WSSA Glasgow.
Methods |
Study design: 3‐arm RCT Country: Scotland Study period: 1972‐1977 Inclusion criteria: aged ≤ 76 years, operable breast cancer, no deep fixation or skin involvement, no fixation of axillary lymph nodes Exclusion criteria: none reported Length of follow‐up: 5 years in EBCTCG 1990 |
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Participants | Simple mastectomy with radiotherapy to the chest wall but not to nodal areas (Arm A) vs simple mastectomy with radiotherapy to both chest wall and nodal areas (Arm B) vs simple mastectomy with axillary clearance and radiotherapy to the chest wall but not to nodal areas (Arm C) No. in trial arm: Arm A: N = 123; Arm B: N = 94; Arm C: N = 118 Age median and range: not reported Stage distribution: not reported Proportion node positive: Arm A: N = 16/123; Arm B: N = 9/94; Arm C: N = 17/118 Pathological type of breast cancer: not reported |
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Interventions | Simple mastectomy with radiotherapy to the chest wall but not to nodal areas (Arm A) vs simple mastectomy with radiotherapy to both chest wall and nodal areas (Arm B) vs simple mastectomy with axillary clearance and radiotherapy to the chest wall but not to nodal areas (Arm C) | |
Outcomes | Overall survival, local recurrence | |
Axillary node surgery |
Minimum no. nodes to be removed according to protocol: see the next 3 lines Arm A: Protocol specifies no disturbance of nodes. Arm B: Protocol specifies no disturbance of nodes. Arm C: Axillary contents were removed. Method of node pathological analysis: not reported Further treatment for node‐positive cases: no |
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Radiotherapy |
Arm A: Radiotherapy to chest wall (42 Gy in 2.1 Gy fractions) Arm B: Radiotherapy to chest wall (42 Gy in 2.1 Gy fractions) and nodal areas, including axilla and supraclavicular fossa (42 Gy in 2.1 Gy fractions) Arm C: Radiotherapy to chest wall (42 Gy in 2.1 Gy fractions) RT same in all trial arms? no |
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Hormone and chemotherapy | Not reported | |
Notes | Study included 3 arms: 1. Simple mastectomy with RT to chest wall but not to nodal areas; 2: Simple mastectomy with RT to both chest wall and nodal areas, including axilla and supraclavicular fossa; and 3: Simple mastectomy with axillary clearance plus RT to chest wall but not to nodal areas: results derived from arms 1 and 3 only. Data from meta‐analysis forest plot only Central randomisation Sealed cards Baseline differences? not reported Intention‐to‐treat analyses? not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Numbered envelopes: It is unclear how sequence was generated. |
Allocation concealment (selection bias) | Unclear risk | Sealed envelopes: It is unclear whether envelopes were opaque. |
Blinding of outcome assessment (detection bias) Disease control in the axilla | Unclear risk | This was not reported. |
Blinding of outcome assessment (detection bias) Breast cancer recurrence | Unclear risk | This was not reported. |
Blinding of outcome assessment (detection bias) Short term adverse events | Unclear risk | Outcome was not reported. |
Blinding of outcome assessment (detection bias) Long term adverse events | Unclear risk | Outcome was not reported. |
Incomplete outcome data (attrition bias) Survival | Low risk | Data appear to be available for all included participants. |
Incomplete outcome data (attrition bias) Axillary recurrence | Low risk | Data appear to be available for all included participants. |
Incomplete outcome data (attrition bias) Breast cancer recurrence | Low risk | Data appear to be available for all included participants. |
Incomplete outcome data (attrition bias) Short term adverse events | Unclear risk | Outcome was not reported. |
Incomplete outcome data (attrition bias) Long term adverse events | Unclear risk | Outcome was not reported. |
Selective reporting (reporting bias) | Unclear risk | Short‐term and long‐term adverse events were not reported. |