Long-term patient-reported outcomes of immediate breast reconstruction after mastectomy for breast cancer: population-based cohort study.

BACKGROUND: Breast reconstruction is offered to improve quality of life for women after mastectomy for breast cancer, but information regarding the long-term patient-reported outcomes of different reconstruction procedures is currently lacking. The Brighter study aimed to evaluate long-term patient-reported outcomes after immediate breast reconstruction (IBR) in a population-based cohort. METHODS: Women who underwent mastectomy with IBR for breast cancer in England between 1 January 2008 and 31 March 2009 were identified from National Health Service Hospital Episode Statistics. Surviving women were invited to complete the BREAST-Q, EQ-5D-5L™, and ICECAP-A at least 12 years after the index procedure. Questionnaires were scored according to developers' instructions and compared by IBR type. RESULTS: Some 1236 women underwent IBR; 343 (27.8 per cent) had 2-stage expander/implant, 630 (51.0 per cent) latissimus dorsi, and 263 (21.3 per cent) abdominal flap reconstructions, with a mean(s.d.) follow-up of 13.3(0.5) years. Women who underwent abdominal flap reconstruction reported higher scores in all BREAST-Q domains than those who had other procedures. These differences remained statistically significant and clinically meaningful after adjusting for age, ethnicity, geographical region, socioeconomic status, smoking, BMI, and complications. The greatest difference was seen in scores for satisfaction with breasts; women who had abdominal flap reconstructions reported scores that were 13.17 (95 per cent c.i. 9.48 to 16.87) points; P < 0.001) higher than those among women who had two-stage expander/implant procedures. Women who underwent latissimus dorsi reconstruction reported significantly more pain/discomfort on the EQ-5D-5L™, but no other differences between procedures were seen. CONCLUSION: Long-term patient-reported outcomes are significantly better following abdominal flap reconstruction than other traditional procedure types. These findings should be shared with women considering IBR to help them make informed decisions about their surgical options.

Impact of procedure type on revisional surgery and secondary reconstruction after immediate breast reconstruction in a population-based cohort.

BACKGROUND: Women considering immediate breast reconstruction require high-quality information about the likely need for secondary reconstruction and the long-term risk of revisional surgery to make fully informed decisions about different reconstructive options. Such data are currently lacking. This study aimed to explore the impact of reconstruction type on the number of revisions and secondary reconstructions performed 3, 5, and 8 years after immediate breast reconstruction in a large population-based cohort. METHODS: Women undergoing unilateral mastectomy and immediate breast reconstruction for breast cancer or ductal carcinoma in situ in England between 1 April 2009 and 31 March 2015 were identified from National Health Service Hospital Episode Statistics. Numbers of revisions and secondary reconstructions in women undergoing primary definitive immediate breast reconstruction were compared by procedure type at 3, 5, and 8 years after index surgery. RESULTS: Some 16 897 women underwent immediate breast reconstruction with at least 3 years' follow-up. Of these, 14 069 had a definitive reconstruction with an implant only (5193), latissimus dorsi flap with (3110) or without (2373) an implant, or abdominal free flap (3393). Women undergoing implant-only reconstruction were more likely to require revision, with 69.5 per cent (747 of 1075) undergoing at least one revision by 8 years compared with 49.3 per cent (1568 of 3180) in other reconstruction groups. They were also more likely to undergo secondary reconstruction, with the proportion of women having further reconstructive procedures increasing over time: 12.8 per cent (663 of 5193) at 3 years, 14.3 per cent (535 of 3752) at 5 years, and 17.6 per cent (189 of 1075) at 8 years. CONCLUSION: Long-term rates of revisions and secondary reconstructions were considerably higher after primary implant-based reconstruction than autologous procedures. These results should be shared with patients to support informed decision-making.

BACKGROUND: Breast reconstruction is performed to improve well-being for women who need mastectomy (removal of the breast) as part of breast cancer treatment. There are many different types of breast reconstruction operation, and it can be difficult for women to decide which operation, if any, is right for them. Information about the number of extra operations that a woman is likely to need after breast reconstruction surgery is an important factor in helping them make this decision. This study aimed to investigate the number of extra operations that women who had breast reconstruction needed by 3, 5, and 8 years after surgery, and how this differed by the type of breast reconstruction surgery they had. Routinely collected hospital record data were used to identify women having breast reconstruction at the time of mastectomy for breast cancer, and identify any extra operations performed for problems related to the reconstruction in the 8 years after the first operation. The number of extra operations performed after different types of breast reconstructions was compared at 3, 5, and 8 years after the mastectomy. Women who had implant-based reconstruction required more extra operations than those having reconstruction using their own tissue. They were also more likely to have the implant replaced with another type of breast reconstruction than women undergoing tissue-based reconstruction at 3, 5, and 8 years after the first surgery. This information should be discussed with women thinking about breast reconstruction to help them decide what type of operation would be best for them.

Protocol for a national cohort study to explore the long-term clinical and patient-reported outcomes and cost-effectiveness of implant-based and autologous breast reconstruction after mastectomy for breast cancer: the brighter study.

INTRODUCTION: Breast 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 ANALYSIS: Women 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 DISSEMINATION: The 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.

Patients' satisfaction with the reconstructive options provided to them measured 18 months after mastectomy surgery for breast cancer.

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 <0.001). CONCLUSIONS: Satisfaction varied by offer and uptake status, age and suitability score. Clinicians should target equity for women deemed unsuitable by exploring their needs and desired outcomes, standardising operative fitness assessments and utilising shared decision-making aids.

Measuring the patient perspective on latissimus dorsi donor site outcomes following breast reconstruction.

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 <0.05). Higher levels of aesthetic bother were observed in women who had suffered a perioperative complication at the donor site (p = 0.003). CONCLUSION: These results can inform patients of the morbidity associated with latissimus dorsi reconstruction. The new scales can be used to compare groups undergoing different variations of the procedure and to monitor individual patients.

The association between complications and quality of life after mastectomy and breast reconstruction for breast cancer.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Surgical Determinants of Patient-Reported Outcomes following Postmastectomy Reconstruction in Women with Breast Cancer.

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.