Effect of Total Breast Reconstruction With Autologous Fat Transfer Using an Expansion Device vs Implants on Quality of Life Among Patients With Breast Cancer

Abstract

ImportanceThere is a need for a new, less invasive breast reconstruction option for patients who undergo mastectomy in their breast cancer treatment.ObjectiveTo investigate quality of life (QoL) among patients undergoing a new breast reconstruction technique, autologous fat transfer (AFT), compared with that among patients undergoing implant-based reconstruction (IBR).Design, Setting, and ParticipantsThe BREAST trial was a randomized clinical trial conducted between November 2, 2015, and October 31, 2021, performed in 7 hospitals across the Netherlands. Follow-up was 12 months. Referrals could be obtained from general practitioners and all departments from participating or nonparticipating hospitals. The patients with breast cancer who had undergone mastectomy and were seeking breast reconstruction were screened for eligibility (radiotherapy history and physique) by participating plastic surgeons. Patients receiving postmastectomy radiotherapy were excluded.InterventionsBreast reconstruction with AFT plus expansion or 2-phased IBR. Randomization was done in a 1:1 ratio.Main Outcomes and MeasuresThe statistical analysis was performed per protocol. The predefined primary outcome was QoL at 12 months after final surgery. This was measured by the BREAST-Q questionnaire, a validated breast reconstruction surgery questionnaire. Questions on the BREAST-Q questionnaire are scored from 0 to 100, with a higher score indicating greater satisfaction or better QoL (depending on the scale). Secondary outcomes were breast volume and the safety and efficacy of the techniques.ResultsA total of 193 female patients (mean [SD] age, 49.2 [10.6] years) 18 years or older who desired breast reconstruction were included, of whom 91 patients in the AFT group (mean [SD] age, 49.3 [10.3] years) and 80 in the IBR group (mean age, 49.1 [11.0] years) received the allocated intervention. In total, 64 women in the AFT group and 68 women in the IBR group completed follow-up. In the IBR group, 18 patients dropped out mainly due to their aversion to implant use while in the AFT group 6 patients ended their treatment prematurely because of the burden (that is, the treatment being too heavy or tiring). The BREAST-Q scores were higher in the AFT group in all 5 domains and significantly higher in 3: satisfaction with breasts (difference, 9.9; P = .002), physical well-being: chest (difference; 7.6; P = .007), and satisfaction with outcome (difference, 7.6; P = .04). Linear mixed-effects regression analysis showed that QoL change over time was dependent on the treatment group in favor of AFT. The mean (SD) breast volume achieved differed between the groups (AFT: 300.3 [111.4] mL; IBR: 384.1 [86.6] mL). No differences in oncological serious adverse events were found.Conclusions and RelevanceThis randomized clinical trial found higher QoL and an increase in QoL scores over time in the AFT group compared with the IBR group. No evidence was found that AFT was unsafe. This is encouraging news since it provides a third, less invasive reconstruction option for patients with breast cancer.Trial RegistrationClinicalTrials.gov Identifier: NCT02339779

A systematic review of randomised controlled trials in breast reconstruction

“…The study comparing immediate and delayed breast reconstruction was conducted in 1983 when breast reconstruction was much less common than it is today. Four studies compared different categories of breast reconstruction techniques head-to-head (Table 3), one Dutch [6] and three Swedish, from three different centres [7][8][9][10][11].…”

“…In four of the studies [7,8,11,12], a substantial part of the eligible patients (25% [30/121], 38% [54/141], 41% [51/125], and 43% [172/405], respectively) declined participation in the study, most frequently because they had a preferences for a particular reconstructive technique [7,12]. Some participants dropped-out of the studies after randomisation, most commonly because they did not want the procedure that they had been randomised, 18% (16/91) and 19% (18/93), respectively [6,12]. In one of studies [11], a total of 13% (31/233) of the participants, were excluded after randomisation both due to patients' and surgeons' preferences.…”

Imaging findings after a total reconstructed breast with autologous fat transfer: what the radiologist needs to know

“…In general, 4 procedures are necessary to complete a total breast reconstruction with AFT. 7 As higher volumes are injected with each procedure, the risk for the onset of fat necrosis increases. Therefore, radiological differentiation between benign and suspicious findings is crucial to avoid unnecessary biopsies.…”

UpToDate®

“…In the BREAST trial, which compared AFG with implantbased reconstruction, Breast-Q scores for satisfaction with breasts, physical well-being, and satisfaction with outcome were significantly higher at 12 months in the AFG group. 1 The rate of serious adverse events, including oncologic events, was similar for both groups. AFG provides a reasonable alternative with good patient satisfaction; however, larger trials with complete and longer follow-up, comparison of AFG with other types of total breast reconstruction, and more widespread availability of the skin expansion device are needed.…”