Mastectomy Reconstruction Outcomes Consortium Study Research Articles

Physical well-being recovery trajectories by reconstruction modality in women undergoing mastectomy and breast reconstruction: Significant predictors and health-related quality of life outcomes.

We sought to identify trajectories of patient-reported outcomes, specifically physical well-being of the chest (PWBC), in patients who underwent postmastectomy breast reconstruction, and further assessed its significant predictors, and its relationship with health-related quality of life (HRQOL). We used data collected as part of the Mastectomy Reconstruction Outcomes Consortium study within a 2-year follow-up in 2012-2017, with 1422, 1218,1199, and 1417 repeated measures at assessment timepoints of 0,3,12, and 24 months, respectively. We performed latent class growth analysis (LCGA) in the implant group (IMPG) and autologous group (AUTOG) to identify longitudinal change trajectories, and then assessed its significant predictors, and its relationship with HRQOL by conducting multinomial logistic regression. Of the included 1424 patients, 843 were in IMPG, and 581 were in AUTOG. Both groups experienced reduced PWBC at follow-up. LCGA identified four distinct PWBC trajectories (χ2 = 1019.91, p<0.001): low vs medium high vs medium low vs high baseline PWBC that was restored vs. not-restored after 2 years. In 76.63%(n = 646) of patients in IMPG and 62.99% (n = 366) in AUTOG, PWBC was restored after two years. Patients in IMPG exhibited worse PWBC at 3 months post-surgery than that in AUTOG. Patients with low baseline PWBC that did not improve at 2-year follow up (n = 28, 4.82% for AUTOG) were characterized by radiation following reconstruction and non-white ethnicity. In IMPG, patients with medium low-restored trajectory were more likely to experience improved breast satisfaction, while patients developing high-restored trajectories were less likely to have worsened psychosocial well-being. Although more women in IMPG experienced restored PWBC after 2 years, those in AUTOG exhibited a more favorable postoperative trajectory of change in PWBC. This finding can inform clinical treatment decisions, help manage patient expectations for recovery, and develop rehabilitation interventions contributing to enhancing the postoperative quality of life for breast cancer patients.

QS31. Patient-reported Outcomes as a Clinical Vital Sign: BREAST-Q Implementation Lessons and Clinical Reference Values

Background: The BREAST-Q is the gold standard patient-reported outcome measure (PROM) of health-related quality of life and patient satisfaction following breast reconstruction. However, the routine, longitudinal implementation of the BREAST-Q has been challenging, so the BREAST-Q remain underutilized in patient care. We describe our institution’s improvements to BREAST-Q clinical implementation through increasing patient engagement and creating reference values. Methods: We reviewed BREAST-Qs completed by postmastectomy breast reconstruction patients at Memorial Sloan Kettering Cancer Center (MSK) in 2011-2019. In 2018, we began implementing BREAST-Q as a vital sign; BREAST-Qs were automatically administered before every encounter through an online patient portal. Clinics had a “BREAST-Q Champion” to troubleshoot implementation issues, assisted by a digital dashboard that tracked response rates. We examined annual BREAST-Q completion rates for 2011-2019. Annual completion rates prior to quality-improvement intervention were compared to those after intervention. Based on 2011-2017 scores, descriptive statistics were used to create reference values for BREAST-Q satisfaction subscales at preoperative and 6 months, 1 year, and 2 years after surgery and for BREAST-Q quality-of-life subscales at preoperative and 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after surgery. Separate reference values were generated for implant and autologous patients. Reference values were externally validated by comparing patient characteristics and BREAST-Q scores between the MSK and the Mastectomy Reconstruction Outcomes Consortium (MROC) study cohorts. Results: Out of 109,435 requested BREAST-Qs, 41,981 BREAST-Qs were completed. Of BREAST-Qs requested within 2-years of surgery, the average annual BREAST-Q completion rate increased from 42.8% in 2011-2017 to 87.6% in 2019, the last full year of our study period. High completion rates were maintained January-July 2020; however, a significantly larger proportion of BREAST-Qs were completed at home in 2020 versus the same period in 2019 (49.7% vs. 38.8%, p<0.001), potentially due to the COVID-19 pandemic. Reference values were based on 3268 MSK patients (2932 implant, 336 autologous) and validated with 2814 MROC patients (1958 implant, 856 autologous). Overall, few timepoint comparisons between the datasets reached clinically meaningful and statistical difference. Clinically important differences between MSK and MROC cohorts were most prevalent at 3 months after surgery, with MSK cohort patients having higher Psychosocial Wellbeing (Implants: +9.4 points, p<0.001; Autologous: +4.7 points, p=0.019) and Sexual Wellbeing (Implants: +6.1 points, p<0.001). By 1 year after surgery, differences between MSK and MROC cohorts diminished. Reference values were used to create the BREAST-Q Reconstruction Engagement and Communication Tool (REACT) for implant and autologous patients. Conclusion: Sustained, routine implementation of BREAST-Q is possible, and REACT adds to the clinical applicability of BREAST-Q by providing context to a numerical score.

BREAST-Q REACT: Clinical Reference Values for the BREAST-Q in Post-mastectomy Breast Reconstruction Patients.

The BREAST-Q is the most commonly used patient-reported outcome measure (PROM) for breast reconstruction research. However, clinical implementation of this PROM has been impeded by a lack of context for score interpretation. The aim of this study was to define reference values for the BREAST-Q at discrete timepoints following surgery, generating a tool for real-time score interpretation. BREAST-Q scores were prospectively obtained in women who underwent implant or autologous post-mastectomy breast reconstruction preoperatively and for 2 years following surgery at Memorial Sloan Kettering Cancer Center (MSK). Descriptive statistics were used to create reference values for BREAST-Q satisfaction and quality-of-life subscales. Reference values were externally validated by comparing patient characteristics and BREAST-Q scores between the MSK and the Mastectomy Reconstruction Outcomes Consortium (MROC) study cohorts. Overall, 3268 MSK patients and 2814 MROC patients were included for analysis. When MSK and MROC cohorts were compared for validation, there were some statistical differences in BREAST-Q scores; however, most of these differences did not meet the minimal clinically important difference of 4 points. Reference values were used to create the BREAST-Q Real-time Engagement and Communication Tool (REACT). Using a large cohort of patients, we have defined BREAST-Q reference values for post-mastectomy breast reconstruction patients for use in clinical practice. The BREAST-Q REACT will help breast reconstruction providers gauge patient wellbeing and satisfaction relative to the "average" breast reconstruction patient and determine which patients may benefit from additional intervention.

Association of Clinical Complications of Chemotherapy and Patient-Reported Outcomes After Immediate Breast Reconstruction

Women undergoing immediate breast reconstruction often require chemotherapy. The effects of chemotherapy on reconstruction are not well described. To evaluate the association of neoadjuvant and adjuvant chemotherapy with complications and patient-reported outcomes (PROs) in immediate reconstruction. The Mastectomy Reconstruction Outcomes Consortium Study is a cohort study that prospectively assessed PROs and retrospectively evaluated complications in patients undergoing immediate implant-based or autologous reconstruction at 11 centers from January 1, 2012, to December 31, 2017. Women 18 years or older undergoing immediate reconstruction after mastectomy with 2 years of follow-up were included. Patients were excluded if they had prophylactic mastectomy; delayed reconstruction; mixed-timing reconstruction; mixed reconstruction; a latissimus dorsi, superior gluteal artery perforator, or inferior gluteal artery perforator flap; or both neoadjuvant and adjuvant chemotherapy. Data were analyzed from May 1 to June 30, 2018. Complications and PROs (satisfaction with breast and physical, psychosocial, and sexual well-being) using the BREAST-Q questionnaire, a validated, condition-specific PRO measure. Baseline patient characteristics were collected. A total of 1881 women were included in the analysis (mean [SD] age, 49.9 [9.9] years). Of these, 1373 (73.0%) underwent implant-based procedures; 508 (27.0%), autologous reconstruction; 200 (10.6%), neoadjuvant chemotherapy; 668 (35.5%), adjuvant chemotherapy; and 1013 (53.9%), no chemotherapy. Patients without chemotherapy were significantly older (mean [SD] age, 51.6 [9.4] years; P < .001), and patients with chemotherapy were more likely to have received radiotherapy (108 of 200 [54.0%] for neoadjuvant chemotherapy and 321 of 668 [48.1%] for adjuvant chemotherapy; P < .001). Among the cohort undergoing implant-based reconstruction, the rates of any complication were significantly different, with higher rates seen for adjuvant (153 of 490 [31.2%]) and neoadjuvant (44 of 153 [28.8%]) chemotherapy compared with no chemotherapy (176 of 730 [24.1%]; P = .02). On multivariable analysis, these differences were not statistically significant. For autologous reconstruction, no significant differences in complications were observed. Controlling for clinical covariates, no significant differences were seen across chemotherapy groups for the BREAST-Q subscales except for sexual well-being in the implant cohort, in which adjuvant chemotherapy had significantly lower scores (β, -4.97 [95% CI, -8.68 to -1.27]; P = .009). In this cohort study, neither neoadjuvant nor adjuvant chemotherapy was associated with the likelihood of complications in patients undergoing implant-based or autologous reconstruction, and chemotherapy was not associated with patient satisfaction with reconstruction or psychosocial well-being. This information can help patients and clinicians make informed decisions about breast reconstruction in the setting of chemotherapy.

Development of an evidence-based approach to the use of acellular dermal matrix in immediate expander-implant-based breast reconstruction

Although acellular dermal matrix (ADM) is widely used in expander-implant-based breast reconstructions, previous analyses have been unable to demonstrate improvements in patient-reported outcomes (PROs) with this approach over non-ADM procedures. This study aims to develop a more selective, evidence-based approach to the use of ADM in expander-implant-based breast reconstruction by identifying patient subgroups in which ADM improved clinical outcomes and PROs. The Mastectomy Reconstruction Outcomes Consortium Study prospectively evaluated immediate expander-implant reconstructions at 11 centers from 2012 to 2015. Complications (any/overall and major), and PROs (satisfaction, physical, psychosocial, and sexual well-being) were assessed two years postoperatively using medical records and the BREAST-Q, respectively. Using mixed-models accounting for centers and with interaction terms, we analyzed for differential ADM effects across various clinical subgroups, including age, body mass index, radiation timing, and chemotherapy. Expander-implant-based breast reconstruction was performed in 1451 patients, 738 with and 713 without ADM. Major complication risk was higher in ADM users vs. nonusers (22.9% vs. 16.4% and p = 0.04). Major complication risk with ADM increased with higher BMI (BMI=30, OR=1.70; BMI=35, OR=2.29, interaction p = 0.02). No significant ADM effects were observed for breast satisfaction, psychosocial, sexual, and physical well-being within any subgroups. In immediate expander-implant-based breast reconstruction, ADM was associated with a greater risk of major complications, particularly in high-BMI patients. We were unable to identify patient subgroups where ADM was associated with significant improvements in PROs. Given these findings and the financial costs of ADM, a more critical approach to the use of ADM in expander-implant reconstruction may be warranted.

Hospital Variations in Clinical Complications and Patient-reported Outcomes at 2 Years After Immediate Breast Reconstruction.

Our objectives were to investigate case-mix adjusted hospital variations in 2-year clinical and patient-reported outcomes following immediate breast reconstruction. Over the past few decades, variations in medical practice have been viewed as opportunities to promote best practices and high-value care. The Mastectomy Reconstruction Outcomes Consortium Study is an National Cancer Institute-funded longitudinal, prospective cohort study assessing clinical and patient-reported outcomes of immediate breast reconstruction after mastectomy at 11 leading medical centers. Case-mix adjusted comparisons were performed using generalized linear mixed-effects models to assess variation across the centers in any complication, major complications, satisfaction with outcome, and satisfaction with breast. Among 2252 women in the analytic cohort, 1605 (71.3%) underwent implant-based and 647 (28.7%) underwent autologous breast reconstruction. There were significant differences in the sociodemographic and clinical characteristics, and distribution of procedure types at the different Mastectomy Reconstruction Outcomes Consortium Study centers. After case-mix adjustments, hospital variations in the rates of any and major postoperative complications were observed. Medical center odds ratios for major complication ranged from 0.58 to 2.13, compared with the average major complication rate across centers. There were also meaningful differences in satisfaction with outcome (from the lowest to highest of -2.79-2.62) and in satisfaction with breast (-2.82-2.07) compared with the average values. Two-year postoperative complications varied widely between hospitals following post-mastectomy breast reconstruction. These variations represent an important opportunity to improve care through dissemination of best practices and highlight the limitations of extrapolating single-institution level data and the ongoing challenges of studying hospital-based outcomes for this patient population.

Abstract: Effects of Radiation on Risks and Patient-Reported Outcomes in Expander-Implant Reconstruction: Is There a “Best” Time to Radiate?

INTRODUCTION: The oncologic benefit of radiation therapy for node positive breast cancer is well-known. However, studies have also shown poorer aesthetic outcomes, lower satisfaction, and higher complication rates in patients undergoing breast reconstruction with post-mastectomy radiation therapy (PMRT), compared to non-radiated patients.1,2 The timing of radiation treatment in two-staged, expander-implant reconstruction, whether to radiate before or after expander-implant exchange, has been a subject of contention. Previous research attempting to answer this question has been limited by small sample sizes and single center designs. In the current study, we evaluated the effects of radiation timing on patient reported outcomes (PROs) and complications in patients undergoing immediate expander-implant reconstruction. METHODS: Patients receiving immediate expander-implant reconstruction and PMRT at 11 Mastectomy Reconstruction Outcomes Consortium (MROC) study sites were assessed preoperatively and two years following expander placement. Demographic and clinical data (age, BMI, diabetes, race, laterality, mastectomy type, extent of disease, acellular dermal matrix use, and chemotherapy) were collected. Patient-reported outcomes were assessed with BREAST-Q, PROMIS, and EORTC QLQ-BR23 surveys. Complications and reconstructive failures within two years were also recorded, with complications requiring reoperation or rehospitalization designated as “major”. Survey scores and complication rates were compared across cohorts using multivariate regressions, controlling for demographic and clinical variables. RESULTS: Of the 3120 patients recruited in the MROC study, 317 met inclusion criteria. Of those, 237 patients received radiation treatment before expander-implant exchange (TE-XRT), and 80 received radiation treatment after exchange (Implant-XRT). Controlling for covariates, radiation timing had no significant effects on PRO subscale scores at two years postoperatively. Compared with preoperative assessments, two year PRO scores were significantly lower in both cohorts for satisfaction with breast, physical well-being, and sexual well-being subscales of BREAST-Q (p < 0.05). In addition, for the TE-XRT cohort, the two year PRO scores were significantly lower in the body image subscale of EORTC as well (p < 0.05). Finally, timing of radiation had no significant effects on odds of overall complications, major complications or reconstructive failure. CONCLUSION: In this multicenter, prospective analysis, the timing of radiation (before or after exchange) appeared to have no significant effects on either PROs or complication risks in immediate expander-implant reconstruction. Regardless of radiation timing, two year measures of satisfaction and other PROs did not appear to return to preoperative levels among women undergoing immediate expander-implant reconstruction in conjunction with PMRT. These findings provide patients and providers with additional evidence for treatment decision-making.

Long-term Patient-Reported Outcomes in Postmastectomy Breast Reconstruction

ImportancePrevious outcome studies comparing implant and autologous breast reconstruction techniques have been limited by short-term follow-up, single-center design, and a lack of rigorous patient-reported outcome data. An understanding of the expected satisfaction and breast-related quality of life associated with each type of procedure is central to the decision-making process.ObjectiveTo determine outcomes reported by patients undergoing postmastectomy breast reconstruction using implant or autologous techniques 2 years after surgery.Design, Setting, and ParticipantsPatients were recruited from 11 centers (57 plastic surgeons) across North America for the Mastectomy Reconstruction Outcomes Consortium study, a prospective, multicenter trial, from February 1, 2012, to July 31, 2015. Women undergoing immediate breast reconstruction using implant or autologous tissue reconstruction after mastectomy for cancer treatment or prophylaxis were eligible. Overall, 2013 women (1490 implant and 523 autologous tissue reconstruction) met the inclusion criteria. All patients included in this analysis had 2 years of follow-up.ExposuresProcedure type (ie, implant vs autologous tissue reconstruction).Main Outcomes and MeasuresThe primary outcomes of interest were scores on the BREAST-Q, a validated, condition-specific, patient-reported outcome instrument, which were collected prior to and at 2 years after surgery. The following 4 domains of the BREAST-Q reconstruction module were evaluated: satisfaction with breasts, psychosocial well-being, physical well-being, and sexual well-being. Responses from each scale were summed and transformed on a 0 to 100 scale, with higher numbers representing greater satisfaction or quality of life.ResultsOf the 2013 women in the study (mean [SD] age, 48.1 [10.5] years for the group that underwent implant-based reconstruction and 51.6 [8.7] years for the group that underwent autologous reconstruction), 1217 (60.5%) completed questionnaires at 2 years after reconstruction. After controlling for baseline patient characteristics, patients who underwent autologous reconstruction had greater satisfaction with their breasts (difference, 7.94; 95% CI, 5.68-10.20; P < .001), psychosocial well-being (difference, 3.27; 95% CI, 1.25-5.29; P = .002), and sexual well-being (difference, 5.53; 95% CI, 2.95-8.11; P < .001) at 2 years compared with patients who underwent implant reconstruction.Conclusions and RelevanceAt 2 years, patients who underwent autologous reconstruction were more satisfied with their breasts and had greater psychosocial well-being and sexual well-being than did those who underwent implant reconstruction. These findings can inform patients and their clinicians about expected satisfaction and quality of life outcomes of autologous vs implant-based procedures and further support the adoption of shared decision making in clinical practice.

Comparison of 2-Year Complication Rates Among Common Techniques for Postmastectomy Breast Reconstruction

In breast reconstruction, it is critical for patients and surgeons to have comprehensive information on the relative risks of the available options. However, previous studies that evaluated complications were limited by single-center designs, inadequate follow-up, and confounding. To assess 2-year complication rates across common techniques for postmastectomy reconstruction in a multicenter patient population. This longitudinal, multicenter, prospective cohort study conducted from February 1, 2012, through July 31, 2015, took place at the 11 study sites associated with the Mastectomy Reconstruction Outcomes Consortium study. Eligible patients included women 18 years and older presenting for first-time breast reconstruction with at least 2 years of follow-up. Procedures evaluated included direct-to-implant (DTI) technique, expander-implant (EI) technique, latissimus dorsi (LD) flap, pedicled transverse rectus abdominis myocutaneous (pTRAM) flap, free transverse rectus abdominis myocutaneous (fTRAM) flap, deep inferior epigastric perforator (DIEP) flap, and superficial inferior epigastric artery (SIEA) flap. Postmastectomy breast reconstruction. Development of complications, reoperative complications, and wound infections during 2-year follow-up. Mixed-effects logistic regression analysis controlled for variability among centers and for demographic and clinical variables. A total of 2343 patients (mean [SD] age, 49.5 [10.1] years; mean [SD] body mass index, 26.6 [5.7]) met the inclusion criteria. A total of 1525 patients (65.1%) underwent EI reconstruction, with 112 (4.8%) receiving DTI reconstruction, 85 (3.6%) pTRAM flaps, 95 (4.1%) fTRAM flaps, 390 (16.6%) DIEP flaps, 71 (3.0%) LD flaps, and 65 (2.8%) SIEA flaps. Overall, complications were noted in 771 (32.9%), with reoperative complications in 453 (19.3%) and wound infections in 230 (9.8%). Two years postoperatively, patients undergoing any autologous reconstruction type had significantly higher odds of developing any complication compared with those undergoing EI reconstruction (pTRAM flap: odds ratio [OR], 1.91; 95% CI, 1.10-3.31; P = .02; fTRAM flap: OR, 2.05; 95% CI, 1.24-3.40; P = .005; DIEP flap: OR, 1.97; 95% CI, 1.41-2.76; P < .001; LD flaps: OR, 1.87; 95% CI, 1.03-3.40; P = .04; SIEA flap: OR, 4.71; 95% CI, 2.32-9.54; P < .001). With the exception of LD flap reconstructions, all flap procedures were associated with higher odds of reoperative complications (pTRAM flap: OR, 2.48; 95% CI, 1.33-4.64; P = .005; fTRAM flap: OR, 3.02; 95% CI, 1.73-5.29; P < .001; DIEP flap: OR, 2.76; 95% CI, 1.87-4.07; P < .001; SIEA flap: OR, 2.62; 95% CI, 1.24-5.53; P = .01) compared with EI techniques. Of the autologous reconstructions, only patients undergoing DIEP flaps had significantly lower odds of infection compared with those undergoing EI procedures (OR, 0.45; 95% CI, 0.25-0.29; P = .006). However, DTI and EI procedures had higher failure rates (EI and DTI techniques, 7.1%; pTRAM flap, 1.2%; fTRAM flap, 2.1%; DIEP flap, 1.3%; LD flap, 2.8%; and SIEA flap, 0%; P < .001). Significant differences were noted across reconstructive procedure types for overall and reoperative complications, which is critically important information for women and surgeons making breast reconstruction decisions.

Is chronic postsurgical pain surgery-induced? A study of persistent postoperative pain following breast reconstruction

BackgroundChronic postsurgical pain (CPSP) is a reported risk for women undergoing breast reconstruction, but it remains unclear that such persistent pain is induced by reconstructive surgery. To address this concern, this prospective cohort study examined the prevalence of and risk factors associated with CPSP among women undergoing breast reconstruction. Materials and methodsWomen (n = 1996) recruited for the Mastectomy Reconstruction Outcomes Consortium (MROC) Study were assessed preoperatively and at two-years postoperatively for relevant medical/.surgical variables, pain experience, body physical well-being, anxiety, depression, and reconstruction procedure type and characteristics. ResultsNearly half of the entire sample reported some level of preoperative pain. At two years there were statistically significant but not clinically meaningful increases in both pain intensity and chest/upper body discomfort but a decrease in affective pain rating. Average clinical pain severity was strikingly similar for preoperative and postoperative assessments. Preoperative levels of pain, acute postoperative pain, and (marginally) level of depression held consistent relationship at two-year follow-up with all outcome measures. Autologous flap reconstruction was associated with more severe CPSP compared to TE/I reconstruction. Older age, higher BMI, bilateral reconstruction, and adjuvant radiation and chemotherapy were associated with CPSP and chest/upper body discomfort for at least one outcome measure at two years. ConclusionsThe substantial rate of preoperative pain and comparable prevalence of preoperative and postoperative pain ratings suggest that persistent pain after breast reconstruction may not necessarily reflect surgery-induced pain. Future research will need to determine those factors that contribute to long-term pain following breast reconstruction.

Association of Fat Grafting With Patient-Reported Outcomes in Postmastectomy Breast Reconstruction

Fat grafting has proven to be a useful adjunct to breast reconstruction for the treatment of contour irregularities and volume deficits, but the proposed US Food and Drug Administration regulations may severely limit the ability of plastic surgeons to continue its use in this clinical context. To determine whether fat grafting is associated with patient-reported outcomes (PROs) in patients undergoing breast reconstruction. A longitudinal, multicenter, prospective cohort study was conducted between February 1, 2012, and July 31, 2016, at the 11 sites associated with the Mastectomy Reconstruction Outcomes Consortium Study. Eligible patients included women 18 years or older presenting for breast reconstruction after mastectomy with 2 years or more of follow-up. All primary procedure types (implant based and flap based) were eligible. Patients were excluded if they had not completed breast mound reconstruction by 1 year after starting reconstruction. Fat grafting as an adjunct to breast mound reconstruction. Primary end points were patient-reported outcome measures as assessed by the validated BREAST-Q survey, with higher scores on a 0- to 100-point scale indicating better health-related quality of life. Survey subscales included breast satisfaction, as well as psychosocial, physical, and sexual well-being. Patient-reported outcomes were compared between those who received and did not receive fat grafting. A total of 2048 women were included (mean [SD] age, 49.4 [10] years), with 165 (8.1%) undergoing fat grafting between years 1 and 2. One year postoperatively, patients who later underwent fat grafting reported significantly lower breast satisfaction (adjusted mean difference [AMD], -4.74; 95% CI, -8.21 to -1.28; P = .008), psychosocial well-being (AMD, -3.87; 95% CI, -7.33 to -0.40; P = .03), and sexual well-being (AMD, -5.59; 95% CI, -9.70 to -1.47; P = .008), compared with those who did not receive subsequent fat grafting. Following the procedure, the fat-grafted cohort reported similar breast satisfaction (AMD, -0.68; 95% CI, -4.42 to 3.06; P = .72), psychosocial well-being (AMD, -0.59; 95% CI, -3.92 to 2.74; P = .73), and sexual well-being (AMD, -2.94; 95% CI, -7.01 to 1.12; P = .15) 2 years postoperatively. Fat grafting may improve breast satisfaction, psychosocial well-being, and sexual well-being in patients undergoing breast reconstruction.

Impact of Bilateral Prophylactic Mastectomy and Immediate Reconstruction on Health-Related Quality of Life in Women at High Risk for Breast Carcinoma: Results of the Mastectomy Reconstruction Outcomes Consortium Study.

Although bilateral prophylactic mastectomy (BPM) can reduce the risk of breast cancer, the decision to proceed surgically can have significant consequences and requires careful deliberation. To facilitate decision making for women at high risk for breast carcinoma, the risks and benefits of BPM should be well-elucidated. We sought to determine the effects of BPM and immediate reconstruction on health-related quality-of-life outcomes among a multisite cohort of women at high risk for breast carcinoma. Patient-reported outcome data were prospectively collected as part of the Mastectomy Reconstruction Outcomes Consortium Study, and data on a subgroup of 204 high-risk women who elected to have BPM and immediate reconstruction were evaluated. Baseline scores were compared with scores at 1 or 2years after reconstruction. Satisfaction with breasts and psychosocial well-being were significantly higher at both 1 and 2years (p<0.01); however, anxiety was significantly lower at 1 or 2years (p<0.01) and physical well-being of the chest and upper body was significantly worse at 1year (p<0.01). Our results highlight the impact of BPM and immediate reconstruction on health-related quality-of-life outcomes in this setting. BPM and reconstruction can result in significant, positive, lasting changes in a woman's satisfaction with her breasts, as well as her psychosocial well-being. Furthermore, presurgery anxiety was significantly reduced by 1year post-reconstruction and remained reduced at 2years.With this knowledge, women at high risk for breast carcinoma, and their providers, will be better equipped to make the best individualized treatment decisions.

Radiation Therapy Versus No Radiation Therapy to the Neo-breast Following Skin-Sparing Mastectomy and Immediate Autologous Free Flap Reconstruction for Breast Cancer: Patient-Reported and Surgical Outcomes at 1 Year—A Mastectomy Reconstruction Outcomes Consortium (MROC) Substudy

To determine whether adjuvant radiation therapy (RT) is associated with adverse patient-reported outcomes and surgical complications 1year after skin-sparing mastectomy and immediate autologous free flap reconstruction for breast cancer. We compared 24 domains of patient-reported outcome measures 1year after autologous reconstruction between patients who received adjuvant RT and those who did not. A total of 125 patients who underwent surgery between 2012 and 2015 at our institution were included from the Mastectomy Reconstruction Outcomes Consortium study database. Adjusted multivariate models were created incorporating RT technical data, age, cancer stage, estrogen receptor, chemotherapy, breast size, body mass index, and income to determine whether RT was associated with outcomes. At 1year after surgery, European Organisation for Research and Treatment of Cancer (EORTC) Breast Cancer-Specific Quality of Life Questionnaire breast symptoms were significantly greater in 64 patients who received RT (8-point difference on 100-point ordinal scale, P<.0001) versus 61 who did not receive RT in univariate and multivariate models. EORTC arm symptoms (20-point difference on 100-point ordinal scale, P=.0200) differed on univariate analysis but not on multivariate analysis. All other outcomes-including Numerical Pain Rating Scale, BREAST-Q (Post-operative Reconstruction Module), Patient-Report Outcomes Measurement Information System Profile 29, McGill Pain Questionnaire-Short Form (MPQ-SF) score, Generalized Anxiety Disorder Scale, and Patient Health Questionnaire-were not statistically different between groups. Surgical complications were uncommon and did not differ by treatment. RT to the neo-breast compared with no RT following immediate autologous free flap reconstruction for breast cancer is well tolerated at 1year following surgery despite patients undergoing RT also having a higher cancer stage and more intensive surgical and systemic treatment. Neo-breast symptoms are more common in patients receiving RT by the EORTC Breast Cancer-Specific Quality of Life Questionnaire but not by the BREAST-Q. Patient-reported results at 1year after surgery suggest RT following immediate autologous free flap breast reconstruction is well tolerated.

Patient-Reported Outcomes 1 Year After Immediate Breast Reconstruction: Results of the Mastectomy Reconstruction Outcomes Consortium Study

Purpose The goals of immediate postmastectomy breast reconstruction are to minimize deformity and optimize quality of life as perceived by patients. We prospectively evaluated patient-reported outcomes (PROs) in women undergoing immediate implant-based or autologous reconstruction. Methods Women undergoing immediate postmastectomy reconstruction for invasive cancer and/or carcinoma in situ were enrolled at 11 sites. Women underwent implant-based or autologous tissue reconstruction. Patients completed the BREAST-Q, a condition-specific PRO measure for breast surgery patients, and Patient-Reported Outcomes Measurement Information System-29, a generic PRO measure, before and 1 year after surgery. Mean changes in PRO scores were summarized. Mixed-effects regression models were used to compare PRO scores across procedure types. Results In total, 1,632 patients (n = 1,139 implant, n = 493 autologous) were included; 1,183 (72.5%) responded to 1-year questionnaires. After analysis was controlled for baseline values, patients who underwent autologous reconstruction had greater satisfaction with their breasts than those who underwent implant-based reconstruction (difference, 6.3; P < .001), greater sexual well-being (difference, 4.5; P = .003), and greater psychosocial well-being (difference, 3.7; P = .02) at 1 year. Patients in the autologous reconstruction group had improved satisfaction with breasts (difference, 8.0; P = .002) and psychosocial well-being (difference, 4.6; P = .047) compared with preoperative baseline. Physical well-being of the chest was not fully restored in either the implant group (difference, -3.8; P = .001) or autologous group (-2.2; P = .04), nor was physical well-being of the abdomen in patients who underwent autologous reconstruction (-13.4; P < .001). Anxiety and depression were mitigated at 1 year in both groups. Compared with their baseline reports, patients who underwent implant reconstruction had decreased fatigue (difference, -1.4; P = .035), whereas patients who underwent autologous reconstruction had increased pain interference (difference, 2.0; P = .006). Conclusion At 1 year after mastectomy, patients who underwent autologous reconstruction were more satisfied with their breasts and had greater psychosocial and sexual well-being than those who underwent implant reconstruction. Although satisfaction with breasts was equal to or greater than baseline levels, physical well-being was not fully restored. This information can help patients better understand expected outcomes and may guide innovations to improve outcomes.

Effect of Patient Age on Outcomes in Breast Reconstruction: Results from a Multicenter Prospective Study

Although >40% of new breast cancer diagnoses in the US are in older women, few studies have assessed the outcomes of post-mastectomy reconstruction in this population. Our objective was to evaluate age effects on postoperative complications and patient-reported outcomes in women undergoing breast reconstruction, and to investigate whether age effects differ between reconstructive procedure types. Eligible patients in the Mastectomy Reconstruction Outcomes Consortium study from 11 institutions (57 providers) in North America were analyzed. Two-year complications and patient-reported outcomes via BREAST-Q domains were compared across younger (younger than 45years), middle-aged (45 to 60 years), and older (older than 60 years) women. Mixed-effects regression models were used, controlling for a range of demographic and clinical covariates. A total of 1,531 patients were studied: 494 younger, 803 middle-aged, and 234 older. Age was not a significant predictor of complications. For sexual well-being 2 years post-reconstruction, older women reported 4.25 (p= 0.04) higher mean scores with implant procedures, and 10.39 (p < 0.01) higher mean scores with autologous procedures compared with younger women. No age effect was seen with implant procedures with regard to physical and psychosocial well-being; however, older women who underwent autologous procedures reported 6.07 (p < 0.01) higher physical, and 8.21 (p < 0.01) higher psychosocial well-being scores than younger women. Age did not significantly affect complication rates. Older women demonstrated higher sexual well-being for both procedures, and better satisfaction and physical and psychosocial well-being than younger women with autologous procedures. Post-mastectomy reconstruction is a viable option for older patients, with risks and benefits comparable with those in younger women.

Sociodemographic Predictors of Breast Reconstruction Procedure Choice: Analysis of the Mastectomy Reconstruction Outcomes Consortium Study Cohort.

Background. To promote patient-centered care, it is important to understand the impact of sociodemographic factors on procedure choice for women undergoing postmastectomy breast reconstruction. In this context, we analyzed the effects of these variables on the reconstructive method chosen. Methods. Women undergoing postmastectomy breast reconstruction were recruited for the prospective Mastectomy Reconstruction Outcomes Consortium Study. Procedure types were divided into tissue expander-implant/direct-to-implant and abdominally based flap reconstructions. Adjusted odds ratios were calculated from logistic regression. Results. The analysis included 2,203 women with current or previous breast cancer and 202 women undergoing prophylactic mastectomy. Compared with women <40 years old with current or previous breast cancer, those 40 to 59 were significantly more likely to undergo an abdominally based flap. Women working or attending school full-time were more likely to receive an autologous procedure than those working part-time or volunteering. Women undergoing prophylactic mastectomy who were ≥50 years were more likely to undergo an abdominal flap compared to those <40. Conclusions. Our results indicate that sociodemographic factors affect the reconstructive procedure received. As we move forward into a new era of patient-centered care, providing tailored treatment options to reconstruction patients will likely lead to higher satisfaction and better outcomes for those we serve.

Understanding the recovery phase of breast reconstructions: Patient-reported outcomes correlated to the type and timing of reconstruction

During preoperative discussions with breast reconstruction patients, questions often arise about what to expect during the recovery period. However, there is a paucity of data elucidating post-breast reconstruction pain, fatigue, and physical morbidity. This information is important to patient and physician understanding of reconstructive choices and the postoperative recovery process. We sought to evaluate how recovery may vary for patients based on the timing and type of reconstruction. Patients were recruited as part of the Mastectomy Reconstruction Outcomes Consortium (MROC) study, which is a prospective, multicentered National Institute of Health (NIH)-funded study (1RO1CA152192). Here, patients completed the Numerical Pain Rating Scale (NPRS), McGill Pain Questionnaire, and Breast-Q preoperatively, at 1 week, and 3 months postoperatively. Pain, fatigue, and upper body morbidity were evaluated by the type and timing of reconstruction. A total of 2013 MROC study participants had completed a 3-month follow-up, and therefore they were included for the analysis. A total of 1583 (78.6%) and 1517 patients (75.3%) completed surveys at 1 week and 3 months, respectively, post reconstruction. Across all procedure groups, fatigue and physical well-being scores did not return to preoperative levels by 3 months. At 3 months, pain measured by the NPRS differed across procedure types (P=0.01), with tissue expander/implant (TE/I) having more pain than direct to implant (P<0.01). Similarly, at 3 months, chest and upper body physical morbidity, as measured by BREAST-Q, differed by procedure types (P<0.001), with generally less morbidity for autologous reconstruction as compared with TE/Is. For all reconstructive procedure groups, patients did not fully recover at 3 months post surgery. In addition, postoperative pain and upper body physical morbidity vary significantly by reconstructive procedure with patients undergoing TE/I reporting the most distress.