Dataset Information

Safety and Quality of Life in Women with Immediate Reconstruction with Polyurethane Implants after Neoadjuvant Chemotherapy: Outcomes from The Preq-20 Trial.

ABSTRACT:

Introduction

Various studies have evaluated the impact of neoadjuvant chemotherapy (NAC) on the complications of breast cancer surgery, most of which were retrospective and did not assess the variables related to postoperative risk factors. The aim of this study is to analyse the safety and satisfaction of women included in the PreQ-20 trial who underwent NAC and who underwent mastectomy and immediate reconstruction with prepectoral polyurethane implants.

Material and methods

The patients included in the study belong to the prospective study PreQ-20. The study group consisted of patients who underwent immediate reconstruction after primary systemic therapy. The control groups consisted of patients with immediate reconstruction and adjuvant chemotherapy (control group 1) and patients with an infiltrating carcinoma or in situ ductal carcinoma who did not require chemotherapy (control group 2).

Results

The study included 157 women, 58 (36.9%) of whom underwent primary systemic therapy. The indication for genetic study was significantly greater for the study group (87.9%) than for control groups 1 (49.1%) or 2 (30.4%). Seventy-two (45.9%) of the patients underwent bilateral mastectomy (BM), a procedure that was performed significantly more frequently in the study group (69%) than in control groups 1 (30.2%) or 2 (34.8%). The incidence rate for BM after complete pathologic response was 78%. There were no statistically significant differences in the number of complications between the groups. Implant loss was significantly more frequent in control group 1 (13.2%) than in the study group (3.4%) and control group 2 (2.2%).

Conclusions

Mastectomy with prepectoral polyurethane implant reconstruction in patients with neoadjuvant chemotherapy presented a similar incidence of complications compared with patients who underwent primary surgery. There is a high rate of BM in women with NAC.

SUBMITTER: Acea-Nebril B

PROVIDER: S-EPMC9954288 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Publications

Safety and Quality of Life in Women with Immediate Reconstruction with Polyurethane Implants after Neoadjuvant Chemotherapy: Outcomes from The Preq-20 Trial.

Acea-Nebril Benigno B García-Novoa Alejandra A Cereijo-Garea Carmen C Conde Iglesias Carmen C Bouzón Alejandro Alberto A Díaz Carballada Carlota C

Cancers 20230209 4

<h4>Introduction</h4>Various studies have evaluated the impact of neoadjuvant chemotherapy (NAC) on the complications of breast cancer surgery, most of which were retrospective and did not assess the variables related to postoperative risk factors. The aim of this study is to analyse the safety and satisfaction of women included in the PreQ-20 trial who underwent NAC and who underwent mastectomy and immediate reconstruction with prepectoral polyurethane implants.<h4>Material and methods</h4>The ...[more]

PMID: 36831457

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Project description:BackgroundMastectomy currently constitutes a necessary surgical procedure in the oncologic setting and in the context of high risk. Prepectoral breast reconstruction (PBR) has been proposed as a surgical alternative to retropectoral techniques by providing less postoperative morbidity and a better cosmetic result. However, there is a lack of prospective studies that have evaluated its safety and patient-reported satisfaction.MethodsWe conducted a prospective cohort study to assess the safety, quality of life and cosmetic sequelae of PBR in women with breast cancer and high risk. The study's main objective is to assess the safety of PBR in terms of postsurgical complications and the feasibility of reconstruction (loss of implants). The secondary objectives are to evaluate oncologic safety (local relapses, residual glandular tissue) and to identify factors related to quality of life and cosmetic sequelae. The evaluation of residual tissue will be conducted by MRI 12 to 18 months after the surgery, and the quality-of-life assessment will be performed using the Breast-Q questionnaire. An initial patient evaluation will be conducted 12-18 months after the surgery, and a second evaluation will be performed at 5 years. The estimated sample size is 81 patients.DiscussionThe PreQ-20 study will analyze the impact of PBR on 3 separate measures: safety, quality of life and cosmetic sequelae. Unlike other studies that analyzed these three measures jointly for women with breast cancer and high risk, this study will individualize the results for these 2 patient groups. This differentiation is necessary from the methodological point of view, given that the 2 patient groups have separate clinical and emotional implications. The assessment of these groups will focus on the following aspects: postoperative complications, local relapses, evaluation of residual glandular tissue and incidence rate of primary tumors in the same, the cosmetic sequelae and the satisfaction and the quality-of-life assessment by the patients.Trial registrationClinicalTrials.gov: NCT04642508.

Project description:BackgroundThe impact of neoadjuvant chemotherapy (NACT) on surgical outcomes following immediate breast reconstruction (IBR) remains unclear. While it is generally considered safe practice to perform an IBR post NACT, reported complication rates in published data are highly variable with the majority of studies including fewer than 50 patients in the NACT and IBR arm. To evaluate this further, we conducted a systematic review and meta-analysis on the effect of NACT on autologous and implant based immediate breast reconstructions. We aimed to assess for differences in the post-operative course following IBR between patients who received NACT with those who did not.MethodsPubMed, EMBASE, and Cochrane Library were searched from 1995 to Sept 2, 2020 to identify articles that assessed the impact of NACT on IBR. All included studies assessed outcomes following IBR. Only studies comparing reconstructed patients receiving NACT to a control group of women who did not receive NACT were included. Unadjusted relative risk of outcomes between patients who received or did not receive NACT were synthesized using a fixed-effect meta-analysis. The evidence was assessed using the Newcastle Ottawa Scale scores and GRADE. Primary effect measures were risk ratios (RRs) with 95% confidence intervals.ResultsA total 17 studies comprising 3249 patients were included in the meta-analyses. Overall, NACT did not increase the risk of complications after immediate breast reconstructions (risk ratio [RR]: 0.91, 95% CI 0.74 to 1.11, p = 0.34). There was a moderate, but not significant, increase in flap loss following NACT compared with controls (RR: 1.23, 95% CI 0.70 to 2.18, p = 0.47; I2 = 0%). Most notably, there was a statistically significant increase in implant/expander loss after NACT (RR: 1.54, 95% CI 1.04 to 2.29, p = 0.03; I2 = 34%). NACT was not shown to significantly increase the incidence of hematomas, seromas or wound complications, or result in a significant delay to commencing adjuvant therapy (RR: 1.59, 95% CI 0.66 to 3.87, p = 0.30).ConclusionImmediate breast reconstruction after NACT is a safe procedure with an acceptable post-operative complication profile. It may result in a slight increase in implant loss rates, but it does not delay commencing adjuvant therapy.

Project description:IntroductionTwo-stage implant-based breast reconstruction is the most commonly performed postmastectomy reconstructive technique. During the first stage, a tissue expander creates a sufficiently large pocket for the definite breast implant placed in the second stage. Capsular contracture is a common long-term complication associated with implant-based breast reconstruction, causing functional complaints and often requiring reoperation. The exact aetiology is still unknown, but a relationship between the outer surface of the implant and the probability of developing capsular contracture has been suggested. The purpose of this study is to determine whether polyurethane-covered implants result in a different capsular contracture rate than textured implants.Methods and analysisThe Textured Implants versus Polyurethane-covered Implants (TIPI) trial is a multicentre randomised controlled trial with a 1:1 allocation rate and a follow-up of 10 years. A total of 321 breasts of female adults undergoing a two-stage breast reconstruction will be enrolled. The primary outcome is capsular contracture at 10-year follow-up which is graded with the modified Baker classification. It is analysed with survival analysis using a frailty model for clustered interval-censored data, with both an intention-to-treat and per-protocol approach. Secondary outcomes are other complication rates, surgical revision rate, patient satisfaction and quality of life and user-friendliness. Outcomes are measured 2 weeks, 6 months, 1, 2, 3, 5 and 10 years postoperatively. Interim analysis is performed when 1-year, 3-year and 5-year follow-up is completed.Ethics and disseminationThe trial has been reviewed and approved by the Medical Research Ethics Committee of the Erasmus MC, University Medical Centre Rotterdam (MEC-2018-126) and locally by each participating centre. Written informed consent will be obtained from each study participant. The results will be disseminated by publication in peer-reviewed journals.Trial registrationNTR7265.

Dataset Information

Safety and Quality of Life in Women with Immediate Reconstruction with Polyurethane Implants after Neoadjuvant Chemotherapy: Outcomes from The Preq-20 Trial.

Introduction

Material and methods

Results

Conclusions

Publications

Safety and Quality of Life in Women with Immediate Reconstruction with Polyurethane Implants after Neoadjuvant Chemotherapy: Outcomes from The Preq-20 Trial.

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