Key question: What is the effectiveness of hypofractionated radiotherapy compared to conventionally fractionated radiotherapy for the treatment of early breast cancer?
- For patients who do not meet the selection criteria for Recommendation 1
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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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Some inconsistency which could not be explained due to the smaller number of patients in this sub-population included across the RCTs |
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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Notwithstanding the smaller patient numbers, 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 moderate 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
Longer follow-up and reporting of late effects may change the recommendation
Evidence Statement Matrix
| Component | Rating | Description |
|---|---|---|
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A |
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 |
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C |
Some inconsistency which could not be explained due to the smaller number of patients in this sub-population included across the RCTs |
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B |
Demonstration of non-inferiority for hypofractionated radiotherapy would represent a substantial clinical benefit |
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A |
Sufficient follow-up from a moderate number of patients |
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A |
Key studies were conducted in settings considered to be similar to Australia |
Recommendation
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For women with early breast cancer who require post-operative whole breast radiotherapy and who are outside the selection criteria in Recommendation 1, hypofractionated radiotherapy could be considered as an alternative to conventionally fractionated radiotherapy. |
Grade Of Recommendation |
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C |
Unresolved Issues
Due to the relatively small numbers of patients in sub-group analyses of randomised trials, there is more limited evidence to inform the safety and efficacy of hypofractionated radiotherapy for women:
- aged less than 50 years
- with locally advanced breast cancer
- with node positive disease
- who receive chemotherapy and/or targeted biological therapies.
Implementation Of Recommendation
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Will this recommendation result in changes in usual care? No, this sub-population of patients will continue to receive either hypofractionated or conventionally fractionated radiotherapy based on clinical judgement |
NO |
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Are there any resource implications associated with implementing this recommendation? No, this sub-population of patients will continue to receive standard care |
NO |
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Will the implementation of this recommendation require changes in the way care is currently organised? |
NO |
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Are the guideline development group aware of any barriers to the implementation of this recommendation? |
NO |