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Clinical Trial
. 2015 Aug 19:15:593.
doi: 10.1186/s12885-015-1597-y.

Early salpingectomy (TUbectomy) with delayed oophorectomy to improve quality of life as alternative for risk-reducing salpingo-oophorectomy in BRCA1/2 mutation carriers (TUBA study): a prospective non-randomised multicentre study

Marline G Harmsen  1 , Marieke Arts-de Jong  2 , Nicoline Hoogerbrugge  3 , Angela H E M Maas  4 , Judith B Prins  5 , Johan Bulten  6 , Steven Teerenstra  7 , Eddy M M Adang  8 , Jurgen M J Piek  9   10 , Helena C van Doorn  11 , Marc van Beurden  12 , Marian J E Mourits  13 , Ronald P Zweemer  14 , Katja N Gaarenstroom  15 , Brigitte F M Slangen  16 , M Caroline Vos  17 , Luc R C W van Lonkhuijzen  18 , Leon F A G Massuger  19 , Rosella P M G Hermens  20 , Joanne A de Hullu  21
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Clinical Trial

Early salpingectomy (TUbectomy) with delayed oophorectomy to improve quality of life as alternative for risk-reducing salpingo-oophorectomy in BRCA1/2 mutation carriers (TUBA study): a prospective non-randomised multicentre study

Marline G Harmsen et al. BMC Cancer. .

Abstract

Background: Risk-reducing salpingo-oophorectomy (RRSO) around the age of 40 is currently recommended to BRCA1/2 mutation carriers. This procedure decreases the elevated ovarian cancer risk by 80-96% but it initiates premature menopause as well. The latter is associated with short-term and long-term morbidity, potentially affecting quality of life (QoL). Based on recent insights into the Fallopian tube as possible site of origin of serous ovarian carcinomas, an alternative preventive strategy has been put forward: early risk-reducing salpingectomy (RRS) and delayed oophorectomy (RRO). However, efficacy and safety of this alternative strategy have to be investigated.

Methods: A multicentre non-randomised trial in 11 Dutch centres for hereditary cancer will be conducted. Eligible patients are premenopausal BRCA1/2 mutation carriers after completing childbearing without (a history of) ovarian carcinoma. Participants choose between standard RRSO at age 35-40 (BRCA1) or 40-45 (BRCA2) and the alternative strategy (RRS upon completion of childbearing and RRO at age 40-45 (BRCA1) or 45-50 (BRCA2)). Women who opt for RRS but do not want to postpone RRO beyond the currently recommended age are included as well. Primary outcome measure is menopause-related QoL. Secondary outcome measures are ovarian/breast cancer incidence, surgery-related morbidity, histopathology, cardiovascular risk factors and diseases, and cost-effectiveness. Mixed model data analysis will be performed.

Discussion: The exact role of the Fallopian tube in ovarian carcinogenesis is still unclear. It is not expected that further fundamental research will elucidate this role in the near future. Therefore, this clinical trial is essential to investigate RRS with delayed RRO as alternative risk-reducing strategy in order to improve QoL.

Trial registration: ClinicalTrials.gov ( NCT02321228 ).

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Figures

Fig. 1
Fig. 1
TUBA study design
Fig. 2
Fig. 2
Schedule of follow-up in TUBA study
See this image and copyright information in PMC

References

    1. Antoniou A, Pharoah PD, Narod S, Risch HA, Eyfjord JE, Hopper JL, et al. Average risks of breast and ovarian cancer associated with BRCA1 or BRCA2 mutations detected in case Series unselected for family history: a combined analysis of 22 studies. Am J Hum Genet. 2003;72(5):1117–30. doi: 10.1086/375033. - DOI - PMC - PubMed
    1. Chen S, Parmigiani G. Meta-analysis of BRCA1 and BRCA2 penetrance. J Clin Oncol. 2007;25(11):1329–33. doi: 10.1200/JCO.2006.09.1066. - DOI - PMC - PubMed
    1. Vencken PM, Reitsma W, Kriege M, Mourits MJ, de Bock GH, de Hullu JA, et al. Outcome of BRCA1- compared with BRCA2-associated ovarian cancer: a nationwide study in the Netherlands. Ann Oncol. 2013;24(8):2036–42. doi: 10.1093/annonc/mdt068. - DOI - PubMed
    1. Russo A, Calo V, Bruno L, Rizzo S, Bazan V, Di Fede G. Hereditary ovarian cancer. Crit Rev Oncol Hematol. 2009;69(1):28–44. doi: 10.1016/j.critrevonc.2008.06.003. - DOI - PubMed
    1. Bolton KL, Chenevix-Trench G, Goh C, Sadetzki S, Ramus SJ, Karlan BY, et al. Association between BRCA1 and BRCA2 mutations and survival in women with invasive epithelial ovarian cancer. JAMA. 2012;307(4):382–90. doi: 10.1001/jama.2012.20. - DOI - PMC - PubMed

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