T, Hirano H, Shoji H, Iwasa S, Honma Y, Takashima A, Hamaguchi T, Matsushita H, Nagashima K, Saruta M, Boku N. Safety and efficacy of cell-free and concentrated ascites reinfusion therapy (CART) in gastrointestinal cancer patients with massive ascites treated with systemic chemotherapy. Support Care Cancer, 28:5861-5869, 2020

29. Iwasa S, Kudo T, Takahari D, Hara H, Kato K, Satoh T. Correction to: Practical guidance for the evaluation of disease progression and the decision to change treatment in patients with advanced gastric cancer receiving chemotherapy. Int J Clin Oncol, 25:1233, 2020

30. Nakatani Y, Kato K, Shoji H, Iwasa S, Honma Y, Takashima A, Ushijima T, Ito Y, Itami J, Boku N. Comparison of involved field radiotherapy and elective nodal irradiation in combination with concurrent chemotherapy for T1bN0M0 esophageal cancer. Int J Clin Oncol, 25:1098-1104, 2020

31. Kato K, Doki Y, Ura T, Hamamoto Y, Kojima T, Tsushima T, Hironaka S, Hara H, Kudo T, Iwasa S, Muro K, Yasui H, Minashi K, Yamaguchi K, Ohtsu A, Kitagawa Y. Long-term efficacy and predictive correlates of response to nivolumab in Japanese patients with esophageal cancer. Cancer Sci, 111:1676-1684, 2020

32. Tamura N, Honma Y, Sekine S, Tsukamoto S, Hirano H, Okita N, Shoji H, Iwasa S, Takashima A, Kato K, Boku N. Case report: potential treatment of metastatic amphicrine carcinoma of the rectum with FOLFOXIRI chemotherapy. Oxf Med Case Reports, 2020:omaa097, 2020

33. Otsuka R, Iwasa S, Yanai T, Hirano H, Shoji H, Honma Y, Okita N, Takashima A, Kato K, Hashimoto H, Sekiguchi M, Makino Y, Boku N, Yamaguchi M. Impact of peripheral neuropathy induced by platinum in first-line chemotherapy on second-line chemotherapy with paclitaxel for advanced gastric cancer. Int J Clin Oncol, 25:595-601, 2020

34. Ryu S, Ohuchi M, Yagishita S, Shimoi T, Yonemori K, Tamura K, Fujiwara Y, Hamada A. Visualization of the distribution of nanoparticle-formulated AZD2811 in mouse tumor model using matrix-assisted laser desorption ionization mass spectrometry imaging. Sci Rep, 10:15535, 2020

35. Watanabe S, Shimomura A, Kubo T, Sekimizu M, Seo T, Watanabe SI, Kawai A, Yamamoto N, Tamura K, Kohno T, Ichikawa H, Yoshida A. BRAF V600E mutation is a potential therapeutic target for a small subset of synovial sarcoma. Mod Pathol, 33:1660-1668, 2020

36. Sato J, Kitano S, Motoi N, Ino Y, Yamamoto N, Watanabe S, Ohe Y, Hiraoka N. CD20+ tumor-infiltrating immune cells and CD204+ M2 macrophages are associated with prognosis in thymic carcinoma. Cancer Sci, 111:1921-1932, 2020

38. Kondo S, Tajimi M, Funai T, Inoue K, Asou H, Ranka VK, Wacheck V, Doi T. Phase 1 dose-escalation study of a novel oral PI3K/mTOR dual inhibitor, LY3023414, in patients with cancer. Invest New Drugs, 38:1836-1845, 2020

39. Kang YK, Bang YJ, Kondo S, Chung HC, Muro K, Dussault I, Helwig C, Osada M, Doi T. Safety and Tolerability of Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGFβ and PD-L1, in Asian Patients with Pretreated Recurrent or Refractory Gastric Cancer. Clin Cancer Res, 26:3202-3210, 2020

40. Yoo C, Oh DY, Choi HJ, Kudo M, Ueno M, Kondo S, Chen LT, Osada M, Helwig C, Dussault I, Ikeda M. Phase I study of bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in patients with pretreated biliary tract cancer. J Immunother Cancer, 8:2020

41. Ebata T, Shimizu T, Fujiwara Y, Tamura K, Kondo S, Iwasa S, Yonemori K, Shimomura A, Kitano S, Koyama T, Sato N, Nakai K, Inatani M, Yamamoto N. Phase I study of the indoleamine 2,3-dioxygenase 1 inhibitor navoximod (GDC-0919) as monotherapy and in combination with the PD-L1 inhibitor atezolizumab in Japanese patients with advanced solid tumours. Invest New Drugs, 38:468-477, 2020

42. Hosoba R, Makita S, Shiotsuka M, Kobayashi O, Nakano K, Muroya M, Okada N, Suzuki M, Ida H, Fukuhara S, Munakata W, Suzuki T, Maruyama D, Maeshima AM, Matsushita H, Yamamoto N, Ohe Y, Iwata S, Izutsu K. COVID-19 pneumonia in a patient with adult T-cell leukemia-lymphoma. J Clin Exp Hematop, 60:174-178, 2020

43. Kanda S, Ohe Y, Goto Y, Horinouchi H, Fujiwara Y, Nokihara H, Yamamoto N, Yamamoto T, Tamura T. Five-year safety and efficacy data from a phase Ib study of nivolumab and chemotherapy in advanced non-small-cell lung cancer. Cancer Sci, 111:1933-1942, 2020

44. Koyama T, Shimizu T, Iwasa S, Fujiwara Y, Kondo S, Kitano S, Yonemori K, Shimomura A, Iizumi S, Sasaki T, Furuse J, Yamamoto N. First-in-human phase I study of E7090, a novel selective fibroblast growth factor receptor inhibitor, in patients with advanced solid tumors. Cancer Sci, 111:571-579, 2020

45. Mizuno T, Horinouchi H, Watanabe S, Sato J, Morita R, Murakami S, Goto Y, Kanda S, Fujiwara Y, Yamamoto N, Ohe Y. Number of metastatic organs negatively affects the treatment sequence in patients with EGFR-TKI failure. Thorac Cancer, 11:1038-1044, 2020

46. Murakami S, Shibaki R, Matsumoto Y, Yoshida T, Goto Y, Kanda S, Horinouchi H, Fujiwara Y, Yamamoto N, Ohe Y. Association between serum level soluble programmed cell death ligand 1 and prognosis in patients with non-small cell lung cancer treated with anti-PD-1 antibody. Thorac Cancer, 11:3585-3595, 2020

47. Niho S, Yoshida T, Akimoto T, Sakamaki K, Ono A, Seto T, Nishio M, Yamamoto N, Hida T, Okamoto H, Kurata T, Satouchi M, Goto K, Yamanaka T, Ohe Y. Randomized phase II study of chemoradiotherapy with cisplatin + S-1 versus cisplatin + pemetrexed for locally advanced non-squamous non-small cell lung cancer: SPECTRA study. Lung Cancer, 141:64-71, 2020

48. Nishio M, Kato T, Niho S, Yamamoto N, Takahashi T, Nogami N, Kaneda H, Fujita Y, Wilner K, Yoshida M, Isozaki M, Wada S, Tsuji F, Nakagawa K. Safety and efficacy of first-line dacomitinib in Japanese patients with advanced non-small cell lung cancer. Cancer Sci, 111:1724-1738, 2020

49. Okuma HS, Yonemori K, Narita SN, Sukigara T, Hirakawa A, Shimizu T, Shibata T, Kawai A, Yamamoto N, Nakamura K, Nishida T, Fujiwara Y. MASTER KEY Project: Powering Clinical Development for Rare Cancers Through a Platform Trial. Clin Pharmacol Ther, 108:596-605, 2020

50. Okuma Y, Goto Y, Ohyanagi F, Sunami K, Nakahara Y, Kitazono S, Kudo K, Tambo Y, Kanda S, Yanagitani N, Horiike A, Horinouchi H, Fujiwara Y, Nokihara H, Yamamoto N, Nishio M, Ohe Y, Hosomi Y. Phase II trial of S-1 treatment as palliative-intent chemotherapy for previously treated advanced thymic carcinoma. Cancer Med, 9:7418-7427, 2020

51. Satomi-Tsushita N, Honma Y, Nagashima K, Ito Y, Hirano H, Shoji H, Takashima A, Iwasa S, Kato K, Hamaguchi T, Itami J, Boku N. Risk Factors of Severe Benign Cicatricial Stricture After Definitive Chemoradiation for Localized T3 Esophageal Carcinoma. Anticancer Res, 40:1071-1077, 2020

52. Shibaki R, Murakami S, Matsumoto Y, Yoshida T, Goto Y, Kanda S, Horinouchi H, Fujiwara Y, Yamamoto N, Kusumoto M, Yamamoto N, Ohe Y. Association of immune-related pneumonitis with the presence of preexisting interstitial lung disease in patients with non-small lung cancer receiving anti-programmed cell death 1 antibody. Cancer Immunol Immunother, 69:15-22, 2020

53. Shimizu T, Nishio K, Sakai K, Okamoto I, Okamoto K, Takeda M, Morishita M, Nakagawa K. Phase I safety and pharmacokinetic study of YM155, a potent selective survivin inhibitor, in combination with erlotinib in patients with EGFR TKI refractory advanced non-small cell lung cancer. Cancer Chemother Pharmacol, 86:211-219, 2020

54. Shirasawa M, Yoshida T, Matsumoto Y, Shinno Y, Okuma Y, Goto Y, Horinouchi H, Yamamoto N, Watanabe SI, Ohe Y, Motoi N. Impact of chemoradiotherapy on the immune-related tumour microenvironment and efficacy of anti-PD-(L)1 therapy for recurrences after chemoradiotherapy in patients with unresectable locally advanced non-small cell lung cancer. Eur J Cancer, 140:28-36, 2020

55. Sudo K, Kato K, Matsuzaki J, Takizawa S, Aoki Y, Shoji H, Iwasa S, Honma Y, Takashima A, Sakamoto H, Naka T, Sekine S, Boku N, Ochiya T. Identification of serum microRNAs predicting the response of esophageal squamous-cell carcinoma to nivolumab. Jpn J Clin Oncol, 50:114-121, 2020

56. Tamura N, Fujiwara Y, Hashimoto T, Shiraishi H, Kitano S, Shimizu T, Kuwano K, Yamamoto N, Motoi N. Correlation between the expression of folate receptor alpha (FRα) and clinicopathological features in patients with lung adenocarcinoma. Lung Cancer, 145:152-157, 2020

57. Watanuki R, Shimomura A, Yazaki S, Noda-Narita S, Sumiyoshi-Okuma H, Nishikawa T, Tanioka M, Sudo K, Shimoi T, Noguchi E, Yonemori K, Tamura K. Survival outcomes in patients with human epidermal growth factor receptor 2 positive metastatic breast cancer administered a therapy following trastuzumab emtansine treatment. Medicine (Baltimore), 99:e22331, 2020

58. Yamamoto N, Ryoo BY, Keam B, Kudo M, Lin CC, Kunieda F, Ball HA, Moran D, Komatsu K, Takeda K, Fukuda M, Furuse J, Morita S, Doi T. A phase 1 study of oral ASP5878, a selective small-molecule inhibitor of fibroblast growth factor receptors 1-4, as a single dose and multiple doses in patients with solid malignancies. Invest New Drugs, 38:445-456, 2020