Designing and implementing a bundle of care for patients with early-stage breast cancer: lessons from a pilot program.

We present a case study on the design and implementation of a value-based bundled package of care for patients with early-stage breast cancer treated in the private health sector in Australia. Value-based healthcare is an essential change to how we deliver healthcare, shifting the focus from paying for individual services provided to a focus on the health outcomes gained over a full cycle of care. The Australian health system has unintentionally created barriers to value-based cancer care through fragmented care pathways and complex funding arrangements where patients can unexpectedly encounter high out-of-pocket costs. A team of clinicians, service providers, health systems and funding experts, private health insurers and consumers have collaborated to design and pilot a complete bundled package of care for breast cancer patients which aims to address these challenges. With 40 patients recruited to date, early evaluation results show positive patient experience of 'joined-up' care and financial transparency. This case study provides a high-level overview of the approach taken to design and implement the Breast Cancer Bundle and the lessons learned for its expansion in both public and private settings.

An online intervention to improve oncology health professional self-efficacy in communicating with carers: Hybrid effectiveness-implementation evaluation of the eTRIO program.

OBJECTIVES: Many oncology health professionals (HPs) report communicating with carers as complex; and receive limited carer-relevant training. We developed an online HP education program for supporting and managing carer involvement (eTRIO). We aimed to assess whether HPs' self-efficacy in carer communication, knowledge, and decision-making preferences improve following eTRIO. Satisfaction and implementation potential were assessed. METHODS: This type 1 hybrid effectiveness-implementation study used a pre-post single arm intervention design. HPs completed baseline measures, the eTRIO online module, and measures at 1- and 12-weeks post-intervention. Measures included: self-efficacy in carer communication (13-items), applied knowledge (7-items), preference for carer involvement in decisions (1-item). Fifteen of participants completed feedback interviews which underwent thematic analysis. User analytics were collected and analysed. RESULTS: Fifty-six HPs completed baseline measures, 42 completed post- and follow-up measures. At baseline mean self-efficacy score was 88. HPs showed a statistically significant increase in self-efficacy post-intervention (mean = 105.8, CI [12.99, 20.47]), maintained at 12-weeks (mean = 101.1, CI [8.00, 15.72]). There were no changes in knowledge or decision-making preferences. Program engagement and satisfaction were high, 86.7% participants rated eTRIO as very/extremely helpful. CONCLUSIONS AND PRACTICE IMPLICATIONS: eTRIO provided HPs with confidence to effectively engage with carers and manage complex situations such as family dominance. These gains are noteworthy, as conflict with families/carers contributes to HP burnout.

Development of Web-Based Education Modules to Improve Carer Engagement in Cancer Care: Design and User Experience Evaluation of the e-Triadic Oncology (eTRIO) Modules for Clinicians, Patients, and Carers.

BACKGROUND: Carers often assume key roles in cancer care. However, many carers report feeling disempowered and ill-equipped to support patients. Our group published evidence-based guidelines (the Triadic Oncology [TRIO] Guidelines) to improve oncology clinician engagement with carers and the management of challenging situations involving carers. OBJECTIVE: To facilitate implementation of the TRIO Guidelines in clinical practice, we aimed to develop, iteratively refine, and conduct user testing of a suite of evidence-based and interactive web-based education modules for oncology clinicians (e-Triadic Oncology [eTRIO]), patients with cancer, and carers (eTRIO for Patients and Carers [eTRIO-pc]). These were designed to improve carer involvement, communication, and shared decision-making in the cancer management setting. METHODS: The eTRIO education modules were based on extensive research, including systematic reviews, qualitative interviews, and consultation analyses. Guided by the person-based approach, module content and design were reviewed by an expert advisory group comprising academic and clinical experts (n=13) and consumers (n=5); content and design were continuously and iteratively refined. User experience testing (including "think-aloud" interviews and administration of the System Usability Scale [SUS]) of the modules was completed by additional clinicians (n=5), patients (n=3), and carers (n=3). RESULTS: The final clinician module comprises 14 sections, requires approximately 1.5 to 2 hours to complete, and covers topics such as carer-inclusive communication and practices; supporting carer needs; and managing carer dominance, anger, and conflicting patient-carer wishes. The usability of the module was rated by 5 clinicians, with a mean SUS score of 75 (SD 5.3), which is interpreted as good. Clinicians often desired information in a concise format, divided into small "snackable" sections that could be easily recommenced if they were interrupted. The carer module features 11 sections; requires approximately 1.5 hours to complete; and includes topics such as the importance of carers, carer roles during consultations, and advocating for the patient. The patient module is an adaptation of the relevant carer module sections, comprising 7 sections and requiring 1 hour to complete. The average SUS score as rated by 6 patients and carers was 78 (SD 16.2), which is interpreted as good. Interactive activities, clinical vignette videos, and reflective learning exercises are incorporated into all modules. Patient and carer consumer advisers advocated for empathetic content and tone throughout their modules, with an easy-to-read and navigable module interface. CONCLUSIONS: The eTRIO suite of modules were rigorously developed using a person-based design methodology to meet the unique information needs and learning requirements of clinicians, patients, and carers, with the goal of improving effective and supportive carer involvement in cancer consultations and cancer care.

The distribution of breast density in women aged 18 years and older.

PURPOSE: Age and body mass index (BMI) are critical considerations when assessing individual breast cancer risk, particularly for women with dense breasts. However, age- and BMI-standardized estimates of breast density are not available for screen-aged women, and little is known about the distribution of breast density in women aged < 40. This cross-sectional study uses three different modalities: optical breast spectroscopy (OBS), dual-energy X-ray absorptiometry (DXA), and mammography, to describe the distributions of breast density across categories of age and BMI. METHODS: Breast density measures were estimated for 1,961 Australian women aged 18-97 years using OBS (%water and %water + %collagen). Of these, 935 women had DXA measures (percent and absolute fibroglandular dense volume, %FGV and FGV, respectively) and 354 had conventional mammographic measures (percent and absolute dense area). The distributions for each breast density measure were described across categories of age and BMI. RESULTS: The mean age was 38 years (standard deviation = 15). Median breast density measures decreased with age and BMI for all three modalities, except for DXA-FGV, which increased with BMI and decreased after age 30. The variation in breast density measures was largest for younger women and decreased with increasing age and BMI. CONCLUSION: This unique study describes the distribution of breast density measures for women aged 18-97 using alternative and conventional modalities of measurement. While this study is the largest of its kind, larger sample sizes are needed to provide clinically useful age-standardized measures to identify women with high breast density for their age or BMI.

Association between long-term use of calcium channel blockers (CCB) and the risk of breast cancer: a retrospective longitudinal observational study protocol.

INTRODUCTION: Calcium channel blockers (CCB), a commonly prescribed antihypertensive (AHT) medicine, may be associated with increased risk of breast cancer. The proposed study aims to examine whether long-term CCB use is associated with the development of breast cancer and to characterise the dose-response nature of any identified association, to inform future hypertension management. METHODS AND ANALYSIS: The study will use data from 2 of Australia's largest cohort studies; the Australian Longitudinal Study on Women's Health, and the 45 and Up Study, combined with the Rotterdam Study. Eligible women will be those with diagnosed hypertension, no history of breast cancer and no prior CCB use at start of follow-up (2004-2009). Cumulative dose-duration exposure to CCB and other AHT medicines will be captured at the earliest date of: the outcome (a diagnosis of invasive breast cancer); a competing risk event (eg, bilateral mastectomy without a diagnosis of breast cancer, death prior to any diagnosis of breast cancer) or end of follow-up (censoring event). Fine and Gray competing risks regression will be used to assess the association between CCB use and development of breast cancer using a generalised propensity score to adjust for baseline covariates. Time-varying covariates related to interaction with health services will also be included in the model. Data will be harmonised across cohorts to achieve identical protocols and a two-step random effects individual patient-level meta-analysis will be used. ETHICS AND DISSEMINATION: Ethical approval was obtained from the following Human research Ethics Committees: Curtin University (ref No. HRE2022-0335), NSW Population and Health Services Research Ethics Committee (2022/ETH01392/2022.31), ACT Research Ethics and Governance Office approval under National Mutual Acceptance for multijurisdictional data linkage research (2022.STE.00208). Results of the proposed study will be published in high-impact journals and presented at key scientific meetings. TRIAL REGISTRATION NUMBER: NCT05972785.

The promoting physical activity in regional and remote cancer survivors (PPARCS) trial: Physical activity maintenance.

INTRODUCTION: The study examined whether increased physical activity (PA) in nonmetropolitan cancer survivors was maintained 12 weeks following the PPARCS intervention. METHODS: PA outcomes were assessed using an accelerometer at baseline, end of the intervention, and at 24 weeks. Linear mixed models were used to examine between-group changes in PA outcomes. RESULTS: The increased moderate-to-vigorous PA (MVPA) following intervention was maintained with significantly higher MVPA in the intervention group at 24 weeks (vs. controls) compared to baseline nett change of 52.5 min/week (95% CI 11.0-94.0.4). CONCLUSIONS: Distance-based interventions using wearables and health coaching may produce MVPA maintenance amongst nonmetropolitan cancer survivors.

A randomized controlled trial of Promoting Physical Activity in Regional and Remote Cancer Survivors (PPARCS).

BACKGROUND: Physical activity (PA) is important for cancer survivors. Trials of remotely delivered interventions are needed to assist in reaching under-served non-metropolitan cancer survivors. The objective of this study was to ascertain whether wearable technology, coupled with health coaching was effective in increasing PA in breast and colorectal cancer survivors living in regional and remote areas in Australia. METHODS: Cancer survivors from 5 states were randomized to intervention and control arms. Intervention participants were given a Fitbit Charge 2TM and received up to 6 telephone health coaching sessions. Control participants received PA print materials. Accelerometer assessments at baseline and 12 weeks measured moderate-to-vigorous PA (MVPA), light PA, and sedentary behavior. RESULTS: Eighty-seven participants were recruited (age = 63 ± 11 years; 74 (85%) female). There was a significant net improvement in MVPA of 49.8 min/week, favoring the intervention group (95% confidence interval (95%CI): 13.6-86.1, p = 0.007). There was also a net increase in MVPA bouts of 39.5 min/week (95%CI: 11.9-67.1, p = 0.005), favoring the intervention group. Both groups improved light PA and sedentary behavior, but there were no between-group differences. CONCLUSION: This is the first study to demonstrate that, when compared to standard practice (i.e., PA education), a wearable technology intervention coupled with distance-based health coaching, improves MVPA in non-metropolitan cancer survivors. The results display promise for the use of scalable interventions using smart wearable technology in conjunction with phone-based health coaching to foster increased PA in geographically disadvantaged cancer survivors.

A Multimethod Evaluation of a Specialist Breast Care Nurse-Led Survivorship Clinic in Australia.

OBJECTIVES: To compare the needs and issues faced by breast cancer survivors (BCSs) who received chemotherapy as part of their treatment with those who did not and assess satisfaction with a specialist breast care nurse-led survivorship clinic. SAMPLE & SETTING: BCSs who attended a specialist breast care nurse-led survivorship clinic at a Western Australian private, not-for-profit hospital. METHODS & VARIABLES: A multimethod evaluation included surveys, quality-of-life assessments, and reviews of wellness plans. RESULTS: A total of 68 BCSs participated; the majority had received chemotherapy as part of their treatment and were female. BCSs experienced a diverse range of issues. Significant differences were found between chemotherapy and nonchemotherapy groups for financial difficulties (p = 0.002), body image (p = 0.017), future perspective (p = 0.022), and arm symptoms (p = 0.007). Participants indicated that the specialist breast care nurse-led clinic was appropriately timed and highly valued. IMPLICATIONS FOR NURSING: Specialist breast care nurse-led clinics can identify and address BCSs' ongoing needs.

What are the most effective exercise, physical activity and dietary interventions to improve body composition in women diagnosed with or at high-risk of breast cancer? A systematic review and network meta-analysis.

BACKGROUND: Obesity has been recognized as a risk factor in the development and recurrence of breast cancer and is also associated with poor prognostic outcomes. This systematic review and network meta-analysis aimed to identify the most effective exercise, physical activity, and dietary interventions to reduce fat mass, body fat percentage and body weight as well as potentially increase lean mass in women diagnosed with or at high risk of breast cancer. METHODS: A systematic search of databases was performed up to May 2022. Eligible randomized controlled trials examined the effects of exercise, physical activity and/or dietary interventions on fat mass and lean mass in women diagnosed with or at high risk of breast cancer. A random-effects network meta-analysis was conducted to determine the effects of different interventions across outcomes when sufficient studies were available. RESULTS: Eighty-four studies (n = 6428) were included in this review. Caloric restriction and combined exercise + caloric restriction significantly reduced fat mass (range, -3.9 to -3.7 kg) and body weight (range, -5.3 to -4.7 kg), whereas physical activity + caloric restriction significantly reduced body fat percentage (-2.4%; 95% confidence interval [CI], -3.4% to -13%) and body mass index (-2.2 kg × m-2 ; 95% CI, -3.0 to -1.4 kg × m-2 ) in breast cancer patients. Resistance exercise was the most effective intervention to increase lean mass (0.7 kg; 95% CI, 0.5-1.0 kg) in breast cancer patients. CONCLUSION: Multimodal exercise and diet programs were the most effective interventions to reduce fat mass, body fat percentage, and body weight and increase and/or preserve lean mass.

Interpreting contrast imaging to plan breast surgery.

BACKGROUND: Contrast enhanced mammography (CEM) and magnetic resonance imaging (MRI) are more accurate than conventional imaging (CI) for breast cancer staging. How adding CEM and MRI to CI might change the surgical plan is understudied. METHODS: Surgical plans (breast conserving surgery (BCS), wider BCS, BCS with diagnostic excision (>1BCS), mastectomy) were devised by mock-MDT (radiologist, surgeon and pathology reports) according to disease extent on CI, CI + CEM and CI + MRI. Differences in the mock-MDT's surgical plans following the addition of CEM or MRI were investigated. Using pre-defined criteria, the appropriateness of the modified plans was assessed by comparing estimated disease extent on imaging with final pathology. Surgery performed was recorded from patient records. RESULTS: Contrast imaging modified mock-MDT plans for 20 of 61(32.8%) breasts. The addition of CEM changed the plan in 16/20 (80%) and MRI in 17/20 breasts (85%). Identical changes were proposed by both CEM and MRI in 13/20 (65%) breasts. The modified surgical plan based on CI + CEM was possibly appropriate for 6/16 (37.5%), and CI + MRI in 9/17, (52.9%) breasts. The surgery performed was concordant with the mock-MDT plan for all 10 patients where the plans could be compared (BCS 1, >1 BCS 2 and mastectomy 7). CONCLUSION: Adding CEM or MRI to CI changed mock-MDT plans in up to one third of women, but not all were appropriate. Changing surgical plans following addition of contrast imaging to CI without biopsy confirmation could lead to over or under-treatment.

Women's views about current and future management of Ductal Carcinoma in Situ (DCIS): A mixed-methods study.

Management of low-risk ductal carcinoma in situ (DCIS) is controversial, with clinical trials currently assessing the safety of active monitoring amidst concern about overtreatment. Little is known about general community views regarding DCIS and its management. We aimed to explore women's understanding and views about low-risk DCIS and current and potential future management options. This mixed-method study involved qualitative focus groups and brief quantitative questionnaires. Participants were screening-aged (50-74 years) women, with diverse socioeconomic backgrounds and no personal history of breast cancer/DCIS, recruited from across metropolitan Sydney, Australia. Sessions incorporated an informative presentation interspersed with group discussions which were audio-recorded, transcribed and analysed thematically. Fifty-six women took part in six age-stratified focus groups. Prior awareness of DCIS was limited, however women developed reasonable understanding of DCIS and the relevant issues. Overall, women expressed substantial support for active monitoring being offered as a management approach for low-risk DCIS, and many were interested in participating in a hypothetical clinical trial. Although some women expressed concern that current management may sometimes represent overtreatment, there were mixed views about personally accepting monitoring. Women noted a number of important questions and considerations that would factor into their decision making. Our findings about women's perceptions of active monitoring for DCIS are timely while results of ongoing clinical trials of monitoring are awaited, and may inform clinicians and investigators designing future, similar trials. Exploration of offering well-informed patients the choice of non-surgical management of low-risk DCIS, even outside a clinical trial setting, may be warranted.

Interrupting Endocrine Therapy to Attempt Pregnancy after Breast Cancer.

BACKGROUND: Prospective data on the risk of recurrence among women with hormone receptor-positive early breast cancer who temporarily discontinue endocrine therapy to attempt pregnancy are lacking. METHODS: We conducted a single-group trial in which we evaluated the temporary interruption of adjuvant endocrine therapy to attempt pregnancy in young women with previous breast cancer. Eligible women were 42 years of age or younger; had had stage I, II, or III disease; had received adjuvant endocrine therapy for 18 to 30 months; and desired pregnancy. The primary end point was the number of breast cancer events (defined as local, regional, or distant recurrence of invasive breast cancer or new contralateral invasive breast cancer) during follow-up. The primary analysis was planned to be performed after 1600 patient-years of follow-up. The prespecified safety threshold was the occurrence of 46 breast cancer events during this period. Breast cancer outcomes in this treatment-interruption group were compared with those in an external control cohort consisting of women who would have met the entry criteria for the current trial. RESULTS: Among 516 women, the median age was 37 years, the median time from breast cancer diagnosis to enrollment was 29 months, and 93.4% had stage I or II disease. Among 497 women who were followed for pregnancy status, 368 (74.0%) had at least one pregnancy and 317 (63.8%) had at least one live birth. In total, 365 babies were born. At 1638 patient-years of follow-up (median follow-up, 41 months), 44 patients had a breast cancer event, a result that did not exceed the safety threshold. The 3-year incidence of breast cancer events was 8.9% (95% confidence interval [CI], 6.3 to 11.6) in the treatment-interruption group and 9.2% (95% CI, 7.6 to 10.8) in the control cohort. CONCLUSIONS: Among select women with previous hormone receptor-positive early breast cancer, temporary interruption of endocrine therapy to attempt pregnancy did not confer a greater short-term risk of breast cancer events, including distant recurrence, than that in the external control cohort. Further follow-up is critical to inform longer-term safety. (Funded by ETOP IBCSG Partners Foundation and others; POSITIVE ClinicalTrials.gov number, NCT02308085.).

Localisation accuracy with iodine-125 seed versus wire guidance for breast cancer surgery.

INTRODUCTION: Impalpable breast lesions generally require image-guided localisation for breast-conserving surgery. A standard technique is to place a hook wire (HW) within the lesion. Radioguided occult lesion localisation using iodine seeds (ROLLIS) involves inserting a 4.5 mm iodine-125 seed (seed) into the lesion. We hypothesised that a seed could be more precisely positioned in relation to the lesion than a HW and that this may be associated with a lower re-excision rate. METHODS: Retrospective review of consecutive participant data from three ROLLIS RCT (ACTRN12613000655741) sites. Participants underwent preoperative lesion localisation (PLL) with seed or HW between September 2013 and December 2017. Lesion and procedural characteristics were recorded. Distances between (1) any part of the seed or thickened segment of the HW ('TSHW') and the lesion/clip ('distance to device' DTD) and (2) centre of the TSHW/seed and centre of the lesion/clip (device centre to target centre 'DCTC') were measured on immediate postinsertion mammograms. Pathological margin involvement and re-excision rates were compared. RESULTS: A total of 390 lesions (190 ROLLIS and 200 HWL) were analysed. Lesion characteristics and guidance modality used were similar between groups. Ultrasound-guided DTD and DCTC for seed were smaller than for HW (77.1% and 60.6%, respectively, P-value < 0.001). Stereotactic-guided DCTC for seeds was 41.6% smaller than for HW (P-value = 0.001). No statistically significant difference in the re-excision rates was found. CONCLUSION: Iodine-125 seeds can be more precisely positioned for preoperative lesion localisation than HW, however, no statistically significant difference in re-excision rates was detected.

"I haven't had that information, even though I think I'm really well-informed about most things": a qualitative focus group study on Australian women's understanding and views of potentially modifiable risk factors for breast cancer.

BACKGROUND: Building health literacy about potentially modifiable risk factors for breast cancer may help to empower women to make more informed decisions about their breast health; however there has been limited qualitative research on this topic. This study aimed to explore current knowledge, understanding and experience of potentially modifiable risk factors for breast cancer, and views on current and future communication strategies for this information and related interventions. METHODS: Qualitative study using online focus groups via Zoom in October-November 2022. A diverse sample of women from the Australian community aged 40-74 years were recruited. RESULTS: Fifty-one women from a range of socioeconomic backgrounds took part in nine focus groups. General knowledge of risk factors for breast cancer in the community is limited, particularly in relation to modifiable factors such as alcohol consumption and postmenopausal obesity, with many women describing feelings of 'shock' following this information. Women overwhelming believed that information on modifiable risk factors for breast cancer should be communicated more widely, however communication preferences for receiving this information varied. There was a strong preference amongst the women for a cascade of information which they believed may then help target greater number of women of all ages and backgrounds. Despite worry about long-term compliance, women also supported various lifestyle interventions which may help them and other women to reduce their overall risk. CONCLUSIONS: Findings from this study highlight the need for more widespread community communication and education about risk factors for breast, in particular potentially modifiable risk factors such as alcohol consumption and postmenopausal obesity. As breast screening programs in Australia and globally begin to evaluate the potential for risk-related screening this will provide an additional context for primary prevention, hence planning of messaging and piloting of lifestyle-related prevention strategies in breast cancer is needed now. Gaining an understanding of women's preferences for communication and forms of interventions is vital to ensure their engagement.

Exercise medicine considerations for pregnancy-associated breast cancer: Characteristics, prognosis and treatment.

Breast cancer is the most prevalent cancer in women worldwide and is the most common cancer diagnosis made during pregnancy or in the postpartum period. When breast cancer is diagnosed either during pregnancy or in the first-year postpartum, it is referred to as pregnancy-associated breast cancer. The aim of this review is to assess existing literature regarding the recommendations and outcomes of participating in exercise for people with pregnancy-associated breast cancer. The occurrence of pregnancy-associated breast cancer is increasing as a growing number of women delay first pregnancies. Women undergoing treatment for pregnancy-associated breast cancer are dealing with both cancer and its treatment as well as a pregnancy or postpartum period, and often encounter symptoms associated with cancer diagnosis and treatment, such as nausea, pain and fatigue while simultaneously navigating a pregnancy or early motherhood. These experiences can be barriers to participating in exercise, despite exercise being associated with numerous benefits for both pregnancy health and breast cancer outcomes. Numerous studies report the benefits of exercising during breast cancer treatment in ameliorating associated symptoms, and some studies report that engaging in exercise can lead to healthier and lower risk pregnancies. However, there is a lack of consensus around appropriate exercise programmes for this specific population. Given the associated benefits of participating in exercise for both breast cancer patients and pregnant/postpartum women as separate groups, research into exercise medicine designed specifically for the pregnancy-associated breast cancer population is needed.

Accuracy and precision of contrast enhanced mammography versus MRI for predicting breast cancer size: how "good" are they really?

OBJECTIVE: To evaluate and compare the accuracy and precision of contrast-enhanced mammography (CEM) vs MRI to predict the size of biopsy-proven invasive breast cancer. METHODS: Prospective study, 59 women with invasive breast cancer on needle biopsy underwent CEM and breast MRI. Two breast radiologists read each patient's study, with access limited to one modality. CEM lesion size was measured using low-energy and recombined images and on MRI, the first post-contrast series. Extent of abnormality per quadrant was measured for multifocal lesions. Reference standards were size of largest invasive malignant lesion, invasive (PathInvasive) and whole (PathTotal). Pre-defined clinical concordance ±10 mm. RESULTS: Mean patient age 56 years, 42 (71%) asymptomatic. Lesions were invasive ductal carcinoma 40 (68%) with ductal carcinoma in situ (31/40) in 78%, multifocal in 12 (20%). Median lesion size was 17 mm (invasive) and 27 mm (total), range (5-125 mm). Lin's concordance correlation coefficients for PathTotal 0.75 (95% CI 0.6, 0.84) and 0.71 (95% CI 0.56, 0.82) for MRI and contrast-enhanced spectral mammography (CESM) respectively. Mean difference for total size, 3% underestimated and 4% overestimated, and for invasive 41% and 50% overestimate on MRI and CESM respectively. LOAs for PathTotal varied from 60% under to a 2.4 or almost threefold over estimation. MRI was concordant with PathTotal in 36 (64%) cases compared with 32 (57%) for CESM. Both modalities concordant in 26 (46%) cases respectively. CONCLUSION: Neither CEM nor MRI have sufficient accuracy to direct changes in planned treatment without needle biopsy confirmation. ADVANCES IN KNOWLEDGE: Despite small mean differences in lesion size estimates using CEM or MRI, the 95% limits of agreement do not meet clinically acceptable levels.

Iodine-125 seed versus hook-wire guided breast conserving surgery: do post operative complication rates differ?

BACKGROUND: Radio-guided occult lesion localisation using iodine 125 seeds (ROLLIS) is used to localize impalpable breast cancers for breast conserving surgery (BCS). Previous studies have suggested improved efficiency and patient outcomes with ROLLIS compared with hook-wire localisation (HWL). The aim of this report is to compare the post-operative complication rates and safety profiles of ROLLIS versus hook-wire guided surgery. METHODS: Between September 2013 and March 2018, 690 women with non-palpable breast cancer eligible for breast-conserving surgery were randomly assigned to either pre-operative localisation with 125 I seed or hook-wire as part of the ROLLIS clinical trial. Medical record review of 170 women (30% of the total participants) from three tertiary hospitals in Western Australia was performed. Post-operative complications were classified using the Common Terminology Criteria for Adverse Events(CTCAE) grade I to V. RESULTS: Total of 170 surgeries were performed: 82 by ROLLIS and 88 by hook-wire. The overall complication rate in the ROLLIS group was 19.5%, with 15.9% being grade II and 3.66% grade III. In the HWL group, the complication rate was 22.7% with 20.5% being grade II and 2.27% grade III. There was no statistically significant difference in complication grades between the 2 groups. No grade IV or grade V complications were reported. Complications observed included drainable seroma, drainable haematoma and surgical site infection. CONCLUSION: ROLLIS is a safe method of localisation for surgical resection with similar complication rates as hookwires. We encourage its use as an alternative localisation technique as it has demonstrable superiority and efficacy.

Rates of reoperation after breast conserving cancer surgery in Western Australia before and after publication of the SSO-ASTRO margins guideline.

BACKGROUND: A 2014 SSO-ASTRO guideline on surgical margins aimed to reduce unnecessary reoperation after breast conserving surgery (BCS). We investigate whether publication of the guideline was associated with a reduction in reoperation in Western Australia (WA). METHODS: In this retrospective, population-based cohort study, cases of newly-diagnosed breast cancer were identified from the WA Cancer Registry. Linkage to the Hospital Morbidity Data Collection identified index BCS for invasive cancer between January 2009 and June 2018 (N = 8059) and reoperation within 90 days. Pre-guideline (2009-2013) and post-guideline (2014-2018) reoperation proportions were compared, and temporal trends were estimated with generalised linear regression. RESULTS: The pre-guideline reoperation proportion was 25.8% compared with 21.7% post-guideline (difference -4.0% [95% CI -5.9, -2.2, p < 0.001], odds ratio [OR] 0.80 [95% CI 0.72, 0.89, p < 0.001]). Absolute reductions were similar for repeat BCS (16.3% versus 14.6%; difference -1.8% [95% CI -3.4, -0.2, p = 0.03]) and conversion to mastectomy (9.4% versus 7.2%; difference -2.2% [95% CI -3.4, -1.0, p < 0.001]). Over the study period, there was an annual absolute change in reoperation of -0.8% (95% CI -1.2, -0.5, p < 0.001). Accounting for this linear trend, the difference in reoperation between time periods was -0.5% (95% CI -4.3, 3.3; p = 0.81), reflecting a non-significant reduction in conversion to mastectomy. CONCLUSIONS: Comparisons of pre- versus post-guideline time periods in WA showed reductions in reoperation that were similar to international estimates; however, an annual decline in reoperation predated the guideline. Analyses that do not account for temporal trends are likely to overestimate changes in reoperation associated with the guideline.

Alternative methods to measure breast density in younger women.

BACKGROUND: Breast density is a strong and potentially modifiable breast cancer risk factor. Almost everything we know about breast density has been derived from mammography, and therefore, very little is known about breast density in younger women aged <40. This study examines the acceptability and performance of two alternative breast density measures, Optical Breast Spectroscopy (OBS) and Dual X-ray Absorptiometry (DXA), in women aged 18-40. METHODS: Breast tissue composition (percent water, collagen, and lipid content) was measured in 539 women aged 18-40 using OBS. For a subset of 169 women, breast density was also measured via DXA (percent fibroglandular dense volume (%FGV), absolute dense volume (FGV), and non-dense volume (NFGV)). Acceptability of the measurement procedures was assessed using an adapted validated questionnaire. Performance was assessed by examining the correlation and agreement between the measures and their associations with known determinants of mammographic breast density. RESULTS: Over 93% of participants deemed OBS and DXA to be acceptable. The correlation between OBS-%water + collagen and %FGV was 0.48. Age and BMI were inversely associated with OBS-%water + collagen and %FGV and positively associated with OBS-%lipid and NFGV. CONCLUSIONS: OBS and DXA provide acceptable and viable alternative methods to measure breast density in younger women aged 18-40 years.

Contrast-enhanced mammography (CEM) versus MRI for breast cancer staging: detection of additional malignant lesions not seen on conventional imaging.

BACKGROUND: Contrast-enhanced mammography (CEM) is more available than MRI for breast cancer staging but may not be as sensitive in assessing disease extent. We compared CEM and MRI in this setting. METHODS: Fifty-nine women with invasive breast cancer underwent preoperative CEM and MRI. Independent pairs of radiologists read CEM studies (after reviewing a 9-case set prior to study commencement) and MRI studies (with between 5 and 25 years of experience in breast imaging). Additional lesions were assigned National Breast Cancer Centre (NBCC) scores. Positive lesions (graded NBCC ≥ 3) likely to influence surgical management underwent ultrasound and/or needle biopsy. True-positive lesions were positive on imaging and pathology (invasive or in situ). False-positive lesions were positive on imaging but negative on pathology (high-risk or benign) or follow-up. False-negative lesions were negative on imaging (NBCC < 3 or not identified) but positive on pathology. RESULTS: The 59 women had 68 biopsy-proven malignant lesions detected on mammography/ultrasound, of which MRI demonstrated 66 (97%) and CEM 67 (99%) (p = 1.000). Forty-one additional lesions were detected in 29 patients: six of 41 (15%) on CEM only, 23/41 (56%) on MRI only, 12/41 (29%) on both; CEM detected 1/6 and MRI 6/6 malignant additional lesions (p = 0.063), with a positive predictive value (PPV) of 1/13 (8%) and 6/26 (23%) (p = 0.276). CONCLUSIONS: While MRI and CEM were both highly sensitive for lesions detected at mammography/ultrasound, CEM may not be as sensitive as MRI in detecting additional otherwise occult foci of malignancy. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry: ACTRN 12613000684729.