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Br J Cancer. 2014 Feb 18;110(4):1081-7. doi: 10.1038/bjc.2013.805. Epub 2014 Jan 14.

Impact of rapid genetic counselling and testing on the decision to undergo immediate or delayed prophylactic mastectomy in newly diagnosed breast cancer patients: findings from a randomised controlled trial.

Author information

1
1] Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, PO Box 90203, 1006 BE Amsterdam, The Netherlands [2] Division of Biomedical Genetics, University Medical Center Utrecht, PO Box 85090, 3508 AB Utrecht, The Netherlands.
2
Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, PO Box 90203, 1006 BE Amsterdam, The Netherlands.
3
Family Cancer Clinic, The Netherlands Cancer Institute, PO Box 90203, 1006 BE Amsterdam, The Netherlands.
4
Division of Psychosocial Research and Epidemiology & Family Cancer Clinic, The Netherlands Cancer Institute, PO Box 90203, 1006 BE Amsterdam, The Netherlands.
5
Department of Psychosocial Counseling, The Netherlands Cancer Institute, PO Box 90203, 1006 BE Amsterdam, The Netherlands.
6
Division of Biomedical Genetics, University Medical Center Utrecht, PO Box 85090, 3508 AB Utrecht, The Netherlands.
7
Division of Pathology, The Netherlands Cancer Institute, PO Box 90203, 1006 BE Amsterdam, The Netherlands.
8
Department of Oncological Sciences, Mount Sinai School of Medicine, Icahn Medical Institute, 1425 Madison Avenue, New York, NY 10029, USA.
9
Division of Surgery, Diakonessen Hospital, PO Box 80250, 3508 TG Utrecht, The Netherlands.
10
Division of Surgery, St Antonius Hospital, PO Box 2500, 3430EM Nieuwegein, The Netherlands.
11
Division of Surgery, Meander Medical Center, PO Box 1502, 3800 BM Amersfoort, The Netherlands.
12
Division of Surgery, Rivierenland Hospital, PO Box 6024, 4000 HA Tiel, The Netherlands.
13
Division of Surgery, Onze Lieve Vrouwe Gasthuis, PO Box 95500, 1090 HM Amsterdam, The Netherlands.
14
Division of Surgery, St Lucas Andreas Hospital, PO Box 9243, 1006 AE Amsterdam, The Netherlands.
15
Division of Surgery, Tergooi Hospitals, PO Box 10016, 1201 DA Blaricum, The Netherlands.
16
Division of Surgery, Gelre Hospitals, Albert Schweitzerlaan 31, 7334 DZ Apeldoorn, The Netherlands.
17
Division of Surgery, Kennemer Gasthuis, PO Box 417, 2000 AK Haarlem, The Netherlands.
18
Division of Surgery, Zuwe Hofpoort Hospital, PO Box 8000, 3440 JD Woerden, The Netherlands.
19
Division of Surgery, University Medical Center Utrecht, PO Box 85500, 3508GA Utrecht, The Netherlands.
20
Division of Surgery, the Netherlands Cancer Institute, PO Box 90203, 1006 BE Amsterdam, The Netherlands.

Abstract

BACKGROUND:

Female breast cancer patients with a BRCA1/2 mutation have an increased risk of contralateral breast cancer. We investigated the effect of rapid genetic counselling and testing (RGCT) on choice of surgery.

METHODS:

Newly diagnosed breast cancer patients with at least a 10% risk of a BRCA1/2 mutation were randomised to an intervention group (offer of RGCT) or a control group (usual care; ratio 2 : 1). Primary study outcomes were uptake of direct bilateral mastectomy (BLM) and delayed contralateral prophylactic mastectomy (CPM).

RESULTS:

Between 2008 and 2010, we recruited 265 women. On the basis of intention-to-treat analyses, no significant group differences were observed in percentage of patients opting for a direct BLM (14.6% for the RGCT group vs 9.2% for the control group; odds ratio (OR) 2.31; confidence interval (CI) 0.92-5.81; P=0.08) or for a delayed CPM (4.5% for the RGCT group vs 5.7% for the control group; OR 0.89; CI 0.27-2.90; P=0.84). Per-protocol analysis indicated that patients who received DNA test results before surgery (59 out of 178 women in the RGCT group) opted for direct BLM significantly more often than patients who received usual care (22% vs 9.2%; OR 3.09, CI 1.15-8.31, P=0.03).

INTERPRETATION:

Although the large majority of patients in the intervention group underwent rapid genetic counselling, only a minority received DNA test results before surgery. This may explain why offering RGCT yielded only marginally significant differences in uptake of BLM. As patients who received DNA test results before surgery were more likely to undergo BLM, we hypothesise that when DNA test results are made routinely available pre-surgery, they will have a more significant role in surgical treatment decisions.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00783822.

PMID:
24423928
PMCID:
PMC3929884
DOI:
10.1038/bjc.2013.805
[Indexed for MEDLINE]
Free PMC Article
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