PROgesterone Therapy for Endometrial Cancer Prevention in Obese Women (PROTEC) Trial: A Feasibility Study.
Journal
Cancer prevention research (Philadelphia, Pa.)
ISSN: 1940-6215
Titre abrégé: Cancer Prev Res (Phila)
Pays: United States
ID NLM: 101479409
Informations de publication
Date de publication:
02 2021
02 2021
Historique:
received:
18
05
2020
revised:
22
08
2020
accepted:
16
09
2020
pubmed:
2
10
2020
medline:
8
2
2022
entrez:
1
10
2020
Statut:
ppublish
Résumé
Obesity is the major etiologic driver for endometrial cancer. The levonorgestrel intrauterine system (LNG-IUS) reduces the risk of endometrial cancer and its precursor, atypical hyperplasia. We assessed feasibility and uptake of the LNG-IUS for primary prevention of endometrial cancer in high-risk women and its impact on endometrial tissue biomarkers. Women with class-III obesity [body mass index (BMI) > 40 kg/m
Identifiants
pubmed: 32998940
pii: 1940-6207.CAPR-20-0248
doi: 10.1158/1940-6207.CAPR-20-0248
doi:
Substances chimiques
Biomarkers, Tumor
0
Levonorgestrel
5W7SIA7YZW
Types de publication
Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
263-274Subventions
Organisme : Department of Health
ID : NIHR-CS-012-009
Pays : United Kingdom
Informations de copyright
©2020 American Association for Cancer Research.
Références
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68:394–424.
Crosbie EJ, Morrison J. The emerging epidemic of endometrial cancer: time to take action. Cochrane Database Syst Rev. 2014;12:ED000095.
Setiawan VW, Yang HP, Pike MC, McCann SE, Yu H, Xiang YB, et al. Type I and II endometrial cancers: have they different risk factors?. J Clin Oncol. 2013;31:2607–18.
Arnold M, Pandeya N, Byrnes G, Renehan AG, Stevens GA, Ezzati M, et al. Global burden of cancer attributable to high body-mass index in 2012: a population-based study. Lancet Oncol. 2015;16:36–46.
Crosbie EJ, Zwahlen M, Kitchener HC, Egger M, Renehan AG. Body mass index, sex hormone-related states and endometrial cancer risk: a meta-analysis. Cancer Epidemiol Biomarkers Prev. 2010;19:3119–30.
Calle EE, Kaaks R. Overweight, obesity and cancer: epidemiological evidence and proposed mechanisms. Nat Rev Cancer. 2004;4:579–91.
Ward KK, Roncancio AM, Shah NR, Davis MA, Saenz CC, McHale MT, et al. Bariatric surgery decreases the risk of uterine malignancy. Gynecol Oncol. 2014;133:63–6.
Anveden A, Taube M, Peltonen M, Jacobson P, Andersson-Assarsson JC, Sjoholm K, et al. Long-term incidence of female specific cancer after bariatric surgery or usual care in the Swedish Obese Subjects Study. Gynecol Oncol. 2017;145:224–9.
MacKintosh ML, Derbyshire AE, McVey RJ, Bolton J, Nickkho-Amiry M, Higgins CL, et al. The impact of obesity and bariatric surgery on circulating and tissue biomarkers of endometrial cancer risk. Int J Cancer. 2019;144:641–650.
MacKintosh ML, Crosbie EJ. Obesity-driven endometrial cancer: is weight loss the answer. BJOG. 2013;120:791–4.
Bischoff SC, Damms-Machado A, Betz C, Herpertz S, Legenbauer T, Löw T, et al. Multicenter evaluation of an interdisciplinary 52-week weight loss program for obesity with regard to body weight, comorbidities and quality of life - a prospective study. Int J Obes. 2012;36:614–24.
Rahib L, Smith BD, Aizenberg R, Rosenzweig AB, Fleshman JM, Matrisian LM. Projecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the United States. Cancer Res. 2014;74:2913–21.
Kitson S, Evans DG, Crosbie EJ. Identifying high risk women for endometrial cancer prevention strategies: proposal of endometrial cancer risk prediction model. Cancer Prev Res. 2017;10:1–13.
Bahamondes L, Valeria Bahamondes M, Shulman LP. Non-contraceptive benefits of hormonal and intrauterine reversible contraceptive methods. Hum Reprod Update. 2015;21:640–51.
Jareid M, Thalabard JC, Aarflot M, Bovelstad HM, Lund E, Braaten T. Levonorgestrel-releasing intrauterine system use is associated with a decreased risk of ovarian and endometrial cancer, without increased risk of breast cancer. results from the NOWAC study. Gynecol Oncol. 2018;149:127–32.
Soini T, Hurskainen R, Grenman S, Maenpaa J, Paavonen J, Pukkala E. Cancer risk in women using the levonorgestrel-releasing intrauterine system in Finland. Obstet Gynecol. 2014;124:292–9.
Wan Y-L, Holland C. The efficacy of levonorgestrel intrauterine systems for endometrial protection: a systematic review. Climacteric. 2011;14:622–32.
Gunderson CC, Fader AN, Carson KA, Bristow RE. Oncologic and reproductive outcomes with progestin therapy in women with endometrial hyperplasia and grade 1 adenocarcinoma: a systematic review. Gynecol Oncol. 2012;125:477–82.
Yuk JS, Song JY, Lee JH, Park WI, Ahn HS, Kim HJ. Levonorgestrel-releasing intrauterine systems versus oral cyclic medroxyprogesterone acetate in endometrial hyperplasia therapy: a meta-analysis. Ann Surg Oncol. 2017;24:1322–1329.
Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985;28:412–9.
Emons G, Beckmann MW, Schmidt D, Mallmann P. Uterus commission of the Gynecological Oncology Working Group (AGO). New WHO classification of endometrial hyperplasias. Geburtshilfe Frauenheilkd. 2015;75:135–6.
Kurman RJ, Carcangiu ML, Young RH, Herrington CS. WHO classification of tumours of female reproductive organs. 2014.
Dowsett M, Nielsen TO, A'Hern R, Bartlett J, Coombes RC, Cuzick J, et al. Assessment of Ki67 in breast cancer: recommendations from the international ki67 in breast cancer working group. JNCI J Natl Cancer Inst. 2011;103:1656–64.
Ørbo A, Rise CE, Mutter GL. Regression of latent endometrial precancers by progestin infiltrated intrauterine device. Cancer Res. 2006;66:5613–7.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–70.
Bjelland I, Dahl AA, Tangen T, Neckelmann D. The validity of the hospital anxiety and depression scale an updated literature review. 2002;52:69–77.
Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, et al. The Warwick-Edinburgh mental well-being scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007;5:63.
Putz R, O'Hara K, Taggart F, Stewart-Brown S. Using WEMWBS to measure the impact of your work on mental wellbeing: a practice-based user guide. 2012.
Matteson KA, Scott DM, Raker CA, Clark MA. The menstrual bleeding questionnaire: development and validation of a comprehensive patient-reported outcome instrument for heavy menstrual bleeding. BJOG. 2015;122:681–9.
Moore L, Leongamornlert D, Coorens THH, Sanders MA, Ellis P, Dentro SC, et al. The mutational landscape of normal human endometrial epithelium. Nature. 2020;580:640–6.
Monte NM, Webster KA, Neuberg D, Dressler GR, Mutter GL. Joint loss of PAX2 and PTEN expression in endometrial precancers and cancer. Cancer Res. 2010;70:6225–32.
Guttinger A, Critchley HO. Endometrial effects of intrauterine levonorgestrel. Contraception. 2007;75:S93-‐8.
Dinh A, Sriprasert I, Williams AR, Archer DF. A review of the endometrial histologic effects of progestins and progesterone receptor modulators in reproductive age women. Contraception. 2015;91:360–7.
Villavicencio A, Aguilar G, Arguüello G, Dünner C, Gabler F, Soto E, et al. The effect of overweight and obesity on proliferation and activation of AKT and ERK in human endometria. Gynecol Oncol. 2010;117:96–102.
Zhang K, Luo Y, Dai H, Deng Z. Effects of bariatric surgery on cancer risk: evidence from meta-analysis. Obes Surg. 2020;30:1265‐-72.
Argenta P, Svendsen C, Elishaev E, Gloyeske N, Geller MA, Edwards RP, et al. Hormone receptor expression patterns in the endometrium of asymptomatic morbidly obese women before and after bariatric surgery. Gynecol Oncol. 2014;133:78–82.
Kitson S, Sivalingam VN, Bolton J, McVey R, Nickkho-Amiry M, Powell ME, et al. Ki-67 in endometrial cancer: scoring optimization and prognostic relevance for window studies. Mod Pathol. 2017;30:459–68.
Saito-Tom LY, Soon RA, Harris SC, Salcedo J, Kaneshiro BE. Levonorgestrel intrauterine device use in overweight and obese women. Hawaii J Med Public Health. 2015;74:369–74.
Nilsson CG. Tissue concentrations of levonorgestrel in women using a levonorgestrel-releasing IUD. Clin Endocrinol (Oxf). 1982;529–36.
Apter D, Gemzell-Danielsson K, Hauck B, Rosen K, Zurth C. Pharmacokinetics of two low-dose levonorgestrel-releasing intrauterine systems and effects on ovulation rate and cervical function: pooled analyses of phase II and III studies. Fertil Steril. 2014;101:1656–62.e4.
2014.
Seeber B, Ziehr SC, Gschlieβer A, Moser C, Mattle V, Seger C, et al. Quantitative levonorgestrel plasma level measurements in patients with regular and prolonged use of the levonorgestrel-releasing intrauterine system. Contraception. 2012;86:345–9.
Westin SN, Fellman B, Sun CC, Broaddus RR, Woodall ML, Pal N, et al. Prospective phase ii trial of levonorgestrel intrauterine device: non-surgical approach for complex atypical hyperplasia and early endometrial cancer. Am J Obstet Gynecol. 2020.
Derbyshire AE, Ryan N, Crosbie EJ. Biomarkers needed to predict progestin response in endometrial cancer. BJOG. 2017;124:1584.
Travaglino A, Raffone A, Saccone G, Insabato L, Mollo A, De Placido G, et al. Immunohistochemical predictive markers of response to conservative treatment of endometrial hyperplasia and early endometrial cancer: a systematic review. Acta Obstet Gynecol Scand. 2019;98:1086–99.
Behrouzi R, Ryan NAJ, Barr CE, Derbyshire AE, Wan YL, Maskell Z, et al. Baseline serum HE4 but not tissue HE4 expression predicts response to the levonorgestrel-releasing intrauterine system in atypical hyperplasia and early stage endometrial cancer. Cancers (Basel). 2020;12:276.
Barr CE, Crosbie EJ. The mirena coil is a suitable treatment of early-stage endometrial cancer in obese women: for: careful selection and monitoring is key. BJOG. 2020;127:1001.
Bender NM, Segall-Gutierrez P, Najera SO, Stanczyk FZ, Montoro M, Mishell DR Jr. Effects of progestin-only long-acting contraception on metabolic markers in obese women. Contraception. 2013;88:418–25.
Conz L, Mota BS, Bahamondes L, Dória MT, Derchain SFM, Rieira R, et al. Levonorgestrel-releasing intrauterine system and breast cancer risk: A systematic review and meta-analysis. Acta Obstet Gynecol Scand. 2020;99:970–82.
Wan YL, Beverley-Stevenson R, Carlisle D, Clarke S, Edmondson RJ, Glover S, et al. Working together to shape the endometrial cancer research agenda: the top ten unanswered research questions. Gynecol Oncol. 2016;143:287–93.
Dottino JA, Hasselblad V, Secord AA, Myers ER, Chino J, Havrilesky LJ. Levonorgestrel intrauterine device as an endometrial cancer prevention strategy in obese women: a cost-effectiveness analysis. Obstet Gynecol. 2016;128:747–53.
Bafligil C, Thompson DJ, Lophatananon A, et al. Association between genetic polymorphisms and endometrial cancer risk: a systematic review. J Med Genet. 2020;57:591–600.
O'Mara TA, Crosbie EJ. Polygenic risk score opportunities for early detection and prevention strategies in endometrial cancer. Br J Cancer. 2020 Jul 6.