Breast Cancer & Treatment in ACT and Surrounding Regions QUALITY ASSURANCE PROJECT. Five-year report

Transcription

1 Breast Cancer & Treatment in ACT and Surrounding Regions QUALITY ASSURANCE PROJECT Five-year report

2 Community Health Pathology Southern Area Health Service ACT Health General Practitioners Nurses Social Work Physiotherapy BreastScreen Consumers The Cancer Council ACT Breast ancer Network Australia Medical Oncology Radiation Oncology Surgery Breast Cancer TreatmentC Data Management Sub Committee Members Top from left: George Jacob (Radiation Oncologist), Yanping Zhang (Project Coordinator), John Buckingham (Surgeon), Noel Tait (Surgeon), Sally Naylor (Project Officer). Bottom from left: Jane Dahlstrom (chair of BCTG, Anatomical Pathologist), Bev Gow-Wilson (Director of Quality and Safety Unit, Community Health), Paul Craft (Chair of Sub Committee, Medical Oncologist). Absent: Jenny Brogan (Former Chair of BCTG, Community Health), Bruce Shahadbolt (Epidemiologist), Ros Walker (Former Executive Officer, ACT Cancer Cuncil), and Robert Arthurson (Director of Medical Services, SE NSW). ii

3 Community Health Pathology Southern Area Health Service ACT Health General Practitione Nurses Social Work Physiotherapy BreastScreen Consumers The Cancer Council ACT Breas Cancer Network Australia Medical Oncology Radiation Oncology Surgery Breast Cancer Treatmen Contents Contents... iii List of Figures... v List of Tables...vii Forward... ix Executive Summary...1 Breast Cancer & Treatment in the ACT and Surrounding Regions Quality Assurance Project Section 1: Introduction...4 Breast cancer in Australia... 4 Breast cancer in the ACT... 4 Guidelines for the management of early breast cancer... 4 ACT & SE NSW Breast Cancer Treatment Group... 5 The Breast Cancer Treatment Quality Assurance Project... 5 Section 2: Project Design and Methods...6 Aims and Objectives... 6 Participants... 6 Eligible patients... 6 Enrolment procedure... 7 Treatment outcome... 7 Ethical considerations... 7 Project database... 7 Data entry, quality control, and data analysis... 8 Support for the National Breast Cancer Audit... 8 Reports to Participants... 8 Section 3: Project participation...9 Geographical coverage of the project... 9 Participation of clinicians Participation of patients Assessment of the level of patient participation Comparisons of participation rates with population based cancer registries over a three-year period Linking study between ACT Cancer Registry and Project Section 4: Women with invasive breast cancer pathways of cancer diagnosis Patient Characteristics: Diagnosis and methods of detection Section 5: Surgical stage and pathological features...19 iii

4 Community Health Pathology Southern Area Health Service ACT Health General Practitioners Nurses Social Work Physiotherapy BreastScreen Consumers The Cancer Council ACT Breast ancer Network Australia Medical Oncology Radiation Oncology Surgery Breast Cancer TreatmentC Section 6: Patterns of Care and Treatment...22 Surgery for localised breast cancer Adjuvant treatment Radiation Therapy Chemotherapy Adjuvant Endocrine Therapy Results of first year follow-up Section 7: Ductal carcinoma in situ (DCIS)...35 Patients with DCIS Diagnosis, pathology and clinical disease status Treatment received by women with DCIS Summary Section 8: Summary Conclusions and Future Directions...42 Women with invasive breast cancer - main findings Appendix Data Management tables Demographics of women with unilateral invasive breast cancer tables Method of detection tables Pathological features tables Surgery tables Adjuvant Therapy tables Appendix List of Participating Clinicians Breast Cancer Treatment Group - Terms of reference Project Pamphlet Patient Consent form Notification card Data collection form Follow up form Royal Australasian College of Surgeon - Breast Cancer Audit Requirements Individual Clinician summary report Medical Journal of Australia article Abbreviations...86 References iv

5 Community Health Pathology Southern Area Health Service ACT Health General Practitione Nurses Social Work Physiotherapy BreastScreen Consumers The Cancer Council ACT Breas Cancer Network Australia Medical Oncology Radiation Oncology Surgery Breast Cancer Treatmen List of Figures Figure 3.1 Map of the ACT and SE NSW area... 9 Figure 3.2 An Overview of Breast Cancer & Breast Cancer Treatment in ACT & SE NSW Figure 3.3 Frequency of cases matched and not matched to ACT Cancer Registry Figure 3.4 Age-specific invasive cancer incidence rates in females Figure 4.1 Women with invasive Breast Cancer: Pathways of Care Figure 4.2 Family history, menopausal status, and past cancer history of women with invasive breast cancer Figure 4.3 Method of initial detection by age group Figure 4.4 Nodal status and method of detection Figure 4.5 Tumour size, and method of detection Figure 5.1 Tumour Types of Invasive Cancers Figure 5.2 Tumour Size of Invasive Cancers Figure 5.3 Grades of Invasive Cancers Figure 5. 4 Vessel Invasion of Invasive Cancers Figure 5.5 Lymph Node Status of Invasive Cancers Figure 5.6 Receptor Status of Invasive Cancers Figure 6.1 The Number of Surgical Treatments required and final outcome Figure 6.2 Breast Conservation Surgery and Mastectomy over Five Years Figure 6.3 Percentage profile of the total mastectomy rates among women undergoing breast surgery with initially uninvolved surgical margins by tumour size, nodal involvement and site Figure 6.4 Axillary dissection in breast conservation group Figure 6.5 Axillary dissection in mastectomy group Figure 6.6 Sentinel node biopsy Figure 6.7 Percentage profile of all women who received radiotherapy over five financial years by type of surgery and risk of recurrence Figure 6.8 Post breast-conserving radiotherapy by age Figure 6.9 Post-mastectomy radiotherapy by age Figure 6.10 Post-mastectomy radiotherapy by nodal status Figure 6.11 Post-mastectomy radiotherapy by tumour size Figure 6.12 Post-mastectomy radiotherapy by grade Figure 6.13 Postoperative radiotherapy for women with localised breast cancer by year of presentation Figure 6.14 Time to commencement of adjuvant postoperative radiotherapy by the12 month period in which the patient was enrolled Figure 6.15 Types of post-operative polychemotherapy received by women with early breast cancer Figure 6.16 Post-operative adjuvant chemotherapy by age v

6 Community Health Pathology Southern Area Health Service ACT Health General Practitioners Nurses Social Work Physiotherapy BreastScreen Consumers The Cancer Council ACT Breast ancer Network Australia Medical Oncology Radiation Oncology Surgery Breast Cancer TreatmentC Figure 6.17 Post-operative adjuvant chemotherapy by nodal status Figure 6.18 Post-adjuvant chemotherapy by tumour size Figure 6.19 Post-adjuvant chemotherapy by grade Figure 6.20 Post-adjuvant chemotherapy over five years Figure 6.21 Post-operative chemotherapy by hormonal receptor status Figure 6.22 Tamoxifen use over five year period Figure 7.1 Distribution of women with DCIS by age Figure 7.2 Distribution of women with DCIS by family history Figure 7.3 Distribution of women with DCIS by disease history Figure 7.4 Mode of detection of breast cancer Figure 7.5 Profile of preoperative investigations Figure 7. 6 Location of DCIS in the breast Figure 7.7 Size of DCIS at excision Figure 7.8 Nuclear grades of DCIS Figure 7.9 Hormone receptor status by immunohistochemistry Figure 7.10 Number of surgical operations in women with DCIS Figure 7.11 Adjuvant treatment received in women with DCIS Figure 7.12 Breast conservation and mastectomy by grade Figure 7.13 Breast conservation and mastectomy by size Figure 7.14 Type of surgery and relation to axillary dissection Figure 7.15 Mastectomy and type of axillary surgery in relation to the grade of the tumour vi

7 Community Health Pathology Southern Area Health Service ACT Health General Practitione Nurses Social Work Physiotherapy BreastScreen Consumers The Cancer Council ACT Breas Cancer Network Australia Medical Oncology Radiation Oncology Surgery Breast Cancer Treatmen List of Tables Tables in Sections Table 3.1. Number of participants with breast cancer (stratified by invasive cancer versus DCIS) by year and area Table 3.2 Clinical characteristics of the bilateral tumours Table 4.1 Table 5.1 Investigations performed for preoperative assessment of primary invasive breast cancers Pathological stage for 972 patients with no distant metastases (M0 disease) and full staging information Tables in Appendix 1 Data Management...45 Table 1: Accrual into the project Table 2: Data management activity Demographics of women with unilateral invasive breast cancer...46 Table 3: Age group by family history Table 4: Age group by past history Method of detection...47 Table 5: Method of detection by year of registration Table 6: Method of detection by place of usual residence Table 7: Method of detection by menopausal status Table 8: Method of detection by family history Table 9: Method of detection by past history Table 10: Method of detection by tumour size Table 11: Method of detection by pre-operative investigations Table 12: Method of detection by tumour types Pathological features...50 Table 13: Age (mean) by tumour size Table 14: Pathological tumour size by menopausal status Table 15: Pathological tumour size by lymph node status Table 16: Pathological tumour size by grade Table 17: Pathological tumour size by type Table 18: Pathological tumour size by site Table 19: Pathological tumour size by oestrogen receptor (ER) status Table 20: Pathological tumour size by lymph node status Table 21: Lymph node status by age group vii

8 Community Health Pathology Southern Area Health Service ACT Health General Practitioners Nurses Social Work Physiotherapy BreastScreen Consumers The Cancer Council ACT Breast ancer Network Australia Medical Oncology Radiation Oncology Surgery Breast Cancer TreatmentC Table 22: Number of lymph nodes removed by year of registration Table 23: Lymph node status by patient and tumour characteristics Surgery...58 Table 24: Distribution by hospital where major surgery was performed by region Table 25: Sequencing of surgery Table 26: Sentinel node biopsy by year of registration Table 27: Last operation by surgery procedure Table 28: Last operation by menopausal status Table 29: Last operation by past history Table 30: Last operation by method of detection Table 31: Last operation by tumour type Table 32: Last operation by grade Table 33: Last operation by tumour site Adjuvant Therapy...63 Table 35: Chemotherapy by hormone receptors, and tumour size for node negative patients Table 36: Chemotherapy by hormone receptors and tumour size for node positive patients.. 64 Table 37: Adjuvant therapy combination by hormone receptors Table 38: Results of hormone receptor test and use of adjuvant systemic therapies able 39: Adjuvant systemic therapy combination by five years Table 40: Type of chemotherapy by five years Table 41: Hormone therapy by hormone receptors Table 42: Hormone therapy by five years viii

9 Community Health Pathology Southern Area Health Service ACT Health General Practitione Nurses Social Work Physiotherapy BreastScreen Consumers The Cancer Council ACT Breas Cancer Network Australia Medical Oncology Radiation Oncology Surgery Breast Cancer Treatmen Forward Breast cancer remains the most common cancer in women, when skin cancer is excluded. As reported by the Australian Institute of Health and Welfare (AIHW 2002), the lifetime risk of breast cancer for an Australian woman is one in eleven. Understandably, managing breast cancer remains one of the major public health concerns among medical professionals, policy makers and Australians in general. In 1995, the National Health and Medical Research Council (NHMRC) developed best practice guidelines in the use of surgery and adjuvant therapies to improve the quality of breast cancer treatment and encourage standardisation of practice. Those guidelines were further revised in Also in 1995, the ACT and SE NSW Breast Cancer Treatment Group was established. This dynamic and committed group of professionals illustrates the good work that can be achieved when all key stakeholders come together in a collaborative manner to review and improve clinical practice across the care continuum of diagnosis and treatment. This report is a very important one. It provides a sound basis for monitoring the outcomes from clinical treatment for breast cancer in this region, and provides us with an excellent platform for developing appropriate policies and programs. I would encourage everyone to read and to use the information in this report. Dr Tony Sherbon Chief Executive ACT Health ix

10 Community Health Pathology Southern Area Health Service ACT Health General Practitioners Nurses Social Work Physiotherapy BreastScreen Consumers The Cancer Council ACT Breast ancer Network Australia Medical Oncology Radiation Oncology Surgery Breast Cancer TreatmentC Gathering of the ACT & SE NSW Breast Cancer Treatment Group in November 2003 x

11 Community Health Pathology Southern Area Health Service ACT Health General Practitione Nurses Social Work Physiotherapy BreastScreen Consumers The Cancer Council ACT Breas Cancer Network Australia Medical Oncology Radiation Oncology Surgery Breast Cancer Treatmen Executive Summary Breast Cancer & Treatment in the ACT and Surrounding Regions Quality Assurance Project Introduction: Breast cancer is the most common internal cancer among women in Australia. As reported by the Australian Institute of Health and Welfare (AIHW), 10,592 new breast cancer cases occurred with the disease causing 2,512 deaths in Australia during The lifetime risk of breast cancer for an Australian woman is one in eleven (AIHW 2002). Breast cancer control remains one of the major public health concerns among medical professionals, policy makers, and Australians in general. Studies in Australia and overseas have shown important variations in treatment practices amongst clinicians caring for women with breast cancer 2,3. Such variations have been associated with measurable differences in treatment outcome 4,5. To improve the quality of breast cancer treatment and encourage standardisation of practice, the National Breast Cancer Centre of the National Health and Medical Research Council (NHMRC) developed the Clinical Practice Guidelines for the Management of Early Breast Cancer in These guidelines were further revised in To assist the implementation of these guidelines and improve breast cancer treatment in the Australian Capital Territory (ACT) and South Eastern New South Wales (SE NSW), a Breast Cancer Treatment Group (BCTG) was formed in The group consists of surgeons, medical and radiation oncologists, pathologists, nurses, other health professionals and consumer representatives interested in the management of breast cancer. It was initially chaired by the Chief Health Officer of the ACT and then by the Deputy General Manager of the ACT Community Health, and currently is chaired by an anatomical pathologist from ACT Pathology, The Canberra Hospital. The Quality Assurance Project: One of the activities undertaken by the group is the Breast Cancer Treatment Quality Assurance Project. The project began in May 1997 with the following objectives: to monitor overall treatment provided to men and women presenting with breast cancer in the region and compare that treatment with the national practice guidelines; to provide individual feedback to participating clinicians describing their practice; and to measure treatment outcomes. Through these objectives the aim of the project was to improve breast cancer control and the quality of life of patients. The project developed into a detailed, community-based audit of breast cancer care within the region. Detailed information describing the treatment of 1,266 patients presenting with breast cancer during the first five years has been collected by the project. This information includes details of diagnosis and disease status, the treatment provided, and some treatment outcomes. The project has also collected at least one year follow up data for all 1,266 patients recruited between 1997 and 2002, and three year follow-up data for the cohort of 700 patients recruited before

12 Community Health Pathology Southern Area Health Service ACT Health General Practitioners Nurses Social Work Physiotherapy BreastScreen Consumers The Cancer Council ACT Breast ancer Network Australia Medical Oncology Radiation Oncology Surgery Breast Cancer TreatmentC During the period between July 1997 and June 2002, 1,309 patients were notified to the project. Among those presenting patients notified, 1,266 were eligible and gave written informed consent to have their information included in the project. All enrolled patients gave written informed consent before any data was collected. Of enrolled patients, there were 24 women and 8 men who presented with distant metastases (stage 4 disease), 19 patients with bilateral tumours. The remaining enrolled patients were divided into two groups: 1,078 women with unilateral, localised (stage 1 to 3) invasive breast cancers and 137 women with unilateral ductal carcinoma in situ (DCIS). This report focuses on the 1,266 enrolled individual patients presenting with a new diagnosis of primary invasive breast cancer or DCIS. Participating clinicians were asked to register each sequential new patient with a diagnosis of breast cancer. After patient consent was given, a two page data sheet was completed by the clinician and copies of all pathology reports submitted to the project office. Regular feedback of individual patterns of practice was provided to each clinician, and aggregate results regularly reviewed at multidisciplinary meetings of the Breast Cancer Treatment Group. The initial 14 months data and the feasibility of the project have previously been reported 8. Main Results: Treatment of Invasive Breast Cancer in Women: There were no differences in management of invasive cancers between urban and rural groups. Mastectomy (52%) was slightly more common than breast conservation surgery (48%). In the group of women requiring more than one operation, breast conservation was still achieved in 32%. Over the five year observation period, there has been an increase in the number of sentinel node biopsies and a decrease in the number of axillary dissections. Breast conservation surgery was more common in women for whom the diagnosis was made through a screening program. Overall 97% of women undergoing breast-conserving surgery received postoperative radiotherapy. Post-operative adjuvant chemotherapy was received by 534 (49.5%) of all women with operable breast cancer enrolled in the project. Some changes in adjuvant chemotherapy patterns of treatment were apparent over time, with chemotherapy more frequently provided to women in 2002 compared with The proportion of women receiving an anthracycline containing regimen increased from 35% in 1998 to almost 65% in Nearly 80% of women with operable primary breast cancer received hormonal therapy. Older women were more likely to receive hormonal therapy. Women with Oestrogen receptor or Progesterone receptor (ER/PR) positive tumours were far more likely to receive hormonal treatment than those with ER/PR negative tumours. Around 90% of those with ER/PR positive tumours and less than 20% of those with ER/PR negative tumours were treated with hormonal therapies. Treatment of DCIS Among the 137 women with unilateral DCIS, the mastectomy rate was 36% (59 of 137). Adjuvant hormonal therapy was provided to 15% of these women. No patient undergoing mastectomy for DCIS received adjuvant radiotherapy. Of the 77 women undergoing breast-conserving surgery (57% of all women with unilateral DCIS), 15 (20%) received adjuvant radiotherapy while 22 (29%) received adjuvant endocrine therapy. 2

13 Community Health Pathology Southern Area Health Service ACT Health General Practitione Nurses Social Work Physiotherapy BreastScreen Consumers The Cancer Council ACT Breas Cancer Network Australia Medical Oncology Radiation Oncology Surgery Breast Cancer Treatmen Conclusions: Rates of mastectomy are similar to those reported elsewhere in Australia and were stable over time. Adjuvant chemotherapy has become more frequently used. Adjuvant hormonal therapy is frequent, with the rate of use stable over time. Screen detected cancers were more amenable to breast conserving surgery. Structure of the Report: The report begins with an introduction about breast cancer, the history of the ACT and SE NSW Breast Cancer Treatment Group, and the Breast Cancer Treatment Quality Assurance Project. In the second section, information about the participation in the project is provided. The third section discusses the data collection and related issues. The major outcomes of the study are reported in sections four to seven. Finally, some conclusions and recommendations are made in section eight. Other information and relevant materials are provided in the appendix. Acknowledgements: The Breast Cancer Treatment Quality Assurance Project has received consistent support from participating breast cancer patients and medical professionals. Without their contribution the project would not be possible. The Breast Cancer Treatment Group would also like to acknowledge ACT Community Health and Bosom Buddies for their important financial support to the project. 3

14 Community Health Pathology Southern Area Health Service ACT Health General Practitioners Nurses Social Work Physiotherapy BreastScreen Consumers The Cancer Council ACT Breast ancer Network Australia Medical Oncology Radiation Oncology Surgery Breast Cancer TreatmentC Section 1: Introduction This section provides a brief overview of breast cancer treatment and diagnosis, the NHMRC Breast Cancer Treatment Guidelines, the ACT and SE NSW Breast Treatment Group, and the Breast Cancer Treatment Quality Assurance Project. Breast cancer in Australia Excluding non-melanomatous skin cancer, breast cancer is the most common form of cancer affecting women in Australia. In 1999, Australia reported 10,592 new cases of breast cancer 1. In that year, there were 2,512 deaths attributed to the disease. During the 1990s, breast cancer mortality in Australia actually fell slightly, with a mean decrease of 1.9% annually. However, the incidence of breast cancer continued to rise by an average of 1.8% per year. The fall in mortality in the face of the rising incidence of breast cancer may reflect the effects of screening programs and improved treatment. The lifetime risk of a woman developing breast cancer in 2002 was one in Breast cancer in the ACT In the ACT between 1995 and 1999, approximately 150 women developed breast cancer each year. The standardised breast cancer incidence rate was 101 per 100,000 women and the death rate was about 32 per 100,000 women. Over this five-year period, an average of 43 women died of breast cancer each year. The ACT has a slightly higher reported breast cancer mortality rate compared with other states and territories, against the national average mortality rate of 22 per 100,000 women 1. The ACT also has a slightly higher incidence of breast cancer when compared with the rest of Australia 9. Guidelines for the management of early breast cancer The impetus to develop evidence based treatment guidelines stems from the belief that health gains can be best achieved by more general adoption of standard therapies for breast cancer. Studies in Australia and overseas have shown significant variation in treatment received by women with breast cancer 2,3,4,10. Women living in large Australian cities are more likely to have breast-conserving surgery than those living in rural areas 2. United Kingdom clinicians who regularly treat patients with breast cancer more frequently use breast-conserving surgery. Variations of this kind could lead to measurable differences in treatment outcomes 4. The data suggests that opportunities remain to improve breast cancer treatment and outcomes. Some authorities have suggested that gains in breast cancer survival in the order of 10% may be possible 11, 12. Whether these potential gains exist in Australia is uncertain, however even small improvements in treatment outcomes would be significant across the whole population. 4

15 Community Health Pathology Southern Area Health Service ACT Health General Practitione Nurses Social Work Physiotherapy BreastScreen Consumers The Cancer Council ACT Breas Cancer Network Australia Medical Oncology Radiation Oncology Surgery Breast Cancer Treatmen Having realised the potential gains in breast cancer treatment outcomes achievable by improving standard care in the community, the NHMRC published the Clinical Practice Guidelines for the Management of Early Breast Cancer in The NHMRC developed these guidelines on the basis of the empirical evidence available, and designed them to help both clinicians and patients make sound decisions about treatment in order to improve health outcomes 13. In 2001, the NHMRC further revised the guidelines to incorporate the latest research findings 7. Since 1995, consideration and implementation of these guidelines has become a primary goal for Australian health services and individual clinicians. Similar initiatives have been undertaken internationally 14, 15, 16. ACT & SE NSW Breast Cancer Treatment Group In 1995 in conjunction with the publication of the NHMRC Guidelines for the Management of Early Breast Cancer the ACT Chief Health Officer convened a group of interested clinicians and other parties involved in the management of women with breast cancer in the ACT and region. The ACT and SE NSW Breast Cancer Treatment Group formed out of this initiative. The ACT Chief Health Officer chaired the Breast Cancer Treatment Group initially and the Deputy General Manager of Community Health subsequently undertook this function. The group includes surgeons, radiation and medical oncologists, pathologists, nurses and other health professionals involved in the management of breast cancer in the ACT and SE NSW (in Appendix 2). The group also includes representatives from the ACT Division of General Practice, the ACT Cancer Council and consumer representatives from Bosom Buddies a community organisation of women with breast cancer. This inclusive group encourages the participation of all clinicians interested in breast cancer care. The group s initial activities developed the terms of reference (in Appendix 2) and local protocols for incorporating different treatment modalities within the region and other issues related to the implementation of the NHMRC Clinical Practice Guidelines. For example, the Group has supported the implementation of a community based breast cancer nurses program and provided expert advice to ACT Health via the ACT Cancer Services Advisory Group. The Breast Cancer Treatment Quality Assurance Project In 1996, the ACT Breast Cancer Treatment Group proposed undertaking the Breast Cancer Treatment Quality Assurance Project. The project is a community-based audit of breast cancer treatment, focussed primarily on treatment of early invasive breast cancer, but also collecting information about the treatment of more advanced disease and DCIS. The group designed the project to monitor and study breast cancer treatment and outcomes in the ACT and SE NSW region across all care settings and treatment institutions. Since 1997, the data collection sub-committee has administered the project, and Community Health has managed the project. A focus on returning individualised reports of treatment patterns to contributing clinicians has enabled the project to collect a large amount of information on a voluntary basis. The next section provides details of the project methods, and results from the first five years of the project form the body of this report. 5

16 Community Health Pathology Southern Area Health Service ACT Health General Practitioners Nurses Social Work Physiotherapy BreastScreen Consumers The Cancer Council ACT Breast ancer Network Australia Medical Oncology Radiation Oncology Surgery Breast Cancer TreatmentC Section 2: Project Design and Methods Aims and Objectives The aim of this quality assurance project is to monitor treatment for breast cancer provided to women (and men) within the ACT and SE NSW region. Regular reporting of treatment for breast cancer provides data to inform policy and programs and assists with the implementation of evidence-based treatment guidelines, thereby enhancing patient outcomes. Specific objectives include: Recording all treatment provided for early invasive breast cancer in women and comparing that treatment with indicators based on agreed treatment guidelines. Recording details of treatment provided for advanced breast cancer, DCIS and breast cancer occurring in men. Providing confidential feedback to each individual participating clinician, to allow comparison of treatment provided with local peers and to assist with audit requirements of professional bodies such as Royal Australasian College of Surgeons (RACS). Measuring treatment outcomes (such as freedom from recurrence and breast cancer mortality over time). Participants All clinicians providing treatment to men and women with breast cancer within the region were encouraged to enter their patient s details into the project (in Appendix 2). They were asked to offer enrolment to all eligible patients seen in their clinical practice across all settings and institutions. Eligible patients Data was collected on any person presenting with a new diagnosis of breast cancer. Men and women with invasive cancer, DCIS, bilateral breast cancer, or second primary breast cancer and patients presenting with advanced breast cancer (Stage 4) disease were eligible for inclusion. However, due to the heterogeneous and highly individual nature of treatment for recurrent breast cancer (either local recurrence or metastatic disease), patients presenting with these problems were not included in the project. 6

17 Community Health Pathology Southern Area Health Service ACT Health General Practitione Nurses Social Work Physiotherapy BreastScreen Consumers The Cancer Council ACT Breas Cancer Network Australia Medical Oncology Radiation Oncology Surgery Breast Cancer Treatmen Enrolment procedure Each treating clinician approached individual patients for potential inclusion in the project, providing leaflets (in Appendix 2) and an information sheet/consent form (in Appendix 2). Consenting patients were not required to do anything other than consent for their information to be collected. Clinicians had an option of notifying the project office of an eligible patient through completion of a brief notification card and submitting it to the project office (in Appendix 2). Once consent procedures were complete, the clinician was asked to complete the full data collection form (in Appendix 2). This form included the patient s personal information, details of disease presentation, clinical and pathological staging, and treatment. No data was recorded until a completed consent form had been received. Treatment outcome The project continues to follow up enrolled patients. At one year post diagnosis, a very brief follow up data form is submitted to the reporting clinician and the patient s general practitioner seeking an update on the patient s current disease status, including a question about any further treatment for breast cancer. Additional information requests are sent every two years (in Appendix 2). Ethical considerations The ACT Health Human Research Ethics Committee approved the project in May 1997 and it was notified as a Quality Assurance Project under section seven of the ACT Health Act (1993) in the same month. All data is securely stored in the project office (based in Community Health, Canberra) and entered into a purpose built, and secure, relational database. Participating clinicians can access the data set for analysis or research under the supervision of a subcommittee of the Breast Cancer Treatment Group, with only de-identified data used in these circumstances. Ongoing protection of the privacy of patients is a major priority of the project office. Project database The project coordinator has developed a comprehensive relational database specifically for this project on a Microsoft Access platform. The major functions of the database are data entry, storage and management of data, generating data query letters, and providing summarised results. The database has automated the generation of individualised reports to assist surgeon participants to provide personal audit reports to the Breast Group of the RACS. 7

18 Community Health Pathology Southern Area Health Service ACT Health General Practitioners Nurses Social Work Physiotherapy BreastScreen Consumers The Cancer Council ACT Breast ancer Network Australia Medical Oncology Radiation Oncology Surgery Breast Cancer TreatmentC Data entry, quality control, and data analysis Data recorded on the notification card, data collection form, and follow up form contributed to the project dataset. Project officers routinely checked submitted data for internal consistency, and against information extracted from submitted pathology reports. In addition, some visits were undertaken to treatment facilities to confirm data items and/or complete missing data items. Data items were coded according to highly specific definitions developed by the project. Inconsistencies and missing data items generated data queries over the life of the project, in order to ensure completeness, and confirm accuracy, of submitted information. Members of the Data Management Sub-committee assisted the project in resolving difficulties in interpretation of pathology reports in some cases. Data analyses have been undertaken using Statistical Package for Social Sciences (SPSS) version 11. The analysed data has been used to produce regular reports for the Breast Cancer Treatment Group, generate statistical results for publication, and prepare data for this report. Support for the National Breast Cancer Audit To assist members of the Breast Section of the RACS, the project has developed an individualised audit report for each surgeon, listing de-identified individual patient treatment episodes (In Appendix 2). Surgeons have then been in a position to more easily participate in the national surgical audit of the Breast Section of the RACS. Reports to Participants As an integral part of the project, annual reports are produced for each participating clinician (In Appendix 2). These reports detail the individual clinician s treatment and patient profile, with comparison against the whole cohort for that year. In addition, results from the project are discussed regularly at quarterly Breast Cancer Treatment Group meetings. The Breast Cancer Treatment Group also publishes a regular newsletter which is distributed to consumers and participating clinicians, including General Practitioners of patients registered in the study. 8

19 Community Health Pathology Southern Area Health Service ACT Health General Practitione Nurses Social Work Physiotherapy BreastScreen Consumers The Cancer Council ACT Breas Cancer Network Australia Medical Oncology Radiation Oncology Surgery Breast Cancer Treatmen Section 3: Project participation This section provides details of the geographical coverage of the ACT and SE NSW Breast Cancer Treatment Quality Assurance Project, and of participation in the project by clinicians and patients. Geographical coverage of the project All interested clinicians and their patients participate in this ongoing project through an explicit inclusive membership policy. Participation is not limited to patients attending particular institutions. The focus is on the community, aiming to involve all clinicians and patients within the region. The geographical coverage is the whole of the ACT and also SE NSW s Southern Area Health region, including the centres of Goulburn, Queanbeyan, Bega, and Moruya. (Figure 3.1) The ACT and the SE NSW region together cover an area of 2,432 square kilometres. According to the recent national census, more than half a million people lived within the area in the year 2001, with 321,819 in the ACT and 195,898 in SE NSW 17. ACT Health administers public hospitals and other health services within the ACT. In SE NSW, the Southern Area Health Service administered public hospitals and health services until recent governance changes within NSW Health. Figure 3.1 Map of the ACT and SE NSW area Australian Capital Region Development Council Of the total cohort of 1,266 participating patients, 64% were from the ACT, and 36% from SE NSW. The number of patients with a diagnosis of breast cancer recruited during the period between July 1997 and June 2002 is shown in Table 3.1. Since the project commenced in 1997, an average of 264 new breast cancer patients per year were entered into the project database. 9

20 Community Health Pathology Southern Area Health Service ACT Health General Practitioners Nurses Social Work Physiotherapy BreastScreen Consumers The Cancer Council ACT Breast ancer Network Australia Medical Oncology Radiation Oncology Surgery Breast Cancer TreatmentC Table 3.1. Number of participants with breast cancer (stratified by invasive cancer versus DCIS) by year and area Year Invasive cases (all stages) DCIS (30 June - 1 July) ACT SE NSW ACT SE NSW Total Total Participation of clinicians The project has received a positive response and consistent support from health professionals involved in the treatment of breast cancer in the ACT and surrounding region. 32 clinicians from the region caring for women with breast cancer (made up of 21 surgeons, 4 radiation oncologists and 7 medical oncologists) agreed to participate in the project. Of these, 23 were based in the ACT and 9 in SE NSW (In Appendix 2). All radiation and medical oncologists were based in Canberra, and the principal practices of 9 of 21surgeons were based in SE NSW. Enrolment of patients into the project and completion of baseline data forms has been primarily undertaken by surgical specialist members of the group. Two thirds of the specialist clinicians (16 surgeons, 2 radiation oncologists and 3 medical oncologists) registered newly diagnosed patients. Not all participant clinicians were involved in registering new patients. Some clinicians, including radiation oncologists and medical oncologists in particular, were referred patients who had already been entered into the project by their surgeon immediately following surgery. All participating clinicians provided follow-up data and treatment information for enrolled patients. The mean number of patients enrolled per enrolling clinician was 63 patients over the first five years. The number of patients entered by a single clinician ranged from zero (non-surgical clinicians, as discussed above) to 346. A total of 482 GPs have also been involved in the project with 300 from the ACT and 182 from the surrounding region of NSW. They have provided important follow-up information about the disease status of their patients. Participation of patients As an ongoing quality assurance project examining breast cancer treatment and outcomes, the study focussed primarily on treatment of the disease. To be eligible for inclusion in the project, the person must have had a new diagnosis of histologically or cytologically proven invasive breast cancer or ductal carcinoma in situ (DCIS); attended a participating clinician for at least part of their treatment; and provided written consent to participate (see Section 2 for discussion of eligibility criteria). During the period between July 1997 and June 2002, 1,309 women and men with a new diagnosis of breast cancer were notified to the project. 10

21 Community Health Pathology Southern Area Health Service ACT Health General Practitione Nurses Social Work Physiotherapy BreastScreen Consumers The Cancer Council ACT Breas Cancer Network Australia Medical Oncology Radiation Oncology Surgery Breast Cancer Treatmen Of these, 1266 patients were registered as project participants. Seven notified patients (0.5% of notifications) were ineligible for inclusion in the study because they did not have a new diagnosis of breast cancer. For an additional 36 patients (2.7%), lack of written informed consent prevented registration into the study. Some of these patients had left the region before consent was obtained or were not in a position to give consent (for example, patients with dementia). Only three patients (0.2%) declined to participate after reading the patient information sheet. There were eight male patients (0.6%) with breast cancer enrolled in the project. The results presented in this report were based mainly on the analysis of data collected from 1,266 eligible female patients, which account for more than 96% of the total notified cases. Figure 3.2 shows each person registered into the project according to clinical characteristics and main treatment option. Figure 3.2 An Overview of Breast Cancer & Breast Cancer Treatment in ACT & SE NSW Notified Breast Cancer Patients (N=1309) Registered Breast Cancer Patients, n=1266 (excluded ineligible patients n=43) Invasive n=1078 (85.2%) Bilateral n=19 (1.5%) Ductal carcinoma in situ n=137 (10.8%) Metastatic disease n=24 (1.9%) excluded male patient(2) Male n=8 (0.6%) Unilateral Invasive breast cancer n=1078 Surgery primary therapy n=19 (100%) Surgery primary therapy n= 136 (99%) Surgery primary therapy n=8 (100%) Surgery primary therapy n=1069 (99.2%) Mastectomy n=15 (78.9) Breast conserving n=77 (57%) Mastectomy n=59 (43%) Mastectomy n=8 (100%) Breast Conserving n=513 (48%) Mastectomy n=556 (52%) Radiotherapy n=8 (42.1) Received radiotherapy n=15 (20%) Radiotherapy n=0 Radiotherapy n=3 (37.5) Adj. treatment n=510 (99.4%) Radiotherapy n=495 (96.5%) Chemotherapy n=198 (38.6%) Adj. treatment n=520 (93.5%) Radiotherapy n=210 (37.8%) Chemotherapy n=333 (59.9%) Chemotherapy n=12 (63.2) Tamoxifen n=18 (94.7) Chemotherapy n=0 Hormonal n=22 (29%) Chemotherapy n=0 Hormonal n=9 (15%) Chemotherapy n=4 (50%) Tamoxifen n=6 (75%) Hormonal n=411 (80.1%) Hormonal n=433 (77.9%) Tamoxifen n=19 (25%) Tamoxifen n=7 (12%) Tamoxifen n=397 (77.4%) Tamoxifen n=411 (73.9%) Assessment of the level of patient participation As the Breast Cancer Treatment Quality Assurance Project enrolment was based on a voluntary process of registration by participating clinicians, supported by written informed consent from each individual patient, complete coverage of all incident cases occurring in the region s population could not be obtained. An estimate of the coverage of the project can be obtained by examining the number of ACT patients with invasive breast cancer enrolled in the project compared with the number reported to the ACT Cancer Registry. Registration of all cancers has been mandatory in the ACT since

22 Community Health Pathology Southern Area Health Service ACT Health General Practitioners Nurses Social Work Physiotherapy BreastScreen Consumers The Cancer Council ACT Breast ancer Network Australia Medical Oncology Radiation Oncology Surgery Breast Cancer TreatmentC Comparisons of participation rates with population based cancer registries over a three-year period A comparison between reported breast cancer rates in women in the ACT and the project s participation rates was possible over the three-year period ending December The recent AIHW publication, Cancer in Australia 1999, reports a crude average annual breast cancer incidence in women in the ACT, of 148 during the five-year period The project received 129 female invasive breast cancer registrations (three-year average) resident within the ACT per year during the period between 1997 and In addition, during this three-year period, 20 patients (i.e. seven per year) were notified but not enrolled because written consent was not obtained. Thus, for the ACT only, the average number of new breast cancer diagnoses notified to the project was 136 per year. Assuming that the AIHW data based on compulsory population based cancer registration is complete, then the project s estimated patient participation rate is 86% and notified rate is 92%. Given the likelihood of some ACT patients receiving treatment outside of the ACT region, the estimated participation rates are acceptably high, confirming good compliance of participant clinicians with the notification and enrolment processes. In the two years from January 2000 to December 2001, the registration performance of the Breast Cancer Treatment Group project has further improved. Linking study between ACT Cancer Registry and Project To further determine the level of coverage of the project and to check for bias in the enrolment of patients into the project, a feasibility study of record matching was undertaken. In 2001, the data collected by the project was matched with data recorded by the ACT Cancer Registry using the patient s surname, first name, date of birth, and postcode. This study showed that the number of breast cancer patients registered by the two sources was similar. The project registered 463 breast cancer patients in the ACT during the first three years. Of the recorded patients, 387 (84% of the total) were matched with the records of the Cancer Registry. There were 76 (16%) patients who were included in the project data set but could not be completely matched with the records of the Cancer Registry. 95 patients were recorded in the Cancer Registry data set but not found in the project database. Only patients fully enrolled in the project were included in this matching process. Reasons for a failed match (apart from the patient simply being not registered in one of the data sets) included misspelt names, and errors in recorded date of birth. Exploratory subset analysis has suggested that individuals registered by the project may be less likely to have stage 4 (metastatic) breast cancer at diagnosis (Figure 3.3). 12

23 Community Health Pathology Southern Area Health Service ACT Health General Practitione Nurses Social Work Physiotherapy BreastScreen Consumers The Cancer Council ACT Breas Cancer Network Australia Medical Oncology Radiation Oncology Surgery Breast Cancer Treatmen Figure 3.3 Frequency of cases matched and not matched to ACT Cancer Registry Frequency of cases matched & not matched to ACT Cancer Registry, (N=483) July June 2000 Number of cases July Dec97 Jan Jun98 July Dec98 Time Jan Jun99 July Dec99 Jan Jun00 Unmatched, n=76 Matched, n=387 The most recent aggregate ACT incidence data spanning the five-year period, 1996 to 2000 recorded 742 cases of invasive breast cancer in women 10. This compares with 716 female ACT residents with invasive breast cancer enrolled into the project during the five-year period June 1997 to July Based on these observations, a derived approximate estimate of the overall participation rate for ACT residents was 96%. A comparison has also been made of age specific breast cancer incidence for Australian women (based on national data collected in 1997 and 1998) reported by the Cancer Registries and the age distribution of women enrolled in the study (for five years ending June 2002). As shown in Figure 3.4, the age distribution of enrolled patients in the project and Australian agespecific breast cancer incidence is similar. Relatively fewer patients in the older age groups (particularly age >= 85 years) participated in the project. Figure 3.4 Age-specific invasive cancer incidence rates in females Age distribution of registered patients (five years) and age-specific breast cancer incidence rates in Australia in Number of patients >=85 Age ACT(BCTG) five-year data Rate per 100,000 ACT(AHIW)

24 Community Health Pathology Southern Area Health Service ACT Health General Practitioners Nurses Social Work Physiotherapy BreastScreen Consumers The Cancer Council ACT Breast ancer Network Australia Medical Oncology Radiation Oncology Surgery Breast Cancer TreatmentC Bilateral Breast Cancer There were 19 women (1.5 % of the cohort) reported with synchronous bilateral primary breast cancer. The clinical characteristics of the bilateral tumours is summarised in Table 3.2. There were 18 women with synchronous tumours undergoing same day surgery on both breasts. Table 3.2 Clinical characteristics of the bilateral tumours N % Tumour type: Both invasive One invasive 5 26 Both DCIS 1 5 Primary Surgery: Bilateral mastectomy Unilateral mastectomy 1 5 Bilateral breast conservation 3 16 Both tumours were invasive cancers in 13 women, while one of the primaries was DCIS in the remaining 5. One woman presented with bilateral DCIS only. All women with bilateral breast cancer were treated with primary surgery. The majority underwent bilateral mastectomy (79%). Apart from one woman who underwent unilateral mastectomy, the remaining three women received bilateral breast-conserving surgery. Eight (42%) women received adjuvant radiotherapy, twelve (63%) received adjuvant chemotherapy, and eighteen women (95%) received adjuvant tamoxifen. Overall, the rates of adjuvant therapies were reasonably similar to those patients with unilateral tumours. Male breast cancer There were eight men reported with primary breast cancer, seven with invasive cancer (including two men presenting with metastatic disease), and one man with DCIS only. The median age at diagnosis was 59.4 years (range 51 to 67). All men were treated with primary mastectomy, including the two patients with metastatic disease. Four (50%) received chemotherapy and six (75%) received hormonal therapy (all tamoxifen). Three men were treated with post-operative radiotherapy. 14