Development of the guidance

Context

In Australia, breast cancer is estimated to be the most-commonly diagnosed cancer in 2020. An estimated 19,807 women and 167 men will be diagnosed with breast cancer in Australia in 2020, and approximately one in seven Australian women will develop breast cancer by the age of 85 years. Breast cancer is second only to lung cancer as the leading cause of death from cancer among women in Australia. Most breast cancers are diagnosed at an early stage and approximately 90% of people diagnosed with breast cancer survive their disease for five years or more after diagnosis.

Cancer Australia, the Government’s national cancer control agency, aims to reduce the impact of cancer, address disparities and improve outcomes for people affected by cancer, by leading and coordinating national, evidence-based interventions across the continuum of care.

This Guidance for the management of early breast cancer (the Guidance) updates and replaces Cancer Australia’s previous clinical practice guidelines and topic-specific guidelines on the management of early breast cancer. This includes the second edition of the Clinical Practice Guidelines for the management of early breast cancer, published in 2001, which covered all aspects of the management of early breast cancer, except screening; and several topic-specific updates. Cancer Australia has also developed the Cancer Australia Statement: Influencing best practice in breast cancer which identifies 12 key appropriate and inappropriate practices for breast cancer; and several relevant guidelines on topics across all cancer types.

This Guidance has been developed to meet the need for updated evidence-based guidance that encompasses management of early breast cancer from the point of diagnosis.

Purpose and scope 

The purpose of this Guidance is to provide health professionals with up-to-date evidence-based guidance for the management of patients with early breast cancer that is relevant to the Australian health care setting. This Guidance aims to support the delivery of best practice patient-centred care and to assist health professionals and patients in shared decision-making regarding the management of early breast cancer.

Early breast cancer is defined as invasive breast cancer that is contained in the breast and may or may not have spread to the lymph nodes in the breast or armpit. The scope of this guidance covers the management of early breast cancer in women and men. The scope does not include the management of ductal carcinoma in situ (DCIS) which is non-invasive, or the management of advanced or metastatic cancer.

The scope of this Guidance covers management of early breast cancer across the patient journey from breast cancer diagnosis, through treatment planning and information and support for patients prior to treatment, treatment delivery, to follow-up of after active treatment and survivorship care for people living with and beyond early breast cancer. Screening and initial detection of early breast cancer are not included in the scope of this guidance.

Methods

The Guidance for the management of early breast cancer was developed by Cancer Australia using a ‘meta-guideline’ approach (e.g. Stahl et al 2013), closely aligned to the ADAPTE approach (Adapte Collaboration 2011) and as increasingly used by many guideline developers internationally and in Australia (e.g. the Australian Adult Cancer Pain Management Guideline Working Party).

This pragmatic approach aims to expedite development of up-to-date, evidence-based guidance and be less resource-intensive and time-consuming than development of traditional clinical practice guidelines (CPGs). The management of breast cancer is a high-intensity research area with a very high volume of publications and covers a large scope. The meta-guideline approach was used to meet the challenge of how to update the 2001 clinical guidelines using rigorous, transparent methods that accounted for the full scope and volume of relevant evidence.

The Guidance was developed with oversight and expert input from a Steering Group and an Expert Working Group. Additional experts were consulted on specific areas where required. (Refer to the Methods report for the membership of these groups). During the appointment process all members were required to disclose any potential conflicts of interest, and any conflicts of interest were also declared at the start of each meeting of the groups.

The meta-guideline approach involves analysis, synthesis, and expansion of current, high-quality evidence-based national and international guidelines, to develop a set of up-to-date recommendations and practice points relevant to the Australian health-care setting.

• The first step involved identification and quality appraisal of existing CPGs on the management of early breast cancer. Electronic databases and websites of peak cancer authorities were searched in November-December 2017. Forty-seven CPGs (eight of these from Cancer Australia) were included that were published from 2007 and clearly based on a review of the evidence (refer to the Methods report for details). In addition, the CPG from NICE updated in July 2018 was included at that time. Quality assessment of the CPGs was undertaken using a modified AGREE-II (Appraisal of Guidelines for Research & Evaluation version II) assessment.
• All recommendations that addressed topics within scope were extracted from the included evidence-based guidelines and grouped by topic and sub-topic. A structured process was followed to assess the suitability of these ‘source’ recommendations for adoption or adaptation to the Australian health care context. The reliability, recency, applicability, and generalisability of each source recommendation was taken into consideration (refer to the Methods report for details). The strength of source recommendations was considered during the adoption/adaption process and in the choice of wording for the final recommendation. Some targeted evidence reviews were undertaken to clarify specific aspects of source recommendations or to inform development of practice points, but no new systematic reviews of evidence or evidence-to-decision methods were employed to develop the Guidance.
• The recommendations developed in the Guidance are underpinned by the evidence-based and consensus-based recommendations of other guidelines. The source of each recommendation and rationale for any changes made are documented in the accompanying text. Practice points were also adopted or adapted from existing evidence-based source guidelines where recommendations were explicitly indicated to be based on ‘Expert Opinion’. In addition, practice points were developed ‘de novo’ through an expert consensus process, for aspects of care that were deemed to be clinically important but for which existing evidence-based guidance applicable to the Australian setting was not available. In framing the recommendations and practice points, consideration was given to the benefits and harms associated with specific investigative tests and therapies.
• External consultation on the recommendations and practice points in the Guidance for the management of early breast cancer was undertaken by Cancer Australia with key stakeholders, including professional colleges and relevant cancer organisations and breast cancer care individuals. The stakeholder consultation period was 03 March – 20 April 2020.  Stakeholder feedback was assessed by Cancer Australia, in consultation with members of the expert groups where considered necessary. Changes were made to the recommendations and practice points where these changes were considered appropriate, were evidence-based, and did not interfere with the meta-guideline approach. In some instances, recommendations or practice points are informed and supported by more recently published relevant guidelines.   

The website was developed to assist user access to the guidance. It also allows for specific recommendations and practice points to be updated^[1].

Disclaimer: The Guidance for the management of early breast cancer is based on the best available evidence and information at the time of publication and is designed to assist decision-making and guide best practice in the management of early breast cancer. The recommendations and practice points are a guide to appropriate practice, to be followed subject to the clinician’s judgement and the person’s preference in each individual case.