Key PointsQuestion
Is the quality of life in patients who have undergone mastectomy greater after receiving total breast reconstruction with autologous fat transfer (AFT) compared with reconstruction with implants?
Findings
This randomized clinical trial including 193 patients from 7 hospitals in the Netherlands (91 patients in the AFT group and 80 patients in the implant-based reconstruction group) found that quality of life scores on the BREAST-Q questionnaire were higher following AFT for all 5 BREAST-Q domains, and scores were significantly higher for 3 of 5 domains (satisfaction with breasts, physical well-being: chest, and satisfaction with outcome). Fewer complications were found in the AFT group as well.
Meaning
The findings of this study indicate that AFT offers patients with breast cancer an effective and safe option breast reconstruction that uses their own tissue and is minimally invasive.
Importance
There is a need for a new, less invasive breast reconstruction option for patients who undergo mastectomy in their breast cancer treatment.
Objective
To 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 Participants
The 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.
Interventions
Breast reconstruction with AFT plus expansion or 2-phased IBR. Randomization was done in a 1:1 ratio.
Main Outcomes and Measures
The 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.
Results
A 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 Relevance
This 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 Registration
ClinicalTrials.gov Identifier: NCT02339779