10-Year axillary recurrence in the RACS SNAC1 randomised trial of sentinel lymph node-based management versus routine axillary lymph node dissection.

BACKGROUND: Sentinel node-based management (SNBM) is the international standard of care for early breast cancer that is clinically node-negative based on randomised trials comparing it with axillary lymph node dissection (ALND) and reporting similar rates of axillary recurrence (AR) without distant disease. We report all ARs, overall survival, and breast cancer-specific survival at 10-years in SNAC1. METHODS: 1.088 women with clinically node-negative, unifocal breast cancers 3 cm or less in diameter were randomly assigned to either SNBM with ALND if the sentinel node (SN) was positive, or to SN biopsy followed by ALND regardless of SN involvement. RESULTS: First ARs were more frequent in those assigned SNBM rather than ALND (11 events, cumulative risk at 10-years 1·85%, 95% CI 0·95-3.27% versus 2 events, 0·37%, 95% CI 0·08-1·26%; HR 5·47, 95% CI 1·21-24·63; p = 0·013). Disease-free survival, breast cancer-specific survival, and overall survival were similar in those assigned SNBM versus ALND. Lymphovascular invasion was an independent predictor of AR (HR 6·6, 95% CI 2·25-19·36, p < 0·001). CONCLUSION: First ARs were more frequent with SNBM than ALND in women with small, unifocal breast cancers when all first axillary events were considered. We recommend that studies of axillary treatment should report all ARs to give an accurate indication of treatment effects. The absolute frequency of AR was low in women meeting our eligibility criteria, and SNBM should remain the treatment of choice in this group. However, for those with higher-risk breast cancers, further study is needed because the estimated risk of AR might alter their choice of axillary surgery.

Safety and efficacy of anterior intercostal artery perforator flaps in oncoplastic breast reconstruction.

INTRODUCTION: Partial breast reconstruction based on the anterior intercostal artery perforators (AICAP) has been suggested to avoid the unsightly 'bird's beak' deformity for lower pole breast cancers. The aims of this study were to evaluate the initial clinical experience of AICAP flaps in terms of safety and efficacy in oncoplastic breast reconstruction. METHODS: Between October 2013 and April 2020, AICAP flaps were offered to 30 patients with lower pole breast cancers. Hand-held Acoustic Doppler assessments were undertaken to confirm adequate perforators. Surgical results were evaluated in terms of safety and efficacy. Patients were invited to complete sections of the Breast-Q questionnaire at least 12 months postoperatively to assess patient satisfaction in terms of cosmetic outcome, physical and psychosocial wellbeing. RESULTS: Median operating theatre time for AICAP flap harvesting and positioning was 20 min (range 15-28 min). The median weight of resected breast specimens was 41 g (range 10-127 g). Total tumour size ranged from 7 to 35 mm (median 16 mm; three cases exhibited multifocal disease). Clear radial resection margins were achieved in 29 cases (96.7%). The median post-operative stay was two days (range 2-3 days). There were two postoperative complications comprising delayed wound healing/fat necrosis, which resolved with monitoring and inadine dressings. Based on the Breast-Q results, patients reported high levels of satisfaction with the physical appearance of their reconstructed breast, psychosocial and physical wellbeing. CONCLUSION: AICAP flaps appear to be safe in restoring breast contour after wide excision of lower pole breast cancers, with high levels of patient satisfaction reported postoperatively.

Long-term outcomes of breast reconstruction and the need for revision surgery.

BACKGROUND: Breast reconstruction (BR) often forms part of a patient's breast cancer journey. Revision surgery may be required to maintain the integrity of a BR, although this is not commonly reported in the literature. Different reconstructive methods may have differing requirements for revision. It is important for patients and surgeons to understand the factors leading to the need for revision surgery. METHODS: This retrospective cohort study analyses BRs performed by oncoplastic breast surgeons in public and private settings between 2005 and 2014, with follow-up until December 2018. Surgical and patient factors were examined, including types of BR, complications and reasons for revision surgery. RESULTS: A total of 390 women with 540 reconstructions were included, with a median follow-up of 61 months. Twenty-eight percent (151/540) of reconstructions required at least one revision operation. Overall, implant-based reconstructions (direct-to-implant [DTI] and two-stage expander-implant) had a higher revision rate compared to pedicled flap reconstructions (odds ratio 1.91, 95% confidence interval 1.08, 3.38). DTI reconstructions had the highest odds, and pedicled flap without implants the lowest odds of requiring revision. Post-reconstruction radiotherapy increased the chance of revision surgery, while pre-reconstruction radiotherapy did not. Odds of revision were higher in implant-based reconstructions compared to pedicled flap reconstructions that had radiotherapy. Other factors increasing the rates of revision surgery were being a current smoker and post-operative infection. CONCLUSION: Almost one-third of reconstructive patients require revision surgery. Autologous pedicled flap reconstructions have lower rates of revision compared to implant-based reconstructions. Radiotherapy increases the need for revision surgery, particularly in implant-based reconstructions.

How much does axillary ultrasound contribute in women undergoing breast-conserving surgery with no palpable axillary nodes?

BACKGROUND: The primary objective was evaluation of axillary ultrasound (AxUS) in preoperative staging of patients with invasive carcinoma undergoing breast-conserving surgery. METHODS: This is a retrospective, observational cohort study of patients with clinically node-negative (cN0) biopsy-proven invasive breast carcinoma undergoing breast-conserving surgery between January 2011 and December 2014 who underwent AxUS with fine needle aspiration (FNA) biopsy of sonographically abnormal lymph nodes. Patient records were reviewed. RESULTS: A total of 713 cases were analysed. Four hundred and thirty-three patients underwent formal preoperative AxUS; 100 underwent biopsy for abnormal findings. Of these, 32 had positive FNA biopsy result and underwent level II axillary dissection (axillary lymph node dissection (ALND)). Thirty were T1-2 tumours with AxUS scan/FNA demonstrating sensitivity of 25.2%, specificity of 100%, positive predictive value of 100% and negative predictive value of 76.6%. Forty-six patients had a positive sentinel lymph node (SLN) biopsy and axillary dissection. 34.8% of T1 tumours, 47.8% of T2 tumours and 100% of T3 tumours had further positive nodes. The average number of nodes involved per axilla was 1.8 for the T1 group, 4.1 for the T2 group and 4.6 in the T3 group. Macrometastases were a more common finding than micrometastases for all T stages undergoing ALND. A suspicious preoperative AxUS result was significantly associated with positive SLN. Other risk factors for positive SLN biopsy were oestrogen receptor positivity and lymphovascular invasion. CONCLUSION: AxUS identifies patients with high nodal burdens justifying immediate ALND. AxUS did not adversely affect women with histologically negative sentinel nodes. Three percent may have been overtreated.

Extended duration of adjuvant aromatase inhibitor in breast cancer: a meta-analysis of randomized controlled trials.

BACKGROUND: The risk of hormone positive breast cancer extends beyond 5 years. Extended duration of tamoxifen to 10 years has been shown to improve overall survival (OS) and disease-free survival (DFS). In post-menopausal women aromatase inhibitor (AI) is the gold standard for adjuvant endocrine therapy. Several randomized controlled trials (RCTs) showed benefit with extending the duration of AIs in post-menopausal women. However, the duration and the overall benefit is still controversial. METHODS: Eligible 8 RCTs comprising of 17,190 participants were included in this meta-analysis. RESULTS: Extending the duration of AI did not show any statistically significant advantage in OS with OR of 1.033 (95% CI: 0.925-1.154, P=0.56), DFS OR of 1.049 (95% CI: 0.930-1.185, P=0.435), recurrence-free survival (RFS) OR of 1.063 (95% CI: 0.952-1.187, P=0.276), and contralateral breast cancer (CBC) OR of 1.094 (95% CI: 0.920-1.301, P=0.311). Higher rates of side-effects of arthralgia, myalgia, hot flushes and bone toxicity was seen among the extended AI group. CONCLUSIONS: Based on this meta-analysis and current literature review, extended use of AI after 5 years of endocrine therapy should be used in selected women with high risk tumour factors. Molecular markers and genomic profiling may assist in identifying the high-risk patients. It is important to consider quality of life and patient satisfaction when considering extending the duration of AI.

Active surveillance of women diagnosed with atypical ductal hyperplasia on core needle biopsy may spare many women potentially unnecessary surgery, but at the risk of undertreatment for a minority: 10-year surgical outcomes of 114 consecutive cases from a single center.

A needle core biopsy diagnosis of atypical ductal hyperplasia is an indication for open biopsy. The launch of randomized clinical trials of active surveillance for low-risk ductal carcinoma in situ leads to the paradoxical situation of women with low-grade ductal carcinoma in situ being observed, whereas those with atypical ductal hyperplasia have surgery. If the malignancies diagnosed after surgery for atypical ductal hyperplasia are dominated by low-risk ductal carcinoma in situ, women with atypical ductal hyperplasia may also be considered for surveillance. This 10-year prospective observational study includes women diagnosed with atypical ductal hyperplasia on core biopsy after screening mammography. We retrieved their clinical, imaging and histologic data and carried out a blind review of core biopsy histology, sub-classifying the atypical ductal hyperplasia along a spectrum from hyperplasia to ductal carcinoma in situ. Using the final surgical pathology data, we calculated: (1) The proportion and grades of ductal carcinoma in situ and invasive cancers diagnosed at open biopsy. (2) The histologic extent of the malignancy at surgery. (3) The biomarker profile and nodal status of any invasive cancers. (4) Ascertained any independent predictors of (i) any malignancy, (ii) high-risk malignancy, defined in this study as invasive cancer, or high-grade ductal carcinoma in situ, or intermediate grade ductal carcinoma in situ with any necrosis. (5) Extrapolated the above to simulate active surveillance for women with screen-detected atypical ductal hyperplasia. Between January 2005 and December 2014, 114 women, mean age 59 years (range 40-79 years) were included. Surgical pathology, available in 110 (97%), confirmed malignancy in 46 (40%). All 46 malignant cases had ductal carcinoma in situ, accompanied by invasive carcinoma in 9 (8%) women. Together, 21 (19%) women had either invasive cancer (9%), high-grade ductal carcinoma in situ (6%), or necrotizing, intermediate grade ductal carcinoma in situ (6%). Only one of nine invasive breast cancers was grade 1, 3 were multifocal, all were ≤8 mm, node negative, and ER positive but two were HER2 amplified. The mean extent of the ductal carcinoma in situ in any one specimen was 19.8 mm, median 13 mm, range 2-110 mm. Overall 32 women, 29% of the whole cohort and 70% of those 46 with malignancy, required further surgery, including mastectomy in 12 (11%). A multivariable model for predicting the likelihood of any malignancy showed a statistically significant association only with the post review subtype of atypical ductal hyperplasia, adjusting for lesion size. Independent predictors of high-risk malignancy (invasive cancer or non-low-grade ductal carcinoma in situ) were not identified. If active surveillance is adopted for screen-detected atypical ductal hyperplasia diagnosed on core biopsy, 60% of women will avoid unnecessary surgery and a further 24% would meet eligibility criteria for ductal carcinoma in situ surveillance trials. However, 18% of women will have undiagnosed invasive breast cancer or non-low-risk ductal carcinoma in situ. These women with high-risk lesions are not reliably identified pre-operatively.

Breast cancer characteristics and survival differences between Maori, Pacific and other New Zealand women included in the Quality Audit program of Breast Surgeons of Australia and New Zealand.

BACKGROUND: The Quality Audit (BQA) program of the Breast Surgeons of Australia and New Zealand (NZ) collects data on early female breast cancer and its treatment. BQA data covered approximately half all early breast cancers diagnosed in NZ during roll-out of the BQA program in 1998-2010. Coverage increased progressively to about 80% by 2008. This is the biggest NZ breast cancer database outside the NZ Cancer Registry and it includes cancer and clinical management data not collected by the Registry. We used these BQA data to compare socio-demographic and cancer characteristics and survivals by ethnicity. MATERIALS AND METHODS: BQA data for 1998-2010 diagnoses were linked to NZ death records using the National Health Index (NHI) for linking. Live cases were followed up to December 31st 2010. Socio-demographic and invasive cancer characteristics and disease-specific survivals were compared by ethnicity. RESULTS: Five-year survivals were 87% for Maori, 84% for Pacific, 91% for other NZ cases and 90% overall. This compared with the 86% survival reported for all female breast cases covered by the NZ Cancer Registry which also included more advanced stages. Patterns of survival by clinical risk factors accorded with patterns expected from the scientific literature. Compared with Other cases, Maori and Pacific women were younger, came from more deprived areas, and had larger cancers with more ductal and fewer lobular histology types. Their cancers were also less likely to have a triple negative phenotype. More of the Pacific women had vascular invasion. Maori women were more likely to reside in areas more remote from regional cancer centres, whereas Pacific women generally lived closer to these centres than Other NZ cases. CONCLUSIONS: NZ BQA data indicate previously unreported differences in breast cancer biology by ethnicity. Maori and Pacific women had reduced breast cancer survival compared with Other NZ women, after adjusting for socio-demographic and cancer characteristics. The potential contributions to survival differences of variations in service access, timeliness and quality of care, need to be examined, along with effects of co- morbidity and biological factors.

The clinical utility of assessment of the axilla in women with suspicious screen detected breast lesions in the post Z0011 era.

Axillary ultrasound (AUS) and biopsy are now part of the preoperative assessment of breast cancer based on the assumption that any nodal disease is an indication for axillary clearance (AC). The Z0011 trial erodes this assumption. We applied Z0011 eligibility criteria to patients with screen detected cancers and positive axillary assessment to determine the relevance of AUS to contemporary practice. Women screened between 1/1/2012 and 30/6/2013 and assessed for lesions with highly suspicious imaging features are included. We analysed demographic and assessment data and ascertained the final histopathology with particular reference to axillary nodal status. Among 449 lesions, AUS was recorded in 303 lesions (67.5 %). 290 (96 %) were carcinomas, 30.3 % with nodal disease. AUS was abnormal in 46 (15.9 %). AUS had a sensitivity of 39.8 %, specificity 94.6 %, positive predictive value (PPV) 79.2 % and negative predictive value (NPV) 78.1 %. Axillary FNAB was positive in 27 women, suspicious in two, benign in 16 and not performed in one. In one FNA positive case, the lesion was a nodular breast primary in the axillary tail in a multifocal breast cancer. Combining AUS and FNAB, the sensitivity was 76.5 %, specificity 90.9 %, PPV 96.3 % and NPV 55.6 %. Applying the Z0011 inclusion criteria, 24 of the 27 (88.9 %) women with abnormal AUS and positive FNA were ineligible for Z0011-based management. Of three women eligible for Z0011, one proceeded to AC after SN biopsy, leaving only two women (7.4 %) who might have been considered for SN only management had it not been for the results of the axillary assessment. Among women with negative AUS, nodal metastasis was demonstrated in 21.7 %, 86.8 % of these women having only 1-2 positive nodes. Abnormal AUS and FNA preferentially identify candidates for AC. Negative AUS predicts negative or low nodal burden. Axillary assessment streamlines care.

Breast cancer survival in New Zealand women.

BACKGROUND: The Quality Audit (BQA) of Breast Surgeons of Australia and New Zealand includes a broad range of data and is the largest New Zealand (NZ) breast cancer (BC) database outside the NZ Cancer Registry. We used BQA data to compare BC survival by ethnicity, deprivation, remoteness, clinical characteristic and case load. METHODS: BQA and death data were linked using the National Health Index. Disease-specific survival for invasive cases was benchmarked against Australian BQA data and NZ population-based survivals. Validity was explored by comparison with expected survival by risk factor. RESULTS: Compared with 93% for Australian audit cases, 5-year survival was 90% for NZ audit cases overall, 87% for Maori, 84% for Pacific and 91% for other. CONCLUSIONS: BC survival in NZ appears lower than in Australia, with inequities by ethnicity. Differences may be due to access, timeliness and quality of health services, patient risk profiles, BQA coverage and death-record methodology.

Initial axillary surgery: results from the BreastSurgANZ Quality Audit.

BACKGROUND: The aim of this study was to establish the preference and reasons for initial axillary surgery performed on women with invasive breast cancer in Australia and New Zealand using data from the Breast Surgeon's Society of Australia and New Zealand Quality Audit (BQA) according to whether sentinel lymph node (SLN) biopsy, axillary lymph node dissection (ALND) or no axillary surgery was used. METHODS: Patient data from 1999 to 2011 were categorized according to primary tumour size (≤3 cm or >3 cm) and analysed by year of diagnosis, type of initial axillary surgery and frequency of second axillary surgery following SLN biopsy. Patient age at diagnosis, health insurance status, surgeon caseload and hospital location were also examined as factors affecting the likelihood of performing different types of axillary surgery. RESULTS: Seventy thousand six hundred and eighty-eight episodes of early breast cancer with axillary surgery data were reported to the BQA in the study period. The proportion of patients undergoing SLN biopsy as the first operation increased over this period in both tumour size groups with a concomitant decline in the use of ALND as the first operation over the same interval. Elderly women (>70 years old) were four times less likely to undergo axillary surgery for their initial management when compared with women aged 41-70 years old (P < 0.001). Factors favouring ALND as the initial surgery over SLN biopsy included larger tumour size, elderly age, uninsured status and having surgery in a regional centre. CONCLUSIONS: From 1999 to 2011, SLN biopsy as the initial axillary surgery has been widely adopted by surgeons reporting to the BQA. Future evaluation of the BQA data in the following 3-5 years will be performed to monitor this progression.

Analysing risk factors for poorer breast cancer outcomes in residents of lower socioeconomic areas of Australia.

OBJECTIVE: To investigate patient, cancer and treatment factors associated with the residence of female breast cancer patients in lower socioeconomic areas of Australia to better understand factors that may contribute to their poorer cancer outcomes. METHODS: Bivariable and multivariable analyses were performed using the Breast Quality Audit database of Breast Surgeons of Australia and New Zealand. RESULTS Multivariable regression indicated that patients from lower socioeconomic areas are more likely to live in more remote areas and to be treated at regional than major city centres. Although they appeared equally likely to be referred to surgeons from BreastScreen services as patients from higher socioeconomic areas, they were less likely to be referred as asymptomatic cases from other sources. In general, their cancer and treatment characteristics did not differ from those of women from higher socioeconomic areas, but ovarian ablation therapy was less common for these patients and bilateral synchronous lesions tended to be less frequent than for women from higher socioeconomic areas. CONCLUSIONS: The results indicate that patients from lower socioeconomic areas are more likely to live in more remote districts and have their treatment in regional rather than major treatment centres. Their cancer and treatment characteristics appear to be similar to those of women from higher socioeconomic areas, although they are less likely to have ovarian ablation or to be referred as asymptomatic patients from sources other than BreastScreen. What is known about this topic? It is already known from Australian data that breast cancer outcomes are not as favourable for women from areas of socioeconomic disadvantage. The reasons for the poorer outcomes have not been understood. Studies in other countries have also found poorer outcomes in women from lower socioeconomic areas, and in some instances, have attributed this finding to more advanced stages of cancers at diagnosis and more limited treatment. The reasons are likely to vary with the country and health system characteristics. What does this paper add? The present study found that in Australia, women from lower socioeconomic areas do not have more advanced cancers at diagnosis, nor, in general, other cancer features that would predispose them to poorer outcomes. The standout differences were that they tended more to live in areas that were more remote from specialist metropolitan centres and were more likely to be treated in regional settings where prior research has indicated poorer outcomes. The reasons for these poorer outcomes are not known but may include lower levels of surgical specialisation, less access to specialised adjunctive services, and less involvement with multidisciplinary teams. Women from lower socioeconomic areas also appeared more likely to attend lower case load surgeons. Little difference was evident in the type of clinical care received, although women from lower socioeconomic areas were less likely to be asymptomatic referrals from other clinical settings (excluding BreastScreen). What are the implications for practitioners? Results suggest that poorer outcomes in women from lower socioeconomic areas in Australia may have less to do with the characteristics of their breast cancers or treatment modalities and more to do with health system features, such as access to specialist centres. This study highlights the importance of demographic and health system features as potentially key factors in service outcomes. Health system research should be strengthened in Australia to augment biomedical and clinical research, with a view to best meeting service needs of all sectors of the population.

Subsequent axillary surgery after sentinel lymph node biopsy: results from the BreastSurgANZ Quality Audit 2006-2010.

OBJECTIVES: To use data from the BreastSurgANZ Quality Audit (BQA) to examine the patterns of completion axillary lymph node dissection (cALND) after sentinel lymph node (SLN) biopsy in women treated for early breast cancer in Australia and New Zealand and to compare it to the Australian and New Zealand guidelines in cases of both positive and negative SLN results. MATERIALS AND METHODS: Patients were sub grouped as having primary tumours ≤3 cm and >3 cm and further analysed according to year of surgery, SLN status and final nodal status where cALND was recorded. Multivariate analysis was performed examining tumour size, grade, presence of lymphovascular invasion (LVI), HER2 and oestrogen receptor status, patient age and number of positive sentinel nodes as predictors for subsequent axillary surgery. RESULTS: 14879 patients were identified from 2006 to 2010. 79.8% of patients with a positive SLN result underwent cALND. Age >70 years and a greater number of involved SLN predicted no cALND among SLN positive patients. 10.3% of patients who had a negative SLN result underwent cALND. Younger age, higher grade, lymphovascular invasion and tumour size >3 cm predicted cALND among SLN negative patients. CONCLUSIONS: According to the BQA from 2006 to 2010 the Australian and New Zealand guideline recommendations for SLN positive patients to have cALND and SLN negative patients not to have cALND were adhered to in 79.8% and 89.7% of cases respectively.

Evaluation of office ultrasound usage among Australian and New Zealand breast surgeons.

BACKGROUND: Surgeon performed ultrasound (US) is being increasingly embraced by breast surgeons worldwide as an integral part of patient assessment. The extent of its application within Australia and New Zealand is not well documented. The present study aimed to evaluate its current usage patterns and to determine suitable future training models. METHODS: An online survey was sent to members of Breast Surgeons of Australia and New Zealand (BreastSurgANZ) between July and September 2010, with emphases on practice demographics, access to US equipment, usage, biopsy patterns, and training. RESULTS: Of the 126 surveys sent, 59 were returned. The majority of respondents were metropolitan based (64 %), worked in both public and private sectors (71 %), and practiced endocrine or general surgery (85 %), as well as breast surgery. A preponderance of surgeons had access to equipment (63 %), performed at least 1 US monthly (63 %), but did not perform regular guided biopsies. Rural practice did not affect access or usage patterns. Most respondents underwent structured US training (73 %), which was associated with greater US and biopsy usage, biopsy complexity, intraoperative applications, and cross discipline applications (p < 0.03). Most surgeons favored a structured training program for future trainees (83 %). CONCLUSIONS: The majority of breast surgeons from Australia and New Zealand have adopted office US to varying degrees. Geographic variation did not lead to access inequity and variation in scanning patterns. Formal US training may result in a wider scope of clinical applications by increasing operator confidence and is the preferred model within a specialist breast surgical curriculum.

Factors predictive of treatment by Australian breast surgeons of invasive female breast cancer by mastectomy rather than breast conserving surgery.

BACKGROUND: The National Breast Cancer Audit Database of the Society of Breast Surgeons of Australia and New Zealand is used by surgeons to monitor treatment quality and for research. About 60% of early invasive female breast cancers in Australia are recorded. The objectives of this study are: (1) to investigate associations of socio-demographic, health-system and clinical characteristics with treatment of invasive female breast cancer by mastectomy compared with breast conserving surgery; and (2) to consider service delivery implications. MATERIALS AND METHODS: Bi-variable and multivariable analyses of associations of characteristics with surgery type for cancers diagnosed in 1998-2010. RESULTS: Of 30,299 invasive cases analysed, 11,729 (39%) were treated by mastectomy as opposed to breast conserving surgery. This proportion did not vary by diagnostic year (p>0.200). With major city residence as the reference category, the relative rate (95% confidence limits) of mastectomy was 1.03 (0.99, 1.07) for women from inner regional areas and 1.05 (1.01, 1.10) for those from more remote areas. Low annual surgeon case load (<10) was predictive of mastectomy, with a relative rate of 1.08 (1.03, 1.14) when compared with higher case loads. Tumour size was also predictive, with a relative rate of 1.05 (1.01, 1.10) for large cancers (40+ mm) compared with smaller cancers (<30 mm). These associations were confirmed in multiple logistic regression analysis. CONCLUSIONS: Results confirm previous studies showing higher mastectomy rates for residents of more remote areas, those treated by surgeons with low case loads, and those with large cancers. Reasons require further study, including possible effects of surgeon and woman's choice and access to radiotherapy services.

Risk factors for poorer breast cancer outcomes in residents of remote areas of Australia.

To investigate patient, cancer and treatment characteristics in females with breast cancer from more remote areas of Australia, to better understand reasons for their poorer outcomes, bi-variable and multivariable analyses were undertaken using the National Breast Cancer Audit database of the Society of Breast Surgeons of Australia and New Zealand. Results indicated that patients from more remote areas were more likely to be of lower socio- economic status and be treated in earlier diagnostic epochs and at inner regional and remote rather than major city centres. They were also more likely to be treated by low case load surgeons, although this finding was only of marginal statistical significance in multivariable analysis (p=0.074). Patients from more remote areas were less likely than those from major cities to be treated by breast conserving surgery, as opposed to mastectomy, and less likely to have adjuvant radiotherapy when having breast conserving surgery. They had a higher rate of adjuvant chemotherapy. Further monitoring will be important to determine whether breast conserving surgery and adjuvant radiotherapy utilization increase in rural patients following the introduction of regional cancer centres recently funded to improve service access in these areas.

The clinical impact of the American College of Surgeons Oncology Group Z-0011 trial--results from the BreastSurgANZ National Breast Cancer Audit.

INTRODUCTION: The publication of the American College of Surgeons Oncology Group (ACOSOG) Z-0011 Trial concluded that axillary lymph node clearance is no longer necessary for women having breast conserving treatment with 1-2 positive axillary sentinel lymph glands. The current study was designed to investigate the clinical impact of the Z-0011 Trial in breast surgical practice. MATERIALS AND METHODS: The BreastSurgANZ National Breast Cancer Audit database was interrogated for women treated between 2005 and 2010 who would have met the entry criteria for the Z-0011 Trial. This group was then calculated as a proportion of the total breast cancer episodes treated during this period. RESULTS: A total of 64,883 cases of breast cancer were eligible for analysis. 22,731 underwent breast conserving surgery and sentinel node biopsy for invasive breast cancer. A total of 4482 cases (6.9%) fulfilled the criteria for Z-11 Trial. CONCLUSION: Although the ACOSOG Z-0011 Trial has important implications for sentinel node positive cases undergoing breast conserving treatment, the overall impact of the Trial in breast clinical practice is small. It cannot be described as "practice changing". Women who fulfil the entry criteria for the Z-0011 Trial should be informed of the clinical relevance of the trial and be permitted to participate in informed discussions with members of the multidisciplinary team regarding their treatment options.

Survival from breast cancer: an analysis of Australian data by surgeon case load, treatment centre location, and health insurance status.

OBJECTIVE: Early invasive breast cancer data from the Australian National Breast Cancer Audit were used to compare case fatality by surgeon case load, treatment centre location and health insurance status. METHOD: Deaths were traced to 31 December 2007, for cancers diagnosed in 1998-2005. Risk of breast cancer death was compared using Cox proportional hazards regression. RESULTS: When adjustment was made for age and clinical risk factors: (i) the relative risk of breast cancer death (95% confidence limit) was lower when surgeons' annual case loads exceeded 20 cases, at 0.87 (0.76, 0.995) for 21-100 cases and 0.83 (0.72, 0.97) for higher case loads. These relative risks were not statistically significant when also adjusting for treatment centre location (P ≥ 0.15); and (ii) compared with major city centres, inner regional centres had a relative risk of 1.32 (1.18, 1.48), but the risk was not elevated for more remote sites at 0.95 (0.74, 1.22). Risk of death was not related to private insurance status. CONCLUSION: Higher breast cancer mortality in patients treated in inner regional than major city centres and in those treated by surgeons with lower case loads requires further study.

Operating principles for running a clinical quality registry: are they feasible?

BACKGROUND: The National Breast Cancer Audit (NBCA) was one of six national registries selected by open tender to test and validate the draft Operating Principles and Technical Standards for Australian Clinical Quality Registries. The standardization proposed by the Australian Commission on Safety and Quality in Health Care through this initiative sought to improve the overall efficiency and function of registries, as well as compatibility between registries. The NBCA's role involved testing, and implementing where possible, the proposed principles and standards in the NBCA environment so as to validate them in an operating registry. METHODS: The forty-two draft operating principles were evaluated by the NBCA based on four factors: relevance to the audit, feasibility of implementation by the audit, extent of difficulty in implementation and extent of improvement. An evaluation of the technical standards was also conducted. RESULTS: At the completion of the project, the audit met 27 of the 42 draft principles with only three principles marked as entirely unfeasible or not relevant to the NBCA. The remaining principles were either in the process of being implemented, implemented in part or awaiting discussion through governance channels. CONCLUSION: A revised principles and standards document has been produced. This will have a significant impact on quality of care in Australia as more audits and registries use it as a guide. Changes implemented at the NBCA have enhanced the audit as a tool for improving the quality of care received by early breast cancer patients.