Patient-reported health-related quality of life outcomes following mastectomy for breast cancer, with immediate, delayed or no breast reconstruction: Four-year follow-up from a prospective cohort study.

BACKGROUND: Breast reconstruction (BR) improves women's health-related quality of life (HRQOL) following mastectomy for breast cancer, yet factors contributing to improved HRQOL remain unclear. This study aimed to explore the overall impact of mastectomy with or without BR on participants' perceptions of HRQOL over time in a cohort of women with high-risk breast cancer; to examine differences in mean HRQOL scores between immediate BR, delayed BR and no BR groups; to assess the influence of patient characteristics potentially associated with HRQOL scores; and to determine the feasibility of long-term collection of patient-reported outcome measures in clinical settings. METHODS: A prospective, longitudinal study of 100 women with high-risk breast cancer who underwent mastectomy with or without breast reconstruction and were likely to require post-mastectomy radiotherapy. Four validated patient-reported questionnaires, comprising 21 outcome measures relating to HRQOL, administered at baseline and up to 4 years post-mastectomy. Demographic, clinical and surgical data extracted from patient medical records. RESULTS: Consistently significant declines in perceptions of future health and arm symptoms, consistently significant improvements in treatment side effects, breast symptoms and fatigue, as well as significant improvements, compared to baseline, in social functioning and financial difficulties at 48 months. No significant differences in mean HRQOL scores between women given a choice of reconstructive options. CONCLUSION: Similar trajectories of HRQOL scores were found in women with high-risk breast cancer who were offered a choice of BR. Informed choice may be an independent contributing factor in long-term maintenance of most HRQOL indicators at their pre-mastectomy levels.

Does breast cancer policy meet the needs of Aboriginal and Torres Strait Islander women in Australia? a review.

OBJECTIVE: To evaluate if existing Australian public policy related to screening, diagnosis, treatment and follow up care for breast cancer addresses the needs of and outcomes for Indigenous1 women? METHODS: This review of policy employed a modified Delphi method via an online panel of experts (n = 13), who were purposively recruited according to experience and expertise. A series of online meetings and online surveys were used for data collection. The aims of the study were to: Identify all existing and current breast cancer policy in Australia;  Analyse the extent to which consideration of Indigenous peoples is included in the development, design and implementation of the policy; and Identify policy gaps and make recommendations as to how they could be addressed. The policies were evaluated using 'A Guide to Evaluation under the Indigenous Evaluation Strategy, 2020'. RESULTS: A list of current breast cancer policies (n = 7) was agreed and analysed. Five draft recommendations to improve breast cancer outcomes for Indigenous women were developed and refined by the panel. CONCLUSIONS: Current breast cancer policy in Australia does not address the needs of Indigenous women and requires change to improve outcomes.

Radio-isotope occult lesion localization (ROLL) techniques to identify the clipped node for targeted axillary dissection (TAD) in breast cancer.

BACKGROUND: Breast cancer patients having neoadjuvant systemic therapy (NAST) who have a positive (clipped) lymph node (CN) at presentation must have that CN removed to assess pathologic response at later surgery. Multiple techniques for localizing the CN have been described. We describe a novel ROLL-based approach. METHODS: Consecutive patients between 2018 and 2021, having NAST with biopsy proven positive lymph node(s), had a clip placed into the most abnormal node(s). At later surgery sentinel node and occult lesion localization (SNOLL) was performed with peritumoral radio-isotope (99m Tc-Nanoscan) injected under ultrasound guidance. Planar and single photon emission computed tomography (SPECT-CT) images were used to identify sentinel nodes (SN) and the CN. If the CN was not a SN, then additional 99m Tc-Nanoscan was injected directly into the CN using ultrasound (ROLL). TAD was performed using a gamma probe and intra-operative specimen radiographs to confirm excision of the CN. RESULTS: Thirty-eight patients underwent TAD. 20/38 CNs were SNs on SPECT-CT. 17/38 CN were localized separately. 1/38 CN was not a SN and could not be identified on ultrasound. The remaining 37/38 (97.4%) of the CNs were removed intra-operatively. Pathological complete response in the axilla was identified in 18/38 cases. The CN was the only positive node in 10/20 cases. In 18/20 cases the CN contained the largest tumour deposit. CONCLUSION: Combining SNOLL and ROLL techniques to identify the SNs and, if separate, the CN for TAD is very reliable and logistically robust, especially for units already performing peritumoral lymphoscintigraphy.

Breast Radiotherapy after Oncoplastic Surgery-A Multidisciplinary Approach.

Oncoplastic breast surgery encompasses a range of techniques used to provide equitable oncological outcomes compared with standard breast surgery while, simultaneously, prioritizing aesthetic outcomes. While the outcomes of oncoplastic breast surgery are promising, it can add an extra complexity to the treatment paradigm of breast cancer and impact on decision-making surrounding adjuvant therapies, like chemotherapy and radiotherapy. As such, early discussions at the multidisciplinary team meeting with surgeons, medical oncologists, and radiation oncologists present, should be encouraged to facilitate best patient care.

The role of breast reconstruction choice on body image patient-reported outcomes at four years post-mastectomy for breast cancer: A longitudinal prospective cohort study.

OBJECTIVES: To examine the impact of breast reconstruction on women's perceptions of body image over time and to assess the influence of sociodemographic variables on body image. METHODS: A prospective, longitudinal cohort study, using validated breast cancer-specific questionnaires, to compare patient-reported outcomes in women choosing immediate (n = 61), delayed (n = 16) or no (n = 23) breast reconstruction. RESULTS: One hundred women completed baseline questionnaires that included items on body image; 30 women completed all four annual follow-up sets, while 20 women completed baseline only. The three groups were well matched at baseline and similar trajectories in body image measures were identified over 48 months in all groups. At 12 months post-mastectomy, significant changes were seen in eight of the 10 subscales; this reduced to seven subscales at 24 months and four at 36 months. By 48 months, only three subscales remained significantly different to baseline scores: women remained less vulnerable and had fewer limitations (improved outcomes); the one worse outcome was persistently higher levels of arm concern. Three of the sociodemographic variables (health insurance, age and employment status) showed significant inter-group differences at some time points. CONCLUSION: These findings suggest women recover from the negative impact of mastectomy on body image within four years of surgery, whether they have immediate, delayed or no reconstruction. Our results provide some indirect evidence that having a choice of BR options is important, regardless of the choice made. Four years appears to be a suitable follow-up period for future studies in this area.

Sentinel node occult lesion localization technique for impalpable breast cancer.

BACKGROUND: Mammographic screening has enabled earlier detection of breast cancer, with 25-35% of malignancies being non-palpable at diagnosis. Accurate removal and sentinel node biopsy for staging these lesions are crucial to successful management. Both these aspects are achieved by peritumoural localization with radioisotope and lymphoscintigraphy for sentinel lymph node (SN) mapping using the sentinel node and occult lesion localization (SNOLL) technique. This study reports SNOLL outcomes in a large cohort of women with non-palpable breast cancers to assess its performance and promote its logistic advantages. METHODS: This retrospective cohort study used data from BreastSurgANZ Quality Audit supplemented with private case notes. Inclusion criteria were females >18 years, with invasive breast cancer that was asymptomatic and non-palpable at presentation, who underwent SNOLL (n = 450). Primary outcomes were proportion of successful lesion localization, proportion of patients requiring re-excision and volume of tissue excised. Secondary outcomes focused on lymphoscintigraphy success rate in detecting sentinel nodes and SN positivity rates. RESULTS: Tumours were successfully removed with the initial SNOLL procedure in 449 cases (99.8%). The re-excision rate was 15.1% (n = 68). The mean total excision volume was 54.69 cm3 (95% CI 51.49-57.88 cm3 ; range 2.75-195.33 cm3 ), with a mean closest circumferential margin of 7.05 mm (95% CI 6.60-7.49 mm; range 0 to ≥10 mm). Lymphoscintigraphy was successful in 96.9% (n = 436) of cases. Sentinel nodes were successfully identified and removed in 99.6% (n = 448) of cases. SN positivity rate was 18.4%. CONCLUSION: SNOLL is an efficient and effective technique for localizing non-palpable invasive breast lesions while simultaneously identifying sentinel nodes.

Window of opportunity treatment in breast cancer.

Window of opportunity therapies, which involve short-term administration of systemic therapy between cancer diagnosis and surgery, have raised significant interest in recent years as a mean of assessing the sensitivity of a patient's cancer to therapy prior to surgery. There is now compelling evidence that in patients with early stage hormone-receptor positive breast cancer, a 2-week preoperative treatment with standard hormone therapies in a preoperative window period provides important prognostic information, which in turn helps to aid decision-making regarding treatment options. Changes in short-term biomarker endpoints such as cell proliferation measured by Ki-67 can act as surrogate markers of long-term outcomes. Paired tissues obtained pre- and post-investigational treatment, without having to subject the patient to additional biopsies, can then be used to conduct translational research to investigate predictive biomarkers and pharmacodynamics. In this review, we will examine the utility and challenges of window of opportunities therapies in breast cancer in the current literature, and the current Australian and international trial landscape in this clinical space.

Patient-reported outcomes with neoadjuvant vs adjuvant systemic therapy for operable breast cancer.

BACKGROUND: Neoadjuvant systemic therapy (NAST) is used for large operable or highly proliferative breast cancers. It is not known whether psychological outcomes differ according to the treatment sequence (chemotherapy or surgery first) or tumour response. METHODS: This was a planned analysis of a multi-institutional single arm longitudinal study of patients considering NAST for operable breast cancer. Participants completed patient reported outcome questionnaires before and after the decision about NAST, between chemotherapy and surgery, and 12 months after diagnosis. RESULTS: Fifty-nine women enrolled. Fourteen of 51 (28%) who received NAST experienced pathological complete response (pCR). Patients who had surgery first (n = 7) had higher baseline anxiety, and a greater decrease in anxiety at 12 months follow up, compared with patients who received NAST (n = 50) (a decrease from baseline of 34 pts vs 17 points; p = 0.033). Distress declined at a similar rate in surgery first and NAST groups. Mean satisfaction with decision score post-decision was significantly lower in the adjuvant group compared with NAST (22 vs 26, p = 0.02). No differences were seen between patients with pCR vs residual cancer in: distress, anxiety, satisfaction with decision, fear of progression, and decision regret. CONCLUSION: Most patients in this study proceeded with NAST when their surgeon offered it as an option. This exploratory analysis suggests that patients who chose surgery first tended to be more anxious, and had lower satisfaction with their decision, than those who had NAST. In patients who had NAST, lack of pCR does not appear to correlate with adverse psychological outcomes.

Outcomes of breast reconstruction in older women: patterns of uptake and clinical outcomes in a large metropolitan practice.

BACKGROUND: Older age is associated with lower rates of breast reconstruction (BR) following mastectomy. This study compared a range of factors in women aged 60 years and older who had received mastectomy and BR with those who received no BR (NBR). METHODS: An audit of 338 women aged 60 or over treated with mastectomy with (n = 86) or without (n = 252) BR for primary breast cancer from 2009 to 2016 was conducted. Demographic, tumour, treatment, comorbidity and surgical complication data were obtained from patient medical records. RESULTS: NBR patients were associated with older age (P ≤ 0.001), more comorbidities (P = 0.038) and more extensive disease (P = 0.001) than BR patients. Total number of complications was not significantly different between BR and NBR patients (P = 0.286), or the different types of BR (P = 0.697). BR patients had higher rates of unplanned returns to the operating theatre, particularly in the late post-operative period (P = 0.025). Implant-based reconstruction was associated with more unplanned operating theatre returns than autologous reconstruction in the late post-operative period (P = 0.013). CONCLUSION: Post-mastectomy BR in elderly patients has a clinical complication profile similar to NBR patients. This audit found no clinical-based reasons to not offer oncologically suitable and clinically fit elderly women the option of BR.

Low-Level Laser Treatment Is Ineffective for Capsular Contracture: Results of the LaTCon Randomized Controlled Trial.

BACKGROUND: Breast reconstruction with implants can be complicated by symptomatic capsular contracture, especially after radiotherapy. A phase I, nonrandomized clinical trial demonstrated improvement in capsular contracture and avoidance of revision surgery with low-level laser therapy. This phase II, double-blind, randomized controlled trial assessed the efficacy of low-level laser for treating capsular contracture in women with breast reconstruction following mastectomy for breast cancer. METHODS: Participants had completed their definitive implant-based reconstruction a minimum of 6 months previously and were randomized to weekly treatments over 6 weeks with either an active or inactive low-level laser handpiece (Riancorp LTU-904). Pain, tightness, arm movement, and appearance were assessed by patient questionnaires. Breast symmetry, shape, naturalness, softness, and grade of contracture were assessed by clinician reports. Participants were assessed at 1 and 6 months after completion of the treatments. RESULTS: A total of 42 patients (intervention arm, n = 20; placebo, n = 22) were assessed in the trial. Thirty-two had postmastectomy radiotherapy. There was no significant difference in the change in any patient-reported outcomes or clinician-reported outcomes of breast symmetry, shape, or naturalness for the two groups. There was a significantly greater improvement in clinician-reported breast softness (p < 0.05) and degree of contracture (p < 0.05) in the placebo group at both 1- and 6-month follow-up. CONCLUSION: Low-level laser is not an effective therapy for breast implant capsular contracture in reconstruction patients. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

Patient-reported outcomes of breast reconstruction in older women: Audit of a large metropolitan public/private practice in Sydney, Australia.

OBJECTIVE: Older age is associated with lower rates of breast reconstruction (BR) for women requiring mastectomy. This study compared patient-reported outcomes between women aged 60 years and older who had received mastectomy and BR with those who received no BR (NBR). METHODS: About 135 women aged 60 or over treated between 2009 and 2016 with mastectomy only (N = 87) or mastectomy with BR (N = 48) for primary breast cancer completed patient-reported outcome measures using a set of validated questionnaires. Reasons for choosing or declining BR were also explored using a set of nonvalidated questionnaires. RESULTS: Patients who received BR were generally younger (P = <0.001) and reported greater satisfaction with their bodies (P = 0.048) than NBR patients. Patients with autologous reconstruction reported greater satisfaction with their breasts than implant-based reconstruction patients. Both BR and NBR patients reported good quality of life, low pain scores, good body image, and low levels of decisional regret. CONCLUSIONS: These data do not identify any quality of life-related reasons to not offer clinically fit, well-informed older women the option of BR.

Single-Arm Longitudinal Study to Evaluate a Decision Aid for Women Offered Neoadjuvant Systemic Therapy for Operable Breast Cancer.

Background: Neoadjuvant systemic therapy (NAST) is an increasingly used treatment option for women with large operable or highly proliferative breast cancer. With equivalent survival outcomes between NAST and up-front surgery, the situation-specific preference-sensitive nature of the decision makes it suitable for a decision aid (DA). This study aimed to develop and evaluate a DA for this population. Methods: A DA booklet was developed according to international standards, including information about adjuvant and neoadjuvant treatment, outcome probabilities, and a values clarification exercise. Eligible women, considered by investigators as candidates for NAST, were enrolled in a multi-institutional, single-arm, longitudinal study. Patient-reported outcome measure questionnaires were completed pre- and post-DA, between chemotherapy and surgery, and at 12 months. Outcomes were feasibility (percentage of eligible patients accessing the DA); acceptability to patients (percentage who would recommend it to others) and clinicians (percentage who would use the DA in routine practice); and decision-related outcomes. Results: From 77 eligible women, 59 were enrolled, of whom 47 (79.7%; 95% CI, 69.4-89.9) reported having read the DA; 51 completed the first post-DA questionnaire. Of these 51, 41 participants (80.4%; 95% CI, 69.5-91.3) found the DA useful for their decision about NAST. Of 18 responding investigators, 16 (88.9%; 95% CI, 74.4-103.4) indicated they would continue to use the DA in routine practice. Post-DA, decisional conflict decreased significantly (P<.01); anxiety and distress decreased significantly; and 86.3% (95% CI, 73.7-94.3) achieved at least as much decisional control as they desired. Conclusions: This DA was feasible and acceptable to patients and clinicians, and improvement in decision-related outcomes was demonstrated when used in combination with clinical consultations. This DA could safely be implemented into routine practice for women considering NAST for operable breast cancer.

Impact of selective use of breast MRI on surgical decision-making in women with newly diagnosed operable breast cancer.

BACKGROUND: This study evaluated the impact of breast MRI on surgical planning in selected cases of breast malignancy (invasive cancer or DCIS). MRI was used when there was ambiguity on clinical and/or conventional imaging assessment. METHODS: Consecutive women with breast malignancy undergoing breast MRI were included. Clinical, mammogram and ultrasound findings and surgical plan before and after MRI were recorded. MRI findings and histopathology results were documented and the impact of MRI on treatment planning was evaluated. RESULTS: MRI was performed in 181/1416 (12.8%) cases (invasive cancer 155/1219 (12.7%), DCIS 26/197 (13.2%)). Indications for MRI were: clinically dense breast tissue difficult to assess (n = 66; 36.5%), discordant clinical/conventional imaging assessment (n = 61; 33.7%), invasive lobular carcinoma in clinically dense breast tissue (n = 22; 12.2%), palpable/mass-forming DCIS (n = 11; 6.1%); other (n = 19; 10.5%). The recall rate for assessment of additional lesions was 35% (63/181). Additional biopsy-proven malignancy was found in 11/29 (37.9%) ipsilateral breast recalls and 8/34 (23.5%) contralateral breast recalls. MRI detected contralateral malignancy (unsuspected on conventional imaging) in 5/179 (2.8%). The additional information from MRI changed management in 69/181 (38.1%), with more unilateral surgery (wider excision or mastectomy) in 53/181 (29.3%), change to bilateral surgery in 12/181 (6.6%), less surgery in 4/181 (2.2%). Clinical examination estimated histological size within 20 mm in 57%, conventional imaging in 55% and MRI in 71%. CONCLUSION: MRI was most likely to show concordance with histopathology in the 'discordant assessment' and 'invasive lobular' groups and less likely for 'challenging clinically dense breast tissue.' MRI changed management in 69/181 (38.1%).

Immediate expander/implant breast reconstruction followed by post-mastectomy radiotherapy for breast cancer: Aesthetic, surgical, satisfaction and quality of life outcomes in women with high-risk breast cancer.

BACKGROUND: Immediate tissue expander/implant-based breast reconstruction (BR) is often avoided when post-mastectomy radiotherapy (PMRT) is planned due to concerns about high complication rates and poor aesthetic outcomes. This study evaluated surgical, aesthetic and quality of life (QoL) outcomes in women undergoing immediate implant-based BR (IIBR) followed by PMRT. METHODS: Participants were recruited at least six months after completing the final stage of BR. They completed validated on-line questionnaires assessing satisfaction, QoL, distress, body image and regret. Aesthetic outcomes were rated by their operating surgeon through clinical examination and assessed by an independent surgeon using photographs. RESULTS: Forty-seven participants completed questionnaires and reported good outcomes for QoL (FACT-B = 115; TOI = 73), satisfaction (Breast-Q), distress (Impact of Events scale <4.8 all subscales) and body image (Body Image scale), with a low score on the Decisional Regret scale (mean 12.1). Aesthetic outcomes were rated fair-to-good (Kroll scale). The surgical complication rate was low (expander/implant loss rate 6.4%, wound infection 10.6%, seroma 4.1%). At follow-up, 33 (70.2%) participants retained their permanent implant and 12 (25.5%) converted to a TRAM or DIEP flap; there were two LD flaps. CONCLUSION: This study demonstrated acceptable cosmetic results, high patient satisfaction and low complication rates. It provides evidence that women are willing to accept the potential risks of IIBR in exchange for its benefits including enhanced body image during chemotherapy and PMRT and the possible avoidance of more complicated and costly delayed autologous BR. The results support the importance of access to BR, even in women with high-risk disease.

An evaluation of factors affecting preference for immediate, delayed or no breast reconstruction in women with high-risk breast cancer.

OBJECTIVE: Women with locally advanced breast cancer face many conflicting issues affecting their choice of immediate versus delayed versus no breast reconstruction (BR). This single-centre pilot study assessed high-risk women's reasons and priorities in choosing the timing and type of BR in a setting where all clinically feasible options were discussed with all women. METHODS: Fifty-one women from a metropolitan breast oncology practice, who were likely to require post-mastectomy radiotherapy (PMRT), were recruited after making their decision about BR. Participants completed a questionnaire (69% preoperatively), adapted from Reaby (1998), evaluating the factors affecting their decision. Responses were subsequently classified into eight issue-based domains (feeling normal, feeling good, being practical, influence of others, expectations, fear, timing and unnecessary). Demographic and clinical data were also collected. RESULTS: There were 32 immediate BR (IBR = 63%), seven delayed BR (DBR = 13%) and 12 no BR (NBR = 23%). Analysis using the chi square test showed women over 60 were more likely to choose NBR (p = 0.005), while women living with a partner were more likely to choose IBR (p = 0.032). The most relevant domains for both IBR and DBR were 'feeling good' and 'feeling normal'; and for NBR were 'unnecessary' and 'being practical'. Although all women understood pre-operatively the potential aesthetic limitations of PMRT, 63% still chose IBR. CONCLUSIONS: These data will enable clinicians, researchers and women with breast cancer to gain a clearer understanding of the factors that impact on the choice and timing of BR in women requiring PMRT, a major breast cancer survivorship decision. Copyright © 2016 John Wiley & Sons, Ltd.

The role of ultraviolet marker assessments in demonstrating cleaning efficacy.

Cleaning standards measuring compliance using visual auditing alone can be misleading, because visually clean surfaces might not be cleaned of pathogens. An evidence-based system using both visual auditing and ultraviolet marker (UVM) assessments is recommended. Using a UVM system has enabled our health service to measure infection risk and implement actions to improve results. We recommend adopting a combined monitoring process using visual auditing with UVM audits to enhance cleaning and reduce the risk of health care-associated infection.

Utility of neoadjuvant chemotherapy in the treatment of operable breast cancer.

Neoadjuvant chemotherapy (NAC) is a legitimate alternative to first-line surgical therapy for the treatment of breast cancer patients, as level one evidence shows the effect on overall survival is equivalent to that of adjuvant chemotherapy. In the treatment of women with operable breast cancer, NAC provides a number of potential advantages including: improving the chance of achieving breast-conserving surgery, improving cosmesis after breast-conserving surgery, downstaging the breast and axilla, allowing time to fully consider surgical options, time for genetic testing and facilitating breast reconstruction in otherwise high-risk patients. However, in Australia, NAC is poorly utilized with less than 3% of women with operable breast cancer receiving NAC. This review discusses the potential harms and benefits of NAC, discusses areas of controversy in the use of NAC and describes how we have used NAC in our own practice. We conclude that if it is obviously necessary for the newly presenting breast cancer patient to have chemotherapy as part of the treatment, it is worth considering NAC. In many patients, the potential benefits of NAC outweigh the harms. However, maximizing these benefits is closely aligned with appropriate patient selection and timely multidisciplinary team communication.