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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.

Harmsen MG, Arts-de Jong M, Hoogerbrugge N, Maas AH, Prins JB, Bulten J, Teerenstra S, Adang EM, Piek JM, van Doorn HC, van Beurden M, Mourits MJ, Zweemer RP, Gaarenstroom KN, Slangen BF, Vos MC, van Lonkhuijzen LR, Massuger LF, Hermens RP, de Hullu JA - BMC Cancer (2015)

Bottom Line: The latter is associated with short-term and long-term morbidity, potentially affecting quality of life (QoL).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.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics & Gynaecology, Radboud University Medical Center, PO Box 9101, , 6500 HB, Nijmegen, The Netherlands. Marline.Harmsen@radboudumc.nl.

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 ).

No MeSH data available.


Related in: MedlinePlus

TUBA study design
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Fig1: TUBA study design

Mentions: We will perform a nationwide prospective non-randomised multicentre trial in 11 hospitals with a department for hereditary cancer. Eligible patients will have the opportunity to choose for standard or innovative strategy. Women who opt for RRS but do not want to postpone RRO beyond the currently recommended age or are unsure about this at enrolment are included as well; however, they will not contribute to the number of inclusions needed according to the sample size calculation. See Fig. 1 for an overview of the study design.Fig. 1


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.

Harmsen MG, Arts-de Jong M, Hoogerbrugge N, Maas AH, Prins JB, Bulten J, Teerenstra S, Adang EM, Piek JM, van Doorn HC, van Beurden M, Mourits MJ, Zweemer RP, Gaarenstroom KN, Slangen BF, Vos MC, van Lonkhuijzen LR, Massuger LF, Hermens RP, de Hullu JA - BMC Cancer (2015)

TUBA study design
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4541725&req=5

Fig1: TUBA study design
Mentions: We will perform a nationwide prospective non-randomised multicentre trial in 11 hospitals with a department for hereditary cancer. Eligible patients will have the opportunity to choose for standard or innovative strategy. Women who opt for RRS but do not want to postpone RRO beyond the currently recommended age or are unsure about this at enrolment are included as well; however, they will not contribute to the number of inclusions needed according to the sample size calculation. See Fig. 1 for an overview of the study design.Fig. 1

Bottom Line: The latter is associated with short-term and long-term morbidity, potentially affecting quality of life (QoL).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.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics & Gynaecology, Radboud University Medical Center, PO Box 9101, , 6500 HB, Nijmegen, The Netherlands. Marline.Harmsen@radboudumc.nl.

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 ).

No MeSH data available.


Related in: MedlinePlus