Sledge G(B) 2003.
| Study characteristics | ||
| Methods | Accrual (February 1993 ‐ September 1995)
RCT ‐ methodology not described
North America, multi‐centre Well balanced for race, age, ER status, disease free interval, dominant site of disease, number of sites of disease, performance status and prior systemic therapy |
|
| Participants | 364 women with histologically confirmed breast adenocarcinoma with progressing regional or metastatic disease ‐
May have received adjuvant therapy if it had ceased 6 mths previously or prior to hormonal therapy ‐
100% MBC
71% Firstline Randomised no: 1) n = 242 (Median age 56; 27‐76) 2) n = 244 (Median age 56; 27‐78)) Assessable no: 1) n = 229 2) n = 230 |
|
| Interventions | PACL vs A+PACL 1) Paclitaxel 175 mg/m2/24 hrs 2) Doxorubicin 50 mg/m2 iv + Paclitaxel 150 mg/m2 continuous infusion over 24 hrs Cross over at time of progression |
|
| Outcomes | OS curve ‐ log rank test ‐ OS measured from date of study entry to death/date of progressive disease
TTF curve. Excluded. Median survival 1) 22.5 mths 2) 22.4mths Median TTF 1) 6.3 mths 2) 8.2 mths Response (objective) 1) 78/229 2) 108/ 230 Toxicity Mod ‐ Sev (NCI criteria) Leukopenia 1) 137/229 2) 126/230 Vomiting 1) 6/229 2) 10/230 Lethal toxicity 1) 4/229 2) 4/230 QoL ‐ Functional assessment of cancer therapy ‐ breast (fact B) administered at baseline and 16 weeks |
|
| Notes | F/U survival and TTP min 6mths (based on maximum of eight cycles of 3 weeks) ‐ max 75mths(last event on curve)
Not ITT ‐ 739 patients were initially randomised ‐ 731 total in trial based on group numbers provided in the text.
Text states 16 patients excluded and 33 pts excluded from the analysis for reasons of ineligibility Excluded from firstline analysis |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not reported |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient reporting to permit judgement |
| Selective reporting (reporting bias) | Low risk | All expected outcomes reported |