Annual Report 2020
Division of Biostatistical Research
Taro Shibata, Aya Kuchiba
Introduction
Biostatisticians at the NCC have two key roles. The first role is to contribute to providing best evidence as scientists through planning and implementation of statistical designs and methodsas well as statistical considerations in every stage of a subject-matter research project. The second role is to develop novel statistical and mathematical methods, motivated by methodological issues that arise in various scientific disciplines. While the Biostatistics Division at the Center for Research Administration and Support makes comprehensive efforts to work on any research, the Division of Biostatistical Research at the Center for Public Health Sciences particularly focuses on public health research.
Research activities
Investigators in the Division of Biostatistical Research are actively working on identifying and solving statistical problems, and developing novel methodology in various research areas.
Epidemiology and Prevention Research Area
We have published a research paper on the study for developing prediction models for upper aerodigestive tract cancer, including gene-environment interaction in the case-cohort study. We have also submitted the work on the methods for causal mediation analysis with a potential outcome framework to gain deeper insights into the mechanism of cancer development.
We have been involved in writing the implementation research protocol for the workplace interventional study. In addition, the study results on the effectiveness of a cancer risk prediction tool on lifestyle habits have been published.
Survivorship Research Area
We are involved in projects with breast cancer survivors: the questionnaire survey on physical activity and the development of exercise programs. An interventional study on the efficacy of the proposed exercise program has been published.
Clinical Research Area
▷ Development and utilization of clinical trial database
We are regularly updating information on ongoing clinical trials by establishing collaborative relationships with other sources of cancer information and the project teams of cancer research.
▷ Support system for endoscopic diagnosis with artificial intelligence
We are developing the study protocols for evaluating the diagnostic performance of support systems for endoscopic diagnosis with artificial intelligence. We have contributed to publication of such research papers as well as medical device approval.
▷ Reliability of real-world data (RWD) and patient registry/study design and statistical methods for utilizing RWD
In the projects supported by AMED, we provide perspectives on the requirement for reliability of RWD and patient registry data for pharmaceutical approval. We also review the study designs and statistical methods for utilizing RWD.
Methodological Research
▷ Prediction performance for multi-category outcome
We have submitted a research paper on the methods for interval estimate for F1 scores.
▷ Latent subgroup
We have worked on the statistical method to detect latent subgroups for treatment response and presented at the international statistical workshop.
▷ Multistage sampling framework
Recently, the quantitative methods for generalizability and transportability have been rapidly developed. We have been working on extending the methods for analyzing data with complex sampling structure. We have presented the ongoing project at the international statistical meeting.
Future Prospects
Biostatistics has a close connection with real applications. Working on both methodological projects and real applications is important for future developments of biostatistical research. In 2020, we have started a collaborative activity with the experts in bioinformatics and clinicians to build effective research framework, in addition to the above.
We endeavor to establish a powerful collaborative relationship with researchers throughout the NCC and to identify critical issues that the NCC aims to tackle.
List of papers published in 2020
Journal
1. Imamura Y, Toihata T, Haraguchi I, Ogata Y, Takamatsu M, Kuchiba A, Tanaka N, Gotoh O, Mori S, Nakashima Y, Oki E, Mori M, Oda Y, Taguchi K, Yamamoto M, Morita M, Yoshida N, Baba H, Mine S, Nunobe S, Sano T, Noda T, Watanabe M. Immunogenic characteristics of microsatellite instability-low esophagogastric junction adenocarcinoma based on clinicopathological, molecular, immunological and survival analyses. Int J Cancer, 148:1260-1275, 2021
2. Yuwaki K, Kuchiba A, Otsuki A, Odawara M, Okuhara T, Ishikawa H, Inoue M, Tsugane S, Shimazu T. Effectiveness of a Cancer Risk Prediction Tool on Lifestyle Habits: A Randomized Controlled Trial. Cancer Epidemiol Biomarkers Prev, 30:1063-1071, 2021
3. 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
4. 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
5. Mori M, Morita T, Matsuda Y, Yamada H, Kaneishi K, Matsumoto Y, Matsuo N, Odagiri T, Aruga E, Watanabe H, Tatara R, Sakurai H, Kimura A, Katayama H, Suga A, Nishi T, Shirado AN, Watanabe T, Kuchiba A, Yamaguchi T, Iwase S. How successful are we in relieving terminal dyspnea in cancer patients? A real-world multicenter prospective observational study. Support Care Cancer, 28:3051-3060, 2020
6. Nishimura Y, Ishikura S, Shibata T, Kodaira T, Ito Y, Tsuchiya K, Murakami Y, Saitoh JI, Akimoto T, Nakata K, Yoshimura M, Teshima T, Toshiyasu T, Ota Y, Ishikawa K, Shimizu H, Minemura T, Nakamura K, Hiraoka M. A phase II study of adaptive two-step intensity-modulated radiation therapy (IMRT) with chemotherapy for loco-regionally advanced nasopharyngeal cancer (JCOG1015). Int J Clin Oncol, 25:1250-1259, 2020
7. Oashi K, Shibata T, Namikawa K, Takahashi A, Yokota K, Nakano E, Teramoto Y, Tsutsumida A, Maeda T, Yamazaki N. A single-arm confirmatory trial of pazopanib in patients with paclitaxel-pretreated primary cutaneous angiosarcoma: Japan Clinical Oncology Group study (JCOG1605, JCOG-PCAS protocol). BMC Cancer, 20:652, 2020
8. Iwasa S, Okita N, Kuchiba A, Ogawa G, Kawasaki M, Nakamura K, Shoji H, Honma Y, Takashima A, Kato K, Hamaguchi T, Boku N, Yamada Y. Phase II study of lenvatinib for metastatic colorectal cancer refractory to standard chemotherapy: the LEMON study (NCCH1503). ESMO Open, 5:2020
9. Kagami Y, Yamamoto K, Shibata T, Tobinai K, Imaizumi Y, Uchida T, Shimada K, Minauchi K, Fukuhara N, Kobayashi H, Yamauchi N, Tsujimura H, Hangaishi A, Tominaga R, Suehiro Y, Yoshida S, Inoue Y, Suzuki S, Tokuhira M, Kusumoto S, Kuroda J, Yakushijin Y, Takamatsu Y, Kubota Y, Nosaka K, Morishima S, Nakamura S, Ogura M, Maruyama D, Hotta T, Morishima Y, Tsukasaki K, Nagai H. R-CHOP-14 versus R-CHOP-14/CHASER for upfront autologous transplantation in diffuse large B-cell lymphoma: JCOG0908 study. Cancer Sci, 111:3770-3779, 2020
10. Arita H, Matsushita Y, Machida R, Yamasaki K, Hata N, Ohno M, Yamaguchi S, Sasayama T, Tanaka S, Higuchi F, Iuchi T, Saito K, Kanamori M, Matsuda KI, Miyake Y, Tamura K, Tamai S, Nakamura T, Uda T, Okita Y, Fukai J, Sakamoto D, Hattori Y, Pareira ES, Hatae R, Ishi Y, Miyakita Y, Tanaka K, Takayanagi S, Otani R, Sakaida T, Kobayashi K, Saito R, Kurozumi K, Shofuda T, Nonaka M, Suzuki H, Shibuya M, Komori T, Sasaki H, Mizoguchi M, Kishima H, Nakada M, Sonoda Y, Tominaga T, Nagane M, Nishikawa R, Kanemura Y, Kuchiba A, Narita Y, Ichimura K. TERT promoter mutation confers favorable prognosis regardless of 1p/19q status in adult diffuse gliomas with IDH1/2 mutations. Acta Neuropathol Commun, 8:201, 2020
11. Kitamura H, Hinotsu S, Tsukamoto T, Shibata T, Mizusawa J, Kobayashi T, Miyake M, Nishiyama N, Kojima T, Nishiyama H. Effect of neoadjuvant chemotherapy on health-related quality of life in patients with muscle-invasive bladder cancer: results from JCOG0209, a randomized phase III study. Jpn J Clin Oncol, 50:1464-1469, 2020
12. Kunitoh H, Tsuboi M, Wakabayashi M, Okada M, Suzuki K, Watanabe S, Asamura H, Fukuda H, Shibata T, Kazato T, Mizutani T, Eba J. A phase III study of adjuvant chemotherapy in patients with completely resected, node-negative non-small cell lung cancer (JCOG 0707). JTCVS Open, 4:90-102, 2020
13. Kawai A, Higashi T, Shibata T, Yoshida A, Katoh Y, Fujiwara Y, Nishida T. Rare cancers in Japan: definition, clinical features and future perspectives. Jpn J Clin Oncol, 50:970-975, 2020