Tranum 1982.
| Study characteristics | ||
| Methods | Accrual dates: not reported Sample size: 497 Multicentre, national (USA) Randomisation method not reported Baseline comparability: reported as balanced (no baseline data included in article) | |
| Participants | Female Age range not reported (34% < 50 years) 100% MBC 100% first‐line | |
| Interventions | AC vs FAC vs A+CMFVP
Arm I AC: doxorubicin plus cyclophosphamide
Arm II FAC: 5‐fluorouracil, doxorubicin plus cyclophosphamide
Arm III A+CMFVP: doxorubicin, cyclophosphamide, methotrexate, 5‐fluorouracil, vincristine plus prednisone Tranum 1982a = AC vs FAC |
|
| Outcomes | Overall survival Response Toxicity | |
| Notes | 448/497 evaluable: reasons given for exclusion, did not satisfy eligibility (13), major protocol violation or inadequate data or too recent entry onto study (36). Follow‐up details not reported. Based on minimum length of response: ‐ estimated minimum 7.25 months ‐ estimated maximum 39 months Unclear if time‐to‐event analyses included all patients randomised. Time‐to‐event outcomes not defined. Time‐to‐event data extracted directly from time‐to‐event curve. 11 toxic related deaths reported, however, these could not be included in the review as it is unclear in which arm the treatment deaths occurred. Doses of the same chemotherapy agent are reduced in the addition of a drug arm. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | B ‐ Unclear |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | B ‐ Unclear |
| Incomplete outcome data (attrition bias) Response | Low risk | A ‐ Adequate |
| Incomplete outcome data (attrition bias) Toxicity | Unclear risk | B ‐ Unclear |
| Incomplete outcome data (attrition bias) Overall survival | Unclear risk | B ‐ Unclear |
| Selective reporting (reporting bias) | Low risk | A ‐ Adequate, outcomes reported |
| Other bias | Unclear risk | B ‐ Unclear, no details of baseline characteristics given (e.g. disease free interval, number metastatic sites, ER status) |