mean age at foll http
mean age at follow-up 57.9 years)
Responded to the long-term questionnaires
n=146
(99 without previous breast cancer;
47 with previous breast cancer)
Questionnaire responders that consented for medical
records
n=134
(91 without previous breast cancer;
43 with previous breast cancer)
Non-responding women
Deceased
n=14
Recurrence and metastasised breast
cancer
n=7
Other cancers besides breast cancer, after risk-reducing mastectomy n=11
Declined future participation
n=14
Non-responding women
n=52
36 (26%) without previous breast
cancer,
mean age at follow-up 51.6 years;
No questionnaire answers, but consent
for medical records
n=2
(1 without previous breast cancer;
1 with previous breast cancer)
Fig. 1. Consort diagram, including details about written consent for clinical data collection from medical records.
Table 1
Demographic and clinical data of women that have undergone bilateral or contra-lateral risk-reducing surgery that have consented to extraction of clinical data from medical journals for the long-term follow-up study.
Variable
Cancera
No cancer
Number of women
44
Age at risk-reducing surgery (year)
Median
45
Age at return of questionnaires (year)
BRCA Ethylmalonyl Coenzyme A status
BMI
Bilateral prophylactic salpingo-oophorectomy
Type of breast cancer
None
Type of breast cancer surgery prior risk-reducing surgery
Breast conserving cancer surgery
20 (48)
Type of risk-reducing surgery
Mastectomy with immediate breast reconstruction
42 (95)
Mastectomy without immediate breast reconstruction
Reduction/mastopexy
1
(2)
Radiotherapy
Chemotherapy
Endocrine therapy
Reoperations (unforeseen) after risk-reducing breast surgeryc
Missing
a Women with previous breast cancer n ¼ 42, and gynaecological cancer n ¼ 2.
b BRCAX ¼ women with breast cancer and/or ovarian cancer, screened negative for BRCA1 and BRCA2, and with family history of breast cancer.
c Nipple reconstructions were not included.
group's established database. The mean follow-up time from date of risk-reducing surgery was 11.5 (range 6.0e19.7) years. Limited information about the non-responders was available as we never obtained consent to extract data from their medical charts.
3.1. Satisfaction with breast reconstruction (EORTC QLQ-BRR26)
This questionnaire was used only at follow-up, thus not allowing for analysis over time. Women with previous breast cancer were generally more dissatisfied with the results of the surgery versus women without cancer, Table 2. Statistically significant group
differences were found in the adjusted analyses for the subscales ‘Disease treatment/surgery related symptoms’ (p ¼ 0.006), and ‘Sexuality’ (p ¼ 0.031), with lower levels of problems and higher satisfaction in the group without cancer. Concerning ‘Satisfaction with reconstructed nipple’, a oxytocin between-group difference was found in the unadjusted analyses (p ¼ 0.020) in the same direction. Clin-ical significant differences were noted for ‘Disease treatment/sur-gery related symptoms’ (S), ‘Sexuality’ (M), and ‘Satisfaction with reconstructed nipple’ (M). No other between-group differences were found.
The long-term mean BIS summated scores (range 0e30) re-ported by women with and without previous breast cancer were 7.7 (SD 5.8) and 4.9 (SD 5.2), respectively. An unadjusted mean dif-ference was 2.8 (95% CI, 0.9 to 4.7). When adjusting for confounding factors, no statistical significant difference was found. Fig. 2 shows the proportions of women reporting any level of problem (1e3) for each item at the one-year and the follow-up assessments for both groups. There was a statistical significant improvement in self-consciousness at long-term versus the one-year assessment for women without cancer (p ¼ 0.026). No other statistically significant group differences, or differences at the long-term follow-up were observed for the body image items.
At the long-term assessment, 20 (43%) women with and 57 (61%) without previous breast cancer reported a ‘current active sex-life’, versus 22 (63%) and 52 (76%) at the one-year assessment, respectively. A statistical significant increase in ‘Discomfort’ was found at the long-term assessment, versus one year post-RRM for women with previous breast cancer (p ¼ 0.016), see Table 3. Women without breast cancer showed a statistical significant in-crease in ‘Sexual habit’ over time (p ¼ 0.031). No statistical signifi-cant differences between the groups were observed at the long-term follow-up for ‘Pleasure’, ‘Discomfort’, or ‘Sexual habit’ after adjusting for confounding factors.