Abe 2013.
Methods | Accrual: June 2006 to April 2008 Phase II randomised controlled trial conducted in Japan Adjuvant therapy Multicentre or single centre: not reported Median follow‐up: not reported |
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Participants | Age: median 52 years, range 29 to 64 years 55% postmenopausal Node‐positive or high‐risk node‐negative women Stage I/IIA/IIB: 100% (83% stage II) Axillary lymph node involvement: 0: 57%; 1–3: 33%; ≥ 4: 10% Hormone receptor‐positive: 55% HER2‐positive: 24% Excluded: prior chemotherapy or hormone therapy as neoadjuvant or adjuvant therapy |
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Interventions | Arm 1 ('arm B' in the trial publication): docetaxel (100 mg/m²) every 3 weeks for 3 cycles followed by fluorouracil (500 mg/m²), epirubicin (100 mg/m²), cyclophosphamide (500 mg/m²) every 3 weeks for 3 cycles. Arm 2 ('arm A' in the trial publication): fluorouracil (500 mg/m²), epirubicin (100 mg/m²), cyclophosphamide (500 mg/m²) every 3 weeks for 3 cycles followed by docetaxel (100 mg/m²) every 3 weeks for 3 cycles. For both arms: G‐CSF if ANC < 500 μL (full blood count measured on day 8) or febrile neutropenia |
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Outcomes | Primary outcome
Secondary outcomes
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Notes | Clinical trial registration record not found Trialists contacted in July 2018 requesting information on mean RDI (mismatch of data in Table 2 and text); as of 16 August 2018, no reply received Funding considerations: no information available |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Patients were "randomised to two arms;" no further details provided; however, baseline characteristics across the 2 arms were balanced. |
Allocation concealment (selection bias) | Unclear risk | No details provided in trial publication. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Likely to be an open‐label study. Participants in both groups received the same drugs though in different order. Therefore, it was unlikely that this would lead to a material bias in participants' and physicians' behaviours even when unblinded. |
Blinding of outcome assessment (detection bias) Toxicity and treatment adherence | Unclear risk | Study used formalised toxicity criteria (NCI CTC version 3) and measured a range of toxicity outcomes where some may have been affected by unblinding (e.g. neuropathy) in borderline cases. Dose‐reduction/delays were based on toxicity assessments. Overall, unblinding may have influenced physicians' assessments on a subset of outcomes assessed. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 discontinuation in the intervention arm (due to neutropenia). |
Selective reporting (reporting bias) | Low risk | Clinical trial registry record not found (trial ran from June 2006 to April 2008). All outcomes reported in the Methods section had the corresponding results in the publication. |
Other bias | Low risk | None identified |