Question: What is the effectiveness of hypofractionated radiotherapy compared to conventionally fractionated radiotherapy for the treatment of early breast cancer?
In patients with early breast cancer who require post-operative whole breast radiotherapy who meet the following criteria:
- aged 50 years and over
- with pathological stage T1-2, N0, M0
- who have undergone breast conserving surgery, with clear surgical margins
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1. Evidence base |
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One level I study (meta-analysis of RCTs) with a low risk of bias and six level II (RCTs) studies with a low risk of bias |
A |
One or more level I studies with a low risk of bias or several level II studies with a low risk of bias |
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B |
One or two Level II studies with a low risk of bias or SR/several Level III studies with a low risk of bias |
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C |
One or two Level III studies with a low risk of bias or Level I or II studies with a moderate risk of bias |
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D |
Level IV studies or Level I to III studies/SRs with a high risk of bias |
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2. Consistency |
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Studies reported equivalent outcomes (effectiveness and safety) for hypofractionated radiotherapy compared with standard radiotherapy |
A |
All studies consistent |
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B |
Most studies consistent and inconsistency can be explained |
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C |
Some inconsistency, reflecting genuine uncertainty around question |
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D |
Evidence is inconsistent |
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NA |
Not applicable (one study only) |
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3. Clinical impact |
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The demonstration of non-inferiority for hypofractionated radiotherapy was considered to represent a substantial clinical benefit from the patient’s perspective |
A |
Very large |
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B |
Substantial |
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C |
Moderate |
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D |
Slight/Restricted |
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4. Generalisability |
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The evidence is based on data from a large number of patients with sufficient follow-up to be considered generalisable to the sub-population defined above |
A |
Evidence directly generalisable to target population |
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B |
Evidence directly generalisable to target population with some caveats |
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C |
Evidence not directly generalisable to the target population but could be sensibly applied |
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D |
Evidence not directly generalisable to target population and hard to judge whether it is sensible to apply |
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5. Applicability |
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Key studies were conducted in settings considered to be similar to Australia (the UK, Canada and USA). |
A |
Evidence directly applicable to Australian healthcare context |
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B |
Evidence applicable to Australian healthcare context with few caveats |
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C |
Evidence probably applicable to Australian healthcare context with some caveats |
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D |
Evidence not applicable to Australian healthcare context |
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Other factors
Recent evidence indicates that tumour grade does not need to be taken into account when considering the use of hypofractionated radiotherapy. Consequently this characteristic has been removed from the selection criteria for the Recommendation and it was agreed that this update would be reflected in a corresponding Practice Point (a)
Evidence Statement Matrix
| Component | Rating | Description |
|---|---|---|
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A |
One level I (meta-analysis of RCTs) and six level II (RCTs) studies with a low risk of bias |
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A |
Studies reported equivalent outcomes for hypofractionated radiotherapy compared with standard radiotherapy |
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B |
The demonstration of non-inferiority for hypofractionated radiotherapy was considered to represent a substantial clinical benefit from the patient’s perspective |
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A |
The evidence is based on data from a large number of patients with sufficient follow-up to be considered generalisable to the target sub-population |
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A |
Key studies were conducted in settings considered to be similar to Australia (the UK, Canada and USA). |
Recommendation
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In selected patients* with early breast cancer who require post-operative whole breast radiotherapy, hypofractionated is a suitable alternative to conventionally fractionated radiotherapy, and should be offered where appropriate. *Patients
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Grade Of Recommendation |
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A |
Unresolved Issues
None
Implementation Of Recommendation
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Will this recommendation result in changes in usual care? Yes, the updated recommendation is stronger (now Grade A) and broader (no longer limited by grade of tumour) than the previous recommendation. |
YES |
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Are there any resource implications associated with implementing this recommendation? Yes, at the level of clinicians and service providers, implementation of this guideline may result in reduced waiting times due to an overall shorter treatment program and increased patient turnover. From the perspective of patients and their carers, increased uptake of hypofractionated radiotherapy would reduce the amount of time spent away from work and family, and might reduce out of pocket costs for patients travelling from non-metropolitan areas to receive radiotherapy. |
YES |
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Will the implementation of this recommendation require changes in the way care is currently organised? No, hypofractionated radiotherapy schedules can already be delivered via current systems |
NO |
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Are the guideline development group aware of any barriers to the implementation of this recommendation? |
NO |