Abstract
The use of acellular dermal matrix (ADM) in implant-based breast reconstructions (IBBRs) is established practice. Existing evidence validating ADMs proposed advantages, including improved cosmetics and more single-stage IBBRs, is lacking. To evaluate whether IBBR with ADM results in fewer reoperations and increased health-related quality of life (HRQoL) compared with conventional IBBR without ADM. This was an open-label, multicenter, randomized clinical trial of women with primary breast cancer who planned for mastectomy and immediate IBBR, with a 2-year follow-up for all participants. Participants were enrolled at 5 breast cancer units in Sweden and the United Kingdom between 2014 and May 2017. Exclusion criteria included previous radiotherapy and neo-adjuvant chemotherapy. Data were analyzed until August 2017. Participants were allocated to immediate IBBR with or without ADM. The primary trial end point was number of reoperations at 2 years. HRQoL, a secondary end point, was measured as patient-reported outcome measures using 3 instruments from the European Organization for Research and Treatment of Cancer Quality of life Questionnaire. From start of enrollment on April 24, 2014, to close of trial on May 10, 2017, a total of 135 women were enrolled (mean [SD] age, 50.4 [9.5] years); 64 were assigned to have an IBBR procedure with ADM and 65 to the control group who had IBBR without ADM. There was no statistically significant difference between groups for the primary outcome. Of 129 patients analyzed at 2-year follow-up, 44 of 64 (69%) had at least 1 surgical event in the ADM group vs 43 of 65 (66%) in the control group. In the ADM group, 31 patients (48%) had at least 1 reoperation on the ipsilateral side vs 35 (54%) in the control group. The overall number of reoperations on the ipsilateral side were 42 and 43 respectively. Within the follow-up time of 24 months, 9 patients (14%) in the ADM group had the implant removed compared with 7 (11%) in the control group. We found no significant mean differences in postoperative patient-reported HRQoL domains, including perception of body image (mean difference, 3; 99% CI, -11 to 17; P = .57) and satisfaction with cosmetic outcome (mean difference, 8; 99% CI, -6 to 20; P = .11). Immediate IBBR with ADM did not yield fewer reoperations compared with conventional IBBR without ADM, nor was IBBR with ADM superior in terms of HRQoL or patient-reported cosmetic outcomes. Patients treated for breast cancer contemplating ADM-supported IBBR should be informed about the lack of evidence validating ADM's suggested benefits. ClinicalTrials.gov Identifier: NCT02061527.
Highlights
Breast cancer is the most common form of cancer in women, annually affecting some 1.4 billion patients worldwide and accounting for 23% of all cancers.[1]
We found no significant mean differences in postoperative patient-reported health-related quality of life (HRQoL) domains, including perception of body image and satisfaction with cosmetic outcome
Immediate Implant-based breast reconstruction (IBBR) with acellular dermal matrix (ADM) did not yield fewer reoperations compared with conventional IBBR without ADM, nor was IBBR with ADM superior in terms of HRQoL or patient-reported cosmetic outcomes
Summary
Breast cancer is the most common form of cancer in women, annually affecting some 1.4 billion patients worldwide and accounting for 23% of all cancers.[1] Novel oncoplastic techniques for breast conserving surgery have gained popularity, while many women still undergo mastectomy.[2] Breast reconstruction following mastectomy can have health benefits and is considered a quality measure for breast cancer care in Sweden and the United Kingdom.[3] Autologous and alloplastic reconstructive options are available, both with advantages and limitations.[4] Implant-based breast reconstruction (IBBR) remains predominant, and acellular dermal matrix (ADM) is commonly used in these procedures.[5] ADM as a device for breast reconstruction aims to combine the advantages of early subcutaneous implant placement with the benefits of the submuscular implant position traditionally used today.[6] Applied as an extension of the pectoralis major muscle, ADM enlarges the subpectoral pocket, facilitating larger fixed-volume implants and potentially allowing 1-stage reconstructions.[7] Early reports stated several benefits, including superior cosmetics, less need for tissue expanders, fewer elective reoperations, and less capsular contracture.[8,9] ADM’s proposed advantages have not been universally accepted, and further cause for doubt was created by reports concerning harm, higher rates of infection and implant loss.[10,11] While biological meshes are approved by the Food and Drug Administration (FDA) in the US for reconstructive purposes, such as repair for abdominal hernias, ADM has not reached approval for use in breast reconstruction, and is regarded as off-label.[12,13,14]
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