Germline predictors for bevacizumab induced hypertensive crisis in ECOG-ACRIN 5103 and BEATRICE.

BACKGROUND: Bevacizumab is a beneficial therapy in several advanced cancer types. Predictive biomarkers to better understand which patients are destined to benefit or experience toxicity are needed. Associations between bevacizumab induced hypertension and survival have been reported but with conflicting conclusions. METHODS: We performed post-hoc analyses to evaluate the association in 3124 patients from two phase III adjuvant breast cancer trials, E5103 and BEATRICE. Differences in invasive disease-free survival (IDFS) and overall survival (OS) between patients with hypertension and those without were compared. Hypertension was defined as systolic blood pressure (SBP) ≥ 160 mmHg (n = 346) and SBP ≥ 180 mmHg (hypertensive crisis) (n = 69). Genomic analyses were performed to evaluate germline genetic predictors for the hypertensive crisis. RESULTS: Hypertensive crisis was significantly associated with superior IDFS (p = 0.015) and OS (p = 0.042), but only IDFS (p = 0.029; HR = 0.28) remained significant after correction for prognostic factors. SBP ≥ 160 mmHg was not associated with either IDFS or OS. A common single-nucleotide polymorphism, rs6486785, was significantly associated with hypertensive crisis (p = 8.4 × 10-9; OR = 5.2). CONCLUSION: Bevacizumab-induced hypertensive crisis is associated with superior outcomes and rs6486785 predicted an increased risk of this key toxicity.

'What is it we are trying to achieve here'? Community maternal and child health nurses and clinical supervision: A qualitative descriptive study.

AIMS: To explore clinical supervision practice by Victorian Maternal and Child Health nurses, identify the self-reported supervision needs of nurses and the facilitators and barriers to meeting those needs. BACKGROUND: Community-based Maternal and Child Health nurses have responsibilities for the safety and wellbeing of children and specific clinical support needs. Clinical supervision has the potential to support nurses' clinical practice and reflective skills; however, little is known internationally about child and family health nurses' supervision practices. DESIGN: Qualitative descriptive study. METHODS: Twenty-three semi-structured interviews were conducted between October and December 2021 with nurses, managers and supervisors across metropolitan, regional/rural areas of Victoria, Australia. Inductive thematic analysis was applied to the data. The Consolidated Criteria for Reporting Qualitative Research guided this study. RESULTS: Three main themes, with subthemes were generated; 'Understand what we do', 'It's the gathering of the nurses' and 'Bringing a case'. A lack of agreed purpose, aims and varied understandings of clinical supervision contributed to suboptimal clinical supervision. Although participants agreed about the importance of clinical supervision, the perceived benefits were inconsistently realized. CONCLUSIONS: This study points to a need for greater organizational awareness of the conditions and leadership needed to build reflective skills and culture in community-based child and family nursing. REPORTING METHOD: The Consolidated Criteria for Reporting Qualitative Research has guided this study. NO PATIENT OR PUBLIC CONTRIBUTION: There was no patient or public contribution in the conduct of this study. IMPACT: A stronger focus is needed to build reflective culture and skill in child and family nursing. Areas for improving child and family nurses' use of clinical supervision have been identified. This study can inform nurse education, policy and service leaders, to strengthen clinical supervision in child and family nursing contexts.

Intraoperative vasopressor use does not increase complications in microvascular post-mastectomy breast reconstruction: Experience in 1729 DIEP flaps at a single center.

INTRODUCTION: Vasopressors are traditionally avoided in microsurgery due to concerns about their effect on free flap survival. We examine the impact of intraoperative vasopressors on microsurgical outcomes in a large series of DIEP flap breast reconstructions. METHODS: A retrospective chart review was performed of patients who underwent DIEP breast reconstruction between January 2010 and May 2020. Intraoperative and postoperative microsurgical outcomes were compared in patients who received vasopressors and those who did not. RESULTS: The study included 1102 women who underwent 1729 DIEP. 878 patients (79.7%) received intraoperative phenylephrine, ephedrine, or a combination of both. There was no significant difference in overall complications, intraoperative microvascular events, takebacks for microvascular complications, or partial or total flap loss between groups. Outcomes were not affected by vasopressor type, dose, or timing of administration. The vasopressor group received significantly lower intraoperative fluid volumes. Multivariate logistic regression found a significant association between overall complications and excessive fluids (OR 2.03, 99% CI 0.98-5.18, p = 0.03) but not vasopressor use (OR 0.79, 99% CI 0.64-3.16, p = 0.7) CONCLUSION: This study demonstrates that vasopressors do not adversely affect clinical outcomes after DIEP breast reconstruction. Withholding vasopressors results in excessive intravenous fluid administration and increased postoperative complications.

"Spin" in Observational Studies in Deep Inferior Epigastric Perforator Flap Breast Reconstruction: A Systematic Review.

The deep inferior epigastric artery perforator (DIEP) flap is widely used in autologous breast reconstruction. However, the technique relies heavily on nonrandomized observational research, which has been found to have high risk of bias. "Spin" can be used to inappropriately present study findings to exaggerate benefits or minimize harms. The primary objective was to assess the prevalence of spin in nonrandomized observational studies on DIEP reconstruction. The secondary objectives were to determine the prevalence of each spin category and strategy. Methods: MEDLINE and Embase databases were searched from January 1, 2015, to November 15, 2022. Spin was assessed in abstracts and full-texts of included studies according to criteria proposed by Lazarus et al. Results: There were 77 studies included for review. The overall prevalence of spin was 87.0%. Studies used a median of two spin strategies (interquartile range: 1-3). The most common strategies identified were causal language or claims (n = 41/77, 53.2%), inadequate extrapolation to larger population, intervention, or outcome (n = 27/77, 35.1%), inadequate implication for clinical practice (n = 25/77, 32.5%), use of linguistic spin (n = 22/77, 28.6%), and no consideration of the limitations (n = 21/77, 27.3%). There were no significant associations between selected study characteristics and the presence of spin. Conclusions: The prevalence of spin is high in nonrandomized observational studies on DIEP reconstruction. Causal language or claims are the most common strategy. Investigators, reviewers, and readers should familiarize themselves with spin strategies to avoid misinterpretation of research in DIEP reconstruction.

A Size-Based Criteria for Flap Reconstruction After Thigh-Adductor, Soft-Tissue Sarcoma Resection.

BACKGROUND: Resection of soft-tissue sarcomas from the adductor compartment is associated with significant complications. Free/pedicled flaps often are used for wound closure, but their effect on healing is unclear. We compared wound complications, oncologic, and functional outcomes for patients undergoing flap reconstruction or primary closure following resection of adductor sarcomas. METHODS: A total of 177 patients underwent resection of an adductor sarcoma with primary closure (PrC) or free/pedicled flap reconstruction (FR). Patient, tumor, and treatment characteristics were compared, as well as wound complications, oncologic, and functional outcomes (TESS/MSTS87/MSTS93). To examine the relative benefit of flap reconstruction, number needed to treat (NNT) was calculated. RESULTS: In total, 143 patients underwent PrC and 34 had FR, 68% of which were pedicled. There were few differences in demographic, tumor, or treatment characteristics. No significant difference was found in the rate of wound complications. Length of stay was significantly longer in FR (18 days vs. PrC 8 days; p < 0.01). Oncologic and functional outcomes were similar over 5 years follow-up. Uncomplicated wound healing occurred more often in FR compared with PrC for tumors with ≥15 cm (NNT = 8.4) or volumes ≥ 800 ml (NNT = 8.4). Tumors ≤ 336 ml do not benefit from a flap, whereas those > 600 ml are 1.5 times more likely to heal uneventfully after flap closure. CONCLUSIONS: Although flap use prolonged hospitalization, it decreased wound healing complications for larger tumors, and in all sized tumors, it demonstrated similar functional and oncologic outcomes to primary closure. Our size-based treatment criteria can help to identify patients with large adductor sarcomas who could benefit from flap reconstruction. LEVEL OF EVIDENCE III: (Retrospective cohort study).

The risk of bias of non-randomized observational studies in deep inferior epigastric perforator flap breast reconstruction: A systematic review using ROBINS-I.

INTRODUCTION: The deep inferior epigastric perforator (DIEP) flap is regarded as the gold standard for autologous breast reconstruction. However, due to difficulty designing and conducting randomized controlled trials in surgical interventions, the majority of literature on DIEP flap breast reconstructions are observational studies. As such, it is pivotal that these studies are performed with high internal validity. METHODS: A literature search was performed using MEDLINE, Embase, and CENTRAL from January 1, 2015 to October 23, 2021. Studies identified as observational studies about DIEP breast reconstruction and published in a journal with a Web of Science impact factor above 1.0 were included. Screening and risk of bias (RoB) assessment using the ROBINS-I tool were performed independently and in duplicate by two authors. RESULTS: From 12,371 studies, 66 observational studies were included. The majority were found at RoB, with 11 at moderate, 26 at serious, and 6 at critical RoB. Only two studies had low RoB. The bias most commonly arose due to Domain 1 (confounding variables), Domain 3 (classification of interventions), and Domain 6 (measurement of outcomes). CONCLUSIONS: In this review, we demonstrate the high RoB of observational studies evaluating DIEP breast reconstruction, which may jeopardize the validity of findings. We recommend that authors consult the ROBINS-I tool not only when assessing observational studies for systematic reviews but also when designing or conducting these studies. In our study, we present additional considerations for each domain to provide researchers with guidance on assessing and conducting surgical observational studies.

Inflammatory cytokines and distant recurrence in HER2-negative early breast cancer.

Systemic inflammation is believed to contribute to the distant recurrence of breast cancer. We evaluated serum samples obtained at diagnosis from 249 case:control pairs with stage II-III Her2-negative breast cancer with or without subsequent distant recurrence. Conditional logistic regression analysis, with models fit via maximum likelihood, were used to estimate hazard ratios (HRs) and test for associations of cytokines with distant recurrence risk. The only biomarker associated with a significantly increased distant recurrence risk when adjusted for multiple testing was the proinflammatory cytokine IL-6 (HR 1.37, 95% confidence intervals [CI] 1.15, 1.65, p = 0.0006). This prospective-retrospective study provides evidence indicating that higher levels of the cytokine IL-6 at diagnosis are associated with a significantly higher distant recurrence risk.

Quality of Life Following Receipt of Adjuvant Chemotherapy With and Without Bevacizumab in Patients With Lymph Node-Positive and High-Risk Lymph Node-Negative Breast Cancer.

IMPORTANCE: Breast cancer treatment can impact not only short-term health but may also affect longer-term quality of life (QOL). OBJECTIVE: To describe and evaluate factors associated with diminished QOL following completion of active treatment. DESIGN, SETTING, AND PARTICIPANTS: This was a secondary analysis of a randomized clinical trial included patients with lymph node-positive or high-risk lymph node-negative breast cancer who had undergone definitive surgery and were enrolled in ECOG-ACRIN E5103, a multisite phase 3 trial. A survey was administered 18 months after enrollment to patients enrolled between January and June 2010. Final analysis of the data took place from March to December 2021. INTERVENTIONS: Patients received adjuvant doxorubicin, cyclophosphamide, and paclitaxel with either bevacizumab or placebo. MAIN OUTCOMES AND MEASURES: QOL and health status assessed with the EuroQol 5-Dimension 3-Levels (EQ-5D-3L), EQ-visual analog scale (EQ-VAS), and the Functional Assessment of Cancer Therapy-Breast Cancer, with arm subscale (FACT-B+4). Groups were compared by Fisher exact test, Wilcoxon rank sum, or Kruskal-Wallis test. Multivariable linear regression was used to assess factors independently associated with FACT-B scores. RESULTS: Data at 18 months were available from 455 of 519 patients (87.7%) enrolled in the trial. Median (range) age at enrollment was 52 (25-76) years. No differences in QOL (median [range] FACT-B scores: group A, 123 [67-146]; group B, 114 [54-148]; group C, 117 [42-148]; P = .23) or health status (median [range] EQ-5D-3L index scores: group A, 0.83 [0.28-1.00]; group B, 0.83 [0.20-1.00]; group C, 0.83 [0.17-1.00], P = .80; median EQ-VAS: group A, 85 [20-100]; group B, 85 [0-100]; group C, 85 [0-100]; P = .79) were observed across treatment groups; results for subsequent analyses were therefore reported irrespective of primary treatment. Overall, half of patients (258 of 444 [58%]) reported at least some pain or discomfort; 170 (38%) reported symptoms of anxiety or depression. In multivariable analyses, mastectomy with radiation (vs breast conserving surgery) and Asian, Black, or American Indian or Alaska Native race (vs White race) were associated with lower QOL (mastectomy with radiation: coefficient: -5.5; 95% CI, -10.1 to -0.9; Asian, Black, or American Indian or Alaska Native race: coefficient: -7.3; 95% CI, -13.2, -1.4). CONCLUSIONS AND RELEVANCE: In this study, the addition of bevacizumab to chemotherapy was not negatively associated with QOL at 18 months. A substantial proportion of participants reported problems related to pain or discomfort and anxiety or depression, demonstrating persistent consequences for physical and psychosocial well-being in this heavily treated population. Many problems reported are amenable to intervention, underscoring the need for timely referral to supportive resources, especially for women of color and those who have more extensive local therapy. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00433511.

Neoadjuvant and Adjuvant Nivolumab and Lirilumab in Patients with Recurrent, Resectable Squamous Cell Carcinoma of the Head and Neck.

PURPOSE: Surgery often represents the best chance for disease control in locoregionally recurrent squamous cell carcinoma of the head and neck (SCCHN). We investigated dual immune-checkpoint inhibition [anti-PD-1, nivolumab (N), and anti-KIR, lirilumab (L)] before and after salvage surgery to improve disease-free survival (DFS). PATIENTS AND METHODS: In this phase II study, patients received N (240 mg) + L (240 mg) 7 to 21 days before surgery, followed by six cycles of adjuvant N + L. Primary endpoint was 1-year DFS; secondary endpoints were safety, pre-op radiologic response, and overall survival (OS). Correlatives included tumor sequencing, PD-L1 scoring, and immunoprofiling. RESULTS: Among 28 patients, the median age was 66, 86% were smokers; primary site: 9 oral cavity, 9 oropharynx, and 10 larynx/hypopharynx; 96% had prior radiation. There were no delays to surgery. Grade 3+ adverse events: 11%. At the time of surgery, 96% had stable disease radiologically, one had progression. Pathologic response to N + L was observed in 43% (12/28): 4/28 (14%) major (tumor viability, TV ≤ 10%) and 8/28 (29%) partial (TV ≤ 50%). PD-L1 combined positive score (CPS) at surgery was similar regardless of pathologic response (P = 0.71). Thirteen (46%) recurred (loco-regional = 10, distant = 3). Five of 28 (18%) had positive margins, 4 later recurred. At median follow-up of 22.8 months, 1-year DFS was 55.2% (95% CI, 34.8-71.7) and 1-year OS was 85.7% (95% CI, 66.3-94.4). Two-year DFS and OS were 64% and 80% among pathologic responders. CONCLUSIONS: (Neo)adjuvant N + L was well tolerated, with a 43% pathologic response rate. We observed favorable DFS and excellent 2-year OS among high-risk, previously treated patients exhibiting a pathologic response. Further evaluation of this strategy is warranted.See related commentary by Sacco and Cohen, p. 435.

Multidisciplinary Intervention in Radiation-Associated Angiosarcoma of the Breast: Patterns of Recurrence and Response to Treatment.

BACKGROUND: Radiation-associated angiosarcoma (RAAS) of the breast is an aggressive malignancy affecting 1 in 1000 breast cancer patients. This study aimed to determine differences in treatments and outcomes for RAAS initially managed through a sarcoma multi-disciplinary team (SMDT) compared with an outside center (OC) and to describe outcomes after recurrence. METHODS: Patients with a diagnosis of breast RAAS between 2004 and 2019 were identified from our sarcoma database. Clinicopathologic characteristics, recurrence patterns, and factors predictive of survival were assessed. Differences in local recurrence-free survival (LRFS) and disease-specific survival (DSS) were estimated using Kaplan-Meier and compared using the log-rank test. RESULTS: Surgery was performed for 49 women with RAAS, who had a median age of 74 years (range 41-89 years). Primary management was performed by SMDT for 26 patients and by OC for 23 patients. Radical mastectomy and reconstruction were performed for 96% of the SMDT group versus 17% of the OC group (p = 0.00001). The proportion patients who received chemotherapy, radiation, or both was 42.3% in the SMDT group and 0% in the OC group. During a median follow-up period of 26 months, recurrence was experienced by 38% (10/26) of the SMDT cohort and 83% (19/23) of the OC cohort (p = 0.002). The 3-year LRFS was better in the SMDT cohort (59.3% vs 31.8%; p = 0.019). Of the 29 recurrences 16 received chemotherapy and 6 received radiation, surgery, or both. At the last follow-up visit, 20 patients were in first remission, 1 patient was in second remission, 8 patients were alive with disease, and 20 patients had died of disease. CONCLUSION: Initial treatment by SMDT was associated with more extensive surgery, multimodal treatments, and a better 3-year LRFS. Patients with breast RAAS likely benefit from early referral and treatment by an SMDT.

Longitudinal Study of Psychosocial Outcomes Following Surgery in Women with Unilateral Nonhereditary Breast Cancer.

INTRODUCTION: Rates of bilateral mastectomy are rising in women with unilateral, nonhereditary breast cancer. We aim to characterize how psychosocial outcomes evolve after breast cancer surgery. PATIENTS AND METHODS: We performed a prospective cohort study of women with unilateral, sporadic stage 0-III breast cancer at University Health Network in Toronto, Canada between 2014 and 2017. Women completed validated psychosocial questionnaires (BREAST-Q, Impact of Event Scale, Hospital Anxiety & Depression Scale) preoperatively, and at 6 and 12 months following surgery. Change in psychosocial scores was assessed between surgical groups using linear mixed models, controlling for age, stage, and adjuvant treatments. P < .05 were significant. RESULTS: A total of 475 women underwent unilateral lumpectomy (42.5%), unilateral mastectomy (38.3%), and bilateral mastectomy (19.2%). There was a significant interaction (P < .0001) between procedure and time for breast satisfaction, psychosocial and physical well-being. Women having unilateral lumpectomy had higher breast satisfaction and psychosocial well-being scores at 6 and 12 months after surgery compared with either unilateral or bilateral mastectomy, with no difference between the latter two groups. Physical well-being declined in all groups over time; scores were not better in women having bilateral mastectomy. While sexual well-being scores remained stable in the unilateral lumpectomy group, scores declined similarly in both unilateral and bilateral mastectomy groups over time. Cancer-related distress, anxiety, and depression scores declined significantly after surgery, regardless of surgical procedure (P < .001). CONCLUSIONS: Psychosocial outcomes are not improved with contralateral prophylactic mastectomy in women with unilateral breast cancer. Our data may inform women considering contralateral prophylactic mastectomy.

Impact of insurance and neighborhood socioeconomic status on clinical outcomes in therapeutic clinical trials for breast cancer.

The objective of this study was to evaluate the impact of insurance and neighborhood SES (nSES) on chemotherapy completion and overall mortality among participants in breast cancer clinical trials. The data sources for this study were two adjuvant breast cancer trials (ECOG E1199 and E5103) collectively including 9790 women. Insurance status at trial registration was categorized into private, government (Medicaid, Medicare, and other government type insurance), and self-pay. An Agency for Healthcare Research Quality (AHRQ) nSES index was calculated using residential zip codes linked to county level data on occupation, income, poverty, wealth, education, and crowding. Logistic regression and Cox Proportional Hazard models estimated odds ratios (OR) for chemotherapy treatment completion and hazard ratios (HR) for mortality, respectively, for insurance status and nSES. The models adjusted for: race, age, tumor size, nodal status, hormone receptor status, and primary surgery. The majority of patients had private insurance at trial registration: E1199: 85.6% (4154/4854) and E5103: 82.4% (3987/4836); median SES index was 53.8 (range: 41.8-66.8) and 54.1 (range: 44.5-66.1), respectively. Patients with government insurance were less likely to complete chemotherapy treatment (E1199 OR (95%CI): 0.73 (0.57-0.94); E5103 0.76 (0.64-0.91)) and had an increased risk of death (E1199 HR (95%CI): 1.44 (1.22-1.70); E5103 1.29 (1.06-1.58)) compared to the privately insured patients. There was no association between nSES and chemotherapy completion or overall mortality. Patients with government insurance at trial registration appeared to face barriers in chemotherapy completion and had a higher overall mortality compared to their privately insured counterparts.

Preconsultation Educational Group Intervention Can Address the Knowledge Gap in Postmastectomy Breast Reconstruction.

BACKGROUND: Whether to undergo postmastectomy breast reconstruction (PMBR) is a challenging, preference-sensitive decision. It is therefore paramount to optimize decision quality through ensuring patients' knowledge and aligning treatments with their personal preferences. This study assessed the effects of a preconsultation educational group intervention (PEGI) on patient knowledge, state-trait anxiety, and decisional conflict (patient uncertainty in decision making) during the decision-making process. METHODS: This phase 3 randomized controlled trial assessed effects of a PEGI in women without active breast cancer undergoing delayed PMBR, or prophylactic mastectomy with immediate PMBR. Both groups underwent routine education before consultation. In addition, the intervention group underwent a PEGI composed of presentations from a plastic surgeon and nurse, a value clarification exercise, and shared experiences from PMBR patients before the consultation with the plastic surgeon. Before and 1-week after consultation, outcome measures were assessed using the Decisional Conflict Scale, State-Trait Anxiety Inventory, and the BREAST-Q. RESULTS: Of the 219 women deemed eligible, a total of 156 women were recruited and randomized. Treatment fidelity was 96% and retention was 88%. At baseline, there were no significant differences in terms of demographic or clinical status, knowledge, state-trait anxiety, and decisional conflict. Patient knowledge about PMBR improved in both groups; however, the degree of knowledge attainment was significantly greater in the PEGI group (24.5% improvement in the intervention group compared with 13.5% in the routine education group, P < 0.001). The reduction in decisional conflict from baseline to follow-up was greater in the intervention group compared with the routine education; however, the difference only approached significance (P = 0.09). CONCLUSIONS: The provision of a preconsultation educational group intervention has been shown to significantly close the knowledge gap on PMBR in patients seeking delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction compared with routine education alone.

Early Postoperative Complications From National Surgical Quality Improvement Program: A Closer Examination of Timing and Technique of Breast Reconstruction.

BACKGROUND: Despite the recent surge in rates of immediate breast reconstruction, there is a paucity of large multicenter studies to compare differences in morbidity after immediate versus delayed breast reconstruction. This study used the National Surgical Quality Improvement Program (NSQIP) to study the association between timing of breast reconstruction and complication rates, stratified by reconstructive modality. STUDY DESIGN: The NSQIP database was used to identify breast reconstructions from 2005 to 2012. Rates of major complications were compared by timing within each reconstructive modality (implant vs autologous). Cohort differences in baseline characteristics and variables associated with increased complication rates were identified in bivariate analyses. A multivariable model was created to compare the association between the timing of reconstruction and major complications. RESULTS: Of 24,506 postmastectomy reconstructions, 85.8% were immediate, 14.2% were delayed, 84% were implant, and 16% were autologous reconstructions. Overall, 10.0% of patients suffered a major complication. After stratification, only implant reconstructions showed a statistically higher complication rate with immediate (8.8%) reconstruction compared with delayed (5.3%) (odds ratio, 1.7, P < 0.01). There was no significant difference in complication rates between autologous immediate (18.4%) or delayed (19.0%) reconstructions. After controlling for baseline cohort differences and other risk factors, immediate reconstruction remained as an independent significant predictor of major complications in implant reconstructions (odds ratio, 1.8, P < 0.01). CONCLUSIONS: Immediate rather than delayed breast reconstruction is associated with a significantly higher rate of major complications in implant reconstruction but not in autologous reconstruction. It is important to include these findings in the routine preoperative surgeon-patient discussion of reconstructive options.

Contralateral prophylactic mastectomy at the time of delayed microvascular breast reconstruction adversely affects patient-reported outcomes: A retrospective cohort study.

PURPOSE: An increasing number of women with unilateral breast cancer are seeking bilateral mastectomies and reconstruction. At our centre, many women who have undergone previous unilateral therapeutic mastectomy request contralateral prophylactic mastectomy (CPM) at the time of delayed reconstruction. These mixed timing reconstructions are particularly challenging as patients have an immediate reconstruction on one side and delayed reconstruction on the other, which may result in asymmetry. This retrospective cohort study evaluates patient-reported satisfaction following mixed timing breast reconstruction and compares them to unilateral delayed reconstruction. METHODS: One hundred and forty-one patients who underwent successful deep inferior epigastric artery perforator (DIEP) flap breast reconstruction and completed baseline and 12-month BREAST-Qs were included in the study. Patient-reported outcomes following bilateral mixed timing reconstruction (n = 56) were compared to those of unilateral delayed reconstruction (UDR) without CPM (n = 85). RESULTS: Women who sought CPM were significantly younger and had lower annual incomes when compared with those who underwent unilateral reconstruction. Mixed timing reconstruction was associated with significantly lower levels of breast satisfaction and psychosocial function as compared to UDR at 12 months post-operatively. BREAST-Q scores (18 months) were available for 75 patients in the cohort and indicated that this decreased breast satisfaction and psychosocial impairment was sustained in the longer-term. CONCLUSIONS: Patients who seek CPM at the time of delayed reconstruction should be advised that this is associated with lower levels of breast satisfaction and psychosocial well-being as compared to unilateral delayed breast reconstruction.