Real-World Outcomes of Systemic Therapy in Japanese Patients with Cancer (Tokushukai REAl-World Data Project: TREAD): Study Protocol for a Nationwide Cohort Study

doi:10.3390/healthcare10112146

. 2022 Oct 28;10(11):2146.

doi: 10.3390/healthcare10112146.

Real-World Outcomes of Systemic Therapy in Japanese Patients with Cancer (Tokushukai REAl-World Data Project: TREAD): Study Protocol for a Nationwide Cohort Study

Rai Shimoyama¹, Yoshinori Imamura², Kiyoaki Uryu³, Takahiro Mase⁴, Yoshiaki Fujimura⁵, Maki Hayashi⁶, Megu Ohtaki⁷, Keiko Ohtani⁷, Nobuaki Shinozaki^{1

8}, Hironobu Minami^{2

9}

Affiliations

¹ Department of General Surgery, Shonankamakura General Hospital, Kamakura 247-8533, Japan.
² Department of Medical Oncology and Hematology, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan.
³ Department of Medical Oncology, Yao Tokushukai General Hospital, Yao 581-0011, Japan.
⁴ Department of Breast Surgery, Ogaki Tokushukai Hospital, Ogaki 503-0015, Japan.
⁵ Tokushukai Information System Inc., Osaka 530-0001, Japan.
⁶ Mirai Iryo Research Center Inc., Tokyo 102-0083, Japan.
⁷ deCult Co., Ltd., Hatsukaichi 739-0413, Japan.
⁸ General Incorporated Association Tokushukai, Tokyo 102-0074, Japan.
⁹ Cancer Center, Kobe University Hospital, Kobe 650-0017, Japan.

PMID: 36360487
PMCID: PMC9690553
DOI: 10.3390/healthcare10112146

Real-World Outcomes of Systemic Therapy in Japanese Patients with Cancer (Tokushukai REAl-World Data Project: TREAD): Study Protocol for a Nationwide Cohort Study

Rai Shimoyama et al. Healthcare (Basel). 2022.

. 2022 Oct 28;10(11):2146.

doi: 10.3390/healthcare10112146.

Authors

Rai Shimoyama¹, Yoshinori Imamura², Kiyoaki Uryu³, Takahiro Mase⁴, Yoshiaki Fujimura⁵, Maki Hayashi⁶, Megu Ohtaki⁷, Keiko Ohtani⁷, Nobuaki Shinozaki^{1

8}, Hironobu Minami^{2

9}

Affiliations

¹ Department of General Surgery, Shonankamakura General Hospital, Kamakura 247-8533, Japan.
² Department of Medical Oncology and Hematology, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan.
³ Department of Medical Oncology, Yao Tokushukai General Hospital, Yao 581-0011, Japan.
⁴ Department of Breast Surgery, Ogaki Tokushukai Hospital, Ogaki 503-0015, Japan.
⁵ Tokushukai Information System Inc., Osaka 530-0001, Japan.
⁶ Mirai Iryo Research Center Inc., Tokyo 102-0083, Japan.
⁷ deCult Co., Ltd., Hatsukaichi 739-0413, Japan.
⁸ General Incorporated Association Tokushukai, Tokyo 102-0074, Japan.
⁹ Cancer Center, Kobe University Hospital, Kobe 650-0017, Japan.

PMID: 36360487
PMCID: PMC9690553
DOI: 10.3390/healthcare10112146

Abstract

Cohort studies using large-scale databases have become increasingly important in recent years. The Tokushukai Medical Group is a leading medical group in Japan that includes 71 general hospitals nationwide from Hokkaido to Okinawa, with a total of 18,000 beds, and a unified electronic medical record system. This retrospective cohort study aims to evaluate the real-world outcomes of systemic therapy for Japanese patients with cancer using this merit of scale. All adult patients with cancer who received systemic therapy using a centrally registered chemotherapy protocol system at 46 hospitals from April 2010 to March 2020 will be identified (~48,850 patients). Key exclusion criteria include active double cancer and inadequate data extraction. Data will be obtained through electronic medical records, diagnosis procedure combination data, medical prescription data, and the national cancer registration system that includes sociodemographic variables, diagnostic and laboratory tests, concomitant drug prescriptions, cost, and overall survival. Kaplan-Meier estimates will be calculated for time-to-event analyses. Stratified/conventional Cox proportional hazards regression analyses will be conducted to examine the relationships between overall survival and related factors. Our findings provide important insights for future research directions, policy initiatives, medical guidelines, and clinical decision-making.

Keywords: National Cancer Registry; cancer chemotherapy; diagnosis procedure combination data; real-world data.

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Conflict of interest statement

Some of the authors have received research funding, honoraria, or scholarship donations from various pharmaceutical companies and other organizations outside of the submitted work, none of which construe actual or potential conflicts of interest. Y.I. received speakers’ bureau fees/honoraria from Bayer, Bristol-Myers Squibb, Daiichi-Sankyo, Pfizer, and Ono Pharm, outside of the submitted work. H.M. has received speakers’ bureau fees/honoraria from Daiichi-Sankyo and Ono Pharm; research funding from Astelas-Amgen Biopharma, Bayer, Bristol Myers Squibb, Chugai, Daiichi-Sankyo, Incite, Novartis, Ono Pharm, Pfizer, and Rakuten-Medical; and scholarship donations from Bayer, Chugai, Daiichi-Sankyo, Eisai, Kyowa-Kirin, Lilly, Ono Pharmaceutical, Pfizer, Taiho Pharma, and Takeda, outside of the submitted work. These organizations had no role in the design, conduct, or reporting of this work.

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[1] Streptomycin in Tuberculosis Trials Committee Streptomycin treatment of pulmonary tuberculosis. Br. Med. J. 1948;2:769–782. doi: 10.1136/bmj.2.4582.769. - DOI - PMC - PubMed

[2] Streptomycin in Tuberculosis Trials Committee Streptomycin treatment of pulmonary tuberculosis. Br. Med. J. 1948;2:769–782. doi: 10.1136/bmj.2.4582.769. - DOI - PMC - PubMed

[3] Bothwell L.E., Podolsky S.H. The emergence of the randomized, controlled trial. N. Engl. J. Med. 2016;375:501–504. doi: 10.1056/NEJMp1604635. - DOI - PubMed

[4] Bothwell L.E., Podolsky S.H. The emergence of the randomized, controlled trial. N. Engl. J. Med. 2016;375:501–504. doi: 10.1056/NEJMp1604635. - DOI - PubMed

[5] Milsted R. Cancer drug approval in the United States, Europe, and Japan. Adv. Cancer Res. 2006;96:371–391. doi: 10.1016/S0065-230X(06)96012-6. - DOI - PubMed

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[7] Townsley C.A., Selby R., Siu L.L. Systematic review of barriers to the recruitment of older patients with cancer onto clinical trials. J. Clin. Oncol. 2005;23:3112–3124. doi: 10.1200/JCO.2005.00.141. - DOI - PubMed

[8] Townsley C.A., Selby R., Siu L.L. Systematic review of barriers to the recruitment of older patients with cancer onto clinical trials. J. Clin. Oncol. 2005;23:3112–3124. doi: 10.1200/JCO.2005.00.141. - DOI - PubMed

[9] Liu R., Rizzo S., Whipple S., Pal N., Pineda A.L., Lu M., Arnieri B., Lu Y., Capra W., Copping R., et al. Evaluating eligibility criteria of oncology trials using real-world data and AI. Nature. 2021;592:629–633. doi: 10.1038/s41586-021-03430-5. - DOI - PMC - PubMed

[10] Liu R., Rizzo S., Whipple S., Pal N., Pineda A.L., Lu M., Arnieri B., Lu Y., Capra W., Copping R., et al. Evaluating eligibility criteria of oncology trials using real-world data and AI. Nature. 2021;592:629–633. doi: 10.1038/s41586-021-03430-5. - DOI - PMC - PubMed

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Real-World Outcomes of Systemic Therapy in Japanese Patients with Cancer (Tokushukai REAl-World Data Project: TREAD): Study Protocol for a Nationwide Cohort Study

Affiliations

Real-World Outcomes of Systemic Therapy in Japanese Patients with Cancer (Tokushukai REAl-World Data Project: TREAD): Study Protocol for a Nationwide Cohort Study

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Affiliations

Abstract

Conflict of interest statement

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