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Annual Report 2021

Division of Biostatistical Research

Taro Shibata, Aya Kuchiba

Introduction

 The investigators in the Division of Biostatistical Research develop statistical methods and research methodology, motivated by the statistical problems in public health research. We collaborate with various divisions in the National Cancer Center, and contribute to better understanding of specific research questions and improving public health through developing and applying statistical methodology. Our expertise in quantitative methods enhances the research platforms by providing advice for formulating research hypotheses, choosing study designs, collecting and managing research data, designing databases, and analyzing data.

 We are closely working with the investigators in the Biostatistics Division, Center for Research Administration and Support.

Research activities

Methodological Research

  • For multi-category classification problems, a collaborative research paper on estimating the confidence intervals for F1 scores has been accepted.
  • Recently, quantitative methods for generalizability and transportability have been rapidly developing. We have been working on extending the methods for analyzing data with a complex sampling structure and applying our methods to real research data.

Research Methodology with Registry/Real-World Data

  • We are regularly updating information on ongoing clinical trials by establishing collaborative relationships with other sources of cancer information and the project teams in cancer research.
  • As part of a project supported by AMED, we hosted symposiums on RWD utilization, and presented perspectives on the requirement for reliability of RWD and patient registry data for pharmaceutical approval, and study designs and statistical methods for utilizing RWD.

Building and Utilizing Research Platforms

  • We are preparing a framework for providing consultation on the methods in biostatistics and bioinformatics for clinical research with omics data, in cooperation with the investigators in the Division of Bioinformatics, Research Institute.
  • Collaborative research with clinicians, biostatisticians, and bioinformaticians on exploring prognostic biomarkers for early esophageal cancer has been published (JCOG0502A1).

Collaborative Research

  • We are working on applying causal mediation analysis with a potential outcome framework to get deeper insights into the mechanisms of cancer development.
  • We are involved in projects on implementation research for quitting smoking from the planning stage.
  • survivors from the planning stage. The results from an interventional study on the efficacy of a proposed exercise program have been presented at an academic conference.
  • We are developing the study protocols for evaluating the diagnostic performance of support systems for endoscopic diagnosis using artificial intelligence.

Future Prospects

 Biostatistics has a close connection with real applications. In 2021, we continued to collaborate in projects in epidemiology, implementation research, and cancer survivorship, as well as in methodological research. In addition, we have started collaborative activities with experts in bioinformatics to build effective research frameworks and develop analysis methods. We endeavor to establish a powerful collaborative relationship with researchers throughout the NCC and to identify critical issues that the NCC needs to tackle.

List of papers published in 2021

Journal

1. Oshima K, Kato K, Ito Y, Daiko H, Nozaki I, Nakagawa S, Shibuya Y, Kojima T, Toh Y, Okada M, Hironaka S, Akiyama Y, Komatsu Y, Maejima K, Nakagawa H, Onuki R, Nagai M, Kato M, Kanato K, Kuchiba A, Nakamura K, Kitagawa Y. Prognostic biomarker study in patients with clinical stage I esophageal squamous cell carcinoma: JCOG0502-A1. Cancer science, 113:1018-1027, 2022

2. Tsukamoto S, Kuchiba A, Moritani K, Shida D, Katayama H, Yorikane E, Kanemitsu Y. Laparoscopic surgery using 8 K ultra-high-definition technology: Outcomes of a phase II study. Asian journal of endoscopic surgery, 15:7-14, 2022

3. Shimizu Y, Tsuji K, Ochi E, Okubo R, Kuchiba A, Shimazu T, Tatematsu N, Sakurai N, Iwata H, Matsuoka YJ. Oncology care providers' awareness and practice related to physical activity promotion for breast cancer survivors and barriers and facilitators to such promotion: a nationwide cross-sectional web-based survey. Supportive care in cancer: official journal of the Multinational Association of Supportive Care in Cancer, 30:3105-3118, 2022

4. Ochi E, Tsuji K, Narisawa T, Shimizu Y, Kuchiba A, Suto A, Jimbo K, Takayama S, Ueno T, Sakurai N, Matsuoka Y. Cardiorespiratory fitness in breast cancer survivors: a randomised controlled trial of home-based smartphone supported high intensity interval training. BMJ supportive & palliative care, 12:33-37, 2022

5. Takahashi K, Yamamoto K, Kuchiba A, Koyama T. Confidence interval for micro-averaged F1 and macro-averaged F1 scores. Applied intelligence (Dordrecht, Netherlands), 52:4961-4972, 2022

6. Tsuji K, Matsuoka YJ, Kuchiba A, Suto A, Ochi E. Accuracy of exercise-based tests for estimating cardiorespiratory fitness and muscle strength in early-stage breast cancer survivors in Japan. Supportive care in cancer: official journal of the Multinational Association of Supportive Care in Cancer, 30:3857-3863, 2022

7. Ishikawa M, Shibata T, Iwata T, Nishio S, Takada T, Suzuki S, Horie K, Kudaka W, Kagabu M, Tanikawa M, Kitagawa R, Takekuma M, Kobayashi H, Yaegashi N. A randomized phase II/III trial of conventional paclitaxel and carboplatin with or without bevacizumab versus dose-dense paclitaxel and carboplatin with or without bevacizumab, in stage IVB, recurrent, or persistent cervical carcinoma (JCOG1311): Primary analysis. Gynecologic oncology, 162:292-298, 2021

8. Shimomura A, Tamura K, Tanaka K, Mizutani T, Sasaki K, Sekino Y, Sawaki M, Shien T, Shibata T, Iwata H. A randomized phase III study comparing trastuzumab emtansine with trastuzumab, pertuzumab and docetaxel in elderly patients with advanced stage HER2-positive breast cancer: Japan Clinical Oncology Group Study (JCOG1607, HERB TEA study). Japanese journal of clinical oncology, 51:1471-1474, 2021

9. Hara H, Uemura Y, Hayakawa K, Togano T, Asai Y, Matsunaga N, Terada M, Ohtsu H, Kitajima K, Shimizu Y, Sato L, Ishikane M, Kinoshita-Iwamoto N, Shibata T, Kondo M, Izumi K, Sugiura W, Ohmagari N. Evaluation of the efficacy of anticoagulation therapy in reducing mortality in a nationwide cohort of hospitalized patients with coronavirus disease in Japan. International journal of infectious diseases: IJID: official publication of the International Society for Infectious Diseases, 112:111-116, 2021

10. Matsunaga N, Hayakawa K, Terada M, Ohtsu H, Asai Y, Tsuzuki S, Suzuki S, Toyoda A, Suzuki K, Endo M, Fujii N, Suzuki M, Saito S, Uemura Y, Shibata T, Kondo M, Izumi K, Terada-Hirashima J, Mikami A, Sugiura W, Ohmagari N. Clinical Epidemiology of Hospitalized Patients With Coronavirus Disease 2019 (COVID-19) in Japan: Report of the COVID-19 Registry Japan. Clinical infectious diseases: an official publication of the Infectious Diseases Society of America, 73:e3677-e3689, 2021

11. Fujimoto K, Arita H, Satomi K, Yamasaki K, Matsushita Y, Nakamura T, Miyakita Y, Umehara T, Kobayashi K, Tamura K, Tanaka S, Higuchi F, Okita Y, Kanemura Y, Fukai J, Sakamoto D, Uda T, Machida R, Kuchiba A, Maehara T, Nagane M, Nishikawa R, Suzuki H, Shibuya M, Komori T, Narita Y, Ichimura K. TERT promoter mutation status is necessary and sufficient to diagnose IDH-wildtype diffuse astrocytic glioma with molecular features of glioblastoma. Acta neuropathologica, 142:323-338, 2021

12. Tagawa T, Yamada M, Minagawa T, Sekiguchi M, Konda K, Tanaka H, Takamaru H, Sekiguchi M, Sakamoto T, Matsuda T, Kuchiba A, Yoshida H, Saito Y. Endoscopic characteristics influencing postpolypectomy bleeding in 1147 consecutive pedunculated colonic polyps: a multicenter retrospective study. Gastrointestinal endoscopy, 94:803-811.e6, 2021

13. Okuma HS, Yonemori K, Kojima Y, Tanioka M, Sudo K, Noguchi E, Hijioka S, Wakakuwa K, Kato K, Hirakawa A, Kuchiba A, Kubo T, Ichikawa H, Yoshida A, Yatabe Y, Nakamura K, Mano H, Yamamoto N, Fujiwara Y. Clinical Utility of Circulating Tumor DNA in Advanced Rare Cancers. Frontiers in oncology, 11:732525, 2021

14. 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 epidemiology, biomarkers & prevention: a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology, 30:1063-1071, 2021

15. Nishino K, Fujiwara Y, Ohe Y, Saito R, Miyauchi E, Kobayashi T, Nakai Y, Takahashi T, Shibata T, Hamaguchi T, Kikuchi K, Yamazaki N, Fukuda H, Nozawa K, Kiyohara Y. Results of the non-small cell lung cancer part of a phase III, open-label, randomized trial evaluating topical corticosteroid therapy for facial acneiform dermatitis induced by EGFR inhibitors: stepwise rank down from potent corticosteroid (FAEISS study, NCCH-1512). Supportive care in cancer: official journal of the Multinational Association of Supportive Care in Cancer, 29:2327-2334, 2021