| Study characteristics |
| Methods |
Accrual dates: April 1975 to March 1976
Sample size: 43
Number of centres: unknown (USA)
Randomisation method: not reported
Baseline comparability: imbalance reported with more patients in MA group having skin metastases (15 vs 10), longer disease‐free interval (27 (range 0‐72) vs 8 (range 0‐48) months) and duration of metastases |
| Participants |
Female
Age range 39‐78 years (median 53 (MA) and 59 (MAC))
100% MBC
100% first line unclear: 9/43 had received prior chemotherapy but unclear if this was for metastatic disease |
| Interventions |
MA vs MAC
Arm I: (MA) melphalan + doxorubicin
Arm II: (MAC) melphalan + doxorubicin + cyclophosphamide |
| Outcomes |
Response (defined as ≥ 50% reduction in tumour size)
Duration of response
Toxicity |
| Notes |
40/43 evaluable: reason for exclusion, early death at 3 weeks (1), low dosage of drug therapy with death at 6 weeks (1), absence of measurable disease at 7 weeks (1).
1 treatment related death: severe sepsis (MAC arm)
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 |
Low risk |
A ‐ Adequate |
| Incomplete outcome data (attrition bias)
Duration of response |
Unclear risk |
B ‐ Unclear |
| Selective reporting (reporting bias) |
Low risk |
A ‐ Adequate, outcomes reported |
| Other bias |
High risk |
C ‐ Inadequate, MA group had longer disease free interval and more skin metastases compared to MAC group. |
