Molecular Testing of Lung Cancer in Australia
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In Australia, lung cancer is currently the fifth most diagnosed cancer, but accounts for the highest number of cancer related deaths each year, with more deaths than prostate and breast cancer combined. Patients with lung cancer may live longer and have fewer side effects if they can receive treatments that are targeted to their tumour. Molecular biomarker testing[1] is a type of testing used to identify genetic variants or alterations in tumours. The overall goal of molecular testing is to identify biomarkers that might guide decisions on targeted treatments, and potentially monitor progression and tumour recurrence.
Currently, there is no alignment within Australia on best practices regarding molecular testing of lung cancers. Without standardisation and alignment on minimum standards, variations in practice can lead to differences in patient care and outcomes across Australia. Although guidelines have been developed by professional organisations in other countries, these are not necessarily directly applicable to the Australian healthcare setting.
The Royal College of Pathologists of Australasia (RCPA) initiated a project in 2024 with the Thoracic Oncology Group of Australasia (TOGA) to develop comprehensive, evidence-based, ‘best practice recommendations’ for molecular testing of lung cancers in Australia. The recommendations provide standardisation for molecular testing for lung cancer in Australia on:
- methods and protocols (by biomarker, lung cancer subtype and testing type)
- sample collection, processing and analysis
- quality assurance and reporting
The introduction of best practice recommendations can help ensure that all Australians have equal access to high-quality diagnostic services. By adhering to these recommendations, we anticipate that healthcare providers can optimise resource use, minimise the need for multiple invasive biopsies, reduce patient discomfort and hospital stays and ensure timely initiation of appropriate therapies thereby enhancing patient outcomes including the quality of life for all lung cancer patients. Implementation of the recommendations with a shared approach to care between health professionals and patients can inform and enable optimal lung cancer care pathways for all Australians.
Project scope and approach
A literature review was conducted to identify existing international guidelines and peer-reviewed publications on molecular testing of lung cancers. From this, a scoping document was developed that included background information pertinent to the Australian context and an overview and comparison of key international guidelines and best practice recommendations. A set of 16 draft key questions was compiled with provisional recommendations derived from the scoping document and existing international guidelines.
A multidisciplinary Steering Committee was set up to review the scoping document, confirm the key questions and debate and vote on the provisional evidence-based recommendations.
The Steering Committee included: [1]
- RCPA-nominated pathology representatives from each state
- TOGA-nominated oncology representatives from each state
- Two consumer representatives, nominated by RCPA and TOGA
Each key question and provisional recommendations were discussed and amendments made in real-time to the provisional recommendations. Members were asked to vote on the proposed recommendations and consensus was reached if at least 80% of the Steering Committee members were in agreement with the proposed recommendation. There was unanimous agreement for all proposed recommendations, with only one recommendation (Key Question 8, recommendation 2) requiring a vote, and consensus was achieved.
The key questions and draft evidence-based recommendations were circulated to Steering Committee members with any proposed changes, reflections and discussion points returned via email by the end of September 2024. The key questions and draft evidence-based recommendations were then sent for targeted open consultation.
The Steering Committee met virtually in October 2024 and reviewed consultation comments received. During this period, the CAP/IASLC/AMP[2] Guidelines were updated. A comparison of the updated recommendations with the proposed draft Australian best practice recommendations was also conducted. Based on consultation feedback and comparison with the CAP/IASLC/AMP draft guidelines, the Steering Committee finalised the Key Questions and recommendations.
Recommendations
Molecular Testing of Lung Cancer in Australia. Evidence-Based Best Practice Recommendations 2025
Endorsements
These evidence-based best practice recommendations have been endorsed by:
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Related links and resources
Molecular Testing in Lung Cancer in New Zealand
The best practice recommendations are specific to Australia and have not taken the New Zealand health system into account.