Annual Report 2018
Department of Experimental Therapeutics
Noboru Yamamoto, Toshio Shimizu, Yutaka Fujiwara, Kan Yonemori, Kiyoshi Yoshimura, Shigehisa Kitano, Shunsuke Kondo, Satoru Iwasa, Akihiko Shimomura, Takafumi Koyama, Jun Sato
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 evaluation 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 & medical oncology, gastro-intestinal oncology, hepato-biliary & pancreatic oncology, and immune-oncology).
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 FIH trials, and we also perform phase I trials for solid tumors (i.e., all-comers). Recently, we have joined the global phase I trials to accelerate new drug development in Japan. Web- or teleconferences are held with EU and US sites, and we have been discussing patient enrollment as well as 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 about adverse events, patient enrollment and refer the candidates to each other to accelerate enrollment. Nowadays, most of the phase I trials (i.e., first in Japanese phase I trials, first in human trials) in Japan are conducted at the NCC-hospital and NCC-East hospital with firm collaboration.
Research activities
The elucidation of the proof of concept (POC) is essential in new anti-cancer drug development especially in early phases, so we conduct several translational research (TR) projects in collaboration with associated research institutes. Also, we are 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 analysis in the phase I trials, a phase I biobank study was launched in 2018.
Clinical trials
In fiscal 2018, 45 phase I trials including 18 FIH trials were conducted (Table 1).
Table 1. Phase I trals conducted from April/2018 to Mar/2019
Education
In 2018, the 3rd NCCH Workshop on Methods in Oncology Phase I trials and Translational Research was held on 29 July at the NCC-Tsukiji campus.
List of papers published in 2018
Journal
1. 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
2. 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
3. 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, 2019
4. 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
5. Tanaka R, Yonemori K, Hirakawa A, Kinoshita F, Kobayashi Y, Yamazaki N, Fujimoto M, Tamura K, Fujiwara Y. Anticancer Agent-Induced Life-Threatening Skin Toxicities: A Database Study of Spontaneous Reporting Data. Oncologist, 24:266-272, 2019
6. 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
7. 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, 2019
8. 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
9. 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
10. Shiino S, Matsuzaki J, Shimomura A, Kawauchi J, Takizawa S, Sakamoto H, Aoki Y, Yoshida M, Tamura K, Kato K, Kinoshita T, Kitagawa Y, Ochiya T. Serum miRNA-based Prediction of Axillary Lymph Node Metastasis in Breast Cancer. Clin Cancer Res, 25:1817-1827, 2019
11. 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
12. Shimomura A, Yamamoto N, Kondo S, Fujiwara Y, Suzuki S, Yanagitani N, Horiike A, Kitazono S, Ohyanagi F, Doi T, Kuboki Y, Kawazoe A, Shitara K, Ohno I, Banerji U, Sundar R, Ohkubo S, Calleja EM, Nishio M. First-in-Human Phase I Study of an Oral HSP90 Inhibitor, TAS-116, in Patients with Advanced Solid Tumors. Mol Cancer Ther, 18:531-540, 2019
13. 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 alpha-specific PI3K inhibitor, in Japanese patients with advanced solid tumors. Cancer Sci, 110:1021-1031, 2019
14. Fujiwara Y, Iguchi H, Yamamoto N, Hayama M, Nii M, Ueda S, Komuro K, Sugimoto M, Vlahovic G, Kozuki T. Tolerability and efficacy of durvalumab in Japanese patients with advanced solid tumors. Cancer Sci, 110:1715-1723, 2019
15. 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, 2019
16. Nakayama T, Kitano S. Immunotherapy for genitourinary tumors. Int J Urol, 26:326-333, 2019
17. 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
18. 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
19. Ikeda M, Ohno I, Ueno H, Mitsunaga S, Hashimoto Y, Okusaka T, Kondo S, Sasaki M, Sakamoto Y, Takahashi H, Hara R, Kobayashi S, Nakamura O, Morizane C. Phase I study of resminostat, an HDAC inhibitor, combined with S-1 in patients with pre-treated biliary tract or pancreatic cancer. Invest New Drugs, 37:109-117, 2019
20. Itahashi K, Shimizu T, Koyama T, Kondo S, Fujiwara Y, Yamamoto N. Global trends in the distribution of cancer types among patients in oncology phase I trials, 1991-2015. Invest New Drugs, 37:166-174, 2019
21. Yanai T, Iwasa S, Hashimoto H, Ohyanagi F, Takiguchi T, Takeda K, Nakao M, Sakai H, Nakayama T, Minato K, Arai T, Suzuki K, Shimada Y, Nagashima K, Terakado H, Yamamoto N. A double-blind randomized phase II dose-finding study of olanzapine 10 mg or 5 mg for the prophylaxis of emesis induced by highly emetogenic cisplatin-based chemotherapy. Int J Clin Oncol, 23:382-388, 2018
22. Sasaki Y, Iwasa S, Okazaki S, Goto M, Kojima Y, Naganuma A, Nagashima K, Nagai Y, Hirano H, Honma Y, Takashima A, Kato K, Hamaguchi T. A phase II study of combination therapy with oral S-1 and cisplatin in elderly patients with advanced gastric cancer. Gastric Cancer, 21:439-445, 2018
23. Honma Y, Terauchi T, Tateishi U, Kano D, Nagashima K, Shoji H, Iwasa S, Takashima A, Kato K, Hamaguchi T, Boku N, Shimada Y, Yamada Y. Imaging peritoneal metastasis of gastric cancer with 18F-fluorothymidine positron emission tomography/computed tomography: a proof-of-concept study. Br J Radiol, 91:20180259, 2018
24. Sekine K, Hamaguchi T, Shoji H, Takashima A, Honma Y, Iwasa S, Kato K, Takahashi K, Kato T, Kanemitsu Y, Boku N. Retrospective Analyses of Systemic Chemotherapy and Cytoreductive Surgery for Patients with Ovarian Metastases from Colorectal Cancer: A Single-Center Experience. Oncology, 95:220-228, 2018
25. Kamei R, Yoshimura K, Yoshino S, Inoue M, Asao T, Fuse M, Wada S, Kuramasu A, Furuya-Kondo T, Oga A, Iizuka N, Suzuki N, Maeda N, Watanabe Y, Matsukuma S, Iida M, Takeda S, Ueno T, Yamamoto N, Fukagawa T, Katai H, Sasaki H, Hazama S, Oka M, Nagano H. Expression levels of UL16 binding protein 1 and natural killer group 2 member D affect overall survival in patients with gastric cancer following gastrectomy. Oncol Lett, 15:747-754, 2018
26. Yonemori K, Kodaira M, Satoh T, Kudo T, Takahashi S, Nakano K, Ando Y, Shimokata T, Mori J, Inoue K, Oakley GJ, Sakaguchi S, Tamura K. Phase 1 study of olaratumab plus doxorubicin in Japanese patients with advanced soft-tissue sarcoma. Cancer Sci, 109:3962-3970, 2018
27. Iwasa S, Yamamoto N, Shitara K, Tamura K, Matsubara N, Tajimi M, Lin AB, Asou H, Cai Z, Inoue K, Shibasaki Y, Saito K, Takai H, Doi T. Dose-finding study of the checkpoint kinase 1 inhibitor, prexasertib, in Japanese patients with advanced solid tumors. Cancer Sci, 109:3216-3223, 2018
28. Shimoi T, Hamada A, Yamagishi M, Hirai M, Yoshida M, Nishikawa T, Sudo K, Shimomura A, Noguchi E, Yunokawa M, Yonemori K, Shimizu C, Kinoshita T, Fukuda T, Fujiwara Y, Tamura K. PIK3CA mutation profiling in patients with breast cancer, using a highly sensitive detection system. Cancer Sci, 109:2558-2566, 2018
29. Iizumi S, Shimomura A, Shimoi T, Sudo K, Noguchi E, Yonemori K, Shimizu C, Fujiwara Y, Tamura K. Efficacy of capecitabine in patients with locally advanced or metastatic breast cancer with or without prior treatment with fluoropyrimidine: a retrospective study. Cancer Chemother Pharmacol, 82:275-283, 2018
30. Tamura K, Kodaira M, Shimizu C, Yonemori K, Yunokawa M, Shimomura A, Kobayashi T, Nakano K, Tomomatsu J, Ito Y, Tanaka J, Kuriki H, Gu Z, Takahashi S. Phase I study of taselisib in Japanese patients with advanced solid tumors or hormone receptor-positive advanced breast cancer. Cancer Sci, 109:1592-1601, 2018
31. Kodaira M, Yonemori K, Shimoi T, Yoshida A, Yoshida M, Kitano A, Shimomura A, Yunokawa M, Shimizu C, Takiguchi Y, Fujiwara Y, Tamura K. Prognostic impact of presumed breast or ovarian cancer among patients with unfavorable-subset cancer of unknown primary site. BMC Cancer, 18:176, 2018
32. Bun S, Yunokawa M, Tamaki Y, Shimomura A, Shimoi T, Kodaira M, Shimizu C, Yonemori K, Fujiwara Y, Makino Y, Terakado H, Tamura K. Symptom management: the utility of regional cooling for hand-foot syndrome induced by pegylated liposomal doxorubicin in ovarian cancer. Support Care Cancer, 26:2161-2166, 2018
33. Shimoi T, Yoshida M, Kitamura Y, Yoshino T, Kawachi A, Shimomura A, Noguchi E, Yunokawa M, Yonemori K, Shimizu C, Kinoshita T, Ichimura K, Fukuda T, Fujiwara Y, Tamura K. TERT promoter hotspot mutations in breast cancer. Breast Cancer, 25:292-296, 2018
34. Nagumo Y, Maejima A, Toyoshima Y, Komiyama M, Yonemori K, Yoshida A, Fujimoto H. Neoadjuvant crizotinib in ALK-rearranged inflammatory myofibroblastic tumor of the urinary bladder: A case report. Int J Surg Case Rep, 48:1-4, 2018
35. Inagaki C, Shimoi T, Okuma H, Kitano A, Shimomura A, Noguchi E, Kodaira M, Yunokawa M, Yonemori K, Shimizu C, Yoshida A, Fujiwara Y, Tamura K. A case of heavily pretreated metastatic cardiac angiosarcoma treated successfully using eribulin. Anticancer Drugs, 29:97-101, 2018
36. Sunami K, Takahashi H, Tsuchihara K, Takeda M, Suzuki T, Naito Y, Sakai K, Dosaka-Akita H, Ishioka C, Kodera Y, Muto M, Wakai T, Yamazaki K, Yasui W, Bando H, Fujimoto Y, Fukuoka S, Harano K, Kawazoe A, Kimura G, Koganemaru S, Kogawa T, Kotani D, Kuboki Y, Matsumoto H, Matsumoto S, Mishima S, Nakamura Y, Sawada K, Shingaki S, Shitara K, Umemoto K, Umemura S, Yasuda K, Yoshino T, Yamamoto N, Nishio K. Clinical practice guidance for next-generation sequencing in cancer diagnosis and treatment (Edition 10). Cancer Sci, 109:2980-2985, 2018
37. Nishimura Y, Yoshida A, Yonemori K, Motoi N, Tamura K, Hiraoka N, Mori T. SMARCB-1 deficient squamous cell carcinoma of a mediastinal cyst. Pathol Int, 68:563-566, 2018
38. Kimbara S, Fujiwara Y, Iwama S, Ohashi K, Kuchiba A, Arima H, Yamazaki N, Kitano S, Yamamoto N, Ohe Y. Association of antithyroglobulin antibodies with the development of thyroid dysfunction induced by nivolumab. Cancer Sci, 109:3583-3590, 2018
39. Mizutani T, Ando M, Mizusawa J, Nakamura K, Fukuda H, Tsukada H, Abe T, Takeda K, Yokoyama A, Nakamura S, Nakagawa K, Yamamoto N, Ohe Y. Prognostic value of Lung Cancer Subscale in older patients with advanced non-small cell lung cancer: An integrated analysis of JCOG0207 and JCOG0803/WJOG4307L (JCOG1414A). J Geriatr Oncol, 9:583-588, 2018
40. Shinno Y, Goto Y, Watanabe S, Sato J, Morita R, Matsumoto Y, Murakami S, Kanda S, Horinouchi H, Fujiwara Y, Yamamoto N, Ohe Y. Evaluation of time to failure of strategy as an alternative surrogate endpoint in patients with lung cancer with EGFR mutations. ESMO Open, 3:e000399, 2018
41. Hashimoto H, Abe M, Yanai T, Yamaguchi T, Zenda S, Uchitomi Y, Fukuda H, Mori M, Iwasa S, Yamamoto N, Ohe Y. Study protocol for J-SUPPORT 1604 (J-FORCE): a randomized, double blind, placebo-controlled Phase III study evaluating olanzapine (5 mg) plus standard triple antiemetic therapy for prevention of chemotherapy induced nausea and vomiting in patients receiving cisplatin-based highly emetogenic chemotherapy. Jpn J Clin Oncol, 48:950-952, 2018
42. Sekine K, Kanda S, Goto Y, Horinouchi H, Fujiwara Y, Yamamoto N, Motoi N, Ohe Y. Change in the lymphocyte-to-monocyte ratio is an early surrogate marker of the efficacy of nivolumab monotherapy in advanced non-small-cell lung cancer. Lung Cancer, 124:179-188, 2018
43. Yamamoto N, Kenmotsu H, Goto K, Takeda K, Kato T, Takeda M, Horinouchi H, Saito I, Sarashina A, Tanaka T, Morsli N, Nakagawa K. An open-label feasibility study of nintedanib combined with docetaxel in Japanese patients with locally advanced or metastatic lung adenocarcinoma after failure of first-line chemotherapy. Cancer Chemother Pharmacol, 82:685-694, 2018
44. Tanaka M, Horinouchi H, Goto Y, Kanda S, Fujiwara Y, Nokihara H, Yamamoto N, Ohe Y. Reduction in nephrotoxicities using short hydration for chemotherapy containing cisplatin: a consecutive analysis of 467 patients with thoracic malignancies. ESMO Open, 3:e000342, 2018
45. Fujiwara Y, Takeda M, Yamamoto N, Nakagawa K, Nosaki K, Toyozawa R, Abe C, Shiga R, Nakamaru K, Seto T. Safety and pharmacokinetics of DS-6051b in Japanese patients with nonsmall cell lung cancer harboring ROS1 fusions: a phase I study. Oncotarget, 9:23729-23737, 2018
46. Wu YL, Yang JC, Kim DW, Lu S, Zhou J, Seto T, Yang JJ, Yamamoto N, Ahn MJ, Takahashi T, Yamanaka T, Kemner A, Roychowdhury D, Paolini J, Usari T, Wilner KD, Goto K. Phase II Study of Crizotinib in East Asian Patients With ROS1-Positive Advanced Non-Small-Cell Lung Cancer. J Clin Oncol, 36:1405-1411, 2018
47. Akiyoshi K, Hamaguchi T, Yoshimura K, Takahashi N, Honma Y, Iwasa S, Takashima A, Kato K, Yamada Y, Onodera H, Takeshita S, Yasui H, Sakai G, Akatsuka S, Ogawa K, Horita Y, Nagai Y, Shimada Y. A Prospective, Multicenter Phase II Study of the Efficacy and Feasibility of 15-minute Panitumumab Infusion Plus Irinotecan for Oxaliplatin- and Irinotecan-refractory, KRAS Wildtype Metastatic Colorectal Cancer (Short Infusion of Panitumumab Trial). Clin Colorectal Cancer, 17:e83-e89, 2018
48. 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, 2018
49. Furuse J, Kurata T, Okano N, Fujisaka Y, Naruge D, Shimizu T, Kitamura H, Iwasa T, Nagashima F, Nakagawa K. An early clinical trial of Salirasib, an oral RAS inhibitor, in Japanese patients with relapsed/refractory solid tumors. Cancer Chemother Pharmacol, 82:511-519, 2018
50. Hiramoto S, Kato K, Shoji H, Okita N, Takashima A, Honma Y, Iwasa S, Hamaguchi T, Yamada Y, Shimada Y, Boku N. A retrospective analysis of 5-fluorouracil plus cisplatin as first-line chemotherapy in the recent treatment strategy for patients with metastatic or recurrent esophageal squamous cell carcinoma. Int J Clin Oncol, 23:466-472, 2018
51. Horinouchi H, Kubota K, Miyanaga A, Nakamichi S, Seike M, Gemma A, Yamane Y, Kurimoto F, Sakai H, Kanda S, Fujiwara Y, Nokihara H, Yamamoto N, Tamura T, Ohe Y. Oral rehydration solution (OS-1) as a substitute of intravenous hydration after cisplatin administration in patients with lung cancer: a prospective multicenter trial. ESMO Open, 3:e000288, 2018
52. Kaira K, Higuchi T, Naruse I, Arisaka Y, Tokue A, Altan B, Suda S, Mogi A, Shimizu K, Sunaga N, Hisada T, Kitano S, Obinata H, Yokobori T, Mori K, Nishiyama M, Tsushima Y, Asao T. Metabolic activity by 18F-FDG-PET/CT is predictive of early response after nivolumab in previously treated NSCLC. Eur J Nucl Med Mol Imaging, 45:56-66, 2018
53. Kato K, Ura T, Koizumi W, Iwasa S, Katada C, Azuma M, Ishikura S, Nakao Y, Onuma H, Muro K. Nimotuzumab combined with concurrent chemoradiotherapy in Japanese patients with esophageal cancer: A phase I study. Cancer Sci, 109:785-793, 2018
54. Kato T, Seto T, Nishio M, Goto K, Yamamoto N, Okamoto I, Tao L, Yu W, Khaznadar T, Tajima K, Shibata M, Seki A, Yamamoto N. Erlotinib Plus Bevacizumab Phase ll Study in Patients with Advanced Non-small-Cell Lung Cancer (JO25567): Updated Safety Results. Drug safety, 41:229-237, 2018
55. Kawachi A, Yoshida H, Kitano S, Ino Y, Kato T, Hiraoka N. Tumor-associated CD204+ M2 macrophages are unfavorable prognostic indicators in uterine cervical adenocarcinoma. Cancer Sci, 109:863-870, 2018
56. Kitano S, Nakayama T, Yamashita M. Biomarkers for Immune Checkpoint Inhibitors in Melanoma. Front Oncol, 8:270, 2018
57. Kondo S, Sasaki M, Hosoi H, Sakamoto Y, Morizane C, Ueno H, Okusaka T. Incidence and risk factors for venous thromboembolism in patients with pretreated advanced pancreatic carcinoma. Oncotarget, 9:16883-16890, 2018
58. Ohara S, Kanda S, Okuma H, Goto Y, Horinouchi H, Fujiwara Y, Nokihara H, Ito Y, Yamamoto N, Usui K, Homma S, Ohe Y. Effect of sequential chemoradiotherapy in patients with limited-disease small-cell lung cancer who were ineligible for concurrent therapy: a retrospective study at two institutions. Jpn J Clin Oncol, 48:82- 88, 2018
59. Sato J, Horinouchi H, Goto Y, Kanda S, Fujiwara Y, Nokihara H, Yamamoto N, Ohe Y. Long-term survival without surgery in NSCLC patients with synchronous brain oligometastasis: systemic chemotherapy revisited. J Thorac Dis, 10:1696-1702, 2018
60. Seki Y, Fujiwara Y, Kohno T, Yoshida K, Goto Y, Horinouchi H, Kanda S, Nokihara H, Yamamoto N, Kuwano K, Ohe Y. Circulating cell-free plasma tumour DNA shows a higher incidence of EGFR mutations in patients with extrathoracic disease progression. ESMO Open, 3:e000292, 2018
61. Sudo K, Kato K, Kuwabara H, Sasaki Y, Takahashi N, Shoji H, Iwasa S, Honma Y, Okita NT, Takashima A, Hamaguchi T, Yamada Y, Ito Y, Itami J, Fukuda T, Tobinai K, Boku N. Patterns of Relapse after Definitive Chemoradiotherapy in Stage II/III (Non-T4) Esophageal Squamous Cell Carcinoma. Oncology, 94:47-54, 2018
62. Tomuleasa C, Fuji S, Berce C, Onaciu A, Chira S, Petrushev B, Micu WT, Moisoiu V, Osan C, Constantinescu C, Pasca S, Jurj A, Pop L, Berindan-Neagoe I, Dima D, Kitano S. Chimeric Antigen Receptor T-Cells for the Treatment of B-Cell Acute Lymphoblastic Leukemia. Front Immunol, 9:239, 2018
63. Ueno H, Kondo S, Yoshikawa S, Inoue K, Andre V, Tajimi M, Murakami H. A phase I and pharmacokinetic study of taladegib, a Smoothened inhibitor, in Japanese patients with advanced solid tumors. Invest New Drugs, 36:647-656, 2018
64. Xu RH, Muro K, Morita S, Iwasa S, Han SW, Wang W, Kotaka M, Nakamura M, Ahn JB, Deng YH, Kato T, Cho SH, Ba Y, Matsuoka H, Lee KW, Zhang T, Yamada Y, Sakamoto J, Park YS, Kim TW. Modified XELIRI (capecitabine plus irinotecan) versus FOLFIRI (leucovorin, fluorouracil, and irinotecan), both either with or without bevacizumab, as second-line therapy for metastatic colorectal cancer (AXEPT): a multicentre, open-label, randomised, non-inferiority, phase 3 trial. Lancet Oncol, 19:660-671, 2018
65. Yamaguchi T, Kato K, Nagashima K, Iwasa S, Honma Y, Takashima A, Hamaguchi T, Ito Y, Itami J, Boku N, Higuchi K. Type of second primary malignancy after achieving complete response by definitive chemoradiation therapy in patients with esophageal squamous cell carcinoma. Int J Clin Oncol, 23:652-658, 2018
66. Saito K, Ikeda M, Kojima Y, Hosoi H, Saito Y, Kondo S. Lipid profiling of pre-treatment plasma reveals biomarker candidates associated with response rates and hand-foot skin reactions in sorafenib-treated patients. Cancer Chemother Pharmacol, 82:677-684, 2018
67. Yamazaki N, Tsutsumida A, Takahashi A, Namikawa K, Yoshikawa S, Fujiwara Y, Kondo S, Mukaiyama A, Zhang F, Kiyohara Y. Phase 1/2 study assessing the safety and efficacy of dabrafenib and trametinib combination therapy in Japanese patients with BRAF V600 mutation-positive advanced cutaneous melanoma. J Dermatol, 45:397-407, 2018
68. Fujiwara Y, Yamazaki N, Kiyohara Y, Yoshikawa S, Yamamoto N, Tsutsumida A, Nokihara H, Namikawa K, Mukaiyama A, Zhang F, Tamura T. Safety, tolerability, and pharmacokinetic profile of dabrafenib in Japanese patients with BRAF (V600) mutation-positive solid tumors: a phase 1 study. Invest New Drugs, 36:259-268, 2018
69. Itahashi K, Kondo S, Kubo T, Fujiwara Y, Kato M, Ichikawa H, Koyama T, Tokumasu R, Xu J, Huettner CS, Michelini VV, Parida L, Kohno T, Yamamoto N. Evaluating Clinical Genome Sequence Analysis by Watson for Genomics. Front Med, 5:305, 2018
70. Ebata T, Shimoi T, Bun S, Miyake M, Yoshida A, Shimomura A, Noguchi E, Yonemori K, Shimizu C, Fujiwara Y, Narita Y, Tamura K. Efficacy and Safety of Pazopanib for Recurrent or Metastatic Solitary Fibrous Tumor. Oncology, 94:340-344, 2018
71. Kato M, Nakamura H, Nagai M, Kubo T, Elzawahry A, Totoki Y, Tanabe Y, Furukawa E, Miyamoto J, Sakamoto H, Matsumoto S, Sunami K, Arai Y, Suzuki Y, Yoshida T, Tsuchihara K, Tamura K, Yamamoto N, Ichikawa H, Kohno T, Shibata T. A computational tool to detect DNA alterations tailored to formalin-fixed paraffin-embedded samples in cancer clinical sequencing. Genome Med, 10:44, 2018
72. Yamamoto S, Kondo S. Oral chemotherapy for the treatment of hepatocellular carcinoma. Expert Opin Pharmacother, 19:993- 1001, 2018