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BMJ Open Is Committed to Open Peer Review. As Part of This Commitment We Make the Peer Review History of Every Article We Publish Publicly Available BMJ Open: first published as 10.1136/bmjopen-2018-024583 on 21 February 2019. Downloaded from BMJ Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay- per-view fees (http://bmjopen.bmj.com). If you have any questions on BMJ Open’s open peer review process please email [email protected] http://bmjopen.bmj.com/ on September 27, 2021 by guest. Protected copyright. BMJ Open: first published as 10.1136/bmjopen-2018-024583 on 21 February 2019. Downloaded from BMJ Open Incidence and relative risk for developing cancers in women with gestational diabetes mellitus: a nationwide cohort study in Taiwan ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2018-024583 Article Type: Research Date Submitted by the Author: 03-Jun-2018 Complete List of Authors: Peng, Yun-Shing; Chang Gung Memorial Hospital, Chiayi, Division of Endocrinology and Metabolism; Chang Gung University Lin, Jr-Rung; Chang Gung University, Clinical Informatics and Medical Statistics Research Center Cheng, Bi-Hua Ho, Cheng Lin, Yung-Hsiang Shen, Chien-Hen Tsai, Ming-Hung; Chang Gung Memorial Hospital Linkou Branch, Department of Internal Medicine; Chang Gung University Diabetes in pregnancy < DIABETES & ENDOCRINOLOGY, cancer, http://bmjopen.bmj.com/ Keywords: population-based cohort study on September 27, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open: first published as 10.1136/bmjopen-2018-024583 on 21 February 2019. Downloaded from Page 1 of 35 BMJ Open 1 2 3 4 Article title 5 6 7 Incidence and relative risk for developing cancers in women with gestational diabetes 8 9 mellitus: a nationwide cohort study in Taiwan 10 11 12 13 14 15 Running title: 16 For peer review only 17 18 Increased risk of cancer with previous gestational diabetes 19 20 21 Authors: 22 23 Yun-Shing Peng,1,2 Jr Rung Lin2,3, Bi-Hua Cheng4, Cheng Ho1, Yung-Hsiang Lin1, 24 25 26 Chien-Hen Shen5, Ming-Hung Tsai2,6 27 28 29 1Division of Endocrinology and Metabolism, Chang Gung Memorial Hospital, 30 31 http://bmjopen.bmj.com/ 32 Chia-Yi, Taiwan. 33 34 2 35 Chang Gung University, College of Medicine, Tao-Yuan, Taiwan 36 37 3 38 Clinical Informatics and Medical Statistics Research Center and Graduate Institute of 39 on September 27, 2021 by guest. Protected copyright. 40 Clinical Medicine, Chang Gung University, Taoyuan, Taiwan 41 42 43 4Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Chiayi, 44 45 46 Taiwan. 47 48 5 49 Department of internal medicine, Chang Gung Memorial Hospital, Chia-Yi, Taiwan. 50 51 6 52 Department of internal medicine, Chang Gung Memorial Hospital, Lin-Kuo medical 53 54 center, Taoyoun, Taiwan. 55 56 57 1 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open: first published as 10.1136/bmjopen-2018-024583 on 21 February 2019. Downloaded from BMJ Open Page 2 of 35 1 2 3 4 5 6 7 Corresponding author: 8 9 Ming-Hung Tsai, MD 10 11 12 Department of internal medicine 13 14 15 Chang Gung Memorial Hospital 16 For peer review only 17 18 Chang Gung University 19 20 21 No.5, Fu-Hsing Street, Guei-Shan District, Taoyuan, Taiwan 22 23 Tel: +886-3-3281200 ext. 8108 24 25 26 Fax: +886-3-3288662 27 28 29 E-mail: [email protected] 30 31 http://bmjopen.bmj.com/ 32 33 34 35 Word count 36 37 38 2948 39 on September 27, 2021 by guest. Protected copyright. 40 Number of tables 41 42 43 3 44 45 46 Number of Figures 47 48 49 2 50 51 52 Abbreviations 53 54 GDM, gestational diabetes; T2DM, type 2 diabetes; NHIRD, National Health 55 56 57 2 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open: first published as 10.1136/bmjopen-2018-024583 on 21 February 2019. Downloaded from Page 3 of 35 BMJ Open 1 2 3 4 Insurance Research Database; ICD-9-CM, International Classification of Disease, 9th 5 6 7 Revision, Clinical Modification; OPD, outpatient department; AHR, adjusted hazard 8 9 ratio. 10 11 12 13 14 15 Conflict of interest 16 For peer review only 17 18 The authors declare no conflict of interest. 19 20 21 22 23 24 25 26 27 28 29 30 31 http://bmjopen.bmj.com/ 32 33 34 35 36 37 38 39 on September 27, 2021 by guest. Protected copyright. 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 3 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open: first published as 10.1136/bmjopen-2018-024583 on 21 February 2019. Downloaded from BMJ Open Page 4 of 35 1 2 3 4 ABSTRACT 5 6 7 Objectives: 8 9 To evaluate the risk of developing cancers, particularly site-specific cancers, in 10 11 12 women with gestational diabetes mellitus (GDM) in Taiwan. 13 14 15 Setting: 16 For peer review only 17 18 The National Health Insurance Research Database (NHIRD) of Taiwan. 19 20 21 Participants 22 23 This study was conducted using the nationwide data from 2000 to 2013. In total, 24 25 26 1,466,596 pregnant women with admission for delivery were identified. Subjects with 27 28 29 GDM consisted of 47,373 women, while the control group consisted of 943,199 30 31 http://bmjopen.bmj.com/ 32 women without GDM. The participants were followed from the delivery date to the 33 34 35 diagnosis of cancer, death, the last medical claim or the end of follow-up (December 36 37 38 31 2013), whichever came first. 39 on September 27, 2021 by guest. Protected copyright. 40 Primary outcome measures: 41 42 43 Patients with a new diagnosis of cancer (ICD-9-CM codes 140–208) recorded in 44 45 46 NHRID were identified. The risk of 11 major cancer types was assessed, including 47 48 49 cancers of head and neck, digestive organs, lung and bronchus, bone and connective 50 51 52 tissue, skin, breast, genital organs, urinary system, brain, thyroid and hematological 53 54 system. 55 56 57 4 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open: first published as 10.1136/bmjopen-2018-024583 on 21 February 2019. Downloaded from Page 5 of 35 BMJ Open 1 2 3 4 Results: 5 6 7 The rates of developing cancers were significantly higher in women with GDM 8 9 compared to non-GDM group (2.24% vs. 1.96%; p<0.001). After adjusting for 10 11 12 maternal age at delivery and comorbidities, women with GDM had increased risk of 13 14 15 cancers, including cancers of nasopharynx (adjust hazard ratio (AHR), 1.739; 95 % 16 For peer review only 17 18 CI, 1.400 to 2.161; p<0.0001), kidney (AHR, 2.169; 95 % CI, 1.428 to 3.293; 19 20 21 p=0.0003), lung and bronchus (AHR, 1.372; 95 % CI, 1.044 to 1.803; p=0.0231), 22 23 breast (AHR, 1.234; 95 % CI, 1.093 to 1.393; p=0.007), and thyroid gland (AHR, 24 25 26 1.389; 95 % CI, 1.121 to 1.721; p=0.0026). 27 28 29 Conclusion: Women with GDM have a higher risk of developing cancers. Cancer 30 31 http://bmjopen.bmj.com/ 32 screening is warranted in women with GDM. Future research should be aimed to 33 34 35 establish whether this association is causal. 36 37 38 Keywords：Gestational diabetes, Cancer, National health insurance research database 39 on September 27, 2021 by guest. Protected copyright. 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 5 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open: first published as 10.1136/bmjopen-2018-024583 on 21 February 2019. Downloaded from BMJ Open Page 6 of 35 1 2 3 4 Strengths and limitations of this study 5 6 7 • Our study represents the first one to document that women with GDM have a 8 9 higher risk of developing cancers of nasopharynx, lung and bronchus, and 10 11 12 kidney. 13 14 15 • This nationwide population-based cohort study included more than one million 16 For peer review only 17 18 women, making selection bias minimal. Furthermore, the use of big data from 19 20 21 Taiwan NHIRD also decreased the risk of recall bias which is inherent to 22 23 self-reporting. Thus, our findings are potentially generalizable. 24 25 26 • The data from NHIRD lack information on other factors that may be 27 28 29 associated with GDM and cancer, such as smoking, alcohol consumption, 30 31 http://bmjopen.bmj.com/ 32 obesity, dietary style, environmental exposure, genetic parameters, and family 33 34 35 history of cancers.
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