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Introduction: Women considering immediate breast reconstruction (IBR) after mastectomy for breast cancer require high-quality information about the short and long-term outcomes of different procedure types to allow them to make informed decisions about their surgical options. Long-term multicentre patient-reported outcomes (PROs) comparing the patients’ perspectives of different techniques is currently lacking. The UK Brighter study aimed to compare the long-term patient-reported outcomes of different types of IBR to support informed decision-making. Methods: Women who underwent unilateral mastectomy and/or breast reconstruction for invasive breast cancer or ductal carcinoma in situ (DCIS) in England between 1 April 2008 and 31 March 2009 were identified from National Health Service (NHS) Hospital Episode Statistics (HES), and current contact information for the surviving cohort were provided by the NHS Personal Demographic Service. Women were sent a letter inviting them to complete three validated patient report questionnaires, the BREAST Q, EQ-5D5L and ICECAP-A, electronically or by post at a minimum of 12 years following their index surgery. Questionnaires were scored according to developers’ instructions and results compared by type of IBR procedure performed. Results: 11,977 women were invited to participate of whom 4,207 (35.1%) completed the questionnaires. Of these, 1,236 (29.4%) received IBR with 343 (27.8%) expander/implant (EI) reconstructions, 629 (50.9%) latissimus dorsi (LD) procedures with or without an implant, and 264 (21.4%) abdominal flap (AF) reconstructions. The mean age at index surgery was 52.1 years, standard deviation (SD) 9.5. The majority of respondents were white (n=1,179, 97.4%) and predominantly from areas of the lowest socioeconomic deprivation. The mean body mass index (BMI) was 24.6 (SD 3.9). 141 (11.6%) women actively smoked at the time of surgery and 227 (19.0%) had a complication requiring further surgery. Women undergoing AFs reported significantly higher ‘Satisfaction with Breasts’ (mean 67.7, SD 20.4) than those undergoing LD (mean 58.9, SD 21.1), or EI reconstructions (mean 54.7, SD 19.2), (p< 0.001). ‘Satisfaction with Breasts’ was also greater in women undergoing index surgery over 50 years of age (p=0.02) and in those who did not smoke (p=0.03) whereas experiencing post-operative complications was strongly associated with poorer ‘Satisfaction with Breasts’ in the multivariable analysis (p=0.001). Women receiving AF also reported better ‘Physical Well-being’ (mean 87.8, SD 16.04) than women undergoing LD flap (mean 79.5, SD 20.5) or EI procedures (mean 82.1, SD 18.2), (p< 0.001). Overall, women undergoing AFs were more likely to rate the outcome of their surgery as ‘excellent’ or ‘very good’ (189/256, 73.8%) compared with those receiving other reconstruction types (LD - 386/610, 63.3%; EI - 175/331, 52.9%, p< 0.001). Conclusion: Women undergoing abdominal flap reconstruction report significantly better outcomes 12 years following IBR than women receiving other reconstruction types. These findings should be shared with women considering breast reconstruction to help them make informed decisions about their surgical options. Citation Format: Leigh Johnson, Paul White, Ranjeet Jeevan, John Browne, Carmel Gulliver-Clarke, Joe O’Donoghue, Syed Mohiuddin, William Hollingworth, Patricia Fairbrother, Mairead MacKenzie, Chris Holcombe, Shelley Potter. PD15-09 Impact of procedure type on the long-term patient-reported outcomes of immediate breast reconstruction: The UK Brighter Study [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr PD15-09.

Introduction: Post-mastectomy radiotherapy (PMRT) is an important component of breast cancer treatment and has been shown to improve overall survival for women with large cancers or node positive disease. The long-term effects of radiotherapy on the outcomes of immediate breast reconstruction (IBR) and how these are perceived from the patients’ perspective, however, are largely unknown. The UK Brighter study aimed to evaluate the long-term impact of PMRT on the patient-reported outcomes of IBR to support informed decision-making. Methods: Women who underwent unilateral mastectomy and/or breast reconstruction for invasive breast cancer or ductal carcinoma in situ (DCIS) in England between 1/4/2008 and 31/3/2009 were identified from National Health Service (NHS) Hospital Episode Statistics (HES), and current contact information for the surviving cohort provided by the NHS Personal Demographic Service. Women were sent a letter inviting them to complete three validated patient-reported outcome questionnaires, the BREAST Q, EQ-5D-5L and ICECAP-A, electronically or by post at a minimum of 12 years following their index surgery. Questionnaires were scored according to developers’ instructions and scores for women who had received PMRT following IBR compared with those who underwent IBR without radiotherapy, in the cohort as a whole and by reconstruction type. Results: 11,977 women were invited to participate of whom 4,207 (35.1%) completed the questionnaires. Some 1,236 (29.4%) underwent IBR with 343 (27.8%) expander/implant (EI) reconstructions, 629 (50.9%) latissimus dorsi (LD) flaps with or without (+/-) an implant, and 264 (21.4%) abdominal flap (AF) reconstructions. Of these, 388 (31.4%) (EI n=79 (20.4%); LD+/-implant n=222 (57.2%); AF n=87 (22.4%) received PMRT. In the cohort overall, women who received PMRT following IBR reported significantly lower ‘Satisfaction with Breasts’ scores at 12 years compared with those who did not receive radiotherapy (PMRT mean 56.4. standard deviation (SD) 21.5 vs. no PMRT mean 61.3, SD 20.5), p< 0.001). However, this difference varied across procedure types. Specifically, the ‘Satisfaction with Breasts’ scores of women receiving PMRT following AF reconstruction were 10.5 points lower than those not receiving PMRT (PMRT mean 60.9, SD 20.2; no PMRT mean 71.4, SD 19.6, p< 0.001). This difference was lower in in women undergoing LD reconstruction (mean with PMRT 54.3, SD 21.1; mean without PMRT 61.6, SD 20.7; p< 0.001). There were no significant differences in women undergoing EI reconstruction (PMRT mean 57.5, SD 23.6, no PMRT mean 53.9, SD 17.7). ‘Physical Well-being’ (chest) scores were also significantly lower in women receiving PMRT following IBR in the cohort overall (PMRT mean 78.7, SD 20.1, no PMRT 83.6, SD 18.6, p< 0.001) but women undergoing AF reconstruction showed the greatest difference in scores (PMRT mean 83.2, SD 17.0 vs No PMRT mean 90.1, SD 15.0, p< 0.001). There were no significant differences in ‘Physical Well-being’ scores for women who underwent EI reconstruction with or without PMRT. ‘Psychosocial Well-being’ scores were lower in women receiving PMRT after IBR (PMRT mean 70.8, SD 22.0, No PMRT 75.4, SD 21.0), but again, differential effects were seen by procedure type with no significant differences seen in the EI group but significant differences in scores seen in women receiving PMRT after flap-based procedures. Conclusions: Women undergoing PMRT report significantly lower long-term patient-reported outcomes of flap-based reconstruction, in particular ‘Satisfaction with Breasts’ and ‘Physical Well-being’ scores. This difference was not apparent in women undergoing EI procedures. This information should be shared with patients to help them make fully informed decisions about the type and timing of their reconstructive surgery. Citation Format: Leigh Johnson, Paul White, Ranjeet Jeevan, John Browne, Carmel Gulliver-Clarke, Joe O’Donoghue, Syed Mohiuddin, William Hollingworth, Patricia Fairbrother, Mairead MacKenzie, Chris Holcombe, Shelley Potter. Impact of radiotherapy on the long-term patient-reported outcomes of immediate breast reconstruction: The UK Brighter [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P2-15-03.

Introduction: Women considering immediate breast reconstruction (IBR) after mastectomy for breast cancer require high-quality information about the short and long-term clinical outcomes of different procedure types, including the need for further surgery, to allow them to make fully informed decisions about their breast reconstruction options. Long-term outcome data is currently lacking. The UK Brighter population-based cohort study aimed to compare the need for revisional surgery and secondary reconstruction by type of IBR at a minimum of 12 years following the index procedure to support informed decision-making. Methods: Women who underwent unilateral mastectomy and IBR for invasive breast cancer or ductal carcinoma in situ (DCIS) in England between 1 April 2008 and 31 March 2009 were identified using National Health Service (NHS) Hospital Episode Statistics (HES). Lists of procedure codes indicating revisional surgery, defined as operations performed to the same site as the index reconstruction and/or the donor site (if appropriate), excluding a single planned implant exchange in the expander group, or secondary reconstruction, defined as the replacement of one reconstruction with another, with or without a period of being flat, were iteratively developed and refined. Numbers of revision procedures and secondary reconstructions were compared by type of index reconstruction. Multivariable regression was used to control for potential confounders. Results: 2,260 women underwent IBR during the study period including 742 (32.8%) expander/implant (EI), 1,146 (50.7%) latissimus dorsi (LD) flap reconstructions with (n=649) and without (n=497) an implant and 372 (16.5%) abdominal free-flap (AFF) procedures. Women receiving reconstructions involving implants were significantly more likely to require more revisions over time, with 201/742 (27.1%) patients undergoing EI reconstruction and 154/649 (23.7%) those receiving an implant-assisted LD reconstruction requiring two or more post-reconstruction revision procedures compared with 77/497 (15.5%) patients undergoing autologous LD and 59/372 (15.9%) patients receiving AFF procedures (p< 0.001). Undergoing primary reconstructive surgery before the age of 50, and region of residence at the time of the mastectomy were factors influencing revisional surgery in the multivariable regression analysis. By 12 years, 128/742 (17.3%) of women who initially underwent an expander/implant reconstruction had received a secondary reconstruction compared with 34/1146 (3.0%) patients who had initially received an LD +/- implant procedure and 11/372 (3.0%) patients initially undergoing an AFF reconstruction (p< 0.001). Conclusions: The need for revisional surgery in women electing to undergo IBR involving implants is significantly greater than that for women electing to receive autologous reconstructions and almost 1 in 5 women undergoing primary EI reconstruction required a secondary reconstruction by 12 years. These findings should be shared with women considering IBR to support informed decision making and with healthcare providers and commissioners to support the provision of high-quality, evidence-based reconstructive care. Citation Format: Leigh Johnson, Paul White, Ranjeet Jeevan, John Browne, Carmel Gulliver-Clarke, Joe O’Donoghue, Syed Mohiuddin, William Hollingworth, Patricia Fairbrother, Mairead MacKenzie, Chris Holcombe, Shelley Potter. PD15-10 Impact of procedure type on long-term revisional surgery and secondary reconstruction following immediate breast reconstruction: The UK Brighter national population-based cohort study [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr PD15-10.

IntroductionBreast reconstruction (BR) is offered to improve quality of life for women with breast cancer undergoing mastectomy. As most women will be long-term breast cancer survivors, high-quality information regarding the long-term outcomes of different BR procedures is essential to support informed decision-making. As different techniques vary considerably in cost, policymakers also require high-quality cost-effectiveness evidence to inform care. The Brighter study aims to explore the long-term clinical and patient-reported outcomes (PROs) of implant-based and autologous BR and use health economic modelling to compare the long-term cost-effectiveness of different reconstructive techniques.Methods and analysisWomen undergoing mastectomy and/or BR following a diagnosis of breast cancer between 1 January 2008 and 31 March 2009 will be identified from hospital episode statistics (HES). Surviving women will be contacted and invited to complete validated PRO measures including the BREAST-Q, EQ-5D-5L and ICECAP-A, or opt out of having their data included in the HES analysis. Long-term clinical outcomes will be explored using HES data. The primary outcome will be rates of revisional surgery between implant-based and autologous procedures. Secondary outcomes will include rates of secondary reconstruction and reconstruction failure. The long-term PROs of implant-based and autologous reconstruction will be compared using BREAST-Q, EQ-5D-5L and ICECAP-A scores. Multivariable regression will be used to examine the relationship between long-term outcomes, patient comorbidities, sociodemographic and treatment factors. A Markov model will be developed using HES and PRO data and published literature to compare the relative long-term cost-effectiveness of implant-based and autologous BR.Ethics and disseminationThe Brighter study has been approved by the South-West -Central Bristol Research Ethics Committee (20/SW/0020), and the Confidentiality Advisory Group (20/CAG/0021). Results will be published in peer-reviewed journals and presented at national meetings. We will work with the professional associations, charities and patient groups to disseminate the results.

INTRODUCTION Mastectomy patients' satisfaction with reconstructive options has not been examined. METHODS A national study measured 18-month satisfaction with reconstructive options and collected case-mix and reconstructive offer and uptake data on breast cancer patients having mastectomy with or without immediate reconstruction (IR) in England between January 2008 and March 2009. Multivariable logistic regression examined the relationship between satisfaction, age, IR offer and uptake, and clinical suitability. RESULTS Of 4796 patients, 1889 were not offered IR, 1489 declined an offer and 1418 underwent it. Women not offered IR were more likely older, obese or smokers and had higher ASA grades, ECOG scores, tumour burdens and adjuvant chemotherapy and radiotherapy likelihoods (9% of lowest suitability group offered IR; 81% in highest suitability group). 83.7% were satisfied with their reconstructive options, varying significantly by IR offer and uptake (76.1% for those not offered IR; 85.8% for those who declined IR; 91.7% following IR). Older women and women deemed more suitable for IR were more often satisfied (p-values

BACKGROUND: There is little evidence about the long-term donor site outcome of latissimus dorsi breast reconstruction and no patient-reported outcome measures designed specifically for the procedure. METHODS: A prospective cohort of breast cancer patients having latissimus dorsi reconstruction after a mastectomy was recruited from 270 hospitals in the United Kingdom. An 18-month follow up questionnaire containing two novel scales was sent to consenting patients. The prevalence of aesthetic and functional morbidity at the donor site was described. The two new scales were refined using the Rasch measurement model and subsequently validated. RESULTS: 1,096 women completed the new scales. 78% of patients reported that no back appearance issues had bothered them "most of the time" or "all of the time" in the past two weeks. The equivalent figure for functional morbidity was 60%. Four items were eliminated following initial psychometric testing. This produced an 8-item Back Appearance scale and an 11-item Back and Shoulder Function scale. Both scales showed adequate fit to the Rasch measurement model. Higher levels of aesthetic and functional bother were observed for completely autologous procedures versus those where latissimus dorsi reconstruction was used to cover an implant (p

Medical treatment for breast cancer is associated with substantial toxicity and patient burden. There is less known about the impact of surgical complications. Understanding this impact could provide important information for patients when they are considering surgical options. Between 2008 and 2009, the UK National Mastectomy and Breast Reconstruction Audit recorded surgical complications for a prospective cohort of 17,844 women treated for breast cancer at 270 hospitals; 6405 of these women were surveyed about their quality of life 18 months after surgery. Breast appearance, emotional well-being, and physical well-being were quantified on 0- to 100-point scales. Linear multiple regression models, controlling for a range of baseline prognostic factors, were used to compare the scores of patients who had complications with the scores of those who did not. The overall complication rate was 10.2%. Complications were associated with little or no impairment in women undergoing mastectomy without reconstruction or with delayed reconstruction. The association was much larger for flap-related complications suffered during immediate reconstruction. The breast-appearance scores (adjusted mean difference, -23.8; 95% confidence interval [CI], -31.0 to -16.6) and emotional well-being scores (adjusted mean difference, -14.0; 95% CI, -22.0 to -6.0) of these patients were much lower than those of any other patient group. Implant-related complications were not associated with a lower quality of life in any surgical group. There is a strong case for prospectively collecting flap-complication rates at the surgeon and surgical unit level and for allowing patients to access these data when they make choices about their breast cancer surgery. Cancer 2017. © 2017 American Cancer Society.

Background National guidelines state that patients with breast cancer undergoing mastectomy in England should be offered immediate breast reconstruction (IR), unless precluded by their fitness for surgery or the need for adjuvant therapies. Methods A national study investigated factors that influenced clinicians' decision to offer IR, and collected data on case mix, operative procedures and reconstructive decision-making among women with breast cancer having a mastectomy with or without IR in the English National Health Service between 1 January 2008 and 31 March 2009. Multivariable logistic regression was used to examine the relationship between whether or not women were offered IR and their characteristics (tumour burden, functional status, planned radiotherapy, planned chemotherapy, perioperative fitness, obesity, smoking status and age). Results Of 13 225 women, 6458 (48·8 per cent) were offered IR. Among factors the guidelines highlighted as relevant to decision-making, the three most strongly associated with the likelihood of an offer were tumour burden, planned radiotherapy and performance status. Depending on the combination of their values, the probability of an IR offer ranged from 7·4 to 85·1 per cent. A regression model that included all available factors discriminated well between whether or not women were offered IR (c-statistic 0·773), but revealed that increasing age was associated with a fall in the probability of an IR offer beyond that expected from older patients' tumour and co-morbidity characteristics. Conclusion Clinicians are broadly following guidance on the offer of IR, except with respect to patients' age.

Background/rationale It is the recommendation of the National Institute of Clinical Excellence that breast reconstruction be discussed with all patients scheduled to have a mastectomy for breast cancer with the exception of those with significant morbidity and/or a need for adjuvant therapy. This is irrespective of the availability of the service locally. Aims/objectives To determine the number of patients referred for a mastectomy at the St Richard’s hospital To determine patients who had the breast reconstruction discussion, those who did not and the reasons behind the exclusion To present the result of the audit locally/regionally To ascertain an appropriate intervention if required Data collection/methodology Data was collated retrospectively from clinical notes of patients referred for mastectomy following a diagnosis of breast cancer Inclusion All patients over 18 years and under 85 years referred to a specialist centre such as East Grinsted for their surgery and those whose procedure was to be performed at the St Richards. Exclusion Patients less than 18 years and above 85 years. Patients referred for mastectomy outside the above-stated window period. Key Findings 64% (16 patients) of the subjects discussed breast reconstruction with the breast surgeon, out of which 44% (11 patients) signified a preference for delayed reconstruction. 20% (5 patients) showed no particular preferences based on the available data and at the time of this audit, had not undergone any breast reconstruction. 36% (9 patients) were excluded, 8 based on the comorbidities/need for adjuvant therapy. There was a 2.4% improvement when compared to the 61.6% for the audit in 2014. Recommendations Explicit entries of breast reconstruction discussion and reasons for exemption should be available at the multidisciplinary meeting notes. MDT outcomes to be entered into the Somerset cancer register which now available online.

BACKGROUND: This national prospective cohort study compared the patient-reported outcomes of breast cancer patients undergoing postmastectomy autologous reconstruction to those who had breast implants, in terms of aesthetic appearance; levels of psychological, physical, and sexual well-being; and overall satisfaction. METHODS: Of 5063 women who underwent immediate reconstruction (n = 3349) or delayed reconstruction (n = 1714) between January 1, 2008, and March 31, 2009, in England, 2923 women who gave informed consent were sent validated, procedure-specific, 18-month follow-up questionnaires. Outcome scale scores ranged from 0 (poor) to 100 (excellent); multiple linear regression was used to adjust scores for patient and treatment characteristics. RESULTS: Two thousand two hundred eighty-nine women (78 percent) returned completed questionnaires (immediate reconstruction, n = 1528; delayed reconstruction, n = 761). For immediate reconstruction, mean overall satisfaction scores for the various techniques ranged from 67 to 85 (median, 67 to 93). For delayed reconstruction, mean overall satisfaction scores ranged from 70 to 85 (median, 75 to 100). For both groups, similar gradients were observed for the other outcome scales across techniques. Reconstruction using patients' own tissues tended to have higher mean adjusted scores compared with those techniques using implants alone (p < 0.0001 for aesthetic appearance, psychological well-being, sexual well-being, and satisfaction with outcomes for immediate and delayed reconstruction groups). CONCLUSIONS: Women who underwent autologous reconstruction tended to report greater satisfaction than those who underwent implant reconstruction. These results can inform patients of the anticipated outcomes of their selected surgery, but further research is required to confirm whether autologous reconstruction is superior in general. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Medical treatment for breast cancer is associated with substantial toxicity and patient burden. There is less known about the impact of surgical complications. Understanding this impact could provide important information for patients when they are considering surgical options.Between 2008 and 2009, the UK National Mastectomy and Breast Reconstruction Audit recorded surgical complications for a prospective cohort of 17,844 women treated for breast cancer at 270 hospitals; 6405 of these women were surveyed about their quality of life 18 months after surgery. Breast appearance, emotional well-being, and physical well-being were quantified on 0- to 100-point scales. Linear multiple regression models, controlling for a range of baseline prognostic factors, were used to compare the scores of patients who had complications with the scores of those who did not.The overall complication rate was 10.2%. Complications were associated with little or no impairment in women undergoing mastectomy without reconstruction or with delayed reconstruction. The association was much larger for flap-related complications suffered during immediate reconstruction. The breast-appearance scores (adjusted mean difference, -23.8; 95% confidence interval [CI], -31.0 to -16.6) and emotional well-being scores (adjusted mean difference, -14.0; 95% CI, -22.0 to -6.0) of these patients were much lower than those of any other patient group. Implant-related complications were not associated with a lower quality of life in any surgical group.There is a strong case for prospectively collecting flap-complication rates at the surgeon and surgical unit level and for allowing patients to access these data when they make choices about their breast cancer surgery. Cancer 2017;123:3460-7. © 2017 American Cancer Society.