In a Korean single-institution cohort study reported in JAMA Surgery, Lee et al found that the use of textured surface implants in breast reconstruction following mastectomy for breast cancer was associated with poorer disease-free survival.
Study Details
The study involved data from 650 women (representing 687 cases) who underwent total mastectomy and immediate two-stage tissue expander/implant reconstruction using a smooth (n = 274; 39.9%) or textured surface implant (n = 413; 60.1%) between January 2011 and December 2016 at Samsung Medical Center, Seoul. Patients were followed for at least 2 years after insertion of the implant. The main outcomes of interest were local and regional recurrence–free survival and disease-free survival.
Key Findings
KEY POINTS
- At 5 years, local/regional recurrence–free survival was 97.8% in the smooth group vs 95.9% in the textured group.
- In subgroups, disease-free survival was significantly improved with smooth vs textured implants among the 88.3% and 83.8% of patients with ER-positive disease and among those with invasive disease on multivariate analysis.
- The risk associated with textured implant use was more pronounced among patients with stage II or III disease.
Patients had a mean age of 43.5 years. The smooth implant group and the textured implant group had similar characteristics, including tumor stage (stage I in 37.2% vs 41.9%, stage II in 33.9% vs 28.8%, and stage III in 5.1% vs 4.8%; P = .50) and rates of adjuvant radiotherapy (15.3% vs 11.9%, P = .19) and chemotherapy (41.2% vs 41.4%, P = .97).
Median follow-up was 55.0 months (range = 31–101 months) in the smooth group and 50.0 months (range = 31–106 months) in the textured group. Overall, 28 women (4.1%) had any type of recurrence during follow-up, with recurrence observed in 5 patients in the smooth group vs 23 in the textured group.
At 5 years, local/regional recurrence–free survival was 97.8% in the smooth group vs 95.9% in the textured group (overall P = .25). No differences between groups were observed between groups in multivariate analysis (hazard ratio [HR] = 1.71, 95% confidence interval = 0.61–4.80, P = .31).
At 5 years, disease-free survival was 97.8% vs 93.3% (overall P = .01). In multivariate analysis adjusting for estrogen receptor (ER) status and tumor stage, the smooth group maintained a significant benefit (hazard ratio [HR] = 3.05, 95% CI = 1.16–8.05, P = .02).
In subgroups, disease-free survival was significantly improved with smooth vs textured implants among the 88.3% and 83.8% of patients with ER-positive disease (HR = 3.13, 95% CI = 1.05–9.31, P = .04) and among those with invasive disease (HR = 3.04, 95% CI = 1.15–8.04, P = .03) on multivariate analysis. The risk associated with textured implant use was more pronounced among patients with stage II or III disease (HR = 8.87, 95% CI= 1.15–68.74, P = .04), with no significant difference observed among those with stage 0 or I disease.
The investigators concluded, “This cohort study found that use of textured implants in reconstruction appears to be associated with recurrence of breast cancer. Further investigation is required to verify these results.”
Sa Ik Bang, MD, PhD, of Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, is the corresponding author for the JAMA Surgery article.
Disclosure: For full disclosures of the study authors, visit jamanetwork.com.