Search

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.

Background: POSNOC is a UK-ANZ multicentre, non-inferiority, randomised trial comparing systemic therapy alone with systemic therapy plus Axillary Treatment (Axillary radiotherapy or ALND) for women with ≤2 macrometastases at SNB. The primary outcome is axillary recurrence within 5 years. This paper describes screening, recruitment and compliance data. Methods: Sites were requested on a monthly basis to upload screening data and provide reasons for non-recruitment of eligible patients into the trial. Sites entered in the online database whether the patients were compliant with their randomisation allocation. Results: The study opened in July 2014 and completed target recruitment of 1900 women (24% of those screened) in July 2021, at 95 sites in the UK and 20 sites in Australia and New Zealand. The reason for non-enrolment was unknown in 1300 women. Of the remaining 4774 women with known reasons, who were screened but not randomised, the most common reasons for non-recruitment were due to either patients (n=2219, 46.5%) or their clinicians (n=782, 16.4%) favouring axillary treatment, or patients (n=490, 10.3%) or their clinicians (n=170, 3.6%) not wishing to have axillary treatment. Over the course of the study, there was an increase in the proportion of patients wanting axillary treatment and declining the trial (Mean % patients declined 2015 – 17.9%, 2021 – 39.1%). Mean number of participants recruited per site per month was 0.24 (SD 0.18) overall, 0.25 (SD 0.19) in the UK, and 0.19(SD 0.15) in ANZ. The mean was < 0.3 in 79 sites and >0.9 in only one site. Recruitment rate remained consistent throughout the study (mean 25.3 per month) except for during the first 6 months of recruitment (5.7) and during the COVID pandemic Apr-Sep 2020 (7.5). Of 89 (4.8%) participants non-compliant with allocation, n=45 (50.6%) received systemic therapy alone and n=44 (49.4%) received systemic therapy plus axillary treatment. There was no fluctuation in the direction of non-compliance during the study duration. There was increasing uptake of axillary radiotherapy to treat the axilla instead of ALND over the course of the study in patients receiving axillary treatment (Number who had ART of all who had axilla treatment2014-2017 - 248/454 (54.6 %); 2018-2021 – 315/449 (70.2%)). Conclusion: Recruitment and compliance with randomised allocation remained consistent over a seven-year period. POSNOC with in-built radiotherapy QA will provide definitive data on axillary management in patients undergoing mastectomy or BCS with ≤2 macrometastases on SNB. Citation Format: Amit Goyal, Cydney Bruce, Shabina Sadiq, Mickey Lewis, Alan Montgomery, G Bruce Mann, Heath Badger, Kathryn Monson, Valerie Jenkins, Lesley Fallowfield, Malcolm Reed, David Dodwell, Patricia Fairbrother, Tara Homer, Luke Vale, Roeum Butt, Elizabeth Miles, Shelley Dowey, Lucy Matthews, Hugh Jarrett, Juliet Jackson, Arfan Ali. Recruitment, clinical equipoise, patient acceptance and compliance in the UK-ANZ POSNOC trial [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 P5-01-07.