| Study characteristics |
| Methods |
Accrual dates: March 1987 to May 1990
Sample size: 114
Number of centres: unknown (UK)
Randomisation method: not reported
Baseline comparability: no significant imbalance apparent or reported |
| Participants |
Female
Age range: mean 61‐62 years
Unclear % MBC (advanced and progressive disease)
Approx 90% first line for MBC |
| Interventions |
2M vs 3M
Arm I: (2M) mitozantrone + methotrexate
Arm II: (3M) mitozantrone + methotrexate + mitomycin‐C |
| Outcomes |
Response
Toxicity |
| Notes |
107/114 eligible: reason for exclusion, randomised in error (4), primary site of cancer in doubt (3).
Toxic related deaths not reported. |
| 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 |
| Selective reporting (reporting bias) |
Low risk |
A ‐ Adequate, outcomes reported |
| Other bias |
Low risk |
A ‐ Adequate |
