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Annual Report 2019

Division of Experimental Therapeutics

Kashiwa: Toshihiko Doi, Kiyotaka Yo, Yoichi Naito, Takahiro Kogawa, Kohei Shitara, Hideaki Takahashi, Yasutoshi Kuboki

Tsukiji: Noboru Yamamoto, Toshio Shimizu, Kan Yonemori, Shigehisa Kitano, Shunsuke Kondo, Satoru Iwasa, Tatsuya Yoshida, Kazuki Sudo, Takafumi Koyama, Jun Sato

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 also 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 as well as in Asia. The top priority is to conduct the FIH trials, and we also perform the phase I trials for solid tumors (i.e., all comers). Recently, we have been joining global phase I trials to accelerate new drug development in Japan. Web-or tele-conferences are held with EU and US sites, and we discuss patient enrollment as well as further developmental strategy. Routine web-conferences are also held between the NCC-Hospital (Tokyo) and the NCC-East hospital (Chiba) every Friday morning, and we are sharing information about adverse events and patient enrollment and are referring candidates to each other to accelerate enrollment.

Research activities

We promote the following activities for appropriate conducting of research and trials.

To plan the clinical trial as IITs for achieving POC of new academic seeds
Explanation meetings for researchers and office employees on compliance with laws, ordinances and guidelines.

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

List of papers published in 2019

Journal

Kashiwa

1. Naito Y, Mishima S, Akagi K, Igarashi A, Ikeda M, Okano S, Kato S, Takano T, Tsuchihara K, Terashima K, Nishihara H, Nishiyama H, Hiyama E, Hirasawa A, Hosoi H, Maeda O, Yatabe Y, Okamoto W, Ono S, Kajiyama H, Nagashima F, Hatanaka Y, Miyachi M, Kodera Y, Yoshino T, Taniguchi H. Japan society of clinical oncology/Japanese society of medical oncology-led clinical recommendations on the diagnosis and use of tropomyosin receptor kinase inhibitors in adult and pediatric patients with neurotrophic receptor tyrosine kinase fusion-positive advanced solid tumors, cooperated by the Japanese society of pediatric hematology/oncology. Int J Clin Oncol, 25:403-417, 2020

2. Hatogai K, Fujii S, Kitano S, Kojima T, Daiko H, Yoshino T, Ohtsu A, Takiguchi Y, Doi T, Ochiai A. Relationship between the immune microenvironment of different locations in a primary tumour and clinical outcomes of oesophageal squamous cell carcinoma. Br J Cancer, 122:413-420, 2020

3. Kawazoe A, Shitara K. Trifluridine/tipiracil for the treatment of metastatic gastric cancer. Expert Rev Gastroenterol Hepatol, 14:65-70, 2020

4. Shitara K, Hara H, Yoshikawa T, Fujitani K, Nishina T, Hosokawa A, Asakawa T, Kawakami S, Muro K. Pertuzumab plus trastuzumab and chemotherapy for Japanese patients with HER2-positive metastatic gastric or gastroesophageal junction cancer: a subgroup analysis of the JACOB trial. Int J Clin Oncol, 25:301-311, 2020

5. Shitara K, Honma Y, Omuro Y, Yamaguchi K, Chin K, Muro K, Nakagawa S, Kawakami S, Hironaka S, Nishina T. Efficacy of trastuzumab emtansine in Japanese patients with previously treated HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma: A subgroup analysis of the GATSBY study. Asia Pac J Clin Oncol, 16:5-13, 2020

6. Marabelle A, Le DT, Ascierto PA, Di Giacomo AM, De Jesus-Acosta A, Delord JP, Geva R, Gottfried M, Penel N, Hansen AR, Piha-Paul SA, Doi T, Gao B, Chung HC, Lopez-Martin J, Bang YJ, Frommer RS, Shah M, Ghori R, Joe AK, Pruitt SK, Diaz LA Jr. Efficacy of Pembrolizumab in Patients With Noncolorectal High Microsatellite Instability/Mismatch Repair-Deficient Cancer: Results From the Phase II KEYNOTE-158 Study. J Clin Oncol, 38:1-10, 2020

7. Moritani K, Kanemitsu Y, Shida D, Shitara K, Mizusawa J, Katayama H, Hamaguchi T, Shimada Y. A randomized controlled trial comparing primary tumour resection plus chemotherapy with chemotherapy alone in incurable stage IV colorectal cancer: JCOG1007 (iPACS study). Jpn J Clin Oncol, 50:89-93, 2020

8. Demachi K, Bando H, Nomura H, Shitara K, Yoshino T, Yamaguchi M, Kawasaki T. Clinical impact of renal impairment on the safety and efficacy of S-1 plus oxaliplatin in patients with advanced gastric cancer: a single institutional study. Jpn J Clin Oncol, 50:129-137, 2020

9. Kato H, de Souza P, Kim SW, Lickliter JD, Naito Y, Park K, Kumar S, Mugundu GM, Bang YJ. Safety, Pharmacokinetics, and Clinical Activity of Adavosertib in Combination with Chemotherapy in Asian Patients with Advanced Solid Tumors: Phase Ib Study. Target Oncol, 15:75-84, 2020

10. Naito Y, Kai Y, Ishikawa T, Fujita T, Uehara K, Doihara H, Tokunaga S, Shimokawa M, Ito Y, Saeki T. Chemotherapy-induced nausea and vomiting in patients with breast cancer: a prospective cohort study. Breast Cancer, 27:122-128, 2020

11. Nishida T, Sakai Y, Takagi M, Ozaka M, Kitagawa Y, Kurokawa Y, Masuzawa T, Naito Y, Kagimura T, Hirota S. Adherence to the guidelines and the pathological diagnosis of high-risk gastrointestinal stromal tumors in the real world. Gastric Cancer, 23:118-125, 2020

12. Kogawa T, Fujii T, Wu J, Harano K, Fouad TM, Liu DD, Shen Y, Masuda H, Krishnamurthy S, Chavez-MacGregor M, Lim B, Murthy RK, Valero V, Tripathy D, Ueno NT. Prognostic Value of HER2 to CEP17 Ratio on Fluorescence In Situ Hybridization Ratio in Patients with Nonmetastatic HER2-Positive Inflammatory and Noninflammatory Breast Cancer Treated with Neoadjuvant Chemotherapy with or without Trastuzumab. Oncologist, 25:e909-e919, 2020

13. Shimokawa M, Nosaki K, Seto T, Ohashi K, Morise M, Horinouchi H, Sakakibara J, Murakami H, Yano S, Satouchi M, Matsumoto S, Goto K, Yoh K. Phase II, open-label, multicenter trial of crizotinib in Japanese patients with advanced non-small cell lung cancer harboring a MET gene alteration: Co-MET study. Trials, 21:298, 2020

14. Ikemura S, Yasuda H, Matsumoto S, Kamada M, Hamamoto J, Masuzawa K, Kobayashi K, Manabe T, Arai D, Nakachi I, Kawada I, Ishioka K, Nakamura M, Namkoong H, Naoki K, Ono F, Araki M, Kanada R, Ma B, Hayashi Y, Mimaki S, Yoh K, Kobayashi SS, Kohno T, Okuno Y, Goto K, Tsuchihara K, Soejima K. Molecular dynamics simulation-guided drug sensitivity prediction for lung cancer with rare EGFR mutations. Proc Natl Acad Sci U S A, 116:10025-10030, 2019

15. Koganemaru S, Kuboki Y, Koga Y, Kojima T, Yamauchi M, Maeda N, Kagari T, Hirotani K, Yasunaga M, Matsumura Y, Doi T. U3-1402, a Novel HER3-Targeting Antibody-Drug Conjugate, for the Treatment of Colorectal Cancer. Mol Cancer Ther, 18:2043-2050, 2019

16. Shitara K, Ueha S, Shichino S, Aoki H, Ogiwara H, Nakatsura T, Suzuki T, Shimomura M, Yoshikawa T, Shoda K, Kitano S, Yamashita M, Nakayama T, Sato A, Kuroda S, Wakabayashi M, Nomura S, Yokochi S, Ito S, Matsushima K, Doi T. First-in-human phase 1 study of IT1208, a defucosylated humanized anti-CD4 depleting antibody, in patients with advanced solid tumors. J Immunother Cancer., 7:195, 2019

17. Fujii S, Yoshino T, Yamazaki K, Muro K, Yamaguchi K, Nishina T, Yuki S, Shinozaki E, Shitara K, Bando H, Mimaki S, Nakai C, Matsushima K, Suzuki Y, Akagi K, Yamanaka T, Nomura S, Esumi H, Sugiyama M, Nishida N, Mizokami M, Koh Y, Abe Y, Ohtsu A, Tsuchihara K. Histopathological factors affecting the extraction of high quality genomic DNA from tissue sections for next-generation sequencing. Biomed Rep, 11:171-180, 2019

18. Doi T, Muro K, Ishii H, Kato T, Tsushima T, Takenoyama M, Oizumi S, Gemmoto K, Suna H, Enokitani K, Kawakami T, Nishikawa H, Yamamoto N. A Phase I Study of the Anti-CC Chemokine Receptor 4 Antibody, Mogamulizumab, in Combination with Nivolumab in Patients with Advanced or Metastatic Solid Tumors. Clin Cancer Res, 25:6614-6622, 2019

19. Kamada T, Togashi Y, Tay C, Ha D, Sasaki A, Nakamura Y, Sato E, Fukuoka S, Tada Y, Tanaka A, Morikawa H, Kawazoe A, Kinoshita T, Shitara K, Sakaguchi S, Nishikawa H. PD-1+ regulatory T cells amplified by PD-1 blockade promote hyperprogression of cancer. Proc Natl Acad Sci U S A, 116:9999-10008, 2019

20. Sasaki A, Nakamura Y, Mishima S, Kawazoe A, Kuboki Y, Bando H, Kojima T, Doi T, Ohtsu A, Yoshino T, Kuwata T, Akimoto T, Shitara K. Predictive factors for hyperprogressive disease during nivolumab as anti-PD1 treatment in patients with advanced gastric cancer. Gastric Cancer, 22:793-802, 2019

21. Kaito A, Kuwata T, Tokunaga M, Shitara K, Sato R, Akimoto T, Kinoshita T. HER2 heterogeneity is a poor prognosticator for HER2-positive gastric cancer. World J Clin Cases, 7:1964-1977, 2019

22. Shimomura A, Yonemori K, Yoshida M, Yoshida T, Yasojima H, Masuda N, Aogi K, Takahashi M, Naito Y, Shimizu S, Nakamura R, Hamada A, Michimae H, Hashimoto J, Yamamoto H, Kawachi A, Shimizu C, Fujiwara Y, Tamura K. Gene Alterations in Triple-Negative Breast Cancer Patients in a Phase I/II Study of Eribulin and Olaparib Combination Therapy. Transl Oncol, 12:1386-1394, 2019

23. Naito T, Udagawa H, Sato J, Horinouchi H, Murakami S, Goto Y, Kanda S, Fujiwara Y, Yamamoto N, Zenke Y, Kirita K, Matsumoto S, Yoh K, Niho S, Motoi N, Ohe Y, Ishii G, Goto K. A Minimum Of 100 Tumor Cells in a Single Biopsy Sample Is Required to Assess Programmed Cell Death Ligand 1 Expression in Predicting Patient Response to Nivolumab Treatment in Nonsquamous Non-Small Cell Lung Carcinoma. J Thorac Oncol, 14:1818-1827, 2019

24. Naito T, Umemura S, Nakamura H, Zenke Y, Udagawa H, Kirita K, Matsumoto S, Yoh K, Niho S, Motoi N, Aokage K, Tsuboi M, Ishii G, Goto K. Successful treatment with nivolumab for SMARCA4-deficient non-small cell lung carcinoma with a high tumor mutation burden: A case report. Thorac Cancer, 10:1285-1288, 2019

25. Shitara K, Yodo Y, Iino S. A Phase I Study of Napabucasin Plus Paclitaxel for Japanese Patients With Advanced/Recurrent Gastric Cancer. In Vivo, 33:933-937, 2019

26. Shitara K, Iwata H, Takahashi S, Tamura K, Park H, Modi S, Tsurutani J, Kadowaki S, Yamaguchi K, Iwasa S, Saito K, Fujisaki Y, Sugihara M, Shahidi J, Doi T. Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2-positive gastric cancer: a dose-expansion, phase 1 study. Lancet Oncol, 20:827-836, 2019

27. Doi T, Yoh K, Shitara K, Takahashi H, Ueno M, Kobayashi S, Morimoto M, Okusaka T, Ueno H, Morizane C, Okano N, Nagashima F, Furuse J. First-in-human phase 1 study of novel dUTPase inhibitor TAS-114 in combination with S-1 in Japanese patients with advanced solid tumors. Invest New Drugs, 37:507-518, 2019

28. Kawazoe A, Shitara K. Next-generation sequencing and biomarkers for gastric cancer: what is the future? Ther Adv Med Oncol, 11:1758835919848189, 2019

29. Doi T, Iwasa S, Muro K, Satoh T, Hironaka S, Esaki T, Nishina T, Hara H, Machida N, Komatsu Y, Shimada Y, Otsu S, Shimizu S, Watanabe M. Phase 1 trial of avelumab (anti-PD-L1) in Japanese patients with advanced solid tumors, including dose expansion in patients with gastric or gastroesophageal junction cancer: the JAVELIN Solid Tumor JPN trial. Gastric Cancer, 22:817-827, 2019

30. Ishii T, Kawazoe A, Shitara K. Dawn of precision medicine on gastric cancer. Int J Clin Oncol, 24:779-788, 2019

31. Doi T, Fujiwara Y, Matsubara N, Tomomatsu J, Iwasa S, Tanaka A, Endo-Tsukude C, Nakagawa S, Takahashi S. Phase I study of ipatasertib as a single agent and in combination with abiraterone plus prednisolone in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol, 84:393-404, 2019

32. Shitara K, Satoh T, Iwasa S, Yamaguchi K, Muro K, Komatsu Y, Nishina T, Esaki T, Hasegawa J, Kakurai Y, Kamiyama E, Nakata T, Nakamura K, Sakaki H, Hyodo I. Safety, tolerability, pharmacokinetics, and pharmacodynamics of the afucosylated, humanized anti-EPHA2 antibody DS-8895a: a first-in-human phase I dose escalation and dose expansion study in patients with advanced solid tumors. J Immunother Cancer, 7:219, 2019

33. Doi T, Aramaki T, Yasui H, Muro K, Ikeda M, Okusaka T, Inaba Y, Nakai K, Ikezawa H, Nakajima R. A phase I study of ontuxizumab, a humanized monoclonal antibody targeting endosialin, in Japanese patients with solid tumors. Invest New Drugs, 37:1061-1074, 2019

34. Doi T, Kurokawa Y, Sawaki A, Komatsu Y, Ozaka M, Takahashi T, Naito Y, Ohkubo S, Nishida T. Efficacy and safety of TAS-116, an oral inhibitor of heat shock protein 90, in patients with metastatic or unresectable gastrointestinal stromal tumour refractory to imatinib, sunitinib and regorafenib: a phase II, single-arm trial. Eur J Cancer, 121:29-39, 2019

35. Kotani D, Kuboki Y, Horasawa S, Kaneko A, Nakamura Y, Kawazoe A, Bando H, Taniguchi H, Shitara K, Kojima T, Tsuji A, Yoshino T. Retrospective cohort study of trifluridine/tipiracil (TAS-102) plus bevacizumab versus trifluridine/tipiracil monotherapy for metastatic colorectal cancer. BMC Cancer, 19:1253, 2019

36. Esaki T, Hirai F, Makiyama A, Seto T, Bando H, Naito Y, Yoh K, Ishihara K, Kakizume T, Natsume K, Myers A, Doi T. Phase I dose-escalation study of capmatinib (INC280) in Japanese patients with advanced solid tumors. Cancer Sci, 110:1340-1351, 2019

37. Kato K, Shah MA, Enzinger P, Bennouna J, Shen L, Adenis A, Sun JM, Cho BC, Özgüroğlu M, Kojima T, Kostorov V, Hierro C, Zhu Y, McLean LA, Shah S, Doi T. KEYNOTE-590: Phase III study of first-line chemotherapy with or without pembrolizumab for advanced esophageal cancer. Future Oncol, 15:1057-1066, 2019

38. Masuishi T, Taniguchi H, Kotani D, Bando H, Komatsu Y, Shinozaki E, Nakajima TE, Satoh T, Nishina T, Esaki T, Wakabayashi M, Nomura S, Takahashi K, Ono H, Hirano N, Fujishiro N, Fuse N, Sato A, Ohtsu A, Yoshino T. Rationale and design of the BRAVERY study (EPOC1701): a multicentre phase II study of eribulin in patients with BRAF V600E mutant metastatic colorectal cancer. ESMO Open, 4:e000590, 2019

39. Harding JJ, Bauer TM, Tan DSW, Bedard PL, Rodon J, Doi T, Schnell C, Iyer V, Baffert F, Radhakrishnan R, Fabre C, Juric D. Characterization and phase I study of CLR457, an orally bioavailable pan-class I PI3-kinase inhibitor. Invest New Drugs, 37:271-281, 2019

40. Tamura K, Tsurutani J, Takahashi S, Iwata H, Krop IE, Redfern C, Sagara Y, Doi T, Park H, Murthy RK, Redman RA, Jikoh T, Lee C, Sugihara M, Shahidi J, Yver A, Modi S. Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2-positive breast cancer previously treated with trastuzumab emtansine: a dose-expansion, phase 1 study. Lancet Oncol, 20:816-826, 2019

41. Togashi Y, Shitara K, Nishikawa H. Regulatory T cells in cancer immunosuppression - implications for anticancer therapy. Nat Rev Clin Oncol, 16:356-371, 2019

42. Yamada Y, Boku N, Mizusawa J, Iwasa S, Kadowaki S, Nakayama N, Azuma M, Sakamoto T, Shitara K, Tamura T, Chin K, Hata H, Nakamori M, Hara H, Yasui H, Katayama H, Fukuda H, Yoshikawa T, Sasako M, Terashima M. Docetaxel plus cisplatin and S-1 versus cisplatin and S-1 in patients with advanced gastric cancer (JCOG1013): an open-label, phase 3, randomised controlled trial. Lancet Gastroenterol Hepatol, 4:501-510, 2019

43. Bang YJ, Kang YK, Catenacci DV, Muro K, Fuchs CS, Geva R, Hara H, Golan T, Garrido M, Jalal SI, Borg C, Doi T, Yoon HH, Savage MJ, Wang J, Dalal RP, Shah S, Wainberg ZA, Chung HC. Pembrolizumab alone or in combination with chemotherapy as first-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma: results from the phase II nonrandomized KEYNOTE-059 study. Gastric Cancer, 22:828-837, 2019

44. Yoshikawa T, Muro K, Shitara K, Oh DY, Kang YK, Chung HC, Kudo T, Chin K, Kadowaki S, Hamamoto Y, Hironaka S, Yoshida K, Yen CJ, Omuro Y, Bai LY, Maeda K, Ozeki A, Yoshikawa R, Kitagawa Y. Effect of First-line S-1 Plus Oxaliplatin With or Without Ramucirumab Followed by Paclitaxel Plus Ramucirumab on Advanced Gastric Cancer in East Asia: The Phase 2 RAINSTORM Randomized Clinical Trial. JAMA Netw Open, 2:e198243, 2019

45. Lin CH, Yap YS, Lee KH, Im SA, Naito Y, Yeo W, Ueno T, Kwong A, Li H, Huang SM, Leung R, Han W, Tan B, Hu FC, Huang CS, Cheng AL, Lu YS. Contrasting Epidemiology and Clinicopathology of Female Breast Cancer in Asians vs the US Population. J Natl Cancer Inst, 111:1298-1306, 2019

46. Kobayashi E, Naito Y, Asano N, Maejima A, Endo M, Takahashi S, Megumi Y, Kawai A. Interim results of a real-world observational study of eribulin in soft tissue sarcoma including rare subtypes. Jpn J Clin Oncol, 49:938-946, 2019

47. Yeo W, Ueno T, Lin CH, Liu Q, Lee KH, Leung R, Naito Y, Park YH, Im SA, Li H, Yap YS, Lu YS. Treating HR+/HER2- breast cancer in premenopausal Asian women: Asian Breast Cancer Cooperative Group 2019 Consensus and position on ovarian suppression. Breast Cancer Res Treat, 177:549-559, 2019

48. Kenmotsu H, Yoh K, Mori K, Ono A, Baba T, Fujiwara Y, Yamaguchi O, Ko R, Okamoto H, Yamamoto N, Ninomiya T, Ogura T, Kato T. Phase II study of nab-paclitaxel + carboplatin for patients with non-small-cell lung cancer and interstitial lung disease. Cancer Sci, 110:3738-3745, 2019

49. Naito T, Udagawa H, Umemura S, Sakai T, Zenke Y, Kirita K, Matsumoto S, Yoh K, Niho S, Tsuboi M, Ishii G, Goto K. Non-small cell lung cancer with loss of expression of the SWI/SNF complex is associated with aggressive clinicopathological features, PD-L1-positive status, and high tumor mutation burden. Lung Cancer, 138:35-42, 2019

50. Nakagawa K, Garon EB, Seto T, Nishio M, Ponce Aix S, Paz-Ares L, Chiu CH, Park K, Novello S, Nadal E, Imamura F, Yoh K, Shih JY, Au KH, Moro-Sibilot D, Enatsu S, Zimmermann A, Frimodt-Moller B, Visseren-Grul C, Reck M. Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol, 20:1655-1669, 2019

51. Ota T, Kirita K, Matsuzawa R, Udagawa H, Matsumoto S, Yoh K, Niho S, Ishii G, Goto K. Validity of using immunohistochemistry to predict treatment outcome in patients with non-small cell lung cancer not otherwise specified. J Cancer Res Clin Oncol, 145:2495-2506, 2019

52. Nakamura M, Kageyama SI, Niho S, Okumura M, Hojo H, Motegi A, Nakamura N, Zenda S, Yoh K, Goto K, Akimoto T. Impact of EGFR Mutation and ALK Translocation on Recurrence Pattern After Definitive Chemoradiotherapy for Inoperable Stage III Non-squamous Non-small-cell Lung Cancer. Clin Lung Cancer, 20:e256-e264, 2019

Tsukiji

1. Yamamoto Y, Kondo S, Matsuzaki J, Esaki M, Okusaka T, Shimada K, Murakami Y, Enomoto M, Tamori A, Kato K, Aoki Y, Takizawa S, Sakamoto H, Niida S, Takeshita F, Ochiya T. Highly Sensitive Circulating MicroRNA Panel for Accurate Detection of Hepatocellular Carcinoma in Patients With Liver Disease. Hepatol Commun, 4:284-297, 2020

2. Honma Y, Nagashima K, Hirano H, Shoji H, Iwasa S, Takashima A, Okita N, Kato K, Boku N, Murakami N, Inaba K, Ito Y, Itami J, Kanamori J, Oguma J, Daiko H. Clinical outcomes of locally advanced esophageal neuroendocrine carcinoma treated with chemoradiotherapy. Cancer Med, 9:595-604, 2020

3. 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

4. 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

5. 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

6. Ebata T, Shimizu T, Koyama T, Shimomura A, Iwasa S, Kondo S, Kitano S, Yonemori K, Fujiwara Y, Yamamoto N. Improved survival among patients enrolled in oncology phase 1 trials in recent decades. Cancer Chemother Pharmacol, 85:449-459, 2020

7. Frezza AM, Assi T, Lo Vullo S, Ben-Ami E, Dufresne A, Yonemori K, Noguchi E, Siontis B, Ferraro R, Teterycz P, Duffaud F, Ravi V, Vincenzi B, Gelderblom H, Pantaleo MA, Baldi GG, Desar I, Fedenko A, Maki RG, Jones RL, Benjamin RS, Blay JY, Kawai A, Gounder M, Gronchi A, Le Cesne A, Mir O, Czarnecka AM, Schuetze S, Wagner AJ, Adam J, Barisella M, Sbaraglia M, Hornick JL, Meurgey A, Mariani L, Casali PG, Thornton K, Stacchiotti S. Systemic treatments in MDM2 positive intimal sarcoma: A multicentre experience with anthracycline, gemcitabine, and pazopanib within the World Sarcoma Network. Cancer, 126:98-104, 2020

8. Hashimoto H, Abe M, Tokuyama O, Mizutani H, Uchitomi Y, Yamaguchi T, Hoshina Y, Sakata Y, Takahashi TY, Nakashima K, Nakao M, Takei D, Zenda S, Mizukami K, Iwasa S, Sakurai M, Yamamoto N, Ohe Y. Olanzapine 5 mg plus standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting (J-FORCE): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol, 21:242-249, 2020

9. Ida H, Goto Y, Sato J, Kanda S, Shinno Y, Morita R, Murakami S, Matsumoto Y, Yoshida T, Horinouchi H, Fujiwara Y, Yamamoto N, Fukuda T, Ohashi K, Ohe Y. Clinical characteristics of adrenal insufficiency as an immune-related adverse event in non-small-cell lung cancer. Med Oncol, 37:30, 2020

10. Ito A, Kitano S, Tajima K, Kim Y, Tanaka T, Inamoto Y, Kim SW, Yamamoto N, Fukuda T, Okamoto S. Impact of low-dose anti-thymocyte globulin on immune reconstitution after allogeneic hematopoietic cell transplantation. Int J Hematol, 111:120-130, 2020

11. Ito M, Fujiwara Y, Kubo T, Matsushita H, Kumamoto T, Suzuki T, Sunami K, Yamamoto N, Kohno T. Clonal Hematopoiesis From Next Generation Sequencing of Plasma From a Patient With Lung Adenocarcinoma: A Case Report. Front Oncol, 10:113, 2020

12. 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

13. Kato MK, Yunokawa M, Bun S, Shimoi T, Yonemori K, Miyasaka N, Kato T, Tamura K. Treatment strategies for recurrent ovarian cancer in older adult patients in Japan: a study based on real-world data. J Cancer Res Clin Oncol, 146:1335-1341, 2020

14. Kawachi A, Yamashita S, Okochi-Takada E, Hirakawa A, Tsuda H, Shimomura A, Kojima Y, Yonemori K, Fujiwara Y, Kinoshita T, Ushijima T, Tamura K. BRCA1 promoter methylation in breast cancer patients is associated with response to olaparib/eribulin combination therapy. Breast Cancer Res Treat, 181:323-329, 2020

15. 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

16. Mizuta H, Nakano E, Takahashi A, Koyama T, Namikawa K, Yamazaki N. Hemophagocytic lymphohistiocytosis with advanced malignant melanoma accompanied by ipilimumab and nivolumab: A case report and literature review. Dermatol Ther, 33:e13321, 2020

17. 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

18. 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

19. 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, 2020

20. 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

21. 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

22. Seo T, Noguchi E, Yoshida M, Mori T, Tanioka M, Sudo K, Shimomura A, Yonemori K, Fujiwara Y, Tamura K. Response to Dabrafenib and Trametinib of a Patient with Metaplastic Breast Carcinoma Harboring a BRAF V600E Mutation. Case Rep Oncol Med, 2020:2518383, 2020

23. 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

24. Tamura K, Imamura CK, Takano T, Saji S, Yamanaka T, Yonemori K, Takahashi M, Tsurutani J, Nishimura R, Sato K, Kitani A, Ueno NT, Mushiroda T, Kubo M, Fujiwara Y, Tanigawara Y. CYP2D6 Genotype-Guided Tamoxifen Dosing in Hormone Receptor-Positive Metastatic Breast Cancer (TARGET-1): A Randomized, Open-Label, Phase II Study. J Clin Oncol, 38:558-566, 2020

25. Tanabe Y, Shiraishi S, Hashimoto K, Ikeda K, Nishizawa D, Hasegawa J, Shimomura A, Ozaki Y, Tamura N, Yunokawa M, Yonemori K, Takano T, Kawabata H, Tamura K, Fujiwara Y, Shimizu C. Taxane-induced sensory peripheral neuropathy is associated with an SCN9A single nucleotide polymorphism in Japanese patients. BMC Cancer, 20:325, 2020

26. Yazaki S, Yamauchi T, Higashi T. High hepatitis B virus screening rate among patients receiving systemic anticancer treatment in Japan. Int J Clin Oncol, 25:1327-1333, 2020

27. 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:e000564. doi: 10.1136/jitc-2020-000564, 2020

28. Okuno T, Arakawa S, Yoshida T, Ohe Y. Efficacy of osimertinib in a patient with leptomeningeal metastasis and EGFR uncommon S768I mutation. Lung Cancer, 143:95-96, 2020

29. Koyama T, Kondo S, Shimizu T, Fujiwara Y, Morizane C, Sakamoto Y, Okusaka T, Yamamoto N. Impact of Hepatitis Virus on the Feasibility and Efficacy of Anticancer Agents in Patients With Hepatocellular Carcinoma in Phase I Clinical Trials. Front Oncol, 9:301, 2019

30. Iizumi S, Kuchiba A, Okusaka T, Ikeda M, Sakamoto Y, Kondo S, Morizane C, Ueno H, Osame K, Mitsunaga S, Ohno I, Imaoka H, Hashimoto Y, Takahashi H, Sasaki M, Ohashi K. Impact of the Duration of Diabetes Mellitus on the Outcome of Metastatic Pancreatic Cancer Treated with Gemcitabine: A Retrospective Study. Intern Med, 58:2435-2441, 2019

31. Ueno M, Ikeda M, Morizane C, Kobayashi S, Ohno I, Kondo S, Okano N, Kimura K, Asada S, Namba Y, Okusaka T, Furuse J. Nivolumab alone or in combination with cisplatin plus gemcitabine in Japanese patients with unresectable or recurrent biliary tract cancer: a non-randomised, multicentre, open-label, phase 1 study. Lancet Gastroenterol Hepatol, 4:611-621, 2019

32. Sunami K, Ichikawa H, Kubo T, Kato M, Fujiwara Y, Shimomura A, Koyama T, Kakishima H, Kitami M, Matsushita H, Furukawa E, Narushima D, Nagai M, Taniguchi H, Motoi N, Sekine S, Maeshima A, Mori T, Watanabe R, Yoshida M, Yoshida A, Yoshida H, Satomi K, Sukeda A, Hashimoto T, Shimizu T, Iwasa S, Yonemori K, Kato K, Morizane C, Ogawa C, Tanabe N, Sugano K, Hiraoka N, Tamura K, Yoshida T, Fujiwara Y, Ochiai A, Yamamoto N, Kohno T. Feasibility and utility of a panel testing for 114 cancer-associated genes in a clinical setting: A hospital-based study. Cancer Sci, 110:1480-1490, 2019

33. Mizuguchi Y, Sakamoto T, Hashimoto T, Tsukamoto S, Iwasa S, Saito Y, Sekine S. Identification of a novel PRR15L-RSPO2 fusion transcript in a sigmoid colon cancer derived from superficially serrated adenoma. Virchows Arch, 475:659-663, 2019

34. Watanabe J, Shoji H, Hamaguchi T, Miyamoto T, Hirano H, Iwasa S, Honma Y, Takashima A, Kato K, Ito Y, Itami J, Kanemitsu Y, Boku N. Chemoradiotherapy for Local Recurrence of Rectal Cancer: A Single Center Study of 18 Patients. In Vivo, 33:1363-1368, 2019

35. Sudo K, Kato K, Matsuzaki J, Boku N, Abe S, Saito Y, Daiko H, Takizawa S, Aoki Y, Sakamoto H, Niida S, Takeshita F, Fukuda T, Ochiya T. Development and Validation of an Esophageal Squamous Cell Carcinoma Detection Model by Large-Scale MicroRNA Profiling. JAMA Netw Open, 2:e194573, 2019

36. Ando Y, Iwasa S, Takahashi S, Saka H, Kakizume T, Natsume K, Suenaga N, Quadt C, Yamada Y. Phase I study of alpelisib (BYL719), an α-specific PI3K inhibitor, in Japanese patients with advanced solid tumors. Cancer Sci, 110:1021-1031, 2019

37. Aoki M, Shoji H, Nagashima K, Imazeki H, Miyamoto T, Hirano H, Honma Y, Iwasa S, Okita N, Takashima A, Kato K, Higuchi K, Boku N. Hyperprogressive disease during nivolumab or irinotecan treatment in patients with advanced gastric cancer. ESMO Open, 4:e000488, 2019

38. Arai H, Iwasa S, Boku N, Kawahira M, Yasui H, Masuishi T, Muro K, Minashi K, Hironaka S, Fukuda N, Takahari D, Nakajima TE. Fluoropyrimidine with or without platinum as first-line chemotherapy in patients with advanced gastric cancer and severe peritoneal metastasis: a multicenter retrospective study. BMC Cancer, 19:652, 2019

39. Doi T, Fujiwara Y, Matsubara N, Tomomatsu J, Iwasa S, Tanaka A, Endo-Tsukude C, Nakagawa S, Takahashi S. Phase I study of ipatasertib as a single agent and in combination with abiraterone plus prednisolone in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol, 84:393-404, 2019

40. Doi T, Iwasa S, Muro K, Satoh T, Hironaka S, Esaki T, Nishina T, Hara H, Machida N, Komatsu Y, Shimada Y, Otsu S, Shimizu S, Watanabe M. Phase 1 trial of avelumab (anti-PD-L1) in Japanese patients with advanced solid tumors, including dose expansion in patients with gastric or gastroesophageal junction cancer: the JAVELIN Solid Tumor JPN trial. Gastric Cancer, 22:817-827, 2019

41. Doi T, Muro K, Ishii H, Kato T, Tsushima T, Takenoyama M, Oizumi S, Gemmoto K, Suna H, Enokitani K, Kawakami T, Nishikawa H, Yamamoto N. A Phase I Study of the Anti-CC Chemokine Receptor 4 Antibody, Mogamulizumab, in Combination with Nivolumab in Patients with Advanced or Metastatic Solid Tumors. Clin Cancer Res, 25:6614-6622, 2019

42. Goto K, Fujiwara Y, Isobe T, Chayahara N, Kiyota N, Mukohara T, Tsubata Y, Hotta T, Tamura K, Yamamoto N, Minami H. Pharmacokinetic study of the oral fluorouracil antitumor agent S-1 in patients with impaired renal function. Cancer Sci, 110:1987-1994, 2019

43. Hirakawa A, Sudo K, Yonemori K, Sadachi R, Kinoshita F, Kobayashi Y, Okuma HS, Kawachi A, Tamura K, Fujiwara Y, Rubinstein L, Takebe N. A Comparative Study of Longitudinal Toxicities of Cytotoxic Drugs, Molecularly Targeted Agents, Immunomodulatory Drugs, and Cancer Vaccines. Clin Pharmacol Ther, 106:803-809, 2019

44. Ida H, Honma Y, Hirano H, Shoji H, Iwasa S, Okita N, Takashima A, Kato K, Fukuda T, Boku N. Clinical outcomes of patients with G1/G2 neuroendocrine tumors arising from foregut or hindgut treated with somatostatin analogs: a retrospective study. Invest New Drugs, 37:573-578, 2019

45. Inagaki C, Shimoi T, Sumiyoshi Okuma H, Kawachi A, Sudo K, Shimomura A, Noguchi E, Kodaira M, Yunokawa M, Yonemori K, Shimizu C, Arakawa A, Ogawa C, Yoshida A, Fujiwara Y, Tamura K. Bone marrow examination in patients with Ewing sarcoma/peripheral primitive neuroectodermal tumor without metastasis based on (18)F-fluorodeoxyglucose positron emission tomography/computed tomography. Med Oncol, 36:58, 2019

46. Ito T, Honma Y, Hirano H, Shoji H, Okita N, Iwasa S, Takashima A, Kato K, Boku N. S-1 Monotherapy After Failure of Platinum Plus 5-Fluorouracil Chemotherapy in Recurrent or Metastatic Esophageal Carcinoma. Anticancer Res, 39:3931-3936, 2019

47. Katsuya Y, Horinouchi H, Seto T, Umemura S, Hosomi Y, Satouchi M, Nishio M, Kozuki T, Hida T, Sukigara T, Nakamura K, Kuchiba A, Ohe Y. Single-arm, multicentre, phase II trial of nivolumab for unresectable or recurrent thymic carcinoma: PRIMER study. Eur J Cancer, 113:78-86, 2019

48. Kawajiri A, Kitano S, Maeshima AM, Inamoto Y, Tajima K, Takemura T, Tanaka T, Ito A, Okinaka K, Kurosawa S, Kim SW, Taniguchi H, Ogawa C, Izutsu K, Yamamoto N, Fukuda T. Association of CD204+ macrophages with poor outcomes of malignant lymphomas not in remission treated by allogeneic HCT. Eur J Haematol, 103:578-587, 2019

49. Li CK, Dalvi R, Yonemori K, Ariffin H, Lyu CJ, Farid M, Gonzales-Santos JRN, Zhou Q, Bielack S, Brugieres L, Blondeel A, Essiaf S, Peccatori FA, Jezdic S, Stark DP, Douillard JY, Saloustros E, Mountzios G. Care of adolescents and young adults with cancer in Asia: results of an ESMO/SIOPE/SIOP Asia survey. ESMO Open, 4:e000467, 2019

50. Loong HH, Tan DSW, Shimizu T. Challenges and insights of early phase oncology drug development in the Asia-Pacific region. Chin Clin Oncol, 8:26, 2019

51. Makino Y, Makihara-Ando R, Ogawa T, Sato H, Goto Y, Kanda S, Horinouchi H, Fujiwara Y, Ohe Y, Yamamoto N. Individual optimal dose of amrubicin to prevent severe neutropenia in Japanese patients with lung cancer. Cancer Sci, 110:3573-3583, 2019

52. Masuda K, Fujiwara Y, Shinno Y, Mizuno T, Sato J, Morita R, Matsumoto Y, Murakami S, Goto Y, Kanda S, Horinouchi H, Yamamoto N, Ohe Y. Efficacy and safety of crizotinib in patients with ROS1 rearranged non-small cell lung cancer: a retrospective analysis. J Thorac Dis, 11:2965-2972, 2019

53. Masuda K, Shoji H, Nagashima K, Yamamoto S, Ishikawa M, Imazeki H, Aoki M, Miyamoto T, Hirano H, Honma Y, Iwasa S, Okita N, Takashima A, Kato K, Boku N. Correlation between immune-related adverse events and prognosis in patients with gastric cancer treated with nivolumab. BMC Cancer, 19:974, 2019

54. Monma S, Kato K, Shouji H, Okita N, Takashima A, Honma Y, Iwasa S, Hamaguchi T, Yamada Y, Shimada Y, Boku N, Nagashima K, Ito Y, Itami J. Gastric mucosal injury and hemorrhage after definitive chemoradiotherapy for locally advanced esophageal cancer. Esophagus, 16:402-407, 2019

55. Muto Y, Kitano S, Tsutsumida A, Namikawa K, Takahashi A, Nakamura Y, Yamanaka T, Yamamoto N, Yamazaki N. Investigation of clinical factors associated with longer overall survival in advanced melanoma patients treated with sequential ipilimumab. J Dermatol, 46:498-506, 2019

56. Nagata Y, Sawada R, Takashima A, Shoji H, Honma Y, Iwasa S, Amano K, Kato K, Hamaguchi T, Shimada Y, Saruta M, Boku N. Efficacy and safety of pemetrexed plus cisplatin as first-line chemotherapy in advanced malignant peritoneal mesothelioma. Jpn J Clin Oncol, 49:1004-1008, 2019

57. Naito T, Udagawa H, Sato J, Horinouchi H, Murakami S, Goto Y, Kanda S, Fujiwara Y, Yamamoto N, Zenke Y, Kirita K, Matsumoto S, Yoh K, Niho S, Motoi N, Ohe Y, Ishii G, Goto K. A Minimum Of 100 Tumor Cells in a Single Biopsy Sample Is Required to Assess Programmed Cell Death Ligand 1 Expression in Predicting Patient Response to Nivolumab Treatment in Nonsquamous Non-Small Cell Lung Carcinoma. J Thorac Oncol, 14:1818-1827, 2019

58. Noda-Narita S, Shimomura A, Kawachi A, Sumiyoshi-Okuma H, Sudo K, Shimoi T, Noguchi E, Yonemori K, Shimizu C, Fujiwara Y, Tamura K. Comparison of the efficacy of trastuzumab emtansine between patients with metastatic human epidermal growth factor receptor 2-positive breast cancers previously treated with combination trastuzumab and pertuzumab and with trastuzumab only in Japanese population. Breast Cancer, 26:492-498, 2019

59. Nokihara H, Nishio M, Yamamoto N, Fujiwara Y, Horinouchi H, Kanda S, Horiike A, Ohyanagi F, Yanagitani N, Nguyen L, Yaron Y, Borgman A, Tamura T. Phase 1 Study of Cabozantinib in Japanese Patients With Expansion Cohorts in Non-Small-Cell Lung Cancer. Clin Lung Cancer, 20:e317-e328, 2019

60. Sato J, Shimoi T, Shimomura A, Noguchi E, Kodaira M, Yunokawa M, Yonemori K, Shimizu C, Fujiwara Y, Yoshida M, Tamura K. The Incidence of Nonmalignant Diseases among Patients with Suspected Carcinoma of Unknown Primary Site. Intern Med, 58:1423-1428, 2019

61. Sato J, Shimomura A, Kawauchi J, Matsuzaki J, Yamamoto Y, Takizawa S, Sakamoto H, Ohno M, Narita Y, Ochiya T, Tamura K. Brain metastasis-related microRNAs in patients with advanced breast cancer. PLoS One, 14:e0221538, 2019

62. Shibaki R, Murakami S, Matsumoto Y, Goto Y, Kanda S, Horinouchi H, Fujiwara Y, Yamamoto N, Motoi N, Kusumoto M, Yamamoto N, Ohe Y. Tumor expression and usefulness as a biomarker of programmed death ligand 1 in advanced non-small cell lung cancer patients with preexisting interstitial lung disease. Med Oncol, 36:49, 2019

63. Shibaki R, Murakami S, Shinno Y, Matsumoto Y, Goto Y, Kanda S, Horinouchi H, Fujiwara Y, Motoi N, Yamamoto N, Ohe Y. Malignant pleural effusion as a predictor of the efficacy of anti-PD-1 antibody in patients with non-small cell lung cancer. Thorac Cancer, 10:815-822, 2019

64. Shimomura A, Yonemori K, Yoshida M, Yoshida T, Yasojima H, Masuda N, Aogi K, Takahashi M, Naito Y, Shimizu S, Nakamura R, Hamada A, Michimae H, Hashimoto J, Yamamoto H, Kawachi A, Shimizu C, Fujiwara Y, Tamura K. Gene Alterations in Triple-Negative Breast Cancer Patients in a Phase I/II Study of Eribulin and Olaparib Combination Therapy. Transl Oncol, 12:1386-1394, 2019

65. Shinno Y, Goto Y, Sato J, Morita R, Matsumoto Y, Murakami S, Kanda S, Horinouchi H, Fujiwara Y, Yamamoto N, Ohe Y. Mixed response to osimertinib and the beneficial effects of additional local therapy. Thorac Cancer, 10:738-743, 2019

66. Shitara K, Iwata H, Takahashi S, Tamura K, Park H, Modi S, Tsurutani J, Kadowaki S, Yamaguchi K, Iwasa S, Saito K, Fujisaki Y, Sugihara M, Shahidi J, Doi T. Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2-positive gastric cancer: a dose-expansion, phase 1 study. Lancet Oncol, 20:827-836, 2019

67. Shitara K, Satoh T, Iwasa S, Yamaguchi K, Muro K, Komatsu Y, Nishina T, Esaki T, Hasegawa J, Kakurai Y, Kamiyama E, Nakata T, Nakamura K, Sakaki H, Hyodo I. Safety, tolerability, pharmacokinetics, and pharmacodynamics of the afucosylated, humanized anti-EPHA2 antibody DS-8895a: a first-in-human phase I dose escalation and dose expansion study in patients with advanced solid tumors. J Immunother Cancer, 7:219, 2019

68. Sone M, Arai Y, Sugawara S, Kubo T, Itou C, Hasegawa T, Umakoshi N, Yamamoto N, Sunami K, Hiraoka N, Kubo T. Feasibility of genomic profiling with next-generation sequencing using specimens obtained by image-guided percutaneous needle biopsy. Ups J Med Sci, 124:119-124, 2019

69. Tamura N, Horinouchi H, Sekine K, Matsumoto Y, Murakami S, Goto Y, Kanda S, Fujiwara Y, Yamamoto N, Ohe Y. Efficacy of subsequent docetaxel +/- ramucirumab and S-1 after nivolumab for patients with advanced non-small cell lung cancer. Thorac Cancer, 10:1141-1148, 2019

70. Toki S, Kobayashi E, Yoshida A, Ogura K, Wakai S, Yoshimoto S, Yonemori K, Kawai A. A clinical comparison between dedifferentiated low-grade osteosarcoma and conventional osteosarcoma. Bone Joint J, 101-B:745-752, 2019

71. Watanabe S, Honma Y, Murakami N, Igaki H, Mori T, Hirano H, Okita N, Shoji H, Iwasa S, Takashima A, Kato K, Kobayashi K, Matsumoto F, Yoshimoto S, Itami J, Boku N. Induction chemotherapy with docetaxel, cisplatin and fluorouracil followed by concurrent chemoradiotherapy for unresectable sinonasal undifferentiated carcinoma: Two cases of report. World J Clin Cases, 7:765-772, 2019

72. Yamada Y, Boku N, Mizusawa J, Iwasa S, Kadowaki S, Nakayama N, Azuma M, Sakamoto T, Shitara K, Tamura T, Chin K, Hata H, Nakamori M, Hara H, Yasui H, Katayama H, Fukuda H, Yoshikawa T, Sasako M, Terashima M. Docetaxel plus cisplatin and S-1 versus cisplatin and S-1 in patients with advanced gastric cancer (JCOG1013): an open-label, phase 3, randomised controlled trial. Lancet Gastroenterol Hepatol, 4:501-510, 2019

73. Yamaguchi T, Iwasa S, Shoji H, Honma Y, Takashima A, Kato K, Hamaguchi T, Higuchi K, Boku N. Association between UGT1A1 gene polymorphism and safety and efficacy of irinotecan monotherapy as the third-line treatment for advanced gastric cancer. Gastric Cancer, 22:778-784, 2019

74. Yonemori K, Shimomura A, Yasojima H, Masuda N, Aogi K, Takahashi M, Naito Y, Shimizu S, Nakamura R, Hashimoto J, Yamamoto H, Hirakawa A, Michimae H, Hamada A, Yoshida T, Sukigara T, Tamura K, Fujiwara Y. A phase I/II trial of olaparib tablet in combination with eribulin in Japanese patients with advanced or metastatic triple-negative breast cancer previously treated with anthracyclines and taxanes. Eur J Cancer, 109:84-91, 2019

75. Yoshida K, Kanda S, Shiraishi H, Goto K, Itahashi K, Goto Y, Horinouchi H, Fujiwara Y, Nokihara H, Yamamoto N, Ohe Y. Difference in central nerve system metastasis during gefitinib or erlotinib therapy in patients with EGFR-mutated non-small cell lung cancer: a retrospective study. J Thorac Dis, 11:1347-1354, 2019

76. Yunokawa M, Sasada S, Takehara Y, Takahashi K, Shimoi T, Yonemori K, Ishikawa M, Kato T, Tamura K. Real-world data on initial treatment strategies for older adult patients with endometrial cancer in Japan. Cancer Chemother Pharmacol, 84:1051-1058, 2019

77. Kuroda T, Ogiwara H, Sasaki M, Takahashi K, Yoshida H, Kiyokawa T, Sudo K, Tamura K, Kato T, Okamoto A, Kohno T. Therapeutic preferability of gemcitabine for ARID1A-deficient ovarian clear cell carcinoma. Gynecol Oncol, 155:489-498, 2019